BEUDAMED
    FDA Adverse Event Death Summary report: N

    PTCA CATHETERS

    MDR report key: 532228 · Received June 30, 2004

    Report

    Report Number
    6000093-2004-00547
    Event Type
    Death
    Date Received
    June 30, 2004
    Date of Event
    December 1, 2003
    Report Date
    March 4, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PRESENTED WITH UNSTABLE ANGINA - CLASS 4. THE OSTIAL LEFT CIRCUMFLEX CORONARY ARTERY LESION WAS 90% STENOTIC. THIS LESION WAS CROSSED EASILY WITH A BMW .014" GUIDEWIRE AND A 7F GL3.5 GUIDE CATHETER. AN OPENSAIL 3.0/15 MM BALLOON WAS PLACED ACROSS THE LESION AND INFLATED TO 4 ATMS FOR 20 SECONDS, THEN INFLATED A SECOND TIME TO 8 ATMS FOR 20 SECONDS. THE PHYSICIAN THOUGHT THAT INTERVENTION ON THE CIRCUMFLEX LESION MIGHT JEOPARDIZE THE PROXIMAL AND MID LAD, INCLUDING THE 1ST DIAGONAL AND A LARGE SEPTAL PERFORATOR, SO A CHOICE FLOPPY .014"/182 CM GUIDEWIRE WAS PLACED IN THE LAD AND A CYPHER 3.5/23 MM DRUG ELUTING STENT WAS PLACED - UNDEPLOYED - IN THE PROXIMAL TO MID LAD. INTERVENTION THEN CONTINUED ON THE CIRCUMFLEX LESION AS PREVIOUSLY REPORTED. THE MAVERICK 1.5/20 MM BALLOON USED TO ATTEMPT TO CAPTURETHE DISPLACED VISION STENT WAS ONLY INFLATED TO 4 ATMS FOR 15, THEN 30, THEN 30 SECONDS (PREVIOUSLY REPORTED AS 14 ATMS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN WHICH HAD BEEN INCREASING IN FREQUENCY FOR ONE MONTH AND WHICH WAS RELIEVED WITH NITROGLYCERIN. A CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED RESTENOSIS OF A PROTECTED LEFT MAIN STENT (WHICH HAD BEEN PLACED IN 1999). A FEW DAYS LATER, A PTCA/STENTING TREATMENT PROCEDURE WAS INITIATED IN ORDER TO TREAT AN OSTIAL LEFT CIRCUMFLEX LESION. A GUIDANT VISION 3.0/12 MM STENT WAS ADVANCED TO THE LEFT CIRCUMFLEX, BUT COULD NOT BE MANEUVERED TO THE TARGET LESION. THE STENT DISLODGED FROM THE DELIVERY BALLOON, BUT REMAINED ON THE WIRE. A MAVERICK 1.5/20 MM BALLOON WAS ADVANCED INTO THE UNDEPLOYED STENT AND INFLATED TO 14 ATMS (RBP = 12 ATMS) FOR 15 SEC, THEN 30 SEC, THEN 30 SECONDS IN AN EFFORT TO "TRAP THE STENT ON THE BALLOON" FOR REPOSITIONING, BUT WAS UNSUCCESSFUL. AN INTRA-AORTIC BALLOON PUMP WAS PLACED VIA THE LEFT FEMORAL ARTERY. A CORDIS CYPHER STENT WAS DEPLOYED IN THE LAD CORONARY ARTERY AT 12 ATMS FOR 15 SECONDS. A MAVERICK 2.75/15MM BALLOON WAS INFLATED TO 12 ATMS FOR 15 SECONDS TO DEPLOY THE GUIDANT VISION STENT WITHIN THE LEFT MAIN AND PROXIMAL CIRCUMFLEX CORONARY ARTERIES. RESULTS REVEALED A 90% RESIDUAL STENOSIS WITH TIMI-3 FLOW. THE PROCEDURE WAS ABORTED AND SURGICAL INTERVENTION WAS DISCUSSED WITH THE PATIENT. DESPITE THE HIGH RISK AND THEIR CO-MORBIDITIES, THE PATIENT ELECTED TO PROCEED WITH SURGERY AND WAS SENT FOR AND EMERGENCY CABG FOR REVASCULARIZATION. ATTEMPTS TO WEAN THE PATIENT OFF OF CARDIOPULMONARY BYPASS WITH IABP WERE UNSUCCESSFUL AND THE PATIENT ULTIMATELY DIED. THE FAMILY DECLINED AN AUTOPSY. (SAME CASE AS MANUFACTURER'S REPORT # 6000093-2004-00546).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTCA CATHETERS MAVERICK PTCA CATHETER LOX BOSTON SCIENTIFIC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *