SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

Report

Report Number: 2954936-2008-00056
Event Type: Injury
Date Received: May 6, 2008
Date of Event: April 14, 2008
Report Date: May 5, 2008
Manufacturer: FOX HOLLOW TECHNOLOGIES
Product Code: MCW
PMA / PMN Number: K061188
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SILVERHAWK PLAQUE EXCISION SYSTEM IS CURRENTLY CONTRAINDICATED FOR IN-STENT RESTENOSIS. CATASTROPHIC FAILURES, SUCH AS THIS, CAN OCCUR WHEN YOU ENTER THE STENT WITH THE CUTTER IN THE OPEN POSITION AND/OR ATTEMPT TO "PART-OF" (CLOSE THE CUTTER) WHILE AT THE EDGE OF THE STENT. IN ADDITION, IF STENT FRACTURES ARE PRESENT, SIMILAR COMPLICATIONS MAY OCCUR AT THE FRACTURE LOCATION. THE PT RETURNED FOR AN APPOINTMENT WITH HER PHYSICIAN ON APRIL 30TH AND IS DOING FINE. DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION - DEVICE WAS THROWN AWAY. SUSPECTED PROBLEM IDENTIFIED IN RESULTS AND CONCLUSIONS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFO IS OBTAINED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING DEBULKING OF MID-SFA IN-STENT RESTENOSIS, CUTTER WINDOW APPARENTLY ENGAGED STENT STRUT AND BECAME ENTANGLED. THIS OCCURRED AT PROXIMAL MOUTH OF THE ABSOLUTE STENT MANUFACTURED BY ABBOTT VASCULAR. THE PHYSICIAN INSERTED THE SILVERHAWK LX-M ONCE AND HAD MADE APPROX 3 CUTS PROXIMAL TO THE STENT AND 1 INSIDE OF IT. THE SFA WAS FLUSHED OCCLUDED AT THE VESSEL OSTIUM TO APPROXIMATELY THE PROXIMAL POPLITEAL. THE PT WAS SENT TO THE OR FOR THE PRODUCT TO BE REMOVED SURGICALLY. SURGERY WAS SUCCESSFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM	CATHETER, PERIPHERAL, ATHERECTOMY	MCW	FOX HOLLOW TECHNOLOGIES	FG 10505	NOT REPORTED

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention