FDA Adverse Event
Injury
Summary report: N
3F AORTIC BIOPROSTHETIC HEART VALVE
MDR report key: 2232481
·
Received August 25, 2011
Report
- Report Number
- 2031780-2011-00006
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- July 29, 2011
- Report Date
- July 29, 2011
- Manufacturer
- MEDTRONIC ATS, INC.
- Product Code
- LWR
- PMA / PMN Number
- P060025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS NO SERIAL NUMBER WAS OBTAINED. RESULTS: NO PRODUCT RETURNED. CONCLUSION: CAUSE OF EVENT DETERMINED TO BE RELATED TO IMPLANT TECHNIQUE. ANALYSIS: THE VALVE REMAINS IMPLANTED. CONCLUSION: ACCORDING TO THE REPORT, THE LEAK WAS CAUSED BY SURGEON SUTURE TECHNIQUE OR OTHER ISSUES RELATED TO SUTURING (NOT PRODUCT RELATED).
Description of Event or Problem · 1
(B)(4) RECEIVED INFORMATION THAT APPROXIMATELY (B)(6) FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, RE-OPERATION WAS PERFORMED DUE TO REGURGITATION. PARAVALVULAR LEAK WAS DETERMINED TO BE SECONDARY TO SUTURE TECHNIQUE/TECHNICAL ERROR AT IMPLANT. THE VALVE WAS REPAIRED AND REMAINS IMPLANTED. NO ADVERSE PT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3F AORTIC BIOPROSTHETIC HEART VALVE | LWR | MEDTRONIC ATS, INC. | 1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |