FDA Adverse Event Death Summary report: N

PROTEGE RX CAROTID STENTING SYSTEM

MDR report key: 936968 · Received November 2, 2007

Report

Report Number
2183870-2007-00083
Event Type
Death
Date Received
November 2, 2007
Date of Event
October 16, 2007
Report Date
October 17, 2007
Manufacturer
EV3 INC.
Product Code
NIM
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PHYSICIAN STARTED THE PROCEDURE BY PLACING A SPIDERFX EMBOLIC PROTECTION DEVICE. THE PHYSICIAN THEN PREDILATED BEFORE ATTEMPTING TO PLACE THE PROTEGE RX. THE FIRST PROTEGE RX DEVICE WOULD NOT DEPLOY AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN PULLED THIS SYSTEM OUT AND USED ANOTHER PROTEGE RX (SAME MODEL NUMBER) AND WAS SUCCESSFUL. PROCEDURE COMPLETED WITHOUT COMPLICATIONS AT 10:18 AM. PATIENT TRANSFERRED TO ICU PER NORMAL PROTOCOL. HOWEVER, PATIENT HAD MANY COMORBIDITIES WHICH COMPLICATED ISSUES POST PROCEDURE. WHILE PATIENT WAS UNDER GOING ROUTINELY SCHEDULED DIALYSIS AT 2:30 PM, PATIENT BECAME LIGHT-HEAD AND COMPLAINED OF ABDOMINAL DISCOMFORT AND NAUSEA. THE PT WENT IN VT AND ARRESTED. THE PT WAS BROUGHT EMERGENTLY TO THE CATH LAB AND ANGIOGRAPHY REVEALED AN OCCLUDED CIRCUMFLEX. THE PT UNDERWENT ASPIRATION THROMBECTOMY; PATIENT ALSO HAD A BALLOON PUMP PLACED AND A TEMPORARY PACER. PATIENT THEN RETURNED TO ICU AND DESPITE PRESSORS, BALLOON PUMP AND PACER, THE PACER NO LONGER CAPTURED AND AS SUCH BALLOON PUMP COULD NO LONGER FUNCTION. THE PATIENT HAD NO UNDERLYING PRESSURE OR RHYTHM AND THE PT DECEASED AT 4:49 PM. THE PHYSICIAN COMMUNICATED THAT THE PROTEGE RX STENT DID NOT DIRECTLY RELATE TO THE PT'S DEATH. UNFORTUNATELY, THE PT HAD MULTIPLE CO-MORBIDITIES THAT CONTRIBUTED TO HIS DEMISE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROTEGE RX CAROTID STENTING SYSTEM NIM EV3 INC. SECX-8-6-40-135 2600893

Patients

Seq Age Sex Outcome Treatment
1 68 YR Death