FDA Adverse Event
Injury
Summary report: N
THV 1000-29 3F AORTIC BIO 29MM
MDR report key: 12293319
·
Received August 9, 2021
Report
- Report Number
- 2025587-2021-02487
- Event Type
- Injury
- Date Received
- August 9, 2021
- Date of Event
- December 13, 2019
- Report Date
- August 9, 2021
- Manufacturer
- MEDTRONIC HEART VALVE DIVISION
- Product Code
- LWR
- UDI-DI
- 00613994868268
- PMA / PMN Number
- P060025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1190682 | THV 1000-29 3F AORTIC BIO 29MM | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | MEDTRONIC HEART VALVE DIVISION | 1000-29 | 00613994868268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |