BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4202773 · Received October 27, 2014

    Report

    Report Number
    2953200-2014-02192
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 1, 2013
    Report Date
    October 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. RETROPERITONEAL AORTIC HEMORRHAGE CAUSED BY PENETRATION OF AN ENDOVASCULAR STENT-GRAFT ANCHORING BARB. CHRISTOPHER P. TWINE, ANDREW WINTERBOTTOM, NADEEM SHAIDA, AND JONATHAN R. BOYLE. ENDOVASE THER. 2013, 20:568-570 ON UNKNOWN DATES, AN ENDURANT II STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6.7CM ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: AORTIC PERFORATION, PSEUDOANEURYSM. IMAGE REVIEW ANALYSIS: REVIEW OF 2 POST-IMPLANT CTA'S PHOTO'S CONFIRMED THERE WAS CONTRAST SEEN OUTSIDE THE ANTERIOR WALL OF THE AORTA, ADJACENT TO A SUPRARENAL STENT ATTACHMENT PIN. A PSEUDOANEURYSM IS ALSO SEEN IN THE SAME LOCATION 4-DAYS POST-IMPLANT. NO OTHER STENT GRAFT ISSUES WERE OBSERVED. THE EXACT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT THE PATIENT'S BLOOD THINNING MEDICATION CONTRIBUTED TO THE OBSERVED BLEEDING SEEN POST-IMPLANT. PURPOSE: TO REPORT A RARE CASE OF ACUTE INTRAOPERATIVE RETROPERITONEAL HEMORRHAGE SECONDARY TO AORTIC PENETRATION BY THE SUPRARENAL ANCHORING BARB ON A STENT-GRAFT. CASE REPORT: A (B)(6) PATIENT ON DUAL ANTIPLATELET THERAPY FOR CORONARY STENTS AND LOW MOLECULAR-WEIGHT HEPARIN FOR ATRIAL THROMBUS UNDERWENT ELECTIVE ENDOVASCULAR REPAIR OF A 6.7-CM INFRARENAL ABDOMINAL AORTIC ANEURYSM. A DEVICE WITH SUPRARENAL FIXATION AND METAL ANCHORING BARBS WAS IMPLANTED, AND A MOLDING BALLOON WAS USED THAT AT NO TIME COVERED THE PROXIMAL BARE METAL STENTS OR BARBS. IN RECOVERY, THE PATIENT BECAME TACHYCARDIA AND HYPOTENSIVE. AFTER RESUSCITATION, IMAGING IDENTIFIED AN ANTERIOR BARB PENETRATING THE AORTIC WALL, CAUSING THE ACUTE RETROPERITONEAL HEMORRHAGE. A DECISION TO TREAT CONSERVATIVELY RATHER THAN RESORT TO OPEN SURGERY WAS DIFFICULT, BUT ULTIMATELY INFLUENCED BY THE PATIENTS' HIGH RISK FOR OPEN SURGERY. THE PATIENT WAS TREATED BY AGGRESSIVE REVERSAL OF HEPARIN AND PLATELET TRANSFUSION, AND THE BLEED SETTLED SPONTANEOUSLY. CONCLUSION: MAJOR SURGERY AND SUBSEQUENT MORBIDITY MAY BE AVOIDED BY MEDICAL MANAGEMENT OF WHAT WOULD APPEAR TO BE A SURGICAL PROBLEM.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION REVEALS THAT THE CAUSE OF THE EVENT MAY HAVE BEEN DUE TO THE COMBINATION OF DUAL ANTIPLATELET THERAPY AND HEPARIN WHICH APPEARED TO HAVE FACILITATED BLEEDING AFTER BARB PENETRATION AND MAY HAVE CONTRIBUTED TO THE INABILITY OF THE INJURY TO CLOT AND HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684530 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention