BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1910592 · Received November 30, 2010

    Report

    Report Number
    2024168-2010-02564
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED, SUBSEQUENT INFORMATION INDICATES THE DEVICE IS NOT RETURNING FOR INVESTIGATION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT, AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE LESION CONDITION WAS DESCRIBED AS TOTALLY OCCLUDED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO CROSS. FACTORS WHICH MAY CONTRIBUTE TO RESISTANCE DURING RETRACTION INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, STENT IMPLANT OUTER DIAMETER, PATIENT ANATOMY, DAMAGE TO THE STENT IMPLANT, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, OR DAMAGE TO THE GUIDING CATHETER. IT IS POSSIBLE THAT DURING THE ATTEMPT TO CROSS THE LESION, AN INTERACTION WITH THE LESION/ANATOMY MAY HAVE RESULTED IN DISRUPTION OF THE STENT ON THE BALLOON. THEN, DURING RETRACTION OF THE STENT DELIVERY SYSTEM (SDS), THE STENT INTERACTED WITH THE ANATOMY, CAUSING RESISTANCE AND ULTIMATELY STENT DISLODGEMENT. THE DISLODGED STENT WAS RETRIEVED AND REMOVED FROM THE BODY BY A SNARE DEVICE AND THE TARGET LESION WAS TREATED WITH BALLOON ANGIOPLASTY ONLY. TO HELP ENSURE THIS DIFFICULTY IS NOT RELATED TO A MANUFACTURING DEFICIENCY, THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE. THE SDS USED DURING THE PROCEDURE WAS NOT RETURNED WHICH MAY HAVE ASSISTED IN THE INVESTIGATION AND DETERMINATION OF A CAUSE OF THE REPORTED DIFFICULTIES. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, ON-LINE TEST DATA FOR THIS LOT SHOWS ALL UNITS PASSED THE MANUFACTURING CRITERIA. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE FAILURE TO CROSS IS LIKELY RELATED TO OPERATIONAL CONTEXT, HOWEVER, A DEFINITIVE CAUSE OF THE DIFFICULTY TO REMOVE AND STENT DISLODGMENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    AS REPORTED, THERE WAS A BALLOON BURST AND A NEW FOGARTY CATHETER HAD TO BE USED. NO CLINICAL CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE TOTALLY OCCLUDED, DENOVO LESION IN THE RIGHT CORONARY ARTERY WAS PRE-DILATATED USING TWO BALLOONS, RESISTANCE WAS MET ADVANCING THE STENT DELIVERY SYSTEM AND THE DELIVERY CATHETER COULD NOT REACH THE LESION. DURING REMOVAL OF THE DELIVERY CATHETER, RESISTANCE WAS FELT AND THE STENT DISLODGED FROM THE BALLOON IN THE RIGHT COMMON FEMORAL ARTERY. THE STENT WAS RETRIEVED AND REMOVED FROM THE BODY USING A SNARE VIA THE CONTRALATERAL FEMORAL APPROACH. THERE WAS NO ADVERSE PATIENT SEQUELA. THE TARGET LESION WITH TREATED WITH BALLOON ANGIOPLASTY ONLY. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED 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-CLONMEL 0090341

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention UNSPECIFIED DILATATION BALLOONS (X2)