BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3002632 · Received March 13, 2013

    Report

    Report Number
    2024168-2013-01442
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED (RCA) RIGHT CORONARY ARTERY. NO PREDILATATION WAS PERFORMED PRIOR TO THE ATTEMPT TO STENT. THE FIRST 3.0X12 MM XIENCE XPEDITION FAILED TO CROSS THE LESION AND WAS RETRACTED FROM THE ANATOMY WITHOUT RESISTANCE. AFTER RETRACTION A STENT STRUT WAS OBSERVED TO BE FLARED. PREDILATATION WAS PERFORMED WITH A 3.0 TREK BALLOON CATHETER AT THE LESION AND THE OSTIUM OF THE RCA. THE SECOND 3.0X12 MM XIENCE XPEDITION ADVANCED TO THE LESION WITH SLIGHT RESISTANCE FELT; HOWEVER, DURING THE ATTEMPT TO REPOSITION THE CATHETER, THE STENT IMPLANT DISLODGED FROM THE BALLOON, IN THE INTENDED SITE. A 3.0 TREK BALLOON CATHETER WAS ADVANCED INSIDE THE DISLODGED STENT AND THE STENT WAS DEPLOYED IN THE INTENDED SITE SUCCESSFULLY; HOWEVER, THIS DELAYED THE PROCEDURE WHICH LASTED APPROXIMATELY 3 HOURS LONGER. THE DELAY IN THE PROCEDURE WAS NOT CLINICALLY SIGNIFICANT FOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105296 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2092641

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention