FDA Adverse Event Injury Summary report: N

GORE EMBOLIC FILTER

MDR report key: 2893338 · Received December 26, 2012

Report

Report Number: 2017233-2012-00865
Event Type: Injury
Date Received: December 26, 2012
Date of Event: December 3, 2012
Report Date: December 3, 2012
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: NTE
PMA / PMN Number: K103500
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS DISCARDED, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED. THE IMAGING ANALYSIS CONFIRMED A FILLING DEFECT WITHIN THE ANTERIOR CEREBRAL ARTERY AFTER THE MO.MA BALLOON WAS DEFLATED AND THE EMBOLIC FILTER REMOVED.

Description of Event or Problem · 1

IT WAS REPORTED A PT UNDERWENT CAROTID ARTERY STENTING AND ANGIOPLASTY IN THE (B)(4) STUDY. A GORE EMBOLIC FILTER (GEF) AND A MO.MA SYSTEM WERE USED FOR EMBOLIC PROTECTION. BOTH WERE DEPLOYED SUCCESSFULLY AND AN EV3 STENT WAS PLACED OVER THE LESION. WHEN THE MO.MA BALLOONS WERE DEFLATED, THE PT WAS NOT ABLE TO RESPOND TO COMMANDS BOTH VERBALLY AND PHYSICALLY. AFTER THE PROCEDURE, OCCLUSION WAS NOTED ANGIOGRAPHICALLY AT A BIFURCATION OF THE A2, A3 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY. PERFUSION WAS SEEN SUPERIORLY, BUT NOT INFERIORLY IN THIS REGION. FIFTEEN TO THIRTY MINUTES POST-PROCEDURALLY THE PT WAS ABLE TO RESPOND TO COMMANDS BOTH VERBALLY AND PHYSICALLY. THE PHYSICIAN INDICATED THERE MAY HAVE BEEN SLIGHT RIGHT FOOT PEDAL DEFICIT, YET OTHERWISE THE PT'S SYMPTOMS HAD IMPROVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GORE EMBOLIC FILTER	NTE/TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE	NTE	W.L. GORE & ASSOCIATES		10485359

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Other	PROTEGE STENT\| MO.MA PROXIMAL CEREBRAL PROTECTION DEVICE