BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 9750473 · Received February 25, 2020

    Report

    Report Number
    9612164-2020-00866
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 31, 2017
    Report Date
    March 23, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: EARLY AND LATE ENDOGRAFT LIMB PROXIMAL MIGRATION WITH RESULTING TYPE 1B ENDOLEAK FOLLOWING AN EVAR FOR RUPTURED AAA PATRICK T. JASINSKI, DEMETRI ADRAHTAS, SPYRIDON MONASTIRIOTIS, AND APOSTOLOS K. TASSIOPOULOS. VASCULAR MEDICINE 2017 HTTP://DX.DOI.ORG/10.1155/2017/4931282. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNKNOWN ENDURANT II, SERIAL/LOT#: UNKNOWN, UBD: UNKNOWN, UDI#:UNKNOWN . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM RUPTURED ABDOMINAL AORTIC ANEURYSM. NO ENDOLEAK WAS OBSERVED AT THE END OF THE PROCEDURE AND THE DISTAL ENDS OF THE ILIAC LIMBS WERE CONFIRMED WITH A CENTIMETER WITHIN THE BIFURCATION OF THE ILIAC ARTERIES. IT WAS REPORTED THAT TWO DAYS POST THE INDEX PROCEDURE THE PATIENT BECAME HYPOTENSIVE AND CT SHOWED A POSSIBLE TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY LIMB. PROXIMAL MIGRATION OF THE RIGHT LIMB WAS ALSO OBSERVED. A RIGHT TYPE IB ENDOLEAK WAS CONFIRMED BY AN ARTERIOGRAM IN THE OPERATING ROOM. A RIGHT ENDOGRAFT LIMB WAS EXTENDED DISTALLY TO THE RIGHT COMMON ILIAC BIFURCATION WITH COMPETE SEALING OF THE ENDOLEAK. FOLLOW UP CT¿S AT 1 AND 6 MONTHS SHOWED REGRESSION OF THE ANEURYSM AND NO EVIDENCE OF TYPE I OR TYPE III ENDOLEAKS. CT AT 12 MONTHS¿ HOWEVER, SHOWED A NEW LEFT TYPE IB ENDOLEAK AND MIGRATION. THE ENDOLEAK WAS REPAIRED BY EXTENSION OF THE LEFT ENDOGRAFT LIMB TO THE ILIAC BIFURCATION. CT ANGIOGRAM SIX MONTHS LATER SHOWED RESOLUTION OF THE ENDOLEAK. IT WAS REPORTED THAT THE TRUE DIAMETER OF THE ILIAC ARTERIES WAS UNDERESTIMATED AS A RESULT OF VASOCONSTRICTION (DUE TO THE PATIENTS¿ RUPTURE). THE ILIAC LIMBS WERE THEN INADEQUATELY OVERSIZED AND THIS WAS REPORTED TO BE A SIGNIFICANT FACTOR IN THE PROXIMAL LIMB MIGRATION. THE ANTERIOR DISPLACEMENT OF THE ENDOGRAFTS WAS ALSO REPORTED TO BE A FACTOR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. MEDICAL HISTORY: NEPHROLITHIASIS ABSTRACT INTRODUCTION. SEAL ZONE FAILURE AFTER EVAR LEADS TO TYPE 1 ENDOLEAKS AND INCREASES THE RISK OF DELAYED AORTIC RUPTURE. TYPE 1B ENDOLEAKS, ALTHOUGH RARE, REPRESENT A TRUE RISK TO THE REPAIR. CASE PRESENTATION. WE REPORT THE CASE OF A (B)(6) FEMALE WHO UNDERWENT EMERGENT ENDOVASCULAR REPAIR FOR A RUPTURED INFRARENAL ABDOMINAL AORTIC ANEURYSM AND DEVELOPED BILATERAL TYPE 1B ENDOLEAKS FOLLOWING PROXIMAL MIGRATION OF BOTH ENDOGRAFT LIMBS. THE RIGHT-SIDE FAILURE WAS DIAGNOSED WITHIN 48 HOURS FROM THE INITIAL REPAIR AND THE LEFT SIDE AT THE 1-YEAR FOLLOW-UP. BOTH SIDES WERE SUCCESSFULLY TREATED WITH ENDOVASCULAR TECHNIQUES. A REVIEW OF THE LITERATURE WITH AN ANALYSIS OF POTENTIAL RISK FACTORS IS ALSO REPORTED. CONCLUSION. FOR PATIENTS UNDERGOING EVAR FOR RUPTURED AAA AND WITH NONCALCIFIED ILIAC ARTERIES, MORE AGGRESSIVE OVERSIZING OF THE ILIAC LIMBS IS RECOMMENDED TO PREVENTS DISTAL SEAL ZONE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213139 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention