FDA Adverse Event
Injury
Summary report: N
THV 1000-23 3F AORTIC BIO 23MM
MDR report key: 10580653
·
Received September 24, 2020
Report
- Report Number
- 2025587-2020-02921
- Event Type
- Injury
- Date Received
- September 24, 2020
- Date of Event
- September 14, 2020
- Report Date
- September 24, 2020
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- LWR
- UDI-DI
- 00613994868237
- PMA / PMN Number
- P060025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. 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 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS HIGH GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1046704 | THV 1000-23 3F AORTIC BIO 23MM | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | MEDTRONIC HEART VALVES DIVISION | 1000-23 | 00613994868237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R |