BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK-AAA

    MDR report key: 10736311 · Received October 26, 2020

    Report

    Report Number
    9616099-2020-04014
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 26, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    PMA / PMN Number
    M140017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: GEORGIADIS, G. S., CHATZIGAKIS, P. K., KOUVELOS, G., ARGYRIOU, C., KOPADIS, G. C., GEORGAKARAKOS, E. I., & MATSAGKAS, M. (2020). MULTICENTER MID-TERM RESULTS AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH THE INCRAFT® DEVICE. ANNALS OF VASCULAR SURGERY. DOI:10.1016/J.AVSG.2020.09.018. SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. THE PUBLICATION IS ATTACHED. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE BY, GEORGIADIS, G. S., CHATZIGAKIS, P. K., KOUVELOS, G., ARGYRIOU, C., KOPADIS, G. C., GEORGAKARAKOS, E. I., & MATSAGKAS, M. (2020). MULTICENTER MID-TERM RESULTS AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH THE INCRAFT DEVICE. ANNALS OF VASCULAR SURGERY, S0890-5096(20)30864-5. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.AVSG.2020.09.018 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.09.018 SEVEN PATIENTS RECEIVED ILIAC EXTENSIONS, MAINLY IIA EMBOLIZATION AND OVERSTENTING FOR CIA OR IIA ANEURYSM (PLANNED), TO RESOLVE A TYPE IB ENDOLEAK (UNPLANNED) OR TO REACH THE DESIRED DISTAL LANDING LOCATION (PLANNED) AFTER BEING TREATED WITH THE INCRAFT -AAA DELIVERY SYSTEMS. 77 PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) =50MM IN DIAMETER TREATED WITH THE INCRAFT 42 DEVICE IN THREE VASCULAR CENTERS WERE ENROLLED FROM NOVEMBER 2015 TO JULY 2018. FOLLOW-UP WAS COMPLETED IN AUGUST 2020. SELECTION OF EVAR USING THE INCRAFT DEVICE WAS INDIVIDUALIZED ACCORDING TO AORTO-ILIAC MORPHOLOGIC FEATURES, COMORBIDITIES, HISTORY OF PREVIOUS ABDOMINAL SURGERY AND PREFERENCE OF THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED TO THE PATIENTS. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. NO LOT NUMBERS WERE PROVIDED THEREFORE PRODUCT HISTORY RECORD (PHR) REVIEWS COULD NOT BE GENERATED. THE REPORTED ¿BIFURCATED AORTIC PROSTHESIS ENDOLEAK TYPE 1B¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS NOR WERE PROCEDURAL IMAGES AVAILABLE. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED PHRS COULD NOT BE COMPLETED. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿LEAKS AT THE ATTACHMENT OR CONNECTION SITES SHOULD BE TREATED USING A BALLOON CATHETER TO REMODEL THE PROSTHESIS AGAINST THE VESSEL WALL. MAJOR LEAKS THAT CANNOT BE CORRECTED BY EITHER RE-BALLOONING MAY BE TREATED BY ADDING AORTIC OR ILIAC EXTENSION COMPONENTS TO THE PREVIOUSLY PLACED STENT-GRAFT COMPONENTS OR ANY OTHER METHOD PER LOCAL PRACTICE AND THE CLINICAL SITUATION. ANY LEAK LEFT UNTREATED DURING THE IMPLANTATION PROCEDURE MUST BE CAREFULLY MONITORED AFTER IMPLANTATION.¿ THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENTS; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY, GEORGIADIS, G. S., CHATZIGAKIS, P. K., KOUVELOS, G., ARGYRIOU, C., KOPADIS, G. C., GEORGAKARAKOS, E. I., & MATSAGKAS, M. (2020). MULTICENTER MID-TERM RESULTS AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH THE INCRAFT® DEVICE. ANNALS OF VASCULAR SURGERY, S0890-5096(20)30864-5. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.AVSG.2020.09.018 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.09.018 SEVEN PATIENTS RECEIVED ILIAC EXTENSIONS, MAINLY IIA EMBOLIZATION AND OVERSTENTING FOR CIA OR IIA ANEURYSM (PLANNED), TO RESOLVE A TYPE IB ENDOLEAK (UNPLANNED) OR TO REACH THE DESIRED DISTAL LANDING LOCATION (PLANNED) AFTER BEING TREATED WITH THE INCRAFT -AAA DELIVERY SYSTEMS. 77 PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) =50MM IN DIAMETER TREATED WITH THE INCRAFTR 42 DEVICE IN THREE VASCULAR CENTERS WERE ENROLLED FROM NOVEMBER 2015 TO JULY 2018. FOLLOW-UP WAS COMPLETED IN AUGUST 2020. SELECTION OF EVAR USING THE INCRAFTR DEVICE WAS INDIVIDUALIZED ACCORDING TO AORTO-ILIAC MORPHOLOGIC FEATURES, COMORBIDITIES, HISTORY OF PREVIOUS ABDOMINAL SURGERY AND PREFERENCE OF THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198119 UNK-AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS CORPORATION UNK-AAA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R