BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2193637 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05569
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 11, 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. ALTHOUGH THE RETURN OF THE XIENCE STENT DELIVERY SYSTEM (SDS) MAY HAVE ASSISTED IN DETERMINING A CONCLUSIVE CAUSE, THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE EXPERIENCED DIFFICULTIES. 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 ANATOMICAL CONDITIONS WERE NOT REPORTED, HOWEVER, SINCE ADDITIONAL PRE-DILATATION WAS PERFORMED, THIS SUGGESTS THE LESION WAS DIFFICULT AND THUS LIKELY CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. FURTHER, IT WAS REPORTED THE SDS WAS RE-INSERTED INTO THE ANATOMY AFTER THE FIRST FAILED ATTEMPT TO CROSS. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. [SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED OR/AND DISLODGED FROM THE BALLOON WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER.] IN THIS INSTANCE, THE INTERACTION WITH THE ANATOMY DURING THE MULTIPLE ATTEMPTS TO CROSS THE LESION MOST LIKELY RESULTED IN DISRUPTION OF THE STENT ON THE BALLOON AND ULTIMATELY LEAD TO THE STENT DISLODGEMENT. THE REPORTED ADDITIONAL THERAPY AND DEVICE EMBEDDED IN VESSEL OR PLAQUE APPEARS TO BE SECONDARY EFFECTS OF THE REPORTED STENT DISLODGEMENT AS THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL WITH ANOTHER STENT. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A SAMPLING OF UNITS IS ALSO SUBJECT TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY AND DISLODGEMENT FORCE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR STENT RETENTION ISSUES FOR THIS LOT. THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT, THE REPORTED FAILURE TO ADVANCE, STENT DISLODGEMENT, AND SUBSEQUENT DEVICE EMBEDDED IN VESSEL OR PLAQUE AND ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE DISTAL LEFT CIRCUMFLEX (LCX). AFTER PREDILATATION WAS PERFORMED, AN ATTEMPT WAS MADE TO CROSS THE LESION WITH A 2.5X15 MM XIENCE V STENT DELIVERY SYSTEM (SDS); HOWEVER, IT WOULD NOT CROSS. ADDITIONAL PREDILATATION WAS PERFORMED; HOWEVER, DURING THE ATTEMPT TO CROSS WITH THE SAME XIENCE V SDS, THE STENT DISLODGED FROM THE BALLOON IN THE MID LCX. A NON-ABBOTT STENT WAS DEPLOYED COMPRESSING THE DISLODGED STENT TO THE VESSEL WALL. POST-DILATATION WAS PERFORMED TO COMPLETE THE PROCEDURE. THE TARGET LESION WAS LEFT UNTREATED. 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 1030141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention