FDA Adverse Event
Injury
Summary report: N
COMPLETE SE SFA
MDR report key: 3831647
·
Received May 26, 2014
Report
- Report Number
- 9612164-2014-00540
- Event Type
- Injury
- Date Received
- May 26, 2014
- Date of Event
- October 26, 2013
- Report Date
- August 6, 2015
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIP
- PMA / PMN Number
- P110040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (HEMATOMA). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (HEMATOMA). (B)(4).
Additional Manufacturer Narrative · 1
THE PREVIOUSLY REPORTED BLEED EVENT WAS NOT RELATED TO THE STUDY DEVICE OR DRUG.
Description of Event or Problem · 1
DURING INDEX PROCEDURE, THE PHYSICIAN USED THREE IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERS TO TREAT A LESION LOCATED IN THE SFA OF THE RIGHT LEG. ONE COMPLETE SE STENT WAS IMPLANTED IN THE RIGHT SFA TO TREAT PERSISTENT RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY. MILD BLEEDING OCCURRED AFTER COMPLETE SE STENT IMPLANT WHICH WAS TREATED WITH BALLOONING. IT IS REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE STUDY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309929 | COMPLETE SE SFA | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Required Intervention |