BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-AAA

    MDR report key: 11055868 · Received December 22, 2020

    Report

    Report Number
    9616099-2020-04142
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    September 30, 2020
    Report Date
    January 5, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: 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, OF THE 209 PATIENTS WHO UNDERWENT AAA REPAIR WITH INCRAFT ENDOGRAFT, ONE CASE DUE TO THE MALPOSITIONING OF THE ILIAC BRANCHES A PRIMARY ENDOVASCULAR ATTEMPT OF LIMB SALVAGE WAS PERFORMED, BUT EVENTUALLY THE PATIENT UNDERWENT AN OPEN CONVERSION. 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 ¿IMPLANT MALPOSITION¿ 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. CONVERSION TO OPEN REPAIR IS THE RECOMMENDED ACTION IN THESE CIRCUMSTANCES. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿THE FOLLOWING WARNINGS AND PRECAUTIONS APPLY THROUGHOUT THE IMPLANT PROCEDURE: DO NOT START DEPLOYMENT UNTIL THE DELIVERY SYSTEM IS ACCURATELY PLACED WITHIN THE VASCULATURE AND READY FOR DEPLOYMENT. WHEN DEPLOYING THE PROSTHESIS, BE SURE TO HOLD THE WHITE HANDLE COMPONENT OF THE DELIVERY SYSTEM FIRMLY AGAINST A STATIONARY OBJECT. IF THE OUTER SHEATH IS ACCIDENTALLY WITHDRAWN EXPOSING THE PROSTHESIS, THE DEVICE WILL PREMATURELY DEPLOY AND MAY BE INCORRECTLY POSITIONED. PROSTHESIS MIGRATION OR INCORRECT PROSTHESIS DEPLOYMENT MAY REQUIRE SURGICAL INTERVENTION. UNDER FLUOROSCOPY, CAREFULLY REMOVE THE ILIAC LIMB DELIVERY SYSTEM FROM THE PATIENT, ENSURING THAT THE DELIVERY SYSTEM DOES NOT DISLODGE THE PROSTHESIS AND GUIDE WIRE ACCESS IS MAINTAINED. POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO: SURGICAL CONVERSION TO OPEN SURGERY.¿ THE LIMITED 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.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED. 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, 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, OF THE 209 PATIENTS WHO UNDERWENT AAA REPAIR WITH INCRAFT ENDOGRAFT, ONE CASE DUE TO THE MALPOSITIONING OF THE ILIAC BRANCHES A PRIMARY ENDOVASCULAR ATTEMPT OF LIMB SALVAGE WAS PERFORMED, BUT EVENTUALLY THE PATIENT UNDERWENT AN OPEN CONVERSION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521847 UNK-AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS CORPORATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANTICOAGULANT,| SINGLE OR DOUBLE ANTI-PLATELET| STATIN THERAPY