FDA Adverse Event
Injury
Summary report: N
COMPLETE SE SFA
MDR report key: 7100305
·
Received December 8, 2017
Report
- Report Number
- 9612164-2017-01852
- Event Type
- Injury
- Date Received
- December 8, 2017
- Date of Event
- July 17, 2017
- Report Date
- May 25, 2018
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIP
- PMA / PMN Number
- P110040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CEC HAD ADJUDICATED THAT THE EVENT IS RELATED TO THE DEVICE BUT NOT THE PROCEDURE OR PACLITAXEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE PATIENT HAD A TARGET VESSEL REVASCULARISATION OF THE DISTAL SFA OF THE RIGHT LEG USING AN ADMIRAL XTREME BALLOON CATHETER AND A COMPLETE SE STENT. APPROXIMATELY 8 MONTHS POST REVASCULARIZATION, PATIENT SUFFERED ATHERO-THROMBOTIC REOCCLUSION TARGET LESION. THIS WAS TREATED WITH A BELOW THE KNEE BYPASS GRAFT OF THE RIGHT LEG. THE EVENT IS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 878545 | COMPLETE SE SFA | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |