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 2020-03-25 for EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM E100-27M manufactured by St. Jude Medical, Costa Rica Ltda (cvd).
[186320641]
An event of heart failure, one leaflet no appearing to be firmly attached on echo, and a suspected tear was reported. The results of the investigation are inconclusive since the device remains implanted 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
[186320642]
On (b)(6) 2016 a 27mm epic stented porcine heart valve w/flexfit system was implanted in the patient's mitral position. On (b)(6) 2020, the patient presented to the hospital with symptoms of heart failure. One out of the three leaflets appeared as if not attached on the valve firmly in the echocardiogram. The physician suspects a tear in the valve and the patient is being closely monitored in the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00169 |
| MDR Report Key | 9878013 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2016-02-11 |
| Date Added to Maude | 2020-03-25 |
| 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, COSTA RICA LTDA (CVD) |
| Manufacturer Street | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL |
| Manufacturer City | ALAJUELA, COSTA RICA 01897-405 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 01897-4050 |
| Single Use | 3 |
| Remedial Action | PM |
| 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 | 2020-03-25 |
| Model Number | E100-27M |
| Lot Number | 5406222 |
| Device Expiration Date | 2020-02-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) |
| Manufacturer Address | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 01897-405 CS 01897-4050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-25 |