FDA Adverse Event
Malfunction
Summary report: N
VALIANT
MDR report key: 3950121
·
Received July 22, 2014
Report
- Report Number
- 2953200-2014-01433
- Event Type
- Malfunction
- Date Received
- July 22, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 16, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXACT EVENT DATE IS UNKNOWN. (B)(4).
Additional Manufacturer Narrative · 1
CONCLUSION: UNABLE TO DETERMINE CAUSE.
Description of Event or Problem · 1
A VALIANT STENT GRAFT SYSTEM WAS SELECTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PHYSICIAN OPENED THE DELIVERY SYSTEM PACKAGING THE DELIVERY SYSTEM WAS FOUND BROKEN. ANOTHER VALIANT OF THE SAME SIZE WAS AVAILABLE AND WAS USED TO SUCCESSFULLY COMPLETE THE CASE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Description of Event or Problem · 1
THE COMPLAINT WAS CONFIRMED; A SECTION OF THE SCREWGEAR HAD BROKEN OFF. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, WAS LIKELY DUE TO SHIPPING/HANDLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428439 | VALIANT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V04123609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |