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 2020-03-19 for SJM TRIFECTA VALVE TF-23A manufactured by St. Jude Medical, Brasil Ltda..
[187625410]
An event of heart failure, regurgitation, and a leaflet tear was reported. The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible 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
[187625411]
On (b)(6) 2012, a 23mm sjm trifecta valve was implanted in the patient's aortic position with non-everting mattress suture technique using pledgets at toyota memorial hospital. On (b)(6) 2019, the patient became unstable due to heart failure and aortic regurgitation. A tear was confirmed on the valve during examination. The patient was closely monitored, and a valve in valve procedure was performed on (b)(6) 2019 at (b)(6) university hospital. A 26mm corevalve (manufacturer: medtronic, evolut r, serial#: (b)(4)) was successfully implanted. The patient was discharged from the hospital on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001883144-2020-00023 |
| MDR Report Key | 9856213 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2011-11-23 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SJM TRIFECTA VALVE |
| Generic Name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Product Code | LWR |
| Date Received | 2020-03-19 |
| Model Number | TF-23A |
| Lot Number | 3704333 |
| Device Expiration Date | 2013-11-21 |
| 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 | 2020-03-19 |