FDA Adverse Event
Malfunction
Summary report: N
VALIANT CAPTIVIA
MDR report key: 3932911
·
Received July 14, 2014
Report
- Report Number
- 2953200-2014-01385
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 1, 2014
- Report Date
- June 19, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100041
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (FENESTRATION OF THE STENT GRAFT).
Description of Event or Problem · 1
A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT IN THE THORACIC AORTA. THE VESSEL MORPHOLOGY AT THE TIME OF IMPLANTS AND CURRENTLY ARE UNKNOWN. AT THE TIME OF IMPLANT IT WAS REPORTED THAT THE STENT GRAFT WAS FENESTRATED WITH A STENT IMPLANTED INTO THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN REPORTED THAT THERE IS AN UNKNOWN ENDOLEAK. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411028 | VALIANT CAPTIVIA | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V01024819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR |