BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 1380185 · Received May 8, 2009

    Report

    Report Number
    2134265-2009-02114
    Event Type
    Death
    Date Received
    May 8, 2009
    Date of Event
    December 1, 2008
    Report Date
    April 8, 2009
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A VESSEL PERFORATION OCCURRED AND POST PROCEDURE, PT'S DEATH OCCURRED. THE 50-70% STENOSED LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ACCESS SITE WAS RIGHT FEMORAL. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED OF THE MID LAD AND REVEALED A VERY TIGHT, FIBROTIC, CONCENTRIC LESION WITH A LUMEN AREA OF 2.1MM SQ. A 2.5 X 10MM CUTTING BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 6 ATM. THE BALLOON "DEFLATED JUST FINE." UPON WITHDRAWAL OF THE CUTTING BALLOON, THERE WAS SEVERE EXTRAVASATION OF DYE INTO THE PERICARDIUM SUGGESTIVE OF A LARGE CORONARY PERFORATION. THE PERFORATION WAS EMERGENTLY TREATED WITH ANOTHER MANUFACTURER'S STENT. THE STENT PARTIALLY CLOSED THE PERFORATION, BUT THERE WAS STILL SIGNIFICANT EXTRAVASATION OF THE PERFORATION AS WELL AS DISTALLY. THE PT HAD RESPIRATORY COMPROMISE AND CARDIOVASCULAR COLLAPSE WITH SEVERELY LOW BLOOD PRESSURES. THE PT WAS RESUSCITATED WITH CPR AND INTUBATED. A NON-BSC COVERED STENT WAS IMPLANTED INTO THE APICAL LAD. ANOTHER COVERED STENT WAS PLACED OVERLAPPING TO COVER THE ENTIRE PERFORATED REGION. THE PT WAS SEVERELY HYPOTENSIVE. THE PT HAD ACUTE PERICARDIAL EFFUSION. EMERGENT PERICARDIOCENTESIS WAS PERFORMED WITH PLACEMENT OF A PIGTAIL DRAIN AND ASPIRATION OF ABOUT 200 MM OF BLOOD. THERE WAS IMMEDIATE IMPROVEMENT IN BLOOD PRESSURE AND DECREASE IN HEART RATE. THE CATHETERS WERE REMOVED AFTER REPEAT ANGIOGRAPHY DEMONSTRATED A PATENT STENT IN THE MID LAD WITH NO SIGNIFICANT DISEASE ELSEWHERE. THE PT HEART RATE AND BLOOD PRESSURE STABILIZED. A BALLOON PUMP WAS PLACED. THE PT WAS TRANSFERRED TO THE CORONARY CARE UNIT. MEDICATIONS IN THE PROCEDURE INCLUDED ANGIOMAX, INTEGRILIN, DIPRIVAN, EPINEPHRINE, VASOPRESSIN, ATROPHINE, LEVOPHED, AND DOPAMINE. THE PT EXPIRED "A COUPLE OF DAYS LATER." THE SPECIFIC CAUSE OF DEATH IS UNK. ADDITIONAL INFO WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPPLASTY, PERCUTANEOUS LOX BSC LETTERKENNY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death TERUMO RUN THRU WIRE| 3X15MM XIENCE DRUG-ELUTING STENT| 6 FR XB 3.5 GUIDE CATHETER| GRAFT MASTER 3X12MM STENT| COUGAR WIRE| 3X5 GRAFT MASTER STENT