BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3023091 · Received March 27, 2013

    Report

    Report Number
    2024168-2013-01748
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. ATTACHMENT: UNILATERAL ILIAC ARTERY STENTING IMPROVES PERFUSION AND SYMPTOMS IN BOTH LIMBS IN PATIENTS WITH BILATERAL ILIAC LESION.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE ARTICLE: UNILATERAL ILIAC ARTERY STENTING IMPROVES PERFUSION AND SYMPTOMS IN BOTH LIMBS IN PATIENTS WITH BILATERAL ILIAC LESION. IT WAS REPORTED THAT SIXTEEN PATIENTS WITH CHRONIC OCCLUSIONS WERE TREATED WITH UNILATERAL ANGIOPLASTY/STENTING. CLINICAL SUCCESS WAS 100% FOR THE TREATED LIMB IMMEDIATELY AFTER THE PROCEDURE AND 93.8% FOR THE CONTRALATERAL LIMB. ONE PATIENT WITH ISCHEMIC REST PAIN IN THE OCCLUDED LIMB CONTINUED TO EXPERIENCE SEVERE SYMPTOMS AFTER CONTRALATERAL CIA STENTING DESPITE HEMODYNAMIC IMPROVEMENT; HE HAD A FEMORO-FEMORAL GRAFT IMPLANTED 2 MONTHS AFTER THE INITIAL INTERVENTION AND WAS CONSIDERED THE ONLY CLINICAL FAILURE. DURING A MEAN 24-MONTH FOLLOW-UP, ALL STENTED ARTERIES REMAINED PATENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126344 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R