BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 1901030 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05231
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    May 7, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MFR. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR ID #: 2134265-2010-04634, 2134265-2010-05197, 2134265-2010-05232. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, ST ELEVATION, SLUGGISH FLOW AND A VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED DUE TO MYOCARDIAL INFARCTION AND UNDERWENT CARDIAC CATHETERIZATION. ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY AND STANDARD CATHETERS. ANGIOGRAPHY REVEALED A 95% STENOSED AND 12MM LONG TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) EXTENDING INTO THE PROXIMAL LAD LOCATED BETWEEN THE TWO DIAGONAL BRANCHES WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THERE WAS MILD DIFFUSE DISEASE THROUGHOUT ITS COURSE. TIMI FLOW WAS "2". A NON-BSC GUIDE WIRE WAS USED TO CROSS THE LESION AND PREDILATION WAS CARRIED OUT WITH A 2.5X12MM APEX BALLOON INFLATED TO 8 ATM FOLLOWED BY DEPLOYMENT OF A 3.5X16MM TAXUS LIBERTE STUDY STENT DEPLOYED AT 10 ATM. POST DILATION WAS PERFORMED WITH A 3.5X12MM QUANTUM MAVERICK NON-COMPLIANT BALLOON INFLATED 2 TIMES AT 12 ATM. AT THIS POINT, THE PATIENT DEVELOPED ST SEGMENT ELEVATIONS BUT REMAINED ASYMPTOMATIC. ANGIOGRAPHY REVEALED EVIDENCE OF NO-REFLOW WITH EXTREMELY SLUGGISH FLOW TO THE DISTAL VASCULATURE AND AN ABSENT TIMI BLUSH. THE NON-BSC WIRE WAS THEN RE-EXTENDED AND A 2.0X9MM MAVERICK OVER THE WIRE BALLOON WAS ADVANCED INTO THE DISTAL LAD. THE WIRE WAS REMOVED AND INTRACORONARY NITROPRUSSIDE WAS ADMINISTERED. THE ST SEGMENTS NORMALIZED AND DISTAL FLOW WAS RE-ESTABLISHED. THERE WAS EVIDENCE OF A HAZY LESION JUST AFTER THE FIRST STENT AT THE OSTIUM OF THE SECOND DIAGONAL BRANCH. THE NON-BSC GUIDE WIRE WAS RE-ADVANCED AND INTRAVASCULAR ULTRASOUND (IVUS) REVEALED EVIDENCE OF AN EDGE DISSECTION WITH A SMALL HEMATOMA WHICH WAS TREATED WITH A 3.0X12MM TAXUS LIBERTE STENT DEPLOYED DISTAL TO THE FIRST STENT AT 9 ATM. POST DILATION WAS PERFORMED WITH THE STENT BALLOON AGAIN AT 9 ATM. IT WAS POST DILATED WITH A 3.0X12MM QUANTUM MAVERICK NON-COMPLIANT BALLOON AT 14 ATMS RESULTING IN 0% RESIDUAL STENOSIS AND EXCELLENT FLOW TO THE APEX WITH A NORMAL TIMI BLUSH SCORE. THE PATIENT'S ST SEGMENTS HAD COMPLETELY NORMALIZED. THE CASE WAS THEN CLOSED. NO COMPLICATIONS WERE REPORTED AS A RESULT OF THE DISSECTION AND THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    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 66 YR Required Intervention 3.5X12MM QUANTUM MAVERICK NON COMPLIANT BALLOON| ATLANTIS SR PRO IMAGING CATHETER| 0.014 145CM ADD WIRE| 3.5X16MM TAXUS LIBERTE STENT| 2.0X9MM MAVERICK BALLOON| 0.014 185CM FORTE WIRE