BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 3090856 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02740
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. PT WEIGHT: ESTIMATED WEIGHT. 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. 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER PLACING AN UNSPECIFIED EMBOLIC PROTECTION SYSTEM PAST THE TARGET LESION, AN 8X30X136 XACT CAROTID SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED VIA FEMORAL ACCESS INTO A 6 FRENCH NON-ABBOTT SHEATH AND TO AN ECCENTRIC, 95% STENOSED, DE NOVO LESION IN THE NON-TORTUOUS, PROXIMAL INTERNAL CAROTID ARTERY WITHOUT RESISTANCE. ALTHOUGH THE DEPLOYMENT ACTUATOR KNOB WAS COMPLETELY ROTATED CLOCKWISE, THE STENT DID NOT RELEASE, BUT PARTIALLY EXPANDED. AN ATTEMPT WAS THEN MADE TO RELEASE THE STENT BY PULLING BACK THE DELIVERY SYSTEM (WITHOUT RESISTANCE FELT), BUT THE STENT WOULD NOT RELEASE PROPERLY. WHILE WITHDRAWING THE UNRELEASED STENT, THE STENT RELEASED INSIDE OF THE 6FR NON-ABBOTT SHEATH (AT THE LEVEL OF THE DISTAL THORACIC AORTA) AND WAS RETRIEVED FROM THE SHEATH USING AN UNSPECIFIED BALLOON CATHETER. AN UNSPECIFIED STENT WAS USED TO TREAT THE LESION, FOLLOWED BY POST-DILATATION, RESULTING IN 30% LESION STENOSIS. THERE WERE NO ADVERSE PATIENT SEQUELAE. THOUGH A 2 TO 3 MINUTE DELAY WAS REPORTED, IT WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191457 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2091061

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SHEATH: 6F TERUMO PINNACLE DESTINATION