BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1896863 · Received November 11, 2010

    Report

    Report Number
    2134265-2010-04983
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - 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 MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER NOTED UPON REVIEW OF THE CINE THAT AT THE DISTAL END OF THE STENT, A CONTRAST BLUSH OUTSIDE OF THE VESSEL LUMEN IS VISIBLE CONSISTENT WITH VESSEL PERFORATION. SEVERAL BALLOON INFLATIONS WERE PERFORMED IN THE STENTED VESSEL SEGMENT AND DISTAL TO THE STENT WHICH RESULTED IN NO MORE CONTRAST EXITING THE VESSEL BUT NO MORE FLOW IN THE STENTED VESSEL WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A DEPLOYMENT ISSUE OCCURRED. THE 100% STENOSED DE NOVO LESION WAS LOCATED IN A MILDLY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY TO RAMUS DIAGONALIS ARTERY THAT HAD A VESSEL DIAMETER OF 2.5MM. THE LESION WAS PREDILATED WITH A 2.0X20MM MAVERICK2 BALLOON TO 8 ATMS FOR 60 SECONDS WHICH REDUCED THE STENOSIS TO 60%. A 2.5X32MM PROMUS ELEMENT STENT WAS DEPLOYED AT 16 ATMS IN THE LESION. UNDER ANGIO THE DEPLOYED STENT WAS MEASURED TO BE 2.25MM IN THE CENTER OF THE STENT AND UP TO 3.61MM AT THE PROXIMAL END OF THE STENT AND 3.85MM AT THE DISTAL END OF THE STENT. THE STENT WAS POST-DILATED WITH THE STENT DELIVERY SYSTEM BALLOON FOR THREE INFLATIONS OF 8, 8 AND 6 ATMS RESPECTIVELY. THE STENT WAS THEN FURTHER POST-DILATED WITH A 2.0X15MM MAVERICK2 BALLOON INFLATED TO 10 ATMS FOR TWO INFLATIONS. A 2.5X15MM MAVERICK2 BALLOON WAS THEN INFLATED TO 8 ATMS TO FURTHER POST-DILATE THE LESION AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. THIS DEVICE IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332250 0013602364

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 0.014" 180CM RUNTHROUGH NS GUIDE WIRE| SHERPA NX ACTIVE EBU 3.5 6FR GUIDE CATHETER| 2.0X20MM MAVERICK2 BALLOON