Evidence map›Paper›PMID 42585257›Full record

ArticlePloS one2026

Adverse event reporting and regulatory analysis of pediatric cardiac assist devices.

Songyining Ding, Susmitha Wunnava, Gaite Liu, Hongyi Yu, Sheng Hu, Yaohua Li, Xinyan Zhang, Peiming Zhang, Yunzhang Cheng, Florence T Bourgeois and 1 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Songyining DingSchool of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Susmitha WunnavaHarvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts, United States of America.
Gaite LiuShanghai Institute of Medical Device Testing, Shanghai, China.
Hongyi YuShanghai Institute of Medical Device Testing, Shanghai, China.
Sheng HuShanghai Institute of Medical Device Testing, Shanghai, China.
Yaohua LiYangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai, China.
Xinyan ZhangYangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai, China.
Peiming ZhangSchool of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Yunzhang ChengSchool of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Florence T BourgeoisHarvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts, United States of America.ORCID https://orcid.org/0000-0001-7798-4560
Xun LiuShanghai Institute of Medical Device Testing, Shanghai, China.ORCID https://orcid.org/0000-0002-0691-4589

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDue to differences in anatomy, coagulation and neurodevelopment, the complication rate of pediatric cardiac assist devices during use is much higher than that of adults, which cannot be directly extrapolated from adult data. Moreover, there are deficiencies in the device supervision process.

methodIn this study, 280 adverse events of patients under 18 years old and 1,231 adverse events of adult patients were extracted from the FDA MAUDE database from 2015 to 2025. The pediatric complication spectrum was systematically analyzed, and adult data was compared with pediatric data. Combined with literature and typical case analysis, the limitations of traditional databases were jointly revealed. Finally, in accordance with the existing testing standards, the risks exposed after the product is launched on the market are summarized and the regulatory loopholes are revealed.

resultMAUDE pediatric reports are scarce and variables are missing, making it impossible to directly calculate the incidence rate. The research calls for the establishment of a multi-source real-time monitoring and pediatric exclusive registration system to preliminarily assess and generate hypotheses regarding the risk of mechanical circulatory support in children.

conclusionThis study provides a descriptive evaluation of reporting trend disparities between pediatric and adult cohorts. Given the inherent constraints of passive surveillance data, these exploratory findings should be interpreted as a reference to guide future prospective evaluations and standard optimizations, rather than immediate, broad regulatory mandates.

Indexed as

Heart-Assist DevicesAdolescentAdultChildChild, PreschoolDatabases, FactualFemaleHumansInfantMaleUnited StatesUnited States Food and Drug Administration

Identifiers

PMID42585257
PMCPMC13465822

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.