FDA Adverse Event
Malfunction
Summary report: N
VALIANT STENT GRAFT
MDR report key: 13341452
·
Received January 25, 2022
Report
- Report Number
- 9612164-2022-00319
- Event Type
- Malfunction
- Date Received
- January 25, 2022
- Date of Event
- August 28, 2021
- Report Date
- January 25, 2022
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; EXTENSIVE AORTIC STENT GRAFT COVERAGE FOR THORACOABDOMINAL AORTIC ANEURYSM IS ASSOCIATED WITH HEMORRHAGIC COMPLICATIONS INDUCED BY DISSEMINATED INTRAVASCULAR COAGULATION. KAWASHIMA ET AL, ANN VASC SURG 2022; 78: 152¿160. HTTPS://DOI.ORG/10.1016/J.AVSG.2021.06.017 EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
VALIANT STENT GRAFTS WERE IMPLANTED IN PATIENTS DURING THE ENDOVASCULAR TREATMENT OF THORACOABDOMINAL ANEURYSM REPAIR ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE I, II III AND IV ENDOLEAKS. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687074 | VALIANT STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR | MIH | MEDTRONIC IRELAND | UNK-CV-SR-VALIANT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |