FDA Adverse Event Death Summary report: N

F/G ATLANTIS SR PRO2

MDR report key: 843430 · Received April 23, 2007

Report

Report Number
6000084-2007-00026
Event Type
Death
Date Received
April 23, 2007
Date of Event
March 26, 2007
Manufacturer
BOSTON SCIENTIFIC
Product Code
DQO
PMA / PMN Number
K050577
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN IMAGING CATHETER BECAME STUCK IN A STENT. THE LESION BEING TREATED WAS 90% STENOSED AND CALCIFIED IN A VERY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). AN AXESS GUIDE CATHETER WAS INSERTED THROUGH THE LEFT BRANCHIAL ARTERY, THEN, A NEOS SOFT AND RENATO GUIDEWIRE CROSSED THE LESION SITUATED IN THE LAD. THE LESION WAS PRE-DILATED WITH A TIP TOP2 BALLOON CATHETER. AFTER THE LESION WAS CONFIRMED BY THE IMAGING CATHETER, A DRIVER CORONARY STENT WAS DEPLOYED. IMAGING WAS PERFORMED AFTER STENTING, THEN THE LESION WAS POST-DILATED THREE TIMES WITH AN AVION HP BALLOON CATHETER. FINAL IMAGING WAS PERFORMED AND THEN THE IMAGING CATHETER WAS RETRIEVED TO TERMINATE THE PROCEDURE. DURING RETRIEVAL, THE CATHETER BECAME STUCK WITH THE STENT. PHYSICIAN ATTEMPTED TO RETRIEVE THE IMAGING CATHETER THRU THE INITIAL ACCESS (LEFT BRANCHIAL ARTERY) BY USING A GUIDEWIRE BUT THE ATTEMPT WAS UNSUCCESSFUL. THEN PHYSICIAN ATTEMPTED TO RETRIEVE THE CATHETER, BY USING SEVERAL DEVICES ACCESSING THE FEMORAL AREA BUT WITHOUT SUCCESS. FINALLY, THE IMAGING CATHETER WAS PULLED BY FORCE AND THE DISTAL SECTION (TIP OF THE CATHETER) SEPARATED. THE DISTAL SECTION OF THE IMAGING CATHETER WAS LEFT IN THE PATIENT'S LAD. A DRIVER CORONARY STENT WAS DEPLOYED AT LAD PROXIMAL TO ENTRAP THE DISTAL SECTION LEFT IN THE PATIENT'S BODY. THE PT WAS REPORTED TO BE STABLE AFTER THE PROCEDURE; HOWEVER, IT WAS REPORTED THE PATIENT EXPIRED NINE DAYS LATER. THE CAUSE OF DEATH IS UNKNOWN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 F/G ATLANTIS SR PRO2 IMAGING CATHETER DQO BOSTON SCIENTIFIC 39014 9326544

Patients

Seq Age Sex Outcome Treatment
1 84 YR Death| O| R AVION HP BALLOON CATHETER| TIP TOP2 BALLOON CATHETER| GUIDEWIRE - AXESS SPB| DRIVER CORONARY STENT| NEOS SOFT & RENATO GUIDEWIRE