BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1885199 · Received October 28, 2010

    Report

    Report Number
    2134265-2010-04726
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 80-90% STENOSED, 4MM WIDE BY 36-38MM LONG TARGET LESION HAD A 45 DEGREE BEND AND WAS LOCATED IN THE SEVERELY CALCIFIED AND NON-TORTUOUS LEFT MAIN (LM) TO PROXIMAL TO MID CIRCUMFLEX ARTERY (CX). THE LESION WAS PREDILATED WITH A 3X20MM BALLOON INFLATED TO 14-18BARRS. AFTER PREDILATING THE LESION, THE STENOSIS WAS REDUCED TO 40%. THEN A 4.0X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND IT CROSSED THE PROXIMAL SECTION OF THE LESION BUT COULD NOT ADVANCE TO THE CX. THE STENT WAS PULLED BACK INTO THE GUIDE CATHETER AND THE DELIVERY DEVICE WAS REMOVED. THE LESION WAS FURTHER DILATED WITH A 3.5X20 BALLOON. HOWEVER, WHEN THE SDS WAS RE-ADVANCED IT STILL COULD NOT CROSS THE LESION. UPON PULLING THE DELIVERY SYSTEM BACK INTO THE GUIDE, THE STENT GOT CAUGHT AND DISLODGED IN THE LM. THE STENT WAS LOCATED IN THE LM AND FIRST SEGMENT OF THE CX WITH THE PROXIMAL SEGMENT OF THE STENT LOCATED IN THE AORTA. ATTEMPTS TO RETRIEVE THE STENT WITH A BALLOON AND BASKET DEVICE WERE UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED AT THIS TIME AND THE STENT REMAINS IN THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. POST PROCEDURE, THE PATIENT'S HEMODYNAMIC PARAMETERS WERE NORMAL, THE MYOCARDIAL ENZYMES DID NOT RISE AND THE PATIENT DID NOT HAVE ANGINA. THE PATIENT WILL BE SENT FOR BYPASS SURGERY BUT IT HAS BEEN POSTPONED AS THE PATIENT IS ON CLOPIDOGREL AND ASPIRIN. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 80-90% STENOSED, 4MM WIDE BY 36-38MM LONG TARGET LESION HAD A 45 DEGREE BEND AND WAS LOCATED IN THE SEVERELY CALCIFIED AND NON-TORTUOUS LEFT MAIN (LM) TO PROXIMAL TO MID CIRCUMFLEX ARTERY (CX). THE LESION WAS PREDILATED WITH A 3X20MM BALLOON INFLATED TO (B)(4). AFTER PREDILATING THE LESION, THE STENOSIS WAS REDUCED TO 40%. THEN A 4.0X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND IT CROSSED THE PROXIMAL SECTION OF THE LESION, BUT COULD NOT ADVANCE TO THE CX. THE STENT WAS PULLED BACK INTO THE GUIDE CATHETER AND THE DELIVERY DEVICE WAS REMOVED. THE LESION WAS FURTHER DILATED WITH A 3.5X20 BALLOON. HOWEVER, WHEN THE SDS WAS RE-ADVANCED IT STILL COULD NOT CROSS THE LESION. UPON PULLING THE DELIVERY SYSTEM BACK INTO THE GUIDE, THE STENT GOT CAUGHT AND DISLODGED IN THE LM. THE STENT WAS LOCATED IN THE LM AND FIRST SEGMENT OF THE CX WITH THE PROXIMAL SEGMENT OF THE STENT LOCATED IN THE AORTA. ATTEMPTS TO RETRIEVE THE STENT WITH A BALLOON AND BASKET DEVICE WERE UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED AT THIS TIME AND THE STENT REMAINS IN THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. POST PROCEDURE, THE PATIENT'S HEMODYNAMIC PARAMETERS WERE NORMAL, THE MYOCARDIAL ENZYMES DID NOT RISE AND THE PATIENT DID NOT HAVE ANGINA. THE PATIENT WILL BE SENT FOR BYPASS SURGERY, BUT IT HAS BEEN POSTPONED AS THE PATIENT IS ON CLOPIDOGREL AND ASPIRIN. THIS PRODUCT IS ONLY (B)(4) 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 H7493911338400 13395532

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BMW 0.014" GUIDE WIRE