BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM

    MDR report key: 1020315 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00885
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    December 1, 2004
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-00886. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT FRACTURE, AND IN-STENT RESTENOSIS WAS IDENTIFIED. THE 50% STENOSED OSTIAL LESION BEING TREATED WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X20MM RANGER BALLOON AND A 2.5X15MM NC RANGER BALLOON. A 4.00X10MM AND 3.75X15MM CUTTING BALLOONS WERE ALSO USED. A 4.0X15MM NIR ROYAL STENT WAS DEPLOYED IN THE OSTIAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO RESIDUAL TEAR, DISSECTION, OR DISTAL EMBOLIZATION AND A TIMI III FLOW. FOUR YEARS POST THE DEPLOYMENT OF THE NIR ROYAL STENT, THE OSTIAL RCA WAS FOUND TO BE 90% RESTENOSED AND THE NIR ROYAL STENT WAS FOUND FRACTURED BETWEEN THE MOST PROXIMAL END AND MID PORTION OF THE STENT. THE LESION WAS PREDILATED WITH A 3.0X15MM MAVERICK BALLOON. A 3.5X18MM TAXUS EXPRESS DRUG ELUTING STENT WAS DEPLOYED OVER THE PREVIOUSLY DEPLOYED NIR ROYAL STENT. THE STENT WAS POST DILATED WITH A 4.0X15 QUANTUM BALLOON. SUCCESSFUL REDUCTION OF STENOSIS FROM 90% TO 0% WITH TIMI III FLOW AND NO EVIDENCE OF DISSECTION, DISTAL EMBOLIZATION OR ABRUPT VESSEL CUT OFF. MEDICATION: ANGIOMAX, ASA, AND PLAVIX. THREE YEARS POST THE DEPLOYMENT OF THE TAXUS STENT, THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION. AN INTRA-AORTIC BALLOON PUMP WAS PLACED PRIOR TO THE PROCEDURE. THE PROXIMAL RCA WAS 100% STENOSED. THE PREVIOUSLY PLACED TAXUS STENT WAS FOUND TO BE FRACTURED AND IN-STENT THROMBOSIS WAS IDENTIFIED IN THE OSTIAL PROXIMAL RCA. INFLATIONS WERE MADE WITH A 1.5X15MM, 2.5X20MM, AND 3.0X20MM MAVERICK BALLOONS. A 3.5X23MM NON-BSC BARE METAL STENT WAS DEPLOYED, SPANNING THE FRACTURED TAXUS STENT, AND POST DILATED WITH A 4.0X12MM MAVERICK BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 0% RESIDUAL STENOSIS AND TIMI III FLOW. MEDICATION: ASPIRIN, HEPARIN, DOPAMINE, PLAVIX, CA CHANNEL BLOCKER, AND STATIN. PATIENT STATUS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM MAF - STENT, CORONARY MAF BOSTON SCIENTIFIC 4.00X15 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention