BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2854967 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07642
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE KINKS/BENDS AND SHAFT SEPARATION WERE CONFIRMED. THE FAILURE TO ADVANCE/CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL 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 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 2.5 X 28 RX XIENCE PRIME MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE DEVICE HAS BEEN RECEIVED, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO STENT A LESION FROM THE DISTAL TO PROXIMAL CIRCUMFLEX CORONARY ARTERY, AFTER PRE-DILATING THE LESION, A 2.75 X 28 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD A HEAVILY CALCIFIED DE NOVO LESION IN THE HEAVILY TORTUOUS PROXIMAL CIRCUMFLEX CORONARY ARTERY, HOWEVER, THE SDS WAS UNABLE TO CROSS THE LESION DUE TO THE HEAVY TORTUOSITY AND CALCIFICATION AND THE DISTAL SHAFT SUBSEQUENTLY BENT; DURING AN ATTEMPT TO STRAIGHTEN THE BENT SHAFT WHILE IN THE ANATOMY, THE DISTAL SHAFT SEPARATED INTO TWO PIECES. THE DEVICE WAS ABLE TO BE WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE. ANOTHER ATTEMPT WAS MADE TO CROSS THE LESION WITH A 2.5 X 28 RX XIENCE PRIME SDS, HOWEVER, THIS SDS ALSO FAILED TO CROSS THE LESION AND THE DISTAL SHAFT SUBSEQUENTLY BENT; DURING AN ATTEMPT TO STRAIGHTEN THE BENT SHAFT WHILE IN THE ANATOMY, THE DISTAL SHAFT SEPARATED INTO TWO PIECES FOR THIS DEVICE ALSO. THIS DEVICE WAS ALSO ABLE TO BE WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE. AS BOTH DEVICES WERE UNABLE TO CROSS THE DISTAL LESION AREA, A 2.75 X 23 RX XIENCE PRIME STENT WAS DEPLOYED IN ONLY THE PROXIMAL AREA OF THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED REPORT, THE RETURNED GOODS LAB RECEIVED THE 2.75X28 RX XIENCE PRIME STENT DELIVERY SYSTEM WITH THE HYPOTUBE (PROXIMAL SHAFT) SEPARATED; NO SEPARATION WAS NOTED IN THE DISTAL SHAFT AREA OF EACH DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1092341

    Patients

    Seq Age Sex Outcome Treatment
    1