BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3173593 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03777
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE FAILURE TO ADVANCE/CROSS, RESISTANCE DURING WITHDRAWAL, AND LOOSE STENT IMPLANT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS 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 THIS PROCEDURE WAS TO TREAT PATIENT WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY IN AN UNKNOWN VESSEL. THE 3.5X28 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. DURING RETRACTION OF THE SDS FROM THE PATIENT, RESISTANCE WAS FELT AND THE STENT IMPLANT WAS OBSERVED TO BE LOOSE ON THE BALLOON. DUE TO THE HEAVY CALCIFICATION, THERE WAS CONCERN THAT THE STENT IMPLANT MIGHT DISLODGE; THEREFORE, THE DECISION WAS MADE TO IMPLANT THE STENT IN AN UNINTENDED SITE BEFORE IT REACHED THE TARGET LESION. THE STENT IMPLANT REMAINS IN THE PATIENT'S BODY. THE PROCEDURE WAS FINISHED BY USING NON-ABBOTT PRODUCTS. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273742 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2012741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention