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 2020-03-31 for EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM E100-27M manufactured by St. Jude Medical, Brasil Ltda. (pampulha).
[187626603]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[187626604]
On (b)(6) 2014, a 27mm epic valve was implanted with everting mattress suture technique using pledgets in the patient's mitral position in another hospital due to rheumatic mitral insufficiency. Early 2020, the patient was re-hospitalized due to mitral regurgitation and aortic regurgitation. A double valve replacement (dvr) was performed on (b)(6) 2020. The epic valve was explanted and replaced with a 25mm ats open pivot bileaflet heart valve. Upon explant, a tear was observed along the commissure between leaflets. No infection or pannus in growth was observed on the explanted valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001883144-2020-00029 |
| MDR Report Key | 9903133 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2014-05-22 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Returned To Mfg | 2020-03-23 |
| Model Number | E100-27M |
| Lot Number | 4652026 |
| Device Expiration Date | 2018-05-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-31 |