MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM E100-29M-00 manufactured by St. Jude Medical, Brasil Ltda. (pampulha).
[187626014]
An event of a "defective" valve which was implanted then explanted in the same procedure was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[187626015]
On (b)(6) 2020, a 29mm epic valve was selected for implant. It was reported that the valve was "defective" and exchanged for a new 29mm epic valve. It was reported that the valve was implanted and then removed. Additional information was requested, however is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001883144-2020-00027 |
| MDR Report Key | 9900903 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-09-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) |
| Manufacturer Street | RUA PROFESSOR JOSE VIEIRA DE MENDON ENGENHO NOGUEIRA - BELO HORIZONTE - MG |
| Manufacturer City | BELO HORIZONTE 31310-260 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 31310-260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM |
| Generic Name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Product Code | LWR |
| Date Received | 2020-03-30 |
| Model Number | E100-29M-00 |
| Catalog Number | E100-29M-00 |
| Lot Number | BR00022167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) |
| Manufacturer Address | RUA PROFESSOR JOSE VIEIRA DE MENDON?A 1301 ENGENHO NOGUEIRA - BELO HORIZONTE - MG BELO HORIZONTE 31310-260 BR 31310-260 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |