BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-AAA

    MDR report key: 11051543 · Received December 21, 2020

    Report

    Report Number
    9616099-2020-04139
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    September 30, 2020
    Report Date
    January 5, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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, G6, H1, H2, H3, H6, AND H10. 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, IN 2 CASES WHERE AN INCRAFT AAA DELIVERY SYSTEM WAS IMPLANTED, AT THE FINAL INTRAOPERATORY ANGIOGRAM THERE WAS THE EVIDENCE OF AN ENDOLEAK (EL) TYPE I A THAT REQUIRED ENDOANCHOR FIXATION, WITH RESOLUTION OF THE ENDOLEAK. THE DEVICE WAS IMPLANTED. 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 ¿BIFURCATED AORTIC PROSTHESIS ENDOLEAK TYPE 1A¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PROCEDURAL IMAGES WERE NOT PROVIDED FOR REVIEW. 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. INITIAL TREATMENT WOULD INCLUDE BALLOON MOLDING OF THE PROXIMAL PROSTHESIS COMPONENTS. ACCORDING TO THE SAFETY INSTRUCTIONS IN THE INSTRUCTIONS FOR USE ¿CAUTIONS: ONCE CRANIAL POSITION HAS BEEN IDENTIFIED, DO NOT MOVE THE PATIENT OR IMAGING EQUIPMENT, AS IT MAY COMPROMISE ACCURACY OF PROSTHESIS PLACEMENT. THE DIAGNOSTIC CATHETER CAN BE REMOVED PRIOR TO DEPLOYMENT. HOWEVER, IF IT IS NOT REMOVED UNTIL AFTER DEPLOYMENT, ENSURE THAT THE TIP IS STRAIGHTENED (FOR EXAMPLE, IF IT IS PIGTAIL CATHETER) WITH A GUIDEWIRE BEFORE REMOVAL SO THAT THE PROSTHESIS IS NOT SUBJECT TO MIGRATION. WHEN ALIGNING THE POSITION OF PROSTHESIS, BE SURE THE FLUOROSCOPE IS ANGLED PERPENDICULARLY TO THE CENTER LINE OF THE INFRARENAL AORTA TO AVOID PARALLAX OR OTHER SOURCE OF VISUALIZATION ERROR THAT COULD IMPACT PROPER POSITIONING. SOME CRANIAL-CAUDAL ANGULATION OF THE IMAGE INTENSIFIER TUBE MAY BE NECESSARY TO ACHIEVE THIS, ESPECIALLY IF THERE IS ANTERIOR ANGULATION OF THE ANEURYSM NECK. CAUTIONS: HIGH PRESSURE INJECTION OF CONTRAST MEDIA MADE AT THE EDGES OF THE PROSTHESIS IMMEDIATELY AFTER IMPLANTATION MAY CAUSE AN ENDOLEAK. LEAKS AT THE ATTACHMENT OR CONNECTION SITES SHOULD BE TREATED USING A BALLOON CATHETER TO REMODEL THE PROSTHESIS AGAINST THE VESSEL WALL. MAJOR LEAKS THAT CANNOT BE CORRECTED BY EITHER RE-BALLOONING MAY BE TREATED BY ADDING AORTIC OR ILIAC EXTENSION COMPONENTS TO THE PREVIOUSLY PLACED STENT-GRAFT COMPONENTS OR ANY OTHER METHOD PER LOCAL PRACTICE AND THE CLINICAL SITUATION. ANY LEAK LEFT UNTREATED DURING THE IMPLANTATION PROCEDURE MUST BE CAREFULLY MONITORED AFTER IMPLANTATION. WARNING: FAILURE TO DIAGNOSE RENAL ARTERY FLOW-INTERRUPTION AND ENDOLEAKS POST PROSTHESIS DEPLOYMENT MAY RESULT IN RENAL FAILURE OR RUPTURED ANEURYSM. FAILURE TO DIAGNOSE INTERNAL ILIAC ARTERY INTERRUPTION POST PROSTHESIS DEPLOYMENT MAY RESULT IN BUTTOCK CLAUDICATION, BOWEL ISCHEMIA OR SEXUAL DYSFUNCTION. POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK.¿ THE VERY 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, IN 2 CASES WHERE AN INCRAFT AAA DELIVERY SYSTEM WAS IMPLANTED, AT THE FINAL INTRAOPERATORY ANGIOGRAM THERE WAS THE EVIDENCE OF AN ENDOLEAK (EL) TYPE I A THAT REQUIRED ENDOANCHOR FIXATION, WITH RESOLUTION OF THE ENDOLEAK. THE DEVICE WAS IMPLANTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513973 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