BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AAA

    MDR report key: 10750588 · Received October 28, 2020

    Report

    Report Number
    9616099-2020-04026
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 9, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: G3, G4, G7, H1, H2,H6, AND H11 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 , ONE COMPLICATION OCCURRED AFTER BEING TREATED WITH THE INCRAFT -AAA DELIVERY SYSTEMS, NECESSITATING HYBRID TECHNIQUES FOR REPAIR (DISTAL EXTERNAL ILIAC ARTERY HEMOSTASIS). 77 PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) =50MM IN DIAMETER TREATED WITH THE INCRAFT DEVICE IN THREE VASCULAR CENTERS WERE ENROLLED FROM (B)(6) 2015 TO (B)(6)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 PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, CATALOG OR LOT INFORMATION, OR PROCEDURAL FILMS THE REPORTED EVENT COULD NOT BE CONFIRMED, AND THE EXACT CAUSE COULD NOT BE DETERMINED. POST PROCEDURAL COMPLICATIONS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE AAA STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: ATTACHMENTS, G7,H1,AND H2. THE ATTACHMENT SECTION OF THE REPORT HAS BEEN CORRECTED WITH AN ATTACHMENT OF THE ARTICLE LISTED ON THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    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 , ONE COMPLICATION OCCURRED AFTER BEING TREATED WITH THE INCRAFT -AAA DELIVERY SYSTEMS, NECESSITATING HYBRID TECHNIQUES FOR REPAIR (DISTAL EXTERNAL ILIAC ARTERY HEMOSTASIS). 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 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 DEVICE WILL NOT BE RETURNED AS IT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216984 UNKNOWN AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention