BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3230379 · Received July 16, 2013

    Report

    Report Number
    2024168-2013-04482
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A PROCEDURAL CINE WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE RE-CANALIZED LAD SHOWS LONG DIFFUSE LESION AND THE POSSIBLE PRESENCE OF RESIDUAL THROMBUS. A METALLIC STENT IS BEING POSITIONED, DEPLOYED, AND POST DILATED WITH GOOD RESULT, BUT POSSIBLY UNDER-DEPLOYED. THE LUMEN OF THE LAD APPEARS TO HAVE AREAS OF NON-UNIFORM CONTRAST DENSITY, POSSIBLY DUE TO STENT DISRUPTION, BUT THE PRESENCE OF RESIDUAL THROMBUS CANNOT BE RULED OUT DUE TO THE CHARACTERISTIC APPEARANCE OF MULTIPLE SMALL FILLING DEFECTS ALONG THE LENGTH OF THE STENT. THERE IS A SERIES OF POST DILATATIONS WITH PROGRESSIVELY LARGER BALLOONS AND AN EXCELLENT FINAL RESULT WITH RESOLUTION OF THE FILLING DEFECTS. ALTHOUGH IT SHOULD BE NOTED THAT THE ORIGIN OF THE FIRST DIAGONAL ARTERY JUST DISTAL TO THE END OF THE STENTS CLEARLY HAS A FILLING DEFECT TYPICAL OF RESIDUAL THROMBUS. IT SHOULD BE NOTED THAT THE IFU STATES: ALTHOUGH THE SAFETY AND EFFECTIVENESS OF TREATING MORE THAN ONE VESSEL PER CORONARY ARTERY WITH XIENCE V STENTS HAS NOT BEEN ESTABLISHED, IF THIS IS PERFORMED, PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS. THROMBOSIS IS LISTED IN THE XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DISTAL TO STENT. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE XIENCE V REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, THROMBUS WAS INITIALLY ASPIRATED BEFORE THE LESION PRE-DILATATION. THE 3.5 X 28 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED IN THE PROXIMAL LAD USING 12 ATMOSPHERE (ATM); THE SDS BALLOON WAS USED FOR POST-DILATATION AT 16 ATM. THE SDS WAS REMOVED WITHOUT REPORTED ISSUE. A SECOND 3.5 X 12 MM XIENCE V SDS WAS ADVANCED AND DEPLOYED DISTAL TO THE FIRST STENT OVERLAPPING THE STENT AS IT WAS A LONG SEGMENT TO BE TREATED. AFTER DEFLATION THE SDS BALLOON COULD NOT BE REMOVED AND WAS STUCK WITH THE DEPLOYED STENT. THE PHYSICIAN INFLATED AND DEFLATED THE BALLOON SEVERAL TIMES, PULLING THE BALLOON BETWEEN EACH DEFLATION UNTIL THE BALLOON WAS RELEASED AND COULD BE REMOVED FROM THE ANATOMY. AFTER REMOVAL IT WAS NOTED THAT USING AN LV GRAM THAT THE OVERLAPPED STENT AREA APPEARED DISRUPTED. AN ANGIOGRAM WAS PERFORMED AND THE SEGMENT APPEARED ACCORDIONED/DEFORMED AND THROMBUS WAS NOTED. THE THROMBUS WAS ASPIRATED AND POST-DILATATION OF THE OVERLAPPED AREA WAS PERFORMED MULTIPLE TIMES USING A 3.5 X 12 MM NON-ABBOTT NON-COMPLIANT BALLOON DILATATION CATHETER (BDC) AT 18 ATM, FOLLOWED BY SEVERAL POST-DILATATIONS USING A 4.0 X 12 MM NON-ABBOTT NON-COMPLAINT BDC AT 16 ATM. A GOOD RESULT WAS NOTED AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329037 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2121041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention