BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2170567 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05057
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED STENT DELIVERY SYSTEM (SDS) FOUND NO BLOOD VISIBLE AND CONTRAST ON THE BALLOON AND SHAFT. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS ON THE STYLET. THERE WERE MANGLED STRUTS IN THE DISTAL END AND MIDDLE PORTION OF THE STENT IMPLANT. THE ENTIRE LENGTH OF THE STENT IMPLANT WAS SLIGHTLY SMASHED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS OF THE TIGHTLY FOLDED BALLOON. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE YELLOW PROTECTIVE SHEATH WAS RETURNED. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE FLARED PORTION OF THE YELLOW PROTECTIVE SHEATH. THE STENT IMPLANT OUTER DIAMETERS WERE NOT MEASURED DUE TO THE DAMAGE NOTED. IN THIS CASE, IT DOES NOT APPEAR THAT THE SHEATH INTERACTED OR CONTRIBUTED TO THE STENT DISLODGEMENT AS IT WAS REPORTED THAT THERE WAS NO RESISTANCE DURING SHEATH REMOVAL. IT IS POSSIBLE THAT HANDLING OF THE STENT DURING ATTEMPT TO PREP THE SDS MAY HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT AS THERE WAS EVIDENCE OF CONTRAST ON THE BALLOON AND SHAFT. HOWEVER, THE STENT WAS NOTED TO BE SLIGHTLY SMASHED WHICH MOST LIKELY RESULTED FROM HANDLING OF THE PRODUCT POST-PROCEDURE DURING PACKING FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR INVESTIGATION. POTENTIAL CAUSES FOR STENT DISLODGEMENT, MAY INCLUDE IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION FOR USE, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION FOR USE. ALL STENT DELIVERY SYSTEM ARE INSPECTED FOR PROPER STENT PLACEMENT AND CRIMPED STENT OUTER DIAMETER. IN ADDITION, AS PART OF PRODUCT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR STENT DISLODGEMENT FORCE. ALTHOUGH A CONCLUSIVE CAUSE CAN NOT BE DETERMINED FOR THE REPORTED STENT DISLODGEMENT THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS REVEALED NO NONCONFORMING MATERIAL RECORDS RELATED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR STENT DISLODGEMENT FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE XIENCE V WAS REMOVED FROM THE HOOP AND JUST BEFORE PREP, THE STENT FELL OFF THE BALLOON. THERE WAS NO NOTED RESISTANCE UPON REMOVAL OF THE PROTECTIVE SHEATH OR THE REMOVAL OF THE STYLET. ANOTHER XIENCE V OF THE SAME SIZE WAS USED WITH NO ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 1041541

    Patients

    Seq Age Sex Outcome Treatment
    1