BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-AAA

    MDR report key: 11090583 · Received December 29, 2020

    Report

    Report Number
    9616099-2020-04161
    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
    IT
    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 ILIAC ARTERY STENOSIS. 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. 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, HAD SYMPTOMATIC ILIAC BRANCH STENOSIS AND WAS SUBJECTED TO ILIAC BRANCH STENTING. THE DEVICE WILL NOT BE RETURNED AS IT WAS IMPLANTED. 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. STENOSIS IS ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. WELL DOCUMENTED POTENTIAL COMPLICATION OF STENT PLACEMENT IS SUBSEQUENT INTIMAL HYPERPLASIA AND OCCLUSION. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. 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, HAD SYMPTOMATIC ILIAC BRANCH STENOSIS AND WAS SUBJECTED TO ILIAC BRANCH STENTING. THE DEVICE WILL NOT BE RETURNED AS IT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554112 UNK-AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CARDINAL HEALTH MEXICO UNK-AAA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1