BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061463 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02710
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, INTERACTION WITH THE STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. AS THE BALLOON RUPTURED DURING INFLATION, THE STENT WAS NOT FULLY DEPLOYED, REQUIRING ADDITIONAL TREATMENT TO FULLY DEPLOY THE STENT. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY THE RATED BURST PRESSURE AND BALLOON INTEGRITY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO DEPLOY OR BALLOON RUPTURE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION, THE XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. THE VESSEL AND LESION SITE LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WERE CHARACTERIZED AS NON-TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, DE NOVO AND 90% STENOSED. AT FIRST INFLATION, THE SDS BALLOON RUPTURED AT 7 ATMOSPHERES. THEREFORE, THE PARTIALLY DEPLOYED XIENCE V STENT WAS DILATED WITH A NON-ABBOTT BALLOON CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0102041

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention GW: RUNTHROUGH NS