BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II EXTENSION STENT GRAFT

    MDR report key: 6378463 · Received March 3, 2017

    Report

    Report Number
    2953200-2017-00335
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    January 16, 2017
    Report Date
    March 8, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (MODIFICATION OF DEVICE). FAILURE TO FOLLOW INSTRUCTIONS (NOT IMPLANTING A BIFURCATED STENT GRAFT). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: IATROGENIC SUBCLAVIAN ARTERY PERFORATION RESCUED BY OPERATOR-MODIFIED GRAFT STENT CHIH-HUNG LAI, CHUNG-LIN TSAI, WEI-CHUN CHANG, CHIEH-SHOU SU, AND WEN-LIENG LEE ( YONSEI MED J 2017 MAR;58(2):462-466). AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A SCA PERFORATION WITH HEMOTHORAX. IT WAS REPORTED THAT THE PATIENT THE SUBCLAIVIAN ARTERY (SCA) WAS PERFORATED DURING THE REPAIR OF STENOSIS IN THE SCA WITH ANOTHER MANUFACTURER¿S DEVICE. AN ENDURANT II ILIAC EXTENSION WAS MODIFIED AND USED TO REPAIR THE PERFORATION USING A RETROGRADE APPROACH VIA THE BRACHIAL ARTERY. HOWEVER THIS PROCEDURE WAS COMPLICATED BY THE OCCLUSION OF THE LEFT COMMON CAROTID ARTERY (LCCA). IT WAS NOTED THAT THE ENDURANT II DEVICE WAS NOT EASY TO PLACE IN A PRECISE POSITION AND THE STENT GRAFT ACCIDENTLY OCCLUDED THE LCCA. ANOTHER MANUFACTURER¿S BALLOON EXPANDABLE STENT WAS IMPLANTED IN THE LCCA AND THE EVENT WAS RESOLVED. IT WAS STATED THAT THE CAUSE OF THE EVENT WAS DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. ABSTRACT: SUBCLAVIAN ARTERY (SCA) PERFORATION IS A RARE COMPLICATION WHILE PERFORMING SCA INTERVENTION. IN OUR PRESENT REPORT, A (B)(6) FEMALE, WITH STENOSIS OF THE LEFT SCA AND SITUS INVERSUS, PRESENTED WITH EXERCISE-INDUCED LEFT ARM WEAKNESS. THE SCA STENOSIS WAS TREATED WITH DIRECT STENTING WITH A BALLOON-EXPANSIBLE EXPRESS LD 10×25 MM STENT. HOWEVER, IT CAUSED IATROGENIC SCA PERFORATION AND HEMOTHORAX. THE PERFORATION WAS SEALED BY ENDOVASCULAR REPAIR WITH OPERATOR-MODIFIED ENDURANT II GRAFT STENT, WHICH COMPLICATED WITH OCCLUSION OF LEFT COMMON CAROTID ARTERY. AND, THE CAROTID ARTERY WAS RESCUED BY ANOTHER STENT. THE GRAFT STENT, WHICH WAS ORIGINALLY DESIGNED FOR ABDOMINAL AORTIC ANEURYSM, CAN BE MODIFIED TO SUITABLE LENGTH AND TAKE AS A RESCUE STENT OF LARGE VESSEL WITH IATROGENIC PERFORATION. DUE TO STRONG RADIAL FORCE OF GRAFT STENT, PRESERVATION OF LARGE SIDE BRANCHES SHOULD BEEN WATCHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159337 ENDURANT II EXTENSION STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETEW1010C82EE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention