BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3221690 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04726
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: AROUND 75 YEARS OF AGE. DEVICE IS A COMBINATION PRODUCT. (B)(4). 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

    SAME CASE AS 2134265-2013-04727. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DISLODGED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ADVANCED A 6F FR4 NON-BSC LAUNCHER GUIDE AND A NON-BSC GUIDE WIRE. THE VESSEL WAS WIRED AND A 2.5 X 15MM APEX RX BALLOON CATHETER WAS ADVANCED TO PREDILATE THE LESION. A 4.00X20MM PROMUS ELEMENT PLUS DRUG ELUTING STENT WAS INSERTED BUT FAILED TO CROSS MID RCA. AFTER SEVERAL ATTEMPTS THE PHYSICIAN PULLED THE STENT OUT OF THE BODY TO REDILATE THE MID RCA AND IT WAS NOTICED THAT THE STENT REMAINED IN THE DELIVERY SYSTEM BUT ONE OF THE STRUTS IN THE MID-PORTION WAS RAISED. THE PHYSICIAN THOUGHT THAT THE DEVICE COULD HAVE BEEN CAUGHT AT THE END OF THE GUIDE AND ASKED FOR A NEW STENT. A SECOND DILATION USING THE SAME 2.5 X 15MM APEX BALLOON CATHETER WAS DONE AND THE RESULT WAS GOOD. ANOTHER 4.0 X 20MM PROMUS ELEMENT PLUS DRUG ELUTING STENT WAS INSERTED THROUGH THE SAME GUIDE ON THE SAME WIRE BUT FAILED TO CROSS THE MID RCA. AFTER SEVERAL ATTEMPTS IN PULLING THE STENT BACK THROUGH THE GUIDE, THE STENT CAME OFF THE DELIVERY SYSTEM AND STAYED IN THE PROXIMAL RCA. THE PHYSICIAN BELIEVES THAT THE STENT WAS CAUGHT ON THE DISTAL TIP OF THE GUIDE AND DISLODGED FROM THE DELIVERY BALLOON CATHETER. WITH THE GUIDE WIRE WAS STILL IN THE VESSEL AND THE STENT STILL OVER THE WIRE, A 1.5 X 20MM APEX FLEX BALLOON CATHETER WAS PASSED THROUGH THE EMBOLIZED STENT AND DILATED THE BALLOON AT 6 ATMOSPHERES. THE STENT WAS SUCCESSFULLY RETRIEVED TO THE DISTAL END OF THE GUIDE AND THE BALLOON WAS FURTHER INFLATED UP TO 8 ATMOSPHERES. THE LAUNCHER GUIDE, GUIDE WIRE AND THE BALLOON WAS REMOVED THROUGH THE 6F UNSPECIFIED SHEATH IN THE LEFT GROIN AND IT WAS NOTICED THAT THE STENT WAS NO LONGER ON THE 1.5 X 20MM APEX BALLOON CATHETER,A DETAILED EXAMINATION OF THE GUIDE AND SHEATH PROVIDED TO EVIDENCE OF THE STENT. THE PHYSICIAN ACCESSED THE SAME VESSEL AGAIN WITH A NON-BSC GUIDE CATHETER AND A NON-BSC GUIDE WIRE. THE MID RCA WAS DILATED AND A NON-BSC STENT WAS ADVANCED. THE FIRST ATTEMPT WAS UNSUCCESSFUL BUT AFTER SEVERAL ATTEMPTS THROUGH A NON-BSC GUIDE WIRE AND A GUIDELINER THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319517 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420400 15911608

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F FR4 MEDTRONIC LAUNCHER GUIDE| 4.0 X 20 PROMUS ELEMENT PLUS| 2.5 X 15 APEX RX BALLOON| 1.5 X 20 APEX FLEX BALLOON CATHETER| MEDTRONIC COUGAR GUIDE WIRE