MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-06 for CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED 200S manufactured by Medtronic Heart Valves Division.
[185074485]
Citation: talwar s et al. Surgical repair for common arterial trunk with pulmonary dominance, hypoplasia of ascending aorta, and interrupted aortic arch. Annals of pediatric cardiology. 2019; 12(3):287-291. Doi: 10. 4103/apc. Apc_147_18 earliest date of publish used for event date in b3. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185074486]
Medtronic received information via literature regarding a 1-month-old male patient with respiratory distress, a common arterial trunk, hypoplasia of the ascending aorta, and an interrupted aortic arch who underwent implant of a 12mm medtronic contegra pulmonary valved conduit (no serial number provided). The implant of the contegra was intended to establish continuity between the right ventricle and pulmonary artery as part of a larger repair of the aortic arch and multiple other vessels. It was reported that 8 hours post procedure, the patient experienced sudden bradycardia and hypotension. Cardiopulmonary resuscitation (cpr) was immediately performed, and the patient was placed on extracorporeal membrane oxygenation (ecmo). Two days later, the patient was weaned from ecmo with stable hemodynamics. Ultimately, 7 days post procedure, the patient expired from sepsis. It is unknown if an autopsy was performed. Based on the available information medtronic product was not directly associated with the death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00049 |
| MDR Report Key | 9555847 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-08-21 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-06 |
| 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 - SUPPORTED |
| Generic Name | CONDUIT,VALVED,PULMONIC |
| Product Code | MWH |
| Date Received | 2020-01-06 |
| Model Number | 200S |
| Catalog Number | 200S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Life Threatening; 2. Required No Informationntervention | 2020-01-06 |