FDA Adverse Event
Death
Summary report: N
PACIFIC XTREME
MDR report key: 4505763
·
Received February 11, 2015
Report
- Report Number
- 3004066202-2015-00053
- Event Type
- Death
- Date Received
- February 11, 2015
- Date of Event
- September 1, 2014
- Report Date
- January 19, 2015
- Manufacturer
- INVATEC SPA
- Product Code
- LIT
- PMA / PMN Number
- K103464
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE ONE IN. PACT ADMIRAL PACLITAXEL-ELUTING BALLOON CATHETER WAS USED TO TREAT THE SFA ARTERY OF THE RIGHT LEG. A COMPLETE SE PERIPHERAL STENT WAS ALSO USED DURING THE PROCEDURE TO TREAT PERSISTENT RESIDUAL STENOSIS. APPROXIMATELY 7 .5 MONTHS POST INDEX PROCEDURE 2 PACIFIC PTA BALLOONS WERE USED TO TREAT THE RIGHT SFA. APPROXIMATELY 12.5 MONTHS POST INDEX PROCEDURE 2 PACIFIC PTA BALLOONS, 3 IN. PACT PACIFIC DEB AND 1 SCUBA STENT WERE USED TO TREAT THE RIGHT SFA. APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED, CAUSE UNKNOWN. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102854 | PACIFIC XTREME | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | INVATEC SPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Death |