FDA Adverse Event Death Summary report: N

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 632085 · Received August 26, 2005

Report

Report Number
6000093-2005-00893
Event Type
Death
Date Received
August 26, 2005
Date of Event
July 28, 2005
Report Date
July 29, 2005
Manufacturer
BOSTON SCIENTIFIC
Product Code
NIQ
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT, DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PHYSICIAN EXPERIENCED BALLOON REMOVAL DIFFICULTIES, A DISSECTION AND DEATH OCCURRED. THE PT WAS RECEIVING AN INTEGRILIN INFUSION VIA THE RIGHT SUBCLAVIAN VEIN AT THE TIME OF ARRIVAL IN THE CATHETERIZATION LABORATORY. AN INTRA AORTIC BALLOON PUMP AND A SWAN-GANZ PULMONARY ARTERY CATHETER WERE PLACED BEFORE STARTING THE INTERVENTION. THE PT UNDERWENT LEFT CORONARY ANGIOGRAPHY AND A ROTABLATOR ROTATIONAL ATHERECTOMY DEVICE WAS USED IN THE MID LAD, MID DIAG1 AND OSTIAL DIAG. THE LESIONS WERE NOT PREDILATED WITH A BALLOON. IVUS WAS USED TO VIEW THE MID LAD, LM AND DIAG1. THE PT HAD REC'D A TOTAL OF 400 MCG OF NEO-SYNEPHRINE AT THIS POINT IN THE PROCEUDRE. A 3.00 X 12MM TAXUS EXPRESS2 STENT WAS PLACED IN THE MID LAD AND POST-DILATED WITH A 3.00 X 8MM POWERSAIL BALLOON. THE PHYSICIAN ADVANCED A 2.50 X 12MM TAXUS EXPRESS2 STENT TO THE OSTIAL DIAG AND A 3.50 X 8MM TAXUS EXPRESS2 STENT TO THE LM. ACCORDING TO THE CATHETERIZATION LOG THESE TWO STENTS WERE DEPLOYED AT THE SAME TIME. THE 2.50 X 12MM TAXUS EXPRESS2 STENT DELIVERY SYSTEM BALLOON (SDS) PLACED IN THE DIAG WAS REMOVED WITHOUT DIFFICULTY. UPON WITHDRAWAL OF THE 3.50 X 8MM TAXUS EXPRESS2 SDS BALLOON FROM THE LM, BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON USING A MICRO SNARE, VASCULAR RETRIEVAL FORCEPS. AND BIPOSY FOCEPS AND AFTER 2 HOURS THE BALLOON WAS REMOVED. THE PT DEVELOPED CARDIOGENIC SHOCK AND WAS INTUBATED AND GIVEN RESPIRATORY SUPPORT. NEO-SYNEPHRINE, EPINEPHRINE AND LEVOPHED. AFTER BALLOON REMOVAL IT WAS OBSERVED THAT THE LM WAS DISSECTED. A 3.00 X 30MM VOYAGER BALLOON WAS INFLATED THREE TIMES BUT RECANALIZATION OF THE VESSEL WAS NOT ACHIEVED. THE PT EXPIRED IN THE CATH LAB.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.50 X 8.0 MM 7419709

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Death