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? GT VALVE TFGT-19A manufactured by St. Jude Medical, Costa Rica Ltda.
[184464531]
Further information regarding this event has been requested. 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
[184464532]
On (b)(6) 2020, patient (female (b)(6) years old) had an aortic valve replacement with four bypasses. The surgeon implanted a 19mm trifecta? Gt valve. Once the patient was off pump and during the echo, they noticed a severe central leak. The surgeon decided to go back on pump and replaced the valve. An inspiris 21mm valve was implanted. This led to a prolonged procedure. The physician believes that the annulus was too tight and the trifecta valve was deformed, resulting in an incomplete leaflet coaptation. The patient remained hemodynamically stable throughout the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00135 |
| MDR Report Key | 9856270 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-08-12 |
| 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 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIFECTA? GT VALVE |
| Generic Name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Product Code | LWR |
| Date Received | 2020-03-19 |
| Model Number | TFGT-19A |
| Catalog Number | TFGT-19A |
| Lot Number | 6616236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-19 |