FDA Adverse Event
Injury
Summary report: N
SJM REGENT HEART VALVE W/ FLEX CUFF
MDR report key: 3213872
·
Received July 3, 2013
Report
- Report Number
- 2648612-2013-00032
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 14, 2013
- Manufacturer
- ST. JUDE MEDICAL PUERTO RICO INC
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FINAL MEDWATCH WILL BE SENT AT THE CONCLUSION OF OUR INVESTIGATION.
Description of Event or Problem · 1
THE INFORMATION PROVIDED TO SJM INDICATED A 17MM REGENT VALVE WAS IMPLANTED ON (B)(6) 2013. THE VALVE WAS EXPLANTED ON (B)(6) 2013, DUE TO THROMBUS ON THE PIVOT GUARD IMPEDING THE LEAFLETS. THE PHYSICIAN COMMENTED THAT THE PT'S HEMODYNAMICS AND EXTENSIVE PANNUS MAY HAVE CONTRIBUTED TO THE OBSERVED THROMBUS. THE VALVE WAS REPLACED BY ANOTHER MFR'S 19MM VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303710 | SJM REGENT HEART VALVE W/ FLEX CUFF | REGENT ROTATABLE VALVE | LWQ | ST. JUDE MEDICAL PUERTO RICO INC | 17AGFN-756 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Hospitalization| R |