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 2020-03-18 for EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM E100-29M-00 manufactured by St. Jude Medical, Brasil Ltda..
[187625266]
Further information regarding this event has been requested. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[187625267]
On (b)(6) 2019, a 23mm trifecta gt valve was implanted in aortic position and a 29mm epic valve was implanted in the mitral position. On an unknown date the patient presented with shortness of breath and fatigue. On (b)(6) 2020, the trifecta valve was explanted due to 2 small leaflet holes and was replaced with a medtronic ultra valve. The epic valve seemed to be okay but on an echocardiogram it was reported to have posterior prolapsed leaflet and it was explanted and exchanged for a mosaic ans valve. The patient was reported to be stable condition. Manufacturer report number: 3001883144-2020-00025.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001883144-2020-00026 |
| MDR Report Key | 9851285 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-03-14 |
| Date Added to Maude | 2020-03-18 |
| 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. |
| 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 | 2020-03-18 |
| Model Number | E100-29M-00 |
| Catalog Number | E100-29M-00 |
| Lot Number | BR00019403 |
| 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. |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-18 |