FDA Adverse Event Death Summary report: N

GORE

MDR report key: 653615 · Received August 25, 2005

Report

Report Number
MW1036431
Event Type
Death
Date Received
August 25, 2005
Date of Event
August 8, 2005
Report Date
August 23, 2005
Manufacturer
GORE
Product Code
DSY
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ENDOLUMINAL STENTING. ANGIO AND CT EVIDENCE OF L CAROTID BEING UNOBSTRUCTED; PT ALSO NEURO O.K. THREE DAYS LATER L CVA (SMALL) FOLLOWED 1 WEEK LATER BY LARGE L CVA. POST-MORTEM REVEALED SLIPPAGE OF GRAFT WITH SLIPPAGE OF SHEATH BOTH PROX DO L CAROTID.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GORE TAG DSY GORE * *

Patients

Seq Age Sex Outcome Treatment
1 60 YR Death