BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 628835 · Received August 16, 2005

    Report

    Report Number
    628835
    Event Type
    Death
    Date Received
    August 16, 2005
    Date of Event
    July 28, 2005
    Report Date
    August 12, 2005
    Manufacturer
    BOSTON SCIENTIFIC,
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONLY THE PROXIMAL SECTION OF THE DELIVERY CATHETER WAS RETURNED FOR ANALYSIS. EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE OUTER POLYMER SHAFT WAS SEPARATED 119 CENTIMETERS DISTALLY FROM THE DISTAL EDGE OF THE STRAIN RELIEF. THE OVERALL LENGTH OF THE DEVICE WAS ELONGATED BY APPROX 2 CM. THE SEPARATION AND ELONGATION CAN OCCUR WHEN TENSILE FORCES EXCEED THE SHAFT TENSILE SPECIFICATION. CO IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED BALLOON REMOVAL DIFFICULTY BASED ON THE INFORMATION CO HAS RECEIVED TO DATE AND THE PORTION OF THE RETURNED DEVICE. THE SHOP FLOOR PAPER WORK FOR THIS DEVICE HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW DID NOT IDENTIFY ANY FAILURE OF THE DEVICE TO MEET ITS MATERIAL, ASSEMBLY OR PERFORMANCE SPECIFICATIONS. THE LOT REVIEW FROM WHICH THIS PRODUCT WAS SHIPPED MET THE RELEASE SPECIFICATIONS WHEN IT WAS RELEASED FOR DISTRIBUTION. THEREFORE, THE CIRCUMSTANCES THAT LED UP TO THE SHAFT SEPARATION COULD NOT BE DETERMINED. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. THIS WILL CONTINUE TO BE MONITORED FOR FURTHER TRENDS. 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 RECEIVED A TOTAL OF 400 MCG OF NEO-SYNEPHRINE AT THIS POINT IN THE PROCEDURE. A 3.00 X 12MM TAXUS EXPRESS2 STENT WAS PLACED IN THE MID LAD AND POST-DILATED WITH A 3.00X8MM 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 BIOPSY FORCEPS 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. BOSTON SCIENTIF NOTES THAT THE USE OF THE DEVICE IN THIS CASE VARIED FROM THE DIRECTIONS FOR USE (DFU). BASED ON INFORMATION AVAILABLE TO BOSTON SCIENTIFIC AT THIS TIME IT ISN'T ENTIRELY CLEAR THAT ANY OF THE VARIANCES LISTED BELOW CONTRIBUTED TO THE COMPLICATION OR DEATH. PER THE DFU: THE SAFETY AND EFFECTIVENESS OF THE TAXUS EXPRESS2 STENT HAVE NOT BEEN ESTABLISHED IN PTS WITH LESIONS LOCATED IN THE UNPROTECTED LEFT MAIN CORONARY ARTERY, OSTIAL LESIONS OR LESIONS LOCATED AT THE BIFURCATION. THE SAFETY AND EFFECTIVENESS OF USING MECHANICAL ATHERECTOMY DEVICES (I.E. DIRECTIONAL ATHERECTOMY CATHETERS, ROTATIONAL ATHRECTOMY CATHETERS) OR LASER ANGIOPLASTY CATHETERS IN CONJUNCTION WITH TAXUS EXPRESS2 STENT IMPLANTATION HAVE NOT BEEN ESTABLISHED. THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON, FAILURE TO DO SO MAY INCREASE THE RISK OF PLACEMENT DIFFICULTY AND PROCEDURAL COMPLICATIONS.

    Description of Event or Problem · 1

    BALLOON FRACTURED DURING INTERVENTIONAL CARDIOLOGY PROCEDURE. ATTEMPTS TO RETRIEVE RETAINED PORTION UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC LAD STENT BALLOON NIQ BOSTON SCIENTIFIC, TAXUS EXPRESS *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death