BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AAA

    MDR report key: 11091174 · Received December 29, 2020

    Report

    Report Number
    9616099-2020-04164
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 29, 2020
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE REPORT ALSO REPRESENTS NOTIFICATION OF 1 EVENT FOR STENT OCCLUSION. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS THE INCRAFT STENT GRAFT, BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS (ZAVATTA, M., SQUIZZATO, F., BALESTRIERO, G., BONVINI, S., PERKMANN, R., MILITE, D., GREGO, F., ANTONELLO, M., & TRIVENETO INCRAFT REGISTRY COLLABORATORS (2020). EARLY AND MID-TERM OUTCOMES OF EVAR WITH AN ULTRA LOW-PROFILE ENDOGRAFT FROM THE TRIVENETO INCRAFT REGISTRY). A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE MEDICAL DEVICE REPORTING REFERENCE NUMBER FOR THESE EVENTS ARE 9616099-2020-04161, 9616099-2020-04162, AND 9616099-2020-04163. AS REPORTED IN THE LITERATURE ARTICLE, ZAVATTA, M., SQUIZZATO, F., BALESTRIERO, G., BONVINI, S., PERKMANN, R., MILITE, D., GREGO, F., ANTONELLO, M., & TRIVENETO INCRAFT REGISTRY COLLABORATORS (2020). EARLY AND MID-TERM OUTCOMES OF EVAR WITH AN ULTRA LOW-PROFILE ENDOGRAFT FROM THE TRIVENETO INCRAFT REGISTRY. JOURNAL OF VASCULAR SURGERY, S0741-5214(20)32469-1. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JVS.2020.09.044, ONE PATIENT WHO WAS TREATED WITH AN INCRAFT AAA DELIVERY SYSTEM IMPLANTED, WAS RE-ADMITTED WITH GRAFT LIMB OCCLUSION, WHICH LED TO THROMBECTOMY AND ILIAC BRANCH RELINING. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE STERILE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND WITHOUT FILMS OF THE EVENT, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. LIMB THROMBOSIS/OCCLUSION IN ABDOMINAL AORTIC STENT GRAFTS IS A KNOWN COMPLICATION ASSOCIATED WITH VARYING RATES OF LIMB OCCLUSION RANGING BETWEEN 0% AND 5% AND IS LISTED IN THE IFU AS SUCH. MOST OF THE THROMBOTIC EVENTS OCCUR WITHIN THE FIRST 2 MONTHS AFTER EVAR, AND THE UNDERLYING CAUSES OF LIMB THROMBOSIS ARE STENT-GRAFT KINKING AND EXTENSION OF THE SMALL-DIAMETER STENT GRAFT INTO THE EXTERNAL ILIAC ARTERY. RECENTLY, IT HAS BEEN DEMONSTRATED THAT LIMB OCCLUSION CAN ALSO OCCUR LONG AFTER EVAR. THE PATHOPHYSIOLOGICAL MECHANISM OF LATE (AFTER 4 TO 5 YEARS OF FOLLOW-UP) LIMB OCCLUSION CAN BE MIGRATION AND DISLOCATION OF AN ENDOGRAFT COMPONENT CAUSING MAJOR TURBULENCE OF HEMODYNAMICS AND EVENTUALLY LIMB OR ENTIRE STENT-GRAFT THROMBOSIS. TREATMENT OF LIMB OCCLUSION INCLUDES VARIOUS SURGICAL AND ENDOVASCULAR REVASCULARIZATION TECHNIQUES; THE BEST TREATMENT OPTION DEPENDS ON THE PATIENT'S GENERAL STATUS AS WELL AS ON LOCAL ANATOMIC CHANGES OF THE STENT GRAFT AND EXCLUDED ANEURYSM. IN CONTRAST TO LIMB THROMBOSIS AFTER EVAR, INCIDENTALLY FOUND MURAL THROMBOTIC DEPOSITS ARE MUCH MORE FREQUENT IN BOTH FIRST- (20%) AND SECOND-GENERATION (17 TO 33%) SUPPORTED ENDOGRAFTS. THIS CIRCUMFERENTIAL LAYER OF THROMBOTIC MATERIAL IS CLINICALLY SILENT AND IS NOT ASSOCIATED WITH POTENTIAL STENT-GRAFT THROMBOSIS OR DISTAL EMBOLIZATION. ADDITIONALLY, THERE IS NO DIFFERENCE IN SURVIVAL AMONG PATIENTS PRESENTING WITH MURAL DEPOSITS IN THEIR ENDOGRAFT COMPARED WITH PATIENTS WITHOUT THIS THROMBOTIC LAYER. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. 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.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE, ZAVATTA, M., SQUIZZATO, F., BALESTRIERO, G., BONVINI, S., PERKMANN, R., MILITE, D., GREGO, F., ANTONELLO, M., & TRIVENETO INCRAFT REGISTRY COLLABORATORS (2020). EARLY AND MID-TERM OUTCOMES OF EVAR WITH AN ULTRA LOW-PROFILE ENDOGRAFT FROM THE TRIVENETO INCRAFT REGISTRY. JOURNAL OF VASCULAR SURGERY, S0741-5214(20)32469-1. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JVS.2020.09.044, ONE PATIENT WHO WAS TREATED WITH AN INCRAFT AAA DELIVERY SYSTEM IMPLANTED, WAS RE-ADMITTED WITH GRAFT LIMB OCCLUSION, WHICH LED TO THROMBECTOMY AND ILIAC BRANCH RELINING. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553196 UNKNOWN AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CARDINAL HEALTH MEXICO AAAXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening