FDA Adverse Event
Injury
Summary report: N
THV 1000-27 3F AORTIC BIO 27MM
MDR report key: 9262231
·
Received October 31, 2019
Report
- Report Number
- 2025587-2019-03344
- Event Type
- Injury
- Date Received
- October 31, 2019
- Date of Event
- October 8, 2019
- Report Date
- October 31, 2019
- Manufacturer
- MEDTRONIC HEART VALVE DIVISION
- Product Code
- LWR
- UDI-DI
- 00613994868251
- PMA / PMN Number
- P060025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
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 THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT UNDERWENT A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT DUE TO INCREASED GRADIENTS AND MODERATE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1057159 | THV 1000-27 3F AORTIC BIO 27MM | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | MEDTRONIC HEART VALVE DIVISION | 1000-27 | 00613994868251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |