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 2020-03-23 for EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM E100-25M manufactured by St. Jude Medical, Brasil Ltda. (pampulha).
[187625825]
As reported in a research article, two patients had an epic valve was replaced due to regurgitation. The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[187625826]
It was reported through the japanese association for thoracic surgery, 2019. This research article identifying abbotts epic stented, bio prosthesis, 25mm porcine heart valve w/flexfit system that may be related to a recent valve in valve procedure. Specific patient information is documented as (b)(6) years old female. Details are listed in the attached article, its titled "early outcomes of transcatheter mitral valve replacement for degenerated bio prosthesis in japanese (mitral viv study): a four-case series. " the event describes regurgitation was seen in patients implanted with a epic bio prosthesis (25mm), so mitral valve-in-valve was applied. After the previous surgical, left ventricular dysfunction occurred, and intense adhesions around the cardiac apex were seen when a temporary left ventricular assist device was used. Mitral valve in valve procedure was successful and discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001883144-2020-00020 |
| MDR Report Key | 9864746 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Remedial Action | RL |
| 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 | 2020-03-23 |
| Model Number | E100-25M |
| Catalog Number | E100-25M |
| 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. Other; 2. Required No Informationntervention | 2020-03-23 |