BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2771203 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06269
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. STENT DISLODGEMENT WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED AT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE FIRST DIAGONAL BRANCH. THE XIENCE PRIME 3.0 X 23 MM STENT WAS ADVANCED TO THE LAD, HOWEVER, IT WOULD NOT CROSS. DURING RETRACTION TO THE GUIDING CATHETER, THE STENT DISLODGED FROM THE BALLOON AND MIGRATED TO THE FEMORAL ARTERY. A MICROSNARE CATHETER WAS USED TO SUCCESSFULLY RETRIEVE THE DISLODGED STENT FROM THE FEMORAL ARTERY. A PROMUS 3.0 X 23 MM STENT WAS IMPLANTED IN THE LAD AND A XIENCE 2.25 X 8 MM STENT WAS IMPLANTED IN THE OSTIUM OF THE FIRST DIAGONAL. THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2131541

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention