BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3881627 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03905
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED LEAK WAS CONFIRMED. PHYSICAL RESISTANCE AND DIFFICULTY TO DEPLOY/WALL APPOSITION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE HEAVILY CALCIFIED, MID LEFT ANTERIOR DESCENDING ARTERY. AFTER PLACEMENT OF A WHISPER ES GUIDE WIRE ACROSS THE LESION, PREDILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER AND ATTEMPT WAS MADE TO CROSS WITH THE 2.5X23 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS); HOWEVER, IT FAILED TO CROSS. ADDITIONAL PREDILATATION WAS PERFORMED WITH A DIFFERENT NON-ABBOTT BALLOON CATHETER AND A SECOND ATTEMPT WAS MADE TO CROSS WITH THE SAME XIENCE XPEDITION SDS; HOWEVER, IT STILL FAILED TO CROSS. AFTER EXCHANGING THE GUIDE WIRE A THIRD ATTEMPT TO CROSS THE LESION WITH THE SAME XIENCE XPEDITION SDS AND THIS TIME IT WAS ABLE TO CROSS. THERE WAS NO RESISTANCE REPORTED BETWEEN THE SDS AND EITHER OF THE GUIDE WIRES USED IN THE PROCEDURE. WHEN INFLATING THE XIENCE XPEDITION BALLOON FOR STENT DEPLOYMENT, NO CONTRAST COULD BE SEEN AND THE BALLOON DID NOT MAINTAIN PRESSURE; HOWEVER, THE STENT IMPLANT WAS ABLE TO BE DEPLOYED PARTIALLY AT THE TARGET LESION; HOWEVER, REQUIRED THE NEED FOR AN ADDITIONAL BALLOON CATHETER TO FULLY APPOSE THE STENT IMPLANT TO THE VESSEL WALL. THE XIENCE XPEDITION SDS WAS INSPECTED AND A LEAK WAS OBSERVED DISTAL TO THE GUIDE WIRE EXIT NOTCH. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358085 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4022641

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention GUIDE WIRE: WHISPER ES, ZINGER ES