BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2883641 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02458
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (VESSEL DISSECTION, STENT GRAFT OCCLUSION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OCCLUSIVE DISSECTION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OCCLUSIVE DISSECTION).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PRE-OCCLUSIVE DISSECTION OF LEFT EXTERNAL ILIAC ARTERY AS EVIDENCED BY ANGIOGRAPHY AND SUCCESSFULLY REPAIRED ONE DAY LATER. THE INVESTIGATOR ASSESSED THIS EVENT TO BE RELATED TO THE STUDY PROCEDURE BUT NOT THE STUDY DEVICE OR THE ANEURYSM.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO MONTHS AGO. A 2.0 CM MAXIMUM DIAMETER ANEURYSM WAS ALSO REPORTED IN THE ILIAC ARTERY. PROXIMAL AORTA WAS 22 MM IN DIAMETER AND 30 MM IN LENGTH. RIGHT ILIAC ARTERY WAS 16 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 16 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 8 MM IN DIAMETER. THERE WAS NO PRESENCE OF CIRCUMFERENTIAL THROMBUS OR CALCIFICATION. IT WAS REPORTED AT THE ONE MONTH FOLLOW-UP THE PATIENT WAS ADMITTED FOR LEFT LIMB ISCHEMIA. ACCORDING TO THE PHYSICIAN, THE CAUSE WAS A PRE-OCCLUSIVE DISSECTION OF THE LEFT EXTERNAL ILIAC ARTERY. THE DISSECTION THAT WAS NOTED AT THIS FOLLOW-UP VISIT ALTERED THE FLOW AND AS A CONSEQUENCE THERE WAS AN OCCLUSION IN LEFT CONTRALATERAL SIDE OF STENT GRAFT. A FEM-FEM BYPASS WAS PERFORMED AT A LATER DATE AND THE EVENT WAS UNRESOLVED (CONTINUING). THE INVESTIGATOR ASSESSED THIS EVENT TO BE RELATED TO THE STUDY PROCEDURE AND NOT THE STUDY DEVICE OR THE ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01097236

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention