BEUDAMED
    FDA Adverse Event Death Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 2040171 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-00964
    Event Type
    Death
    Date Received
    April 5, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-00966, 2134265-2011-00965. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. ACCESS WAS OBTAINED THROUGH THE LEFT FEMORAL ARTERY. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE Y-GRAFT TO LEFT ANTERIOR DESCENDING (LAD) ARTERY ANASTOMOSIS. THE Y-GRAFT WAS REPORTED AS THE ONLY REMAINING VIABLE VESSEL. THE OSTIUM HAD BEEN STENTED PREVIOUSLY ON AN UNSPECIFIED DATE WITH AN UNSPECIFIED STENT. THE PREVIOUSLY PLACED STENT WAS PROTRUDING INTO THE AORTA. THE LESION WAS NOT PREDILATED. THE PHYSICIAN ATTEMPTED TO PLACE A 2.25X8MM TAXUS LIBERTE ATOM, BUT EXPERIENCED RESISTANCE. DURING REMOVAL, RESISTANCE WAS INITIALLY EXPERIENCED. UPON REMOVAL, THE PHYSICIAN IDENTIFIED THE STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). THE STENT WAS LOCATED AT THE LESION SITE IN THE LAD. A 2.0X12MM APEX BALLOON WAS INFLATED 3 TIMES TO 6.1-14.7 ATM FOR 8-30 SECONDS, CRUSHING THE 2.25X8MM TAXUS LIBERTE ATOM AGAINST THE STENOSIS, AT THE LESION SITE. THEN THE PHYSICIAN ATTEMPTED TO PLACE A 2.5X8MM PROMUS STENT AT THE LESION SITE TO TREAT THE LESION AND JAIL THE CRUSHED STENT. HOWEVER, RESISTANCE WAS ENCOUNTERED DURING INSERTION AND REMOVAL, CAUSING THE 2.5X8MM PROMUS STENT TO DISLODGE INSIDE THE PATIENT. ANGIOGRAPHY WAS PERFORMED AND THE PROMUS STENT COULD NOT BE LOCATED. THE PHYSICIAN BELIEVES BOTH STENTS BECAME CAUGHT ON THE PREVIOUSLY PLACE UNKNOWN STENT, CAUSING THE STENT DISLODGEMENTS. A 2.25X15MM NON-BSC BALLOON WAS INFLATED TO 12ATM FOR 37 SECONDS. THEN UNSUCCESSFUL ATTEMPTS TO CROSS THE LESION WERE MADE WITH A 2.5X12MM PROMUS STENT, 2.25X8MM NON-BSC STENT, 2.25X8MM NON-BSC STENT, AND A 2.25X8MM NON-BSC STENT. SYSTOLIC BLOOD PRESSURE (SBP) WAS <80 AND VASOPRESSIN WAS GIVEN. ACCESS WAS THEN OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. A 4X20MM NC QUANTUM APEX WAS INFLATED TO 19.3ATMS FOR 13 SECONDS. A NON-BSC 2.5 CARDIAC ASSIST DEVICE WAS PLACED. TIMI FLOW 3 WAS ACHIEVED WITH 20% RESIDUAL STENOSIS. WITHIN 24 HOURS POST PROCEDURE, THE PATIENT ARRESTED DURING REMOVAL OF THE NON-BSC ASSIST DEVICE PATIENT DEATH OCCURRED. THE PHYSICIAN DOES NOT FEEL THE DISLODGED STENTS CONTRIBUTED TO THE EVENT. WHEN THE ANGIOGRAPHY WAS PERFORMED POST BALLOON INFLATION, THERE WAS NO SIGN OF ANY DISSECTION OR OTHER VISIBLE TRAUMA (VISIBLE TO FLUOROSCOPY) TO THE VEIN GRAFT (I.E. THERE WAS NO FLOW LIMITING OR SPIRAL DISSECTION, THERE WAS NO PERFORATION). THE UNSPECIFIED STENT APPEARED TO BE MORE EXPANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 Death