BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2833906 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07193
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. XIENCE XPEDITION IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S. THE PMA# LISTED IS BASED ON THE PREDICATE DEVICE (XIENCE PRIME) AND IS THEREFORE SIMILAR TO A DEVICE SOLD IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). DURING ADVANCEMENT OF THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) TOWARDS THE LESION STRONG RESISTANCE WAS FELT AND THE SDS WOULD NOT CROSS. DURING RETRACTION OF THE SDS FROM THE PATIENT, STRONG RESISTANCE WAS MET WITH THE GUIDING CATHETER, AND IT WAS OBSERVED THAT THE STENT IMPLANT WAS NO LONGER ON THE BALLOON. ANGIOGRAPHY CONFIRMED THE DISLODGED STENT IMPLANT WAS IN THE PROXIMAL RCA. AFTER UNSUCCESSFUL ATTEMPTS TO ADVANCE AN UNKNOWN GUIDE WIRE THROUGH THE DISLODGED STENT IMPLANT, IN AN ATTEMPT TO TRY TO DEPLOY THE STENT WITH A BALLOON CATHETER, THE DECISION WAS MADE TO COMPRESS THE DISLODGED STENT AGAINST THE VESSEL WALL WITH ANOTHER XPEDITION STENT. A NEW 4.0X18 MM XPEDITION WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2070341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATH: SHERPA NX ACTIVE JR4 6F