BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 5141747 · Received October 9, 2015

    Report

    Report Number
    2953200-2015-01713
    Event Type
    Injury
    Date Received
    October 9, 2015
    Date of Event
    September 12, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF RETURNED CT TRANSVERSE IMAGES AND A SINGLE 3D RECON IMAGE FROM 33 MONTHS POST-IMPLANT CONFIRMED THAT AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT. THE AORTA AND ILIAC VESSELS WERE CALCIFIED, AND BOTH ILIAC ARTERIES WERE ANEURYSMAL AND COMMUNICATED WITH EACH OTHER. THERE WAS NO AAA. THE BIFURCATE WAS POSITIONED PROXIMALLY SEVERAL MM¿S BELOW THE LOWEST LEFT RENAL ARTERY. THE PROXIMAL STENT GRAFT OD WAS 29MM. THE BIFURCATE WAS PLACED UP THE LEFT SIDE AND EXTENDED WITH A LIMB INTO THE LEFT EXTERNAL ILIAC ARTERY. THE LCIA WAS APPROXIMATELY 6CM IN DIAMETER AND THE LIIA HAD BEEN COILED. THE CONTRA LIMB WAS PLACED INTO THE DISTAL RCIA. THE MAX DIAMETER RCIA MEASURED 3CM. A LIKELY TYPE II ENDOLEAK WAS SEEN FEEDING THE LCIA ANEURYSM; THE ENDOLEAK CONTRAST WAS CONTINUOUS AS IT TRACKED PROXIMALLY INTO THE ABDOMINAL AORTA AND TERMINATED APPROXIMATELY 1CM DISTAL TO THE LEVEL OF THE CONTRA GATE BETWEEN BOTH THE IPSI AND CONTRA LIMBS. THE CONTRAST COULD NOT BE CONFIRMED (OR RULED OUT) IF ALSO COMING OUT OF A PIN HOLE FROM EITHER THE CONTRA OR IPSI LIMB. THROMBUS WAS SEEN WITHIN THE OVERLAPPING BIFURCATE IPSI LIMB AND LEFT ILIAC EXTENSION, BEGINNING APPROXIMATELY 2CM BELOW THE GATE (NEAR THE PROXIMAL LIMB MARKERS) AND EXTENDED DISTALLY ACROSS THE ANEURYSMAL LEFT ILIAC ARTERY. NO SIGNIFICANT THROMBUS WAS SEEN DISTAL TO THE LEFT ILIAC ANEURYSM OR WITHIN THE DISTAL LEFT LIMB EXTENSION AND LEFT LEG VESSELS. THE ID OF THE LEFT THROMBOSED LIMBS MEASURED 14 ¿ 15MM, AND THE ID OF THE PATENT LEFT LIMB WITHIN THE LEFT EXTERNAL WAS 7 ¿ 9MM. DISTAL TO THE LEFT LIMB, THE LEFT EXTERNAL ILIAC ARTERY DIAMETER RANGED FROM 8 ¿ 7 ¿ 6MM. THROMBUS WAS ALSO SEEN WITHIN THE RIGHT/CONTRA LIMB BEGINNING APPROXIMATELY 3CM BELOW THE LEVEL OF THE GATE AND EXTENDING TO THE DISTAL END OF THE RIGHT LIMB. THE DISTAL STENT GRAFT ID MEASURED 23MM AND THE FLOW LUMEN DIAMETER WAS 18MM. NO STENT GRAFT KINKS OR COMPRESSION WAS SEEN WITH EITHER LIMB. THE EXACT CAUSE OF THE LEFT ILIAC ARTERY ANEURYSM RUPTURE COULD NOT BE DETERMINED FROM THE IMAGES PROVIDED. A LIKELY TYPE II ENDOLEAK WAS SEEN FEEDING THE ANEURYSM WHICH MAY HAVE CONTRIBUTED TO THE RUPTURE. CONTRAST WAS ALSO SEEN ADJACENT TO BOTH LIMBS NEAR THE LEVEL OF THE FLOW DIVIDER; HOWEVER, A POSSIBLE TYPE III FABRIC ENDOLEAK FROM EITHER LIMB COULD NOT BE CONFIRMED AS THIS CONTRAST APPEARED TO BE FROM THE SAME TYPE II SOURCE. IF THERE WAS A PIN HOLE, THE PATIENT¿S ANTICOAGULATION MEDICATION MAY HAVE CONTRIBUTED TO A TYPE III FABRIC ENDOLEAK. THE CAUSE OF THE THROMBUS SEEN WITHIN BOTH LIMBS COULD NOT BE DETERMINED. THIS MAY BE A PATIENT CONDITION; POOR DISTAL RUNOFF. ANGIO IMAGES FROM THE INTERVENTION WHICH RESOLVED THIS REPORTED PIN-HOLE LIMB ENDOLEAK WERE NOT AVAILABLE FOR REVIEW.

    Description of Event or Problem · 1

    AN ENDURANT ILIAC STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND ILIAC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AND COMPLAINED OF ABDOMINAL PAIN. A CT WAS DONE AND CONFIRMED THAT THERE WAS A RUPTURE OF THE LEFT COMMON ILIAC ARTERY ANEURYSM. THE SUSPECTED CAUSE OF THE ANEURYSM RUPTURE WAS A TYPE III ENDOLEAK THAT LOOKS LIKE A PIN HOLE ON THE RIGHT ENDURANT 16/24/124 LIMB. AN ENDURANT 16/24/124 WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND IMPLANTED IN THE SAME LOCATION AS THE PREVIOUS ENDURANT 16/24/124 HAD BEEN IMPLANTED. THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THERE MAY BE A TYPE III LEAK THAT LOOKS LIKE A PIN HOLE ON THE LIMB. IT APPEARS THAT THE LEAK FROM THE RIGHT CONTRALATERAL LIMB REACHED THE LEFT COMMON ILIAC ARTERY ANEURYSM AND CAUSED THE ANEURYSM TO RUPTURE. THROMBOSIS DID NOT OCCUR POSSIBLY BECAUSE OF THE TYPE II ENDOLEAK AS WELL AS MEDICATION OF ASPIRIN. DURING AN INTERNAL REVIEW OF THE FILMS PROVIDED, IT WAS ALSO NOTED THAT THROMBUS WAS SEEN WITHIN THE OVERLAPPING BIFURCATE IPSILATERAL LIMB AND LEFT ILIAC EXTENSION, BEGINNING APPROXIMATELY 2CM BELOW THE GATE (NEAR THE PROXIMAL LIMB MARKERS) AND EXTENDED DISTALLY ACROSS THE ANEURYSMAL LEFT ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670266 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF2816C145EJ

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention