BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143325 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04543
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED BLOOD AND CONTRAST VISIBLE IN THE BALLOON, CONSISTENT WITH PREPARATION AND SUGGESTS THE SEPARATION OCCURRED INSIDE THE PATIENT ANATOMY. ONLY THE DISTAL SEPARATED PORTION WAS RETURNED. THE PROXIMAL PORTION, (INCLUDING THE HUB) WAS NOT RETURNED. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE OUTER MEMBER WAS SEPARATED AT THE PROXIMAL SEAL. THE INNER MEMBER HAD STRETCHED AND SEPARATED PROXIMAL TO THE PROXIMAL SEAL. THE FRACTURE FACES WERE STRETCHED AND JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE ENTIRE LENGTH OF THE INNER MEMBER INSIDE THE BALLOON WAS BUNCHED. FACTORS THAT CAN CONTRIBUTE TO SHAFT SEPARATIONS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING DURING PREPARATION, PRODUCT PLACEMENT TECHNIQUE, FRACTURE/KINKED SHAFT, OR WEAK SEALS. IT IS POSSIBLE THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE RX XIENCE OVER THE GUIDE WIRE, AND AS RESISTANCE WAS ENCOUNTERED, IF EXCESSIVE FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE SHAFT BUNCHING AND ULTIMATELY SEPARATING; HOWEVER, AS NO RESISTANCE WAS REPORTED THIS COULD NOT BE CONFIRMED. ADDITIONAL HANDLING DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS MAY HAVE CONTRIBUTED TO THE NOTED STENT DISLODGEMENT; HOWEVER THIS COULD NOT BE CONFIRMED. SEVERAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION FROM THE ACCOUNT REGARDING THE CASE DETAILS; HOWEVER NO FURTHER INFORMATION WAS AVAILABLE. 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 HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR SHAFT SEPARATIONS OR STENT DISLODGMENTS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITH THE LIMITED INFORMATION RECEIVED ABOUT THE COMPLAINT, A CONCLUSIVE CAUSE FOR THE REPORTED SHAFT SEPARATION AND NOTED STENT DISLODGEMENT COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN THE ANATOMY THE XIENCE V STENT DELIVERY SYSTEM (SDS) SHAFT BROKE WHILE REMOVING THE SDS OFF THE GUIDE WIRE. THERE WERE NO DETAILS PROVIDED OR AVAILABLE FROM THE USER FACILITY ABOUT THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THAT THE DISTAL SHAFT WAS DETACHED; ADDITIONALLY, THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED.

    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 1032841

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR