FDA Adverse Event
Injury
Summary report: N
THV 1000-23 3F AORTIC BIO 23MM
MDR report key: 10796502
·
Received November 5, 2020
Report
- Report Number
- 2025587-2020-03454
- Event Type
- Injury
- Date Received
- November 5, 2020
- Date of Event
- September 30, 2020
- Report Date
- November 5, 2020
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- LWR
- PMA / PMN Number
- P060025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 THAT 11 YEARS AND 6 MONTHS POST IMPLANT OF THIS 23 MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23 MM AORTIC BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. 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 |
|---|---|---|---|---|---|---|---|
| 1255479 | THV 1000-23 3F AORTIC BIO 23MM | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | MEDTRONIC HEART VALVES DIVISION | 1000-23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R |