FDA Adverse Event
Malfunction
Summary report: N
GORE FLOW REVERSAL SYSTEM
MDR report key: 2370035
·
Received November 10, 2011
Report
- Report Number
- 2017233-2011-00600
- Event Type
- Malfunction
- Date Received
- November 10, 2011
- Date of Event
- October 23, 2011
- Report Date
- November 9, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- NTE
- PMA / PMN Number
- K083300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - A DEVICE LOT NUMBER WAS NOT ABLE TO BE OBTAINED, THEREFORE, A REVIEW OF THE MFG RECORDS CANNOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED A PT UNDERWENT CAROTID ARTERY STENTING AND ANGIOPLASTY. A GORE FLOW REVERSAL SYSTEM WAS USED FOR EMBOLIC PROTECTION. DURING STENT DEPLOYMENT THE GORE BALLOON WIRE (GBW) BALLOON WAS PULLED INTO THE BIFURCATION. THE GBW WAS REMOVED AND AN EMBOLIC FILTER WAS PLACED. FOLLOWING FILTER PLACEMENT, THE PHYSICIAN DECIDED TO PLACE ANOTHER GBW. FLOW REVERSAL WAS RE-ESTABLISHED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE FLOW REVERSAL SYSTEM | NTE/TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE | NTE | W.L. GORE & ASSOCIATES | WLG380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | PROTEGE CAROTID STENT| SPIDER EMBOLIC FILTER |