BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2123889 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02232
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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

    SAME CASE AS: 2134265-2011-02454 AND 2134265-2011-02455. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE OSTIAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN EXPERIENCED DIFFICULTY PLACING AN UNKNOWN GUIDE WIRE IN RIGHT POSTEROLATERAL BRANCH. AFTER GUIDE WIRE PLACEMENT, NO ANTEGRADE FLOW OCCURRED. THROMBUS WAS SUCCESSFULLY ASPIRATED USING A NON-BSC EXTRACTION CATHETER RESTORING ANTEGRADE FLOW. ANGIOGRAPHY WAS PERFORMED. DIFFICULTY MANEUVERING A NON-BSC GUIDE WIRE THROUGH A PRE-EXISTING DISSECTION IN THE MID RCA TO RIGHT INTERVENTRICULAR POSTERIOR DESCENDING CORONARY ARTERY (RIVP) WAS EXPERIENCED. SUCCESSFUL ANGIOPLASTY WAS PERFORMED USING AN UNKNOWN 2.0MM AND UNKNOWN 2.5MM BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE A 3.0MM UNKNOWN DRUG ELUTING STENT (DES) IN THE MID RCA, BUT IT KEPT GETTING STUCK IN THE 70% STENOSED PROXIMAL RCA. THE PROXIMAL AND MID RCA WERE DILATED USING A 3.0MM MAVERICK 2 BALLOON. WHILE DILATING THE PROXIMAL STENOSIS, THE 3.0MM MAVERICK BALLOON RUPTURED. SUCCESSFUL DILATATION OF THE PROXIMAL STENOSIS WAS COMPLETED WITH AN UNKNOWN 3.0MM NC BALLOON. WITH SOME EFFORT, A 3.0X24MM PROMUS ELEMENT STENT WAS IMPLANTED, EXTENDING INTO THE RIGHT POSTEROLATERAL BRANCH (OVERLAPPING THE RIVP) WITHOUT RESIDUAL STENOSIS. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER UNKNOWN DES PROXIMAL TO THE 3.00X24MM DES, BUT DIFFICULTY ADVANCING WAS EXPERIENCED. A BALLOON RUPTURE OCCURRED WITH A 3.5MM MAVERICK 2 BALLOON. DILATATIONS, IN THE RCA PROXIMAL TO THE DES, WERE PERFORMED WITH AN UNKNOWN 3.5MM NC BALLOON, APPLYING HIGH PRESSURE. THEN A 3.5X24MM PROMUS ELEMENT STENT WAS IMPLANTED OVERLAPPING THE PREVIOUS STENT, INFLATED TO 3.5MM IN DIAMETER WITH NO RESIDUAL STENOSIS. A KISSING BALLOON TECHNIQUE VIA "STENT MESHES" USING UNKNOWN 1.2MM AND 2.5MM BALLOON FAILED, DUE TO ADVANCEMENT DIFFICULTIES. THE STENT WAS DILATED AGAIN USING AN UNKNOWN 3.5MM BALLOON IN THE "CRUX AREA" WITH GOOD RESULTS. MINOR RESIDUAL DISSECTION REMAINED IN PARALLEL TO THE VESSEL IN THE DESCENDING RIVP. DILATATION WAS PERFORMED IN THE PROXIMAL RCA WITH AN UNKNOWN 3.5MM BALLOON. A 3.5X24MM PROMUS ELEMENT STENT WAS PLACED IN THE PROXIMAL TO COVER THE REMAINING DISSECTION. THE 3.5MM STENT BALLOON WAS INFLATED USING HIGH PRESSURE ( 24 ATM). WHEN WITHDRAWING THE STENT BALLOON, A PORTION OF THE BALLOON REMAINED STUCK IN THE GUIDE CATHETER. THE PHYSICIAN ATTEMPTED TO SECURE THE REMAINING PART OF THE STENT BALLOON INSIDE THE GUIDING CATHETER USING AN UNKNOWN 2.5MM BALLOON, BUT WAS UNSUCCESSFUL. THE PATIENT FELT DESIRE TO VOID AND WAS PLACED ON THE BEDPAN. THE BALLOON PIECE EMBOLIZED INTO THE OSTIUM OF RCA. USING A 4MM SNARE THE RUPTURED BALLOON WAS REMOVED. THE BALLOON APPEARED TO BE PUSHED TOGETHER DISTALLY ("PLUG-LIKE"). THE RUPTURED PROXIMAL PART OF THE STENT BALLOON SHOWS A FREE, 10 CM LONG METALLIC SHAFT SECTION DISTALLY. DURING THE ENTIRE PROCEDURE, INCREASED FRICTION WAS EXPERIENCED AT THE END OF THE UNKNOWN GUIDE CATHETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT 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 H7493911324350 0014148187

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention (2) MAVERICK 2 BALLOONS