FDA Adverse Event
Injury
Summary report: N
SJM AORTIC VALVED GRAFT
MDR report key: 3181318
·
Received June 14, 2013
Report
- Report Number
- 2126673-2013-00001
- Event Type
- Injury
- Date Received
- June 14, 2013
- Report Date
- May 31, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION FROM THE LITERATURE ARTICLE: "MODIFIED CABROL SHUNT AFTER COMPLEX REDO-AORTIC ROOT SURGERY" THE 21ST ANNUAL MEETING OF THE ASIAN SOCIETY FOR CARDIOVASCULAR AND THORACIC SURGERY (2013). THE PATIENT UNDERWENT AN AORTIC ROOT REPLACEMENT USING BUTTON BENT ALL TECHNIQUE WITH THE SJM VALVED GRAFT. BLEEDING OCCURRED FROM THE AORTIC ROOT, BOTH CORONARY BUTTON SITES, AND MANY OPERATIVE SITES DESPITE APPLICATION OF SUTURES, TOPICAL HEMOSTATIC AGENTS, AND RECOMBINANT FACTOR VII. A BOVINE PERICARDIAL PATCH WAS TAILORED TO ISOLATE THE AREA OF BLEEDING AND A MODIFIED CABROL SHUNT WAS PERFORMED. BLEEDING WAS CONTROLLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271040 | SJM AORTIC VALVED GRAFT | AORTIC VALVED GRAFT | LWQ | ST. JUDE MEDICAL, INC. | UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |