BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1903806 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02474
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. FAILURE TO ADVANCE AND DIFFICULT TO REMOVE AN UNDEPLOYED STENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. FURTHER, STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, IMPROPER TECHNIQUE AND HANDLING DURING SHEATH REMOVAL AND PREPARATION FOR USE, OR INTERACTION WITH THE PATIENT ANATOMY AND/OR OTHER DEVICES. BASED ON THE REPORTED INFORMATION, THE REPORTED FAILURE TO ADVANCE, DIFFICULT TO REMOVE AND STENT DISLODGEMENT APPEARS TO BE RELATED TO THE USERS ATTEMPT TO ADVANCE DISTAL TO A RECENTLY IMPLANTED STENT. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE STATES: PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS. REPORTEDLY, AFTER ATTEMPTS TO CRUSH THE DISLODGED STENT, THE BLOOD FLOW WAS OCCLUDED. AS A RESULT, THE PATIENT WAS PLACED ON AN IABP (ADDITIONAL NON-SURGICAL TREATMENT) AND THE OCCLUSION WAS TREATED WITH BALLOON DILATATION (ADDITIONAL PERCUTANEOUS TRANSLUMINAL INTERVENTION (PTI)). BASED ON CONSULTATION WITH AN ABBOTT VASCULAR CLINICAL SPECIALIST, THE REPORTED OCCLUSION WAS LIKELY ASSOCIATED WITH THROMBOSIS FORMATION OF THE DISLODGED AND CRUSHED STENT. TOTAL OCCLUSION AND THROMBOSIS ARE BOTH LISTED AS POTENTIAL ADVERSE EVENTS OF CORONARY STENTING IN THE XIENCE V IFU. THE REPORTED EVENT APPEARS TO BE RELATED TO IMPROPER USE TECHNIQUE OF STENTING DISTAL TO A RECENTLY IMPLANTED STENT AND NOT A PRODUCT QUALITY DEFICIENCY. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR DAMAGE AND MEASURE FOR PROPER CRIMPED STENT PROFILE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA), AFTER PRE-DILATATION, A 3.5 X 23 XIENCE V STENT WAS DEPLOYED SUCCESSFULLY. AN ATTEMPT WAS MADE TO ADVANCE A PLANNED 3.5 X 8 XIENCE V STENT SYSTEM; HOWEVER, THE DEVICE BECAME CAUGHT ON THE PREVIOUSLY IMPLANTED STENT AND COULD NOT ADVANCE. AN ATTEMPT WAS MADE TO WITHDRAW THE STENT SYSTEM AND THE STENT DISLODGED. TWO NON-ABBOTT DILATATION BALLOONS WERE USED TO CRUSH THE STENT IN THE RCA. BLOOD FLOW WAS OCCLUDED AND THE PATIENT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP (IABP). BALLOON DILATATION WAS PERFORMED TO SUCCESSFULLY TREAT THE OCCLUSION. THE IABP WAS REMOVED AT AN UNSPECIFIED TIME AND ONE DAY POST PROCEDURE THE PATIENT WAS REPORTED AS DOING FINE. THOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other DIL CATH: 3.0X15 MAVERICK, 3.0X12 MAVERICK