BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ENDOVASCULAR GRAFT

    MDR report key: 7111872 · Received December 13, 2017

    Report

    Report Number
    2953200-2017-01971
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    May 29, 2017
    Report Date
    December 13, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; LOWER EXTREMITY ISCHEMIA AFTER ABDOMINAL AORTIC ANEURYSM REPAIR. CHRISTIAN-ALEXANDER BEHRENDT, ANAND DAYAMA, EIKE SEBASTIAN DEBUS, FRANZISKA HEIDEMANN, NATHANIEL M. MATOLO, TILO KOLBEL, AND NIKOLAOS TSILIMPARIS (ANN VASC SURG 2017; 45: 206¿212) ANN VASC SURG 2017; 45: 206¿212 HTTP://DX.DOI.ORG/10.1016/J.AVSG.2017.05.037 _ 2017 ELSEVIER INC. ALL RIGHTS RESERVED. 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

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: LOWER EXTREMITY ISCHEMIA WITHIN THE FIRST 48 HOURS AFTER SURGERY, DEATH, MYOCARDIAL INFARCTION, ISCHEMIC COLITIS, PNEUMONIA, SEPSIS, UNPLANNED REINTUBATION, RENAL FAILURE, RENAL INSUFFICIENCY, SUPERFICIAL SURGICAL SITE INFECTION, OPEN WOUND INFECTION, PULMONARY EMBOLISM, POSTOPERATIVE BLEEDING/TRANSFUSIONS, VENTILATION > 48 HOURS, RETURN TO OPERATING ROOM, AN UNPLANNED REOPERATION. IT WAS NOTED BY THE AUTHOR THAT IT WAS NOT POSSIBLE TO CONCLUDE ANY VALID ASSOCIATIONS BETWEEN SPECIFIC DEVICES (OF ANY MANUFACTURER) AND ADVERSE EVENTS. BACKGROUND: TREATMENT REALITY OF ABDOMINAL AORTIC ANEURYSM (AAA) IS CHANGING. UP TO DATE, APPROXIMATELY 65% OF INTACT AAA AND 30% OF RUPTURED AAA ARE TREATED ENDOVASCULARLY. AS MOST COMPARATIVE STUDIES FOCUS UPON MORTALITY AND FEW MAJOR COMPLICATIONS, SOME OUTCOMES AS LOWER EXTREMITY ISCHEMIA (LEI) AFTER INVASIVE AAA REPAIR ARE OFTEN UNDER-REPORTED. HOWEVER, THERE IS EVIDENCE FOR A WORSE OUTCOME OF PATIENTS SUFFERING FROM THIS KIND OF COMPLICATION. METHODS: USING THE (B)(4) VASCULAR SURGERY TARGETED MODULE FROM 2011 TO 2014, WE IDENTIFIED ALL PATIENTS UNDERGOING ENDOVASCULAR AORTIC REPAIR (EVAR) AND OPEN AORTIC REPAIR (OAR) FOR AAA TO ILLUMINATE THE INCIDENCE AND OUTCOME OF LEI AFTER AAA REPAIR. RESULTS: IN TOTAL, 185 PATIENTS (1.9%) DEVELOPED LEI AFTER AAA REPAIR. A 1.6% OF ALL PATIENTS SHOWED LEI AFTER TREATMENT OF ASYMPTOMATIC OR SYMPTOMATIC INTACT AAA, COMPARED WITH 4.8% OF RUPTURED AAA REPAIR (P <(> <<)> 0.001). OPERATION TIME, MALE GENDER, CURRENT SMOKING, AND INCREASED CREATININE LEVELS (>1.5 MG/DL) WERE ASSOCIATED WITH AN INCREASED LIKELIHOOD OF EXHIBITING LEI. NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN EVAR VERSUS OAR WERE NOTED IN THE MULTIVARIATE MODEL. IF LEI OCCURRED, LENGTH OF HOSPITAL STAY (6 VS. 2 DAYS, P <(><<)> 0.001) AND MORTALITY (20.5 VS. 4.6%, P <(><<)> 0.001) WAS SIGNIFICANTLY HIGHER AS COMPARED WITH THE PATIENTS WITHOUT LEI. FURTHERMORE, 30-DAY MORTALITY AND MOST MAJOR COMPLICATIONS WERE MORE COMMON IF LEI OCCURRED. CONCLUSIONS: IN THIS SPECIALIZED ANALYSIS REGARDING LEI AFTER AAA REPAIR UP TO 2% DEVELOP THIS SEVERE ISCHEMIC COMPLICATION. SINCE THE OCCURRENCE OF LEI IS ASSOCIATED WITH SIGNIFICANTLY WORSE OUTCOME, FUTURE RESEARCH AND STRATEGIES TO AVOID THIS COMPLICATION IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894429 ENDURANT ENDOVASCULAR GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention