BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-AAA

    MDR report key: 10763376 · Received October 30, 2020

    Report

    Report Number
    9616099-2020-04031
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 30, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    PMA / PMN Number
    M140017
    Adverse Event
    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, OCCLUSION OF AN ENDOLEG, WAS OBSERVED IN ONE PATIENT, 14 MONTHS RESPECTIVELY AFTER IMPLANTATION OF AN INCRAFT AAA DELIVERY SYSTEM, AND WAS TREATED BY FEMORAL-FEMORAL PTFE BYPASS AFTER UNSUCCESSFUL ENDOVASCULAR RECANALIZATION, REQUIRING OPEN CONVERSION 3MO LATER TO REPAIR COMPROMISED FLOW TO THE INFLOW ILIAC AXIS. 77 PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) =50MM IN DIAMETER TREATED WITH THE INCRAFT DEVICE IN THREE VASCULAR CENTERS WERE ENROLLED FROM NOVEMBER 2015 TO JULY 2018. FOLLOW-UP WAS COMPLETED IN (B)(6) 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED TO THE PATIENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿STENT OCCLUSION¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. AN ANGIOPLASTY PROCEDURE FAILED TO EFFECTIVELY REOPEN THE OCCLUSION THEREFORE AN OPEN FEMORAL TO FEMORAL BYPASS WAS SUCCESSFULLY COMPLETED PER THE ACCEPTED STANDARD OF CARE. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿IT IS RECOMMENDED THAT PHYSICIANS CONDUCT REGULAR EXAMINATIONS AND IMAGING FOR THE PATIENT¿S LIFETIME. FOLLOW-UP IMAGING SHOULD BE DECIDED BASED UPON THE PHYSICIAN¿S CLINICAL ASSESSMENT OF THE PATIENT PRE- AND POST-IMPLANTATION OF THE STENT GRAFT. AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. ANNUAL IMAGING IS RECOMMENDED, INCLUDING ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY (STENT FRACTURE, SEPARATION BETWEEN BIFURCATED DEVICE AND PROXIMAL CUFFS OR LIMB EXTENSIONS, IF APPLICABLE).¿ THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; 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, OCCLUSION OF AN ENDOLEG, WAS OBSERVED IN ONE PATIENT, 14 MONTHS RESPECTIVELY AFTER IMPLANTATION OF AN INCRAFT AAA DELIVERY SYSTEM, AND WAS TREATED BY FEMORAL-FEMORAL PTFE BYPASS AFTER UNSUCCESSFUL ENDOVASCULAR RECANALIZATION, REQUIRING OPEN CONVERSION 3MO LATER TO REPAIR COMPROMISED FLOW TO THE INFLOW ILIAC AXIS. 77 PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) =50MM IN DIAMETER TREATED WITH THE INCRAFTR 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230201 UNK-AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS CORPORATION UNK-AAA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R