FDA Adverse Event
Injury
Summary report: N
ENDURANT II BIFURCATED STENT GRAFT
MDR report key: 4103011
·
Received September 19, 2014
Report
- Report Number
- 2953200-2014-01867
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- August 23, 2014
- Report Date
- August 23, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.0CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE DIAMETER OF THE UPPER PROXIMAL NECK IS 20 MM AND THE DIAMETER AT THE ANEURYSM ENTRY IS 19.8MM. IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL WITH COMPLAINTS OF RIGHT LEG FEELING COLD. FURTHER EVALUATION REVEALED THAT THE LIMB HAD OCCLUDED DUE TO A POSSIBLE RADIAL FORCE PRODUCED BY THE SMALL VESSEL SIZE OF THE OCCLUDED SECTION 18MM OF THE IPSILATERAL LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582152 | ENDURANT II BIFURCATED STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V04214958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR |