FDA Adverse Event
Malfunction
Summary report: N
VALIANT NAVION
MDR report key: 12352780
·
Received August 23, 2021
Report
- Report Number
- 9612164-2021-03231
- Event Type
- Malfunction
- Date Received
- August 23, 2021
- Date of Event
- April 5, 2021
- Report Date
- August 23, 2021
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; THE INITIAL EXPERIENCE ON BRANCHED AND FENESTRATED ENDOGRAFTS IN THE AORTIC ARCH. A SYSTEMATIC REVIEW AMIL ET AL, ANN VASC SURG 2021; 75: 29¿44 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.03.024. AVERAGE PATIENT AGE, MEAN GENDER, EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
VALIANT NAVION STENT GRAFT SYSTEMS WERE IMPLANTED IN CONJUNCTION WITH NON MDT STENT GRAFT SYSTEMS DURING FEVAR AND BEVAR IN PATIENTS WITH THORACIC AORTIC ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE I, III AND V ENDOLEAKS AND ENDOGRAFT INFLOLDING/KINKING. THE CAUSE OF THE EVENTS WERE CANNOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1250958 | VALIANT NAVION | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR | MIH | MEDTRONIC IRELAND | UNK-CV-SR-VAL-NAV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |