BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 304415 · Received November 15, 2000

    Report

    Report Number
    2953738-2000-00068
    Event Type
    Injury
    Date Received
    November 15, 2000
    Date of Event
    October 17, 2000
    Report Date
    October 17, 2000
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28MM X 16MM DIAMETER X 16.5CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 2000. IT WAS NOTED THAT THE AORTIC ANATOMY INCLUDED A SHORT NECK. A ONE-MONTH FOLLOW-UP CT SHOWED NO ENDOLEAK. 5 MONTHS LATER, THE PT PRESENTED SYMPTOMATIC TO THE PHYSICIAN AND A CT SHOWED A PROXIMAL ENDOLEAK. IT IS NOTED THAT THE PHYSICIAN FELT NECK DILATION OCCURRED CAUSING THE PROXIMAL LEAK LEADING TO AN INCREASE IN THE ANEURYSM SIZE FROM 7.5CM TO 9.0CM. THE LEAK WAS NOT ABLE TO BE REPAIRED WITH ENDOVASCULAR TREATMENT DUE TO THE CLOSE PROXIMITY TO THE RENAL ARTERIES; THEREFORE, OPEN REPAIR WAS PERFORMED WITH EXPLANTATION OF THE DEVICES. THERE IS NO FURTHER INFO AVAILABLE AND THERE IS NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT AND THE PT IS DOING WELL.

    Description of Event or Problem · 1

    EXPLANT INVESTIGATION AND ANALYSIS CONCLUDED THAT THE GRAFT, MIGRATION WAS MOST LIKLEY CAUSED DUE TO A SHORT 9MM ANGULATED NECK WHICH MEASURED 53 DEGREES FROM MMS (MEDICAL MEDIA SYSTEMS), WHICH RESULTED IN AN INADEQUATE PROXIMAL SEAL. THE SINGLE FATIGUE FRACTURE NOTED ON RING 3 IS NOTE IN THE SEAL ZONE EVIDENCED BY THE NECK LENGTH OF 9MM, AND HENCE NOT THE LIKELY CAUSE FOR MIGRATION. THE TEAR IN THE GRAFT MATERIAL AND SOME SUTURES BREAKS ARE LIKLEY TO HAVE BEEN CAUSED DURING THE EXPLANT PROCEDURE AND NOT BELIEVED TO BE THE CAUSE FOR MIGRATION.

    Description of Event or Problem · 1

    THE CT SCAN RESULTS WERE SENT FOR FURTHER DESCRIPTION OF THE INCIDENT. THE PRE-IMPLANTATION 5/2000 CT SCAN WITH CONTRAST DEMONSTRATED ANUERYSMAL DILATATION OF THE ABDOMINAL AORTA BEGINNING AT THE TAKE-OFF OF THE BILATERAL RENAL ARTERIES EXTENDING TO OVER AN APPROXIMATELY 7.5CM AREA. DILATATION IS NOTED OF BOTH COMMON ILIAC ARTERIES. A BASELINE CT SCAN WITH CONTRAST ON 6/2000 SHOWED NO EVIDENCE OF A LEAK. THE ILIAC LIMBS OF THE GRAFT ARE TWISTED UPON THEMSELVES; IN THE CRANIAL EXTENT OF THE GRAFT, THE RIGHT ILIAC LIMB IS LEFTWARD AND CROSSED ANTERIOR TO THE LEFT LIMB IN A SPIRAL CONFIGURATION. A NON-CONTRAST CT SCAN ON 9/2000 SHOWS THE APPEARANCE OF THE STENT GRAFT TO BE STABLE. NO RETROPERITONEAL HEMORRHAGE OR SOFT TISSUE MASS IS APPRECIATED. ON OCTOBER 2000 A CT SCAN EARLY IN THE DAY SHOWED INDETERMINATE FINDINGS FOR AORTIC RUPTURE. A LATER CT CAN WAS PERFORMED TO RE-EVALUATE FOR AN AORTIC RUPTURE, WHICH SHOWED THE ABDOMINAL AORTIC ANEURYSM MEASURING 8.8 X 8.0CM IN SIZE. NO EVIDENCE OF AN EXTRA LUMINAL RUPTURE/LEAK IS DEMONSTRATED. HOWEVER, THE CURVE WITHIN THE NATIVE AORTIC ANEURYSM IS A SIGN OF IMPENDING RUPTURE. THIS IS ASSOCIATED WITH THE KNOWN LARGE ENDOVASCULAR LEAK CURRENTLY CONTAINED WITHIN THE NATIVE AORTA AND DOCUMENTED IN THE EARLIER STUDY. WITH THIS UPDATED INFO, THE DEVICE WAS NOT THE ROOT CAUSE OF THE LEAK. THE SHORT AORTIC NECK AND ANATOMY/CONFIGURATION OF THE NECK CONTRIBUTED TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA M0078202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention