MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-24 for SJM TRIFECTA VALVE TF-23A manufactured by St. Jude Medical, Costa Rica Ltda.
[146071740]
Investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[146071741]
On (b)(6) 2016, a 23mm trifecta valve was implanted. On (b)(6) 2019, aortic regurgitation was observed. On (b)(6) 2019, a redo-avr was performed and a 23mm edwards inspiris resilia valve was implanted. Upon explant, a leaflet tear was observed at the stentpost between the right and left coronary cusp. The patient is reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2019-00252 |
| MDR Report Key | 8640535 |
| Report Source | FOREIGN |
| Date Received | 2019-05-24 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-06-24 |
| Device Manufacturer Date | 2016-03-16 |
| Date Added to Maude | 2019-05-24 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, COSTA RICA LTDA |
| 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 | SJM TRIFECTA VALVE |
| Generic Name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Product Code | LWR |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-05-23 |
| Model Number | TF-23A |
| Catalog Number | TF-23A |
| Lot Number | 5450959 |
| Device Expiration Date | 2018-03-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Address | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-24 |