BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 10302765 · Received July 21, 2020

    Report

    Report Number
    2024168-2020-06057
    Event Type
    Death
    Date Received
    July 21, 2020
    Date of Event
    November 1, 2017
    Report Date
    September 4, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    FGE
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT ARTICLE TITLED: "FROM THE AORTIC BIFURCATION TO THE GROIN: LONG-TERM OUTCOMES OF COVERED KISSING STENT PLACEMENT IN COMBINATION WITH ILIOFEMORAL RECONSTRUCTION FOR EXTENSIVE ILIOFEMORAL OCCLUSIVE DISEASE"D1: CORRECTED TO ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM G5: CORRECTED TO PMA P110028.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSOLUTE PRO VASCULAR THAT MAY BE RELATED TO THE FOLLOWING: DEATH, PULMONARY EMBOLISM, CARDIAC FAILURE, HEMATOMA, DELAYED WOUND HEALING, MYOCARDIAL INFARCTION, STENOSIS, THROMBOSIS, IN-STENT RESTENOSIS, REVASCULARIZATION SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: FROM THE AORTIC BIFURCATION TO THE GROIN: LONG-TERM OUTCOMES OF COVERED KISSING STENT PLACEMENT IN COMBINATION WITH ILIOFEMORAL RECONSTRUCTION FOR EXTENSIVE ILIOFEMORAL OCCLUSIVE DISEASE. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS NOTED THAT 35% OF THE STENTS USED IN THE STUDY WERE ABSOLUTE PRO VASCULAR STENTS AND ABSOLUTE PRO VASCULAR STENTS WERE NOT USED IN ALL PROCEDURES. THE ARTICLE INDICATES THAT PATIENT MORTALITY OCCURRED AT 30 DAYS AND LONG TERM; HOWEVER, ¿NO DEATH WAS DIRECTLY RELATED TO PERIPHERAL ARTERY DISEASE¿. ALTHOUGH PATIENT EFFECTS OBSERVED DURING THE STUDY ARE LISTED IN THE ARTICLE, THE RELATIONSHIP OF THE ABSOLUTE PRO VASCULAR DEVICE TO THE PATIENT EFFECTS CANNOT BE ESTABLISHED AS THE ARTICLE DOES NOT LIST THE OUTCOMES IN RELATION TO THE STENT NAME.

    Additional Manufacturer Narrative · 1

    DATES OF DEATH, EVENT, AND IMPLANT: ESTIMATED DATE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS). THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE ABSOLUTE PRO INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL PATIENT EFFECT ASSOCIATED WITH THE USE OF A STENT IN PERIPHERAL ARTERIES AND OR BILIARY TREE. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT DEATHS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT#.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSOLUTE PRO THAT MAY BE RELATED TO THE FOLLOWING: DEATH, PULMONARY EMBOLISM, CARDIAC FAILURE, HEMATOMA, DELAYED WOUND HEALING, MYOCARDIAL INFARCTION, THROMBOSIS, IN-STENT RESTENOSIS, REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: FROM THE AORTIC BIFURCATION TO THE GROIN: LONG-TERM OUTCOMES OF COVERED KISSING STENT PLACEMENT IN COMBINATION WITH ILIOFEMORAL RECONSTRUCTION FOR EXTENSIVE ILIOFEMORAL OCCLUSIVE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769118 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM FGE ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death