MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-01-02 for CONTEGRA PULMONARY VALVED CONDUIT 200S manufactured by Medtronic Heart Valves Division.
[182589938]
Citation: mastropietro cw et al. Characteristics and operative outcomes for children undergoing repair of truncus arteriosus: a contemporary multicenter analysis. J thorac cardiovasc surg. 2019 jun;157(6):2386-2398. E4. Doi: 10. 1016/j. Jtcvs. 2018. 12. 115. Epub 2019 feb 28. Read at the 98th annual meeting of the american association for thoracic surgery, san diego, california, april 28-may 1, 2018. Earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182589939]
Medtronic received information via literature regarding the outcomes of pediatric patients who underwent truncus arteriosus repair and the risk factors for post-operative major adverse cardiac events. All data were retrospectively collected from 15 centers between 2009 and 2016. The study population included 216 patients and was equal numbers male and female with a mean age of 10 days, mean weight of 3. 1 kg and predominant race of white non-hispanic. Of those, 55 were implanted with medtronic contegra valved conduits. No serial numbers were provided. Among all patients, the operative mortality was 6. 9% (15 patients). No other details were reported. Based on the available information, medtronic product was not directly associated with the deaths. Among all patients, adverse events included: unplanned reoperation for bleeding; unplanned cardiac catheterizations; unplanned truncal valve repair or replacement; unplanned right ventricle-to-pulmonary artery conduit revision; unplanned sternal closure; stroke; cardiac arrest; cardiopulmonary resuscitation; extracorporeal membrane oxygenation support; inhaled nitric oxide use; bradyarrhythmia; tachyarrhythmia that required medication or temporary pacing; sepsis/bacteremia; endocarditis; mediastinitis; wound infection/dehiscence; and seizures. Based on the available information, medtronic product may have been associated with the adverse events. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00013 |
| MDR Report Key | 9540896 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-14 |
| Date of Event | 2018-04-28 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Street | 1851 E DEERE AVE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTEGRA PULMONARY VALVED CONDUIT |
| Generic Name | CONDUIT,VALVED,PULMONIC |
| Product Code | MWH |
| Date Received | 2020-01-02 |
| Model Number | 200S |
| Catalog Number | 200S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-02 |