FDA Adverse Event
Injury
Summary report: N
HEART-VALVE, NON-ALLOGRAFT TISSUE
MDR report key: 5216782
·
Received November 11, 2015
Report
- Report Number
- 3007113487-2015-00043
- Event Type
- Injury
- Date Received
- November 11, 2015
- Report Date
- October 20, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)
- Product Code
- LWR
- PMA / PMN Number
- P100029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
ACCORDING TO THE ARTICLE "SURGICAL TREATMENT OF PROSTHETIC VALVE ENDOCARDITIS; TIPS OF COMPLETE RESECTION OF INFECTIVE TISSUE AND VALVE REPLACEMENT" (JAPANESE JOURNAL OF THORACIC SURGERY 2015, 68 (11): 923-929, CASE 6), ONE OF 15 PATIENTS IMPLANTED WITH VALVES BETWEEN 2009-2014 RECEIVED A 23MM TRIFECTA TISSUE VALVE WHICH REQUIRED EXPLANT DUE TO IMPROPER SEATING AND GRADE 4 AORTIC REGURGITATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748685 | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) | TF-23A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |