BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3133364 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03340
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (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. AS THE STENT IMPLANT WAS DEPLOYED IN THE LESION, STENT MOVEMENT COULD NOT BE VERIFIED. 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. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED AND TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD), PRE-DILATATION WAS PERFORMED AND A 2.5X28 RX XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED VIA FEMORAL ACCESS FOR TREATMENT OF A DE NOVO LESION. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE SDS AND THE PHYSICIAN CONTINUED TO PUSH THE SDS. THE STENT BECAME LOOSE ON THE BALLOON. THE DECISION WAS MADE TO DEPLOY THE STENT IN THE LAD BEFORE REACHING THE TARGET LESION AS THERE WAS CONCERN THAT THE STENT MIGHT DISLODGE PRIOR TO REACHING THE TARGET SITE DUE TO THE HEAVY CALCIFICATION IN THE VESSEL. THE TARGET LESION WAS TREATED USING NON-ABBOTT DEVICES. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE RETURNED DEVICE ANALYSIS FOUND THAT THE HUB HAD SEPARATED FROM THE SDS AND WAS NOT RETURNED. ADDITIONAL REPORTED INFORMATION CONFIRMED THAT THE HUB SEPARATED DURING RETURN PACKAGING AND THE HUB WAS DISCARDED BY THE SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237220 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other