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 TRIFECTA STENTED TISSUE VALVE manufactured by St. Jude Medical Catd.
[184148528]
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
[184148529]
In 2014, an unknown sized trifecta valve was implanted. On (b)(6) 2020, the valve was explanted due to aortic insufficiency observed on echo. Upon explant, a non-coronary leaflet tear was observed. No patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00099 |
| MDR Report Key | 9853628 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-19 |
| 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, 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 1897-4050 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 1897-4050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIFECTA STENTED TISSUE VALVE |
| Generic Name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Product Code | LWR |
| Date Received | 2020-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL CATD |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-19 |