BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 11387954 · Received February 26, 2021

    Report

    Report Number
    3011175548-2021-00227
    Event Type
    Injury
    Date Received
    February 26, 2021
    Report Date
    August 12, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS BASED ON INFORMATION WITHIN AN ARTICLE AND NO SPECIFIC DEVICE INFORMATION HAS BEEN PROVIDED. AS THERE IS INSUFFICIENT DETAILS OF AN ACTUAL DEVICE MALFUNCTION OR ADVERSE EVENT THAT OCCURRED THE COMPLAINT CANNOT BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE DEVICE PRODUCT PART NUMBER AND LOT NUMBER WAS NOT PROVIDED WITHIN THE ARTICLE. CONCLUSION: THE INSTRUCTIONS FOR USE CLEARLY STATES THAT POTENTIAL ADVERSE EFFECTS OF ADVANTA V12 BALLOON-EXPANDABLE STENT INCLUDE, BUT MAY BE NOT LIMITED TO: INADEQUATE IMPLANTATION OR INTIMAL TRAUMA, RESTENOSIS OF STENTED LESION, STENT MISPLACEMENT, MIGRATION OR DEFORMATION, SYSTEMIC EMBOLIZATION OR THROMBOEMBOLIC EPISODES. AFTER REVIEW OF THE DETAILS PROVIDED AND CONSIDERING THE FACT THAT SEAT BELT AORTA IS A DEADLY CONDITION, FREQUENTLY ASSOCIATED WITH BLUNT THORACOABDOMINAL TRAUMA WITH CONCOMITANT INJURIES AND ALSO CONSIDERING THE POSSIBLE RISKS AND COMPLICATIONS KNOWN TO OCCUR FOLLOWING IMPLANTATION OF GETINGE¿S ADVANTA V12TM BALLOON EXPANDABLE COVERED BRIDGING STENTS, ONE CAN INFER THE UNFORTUNATE INJURIES SUFFERED BY THESE STUDY PATIENTS ARE POTENTIALLY MULTIFACTORIAL AND AN ADVANTA V12 DEVICE WAS NOT THE ONLY ATTRIBUTING FACTOR. THE FACTORS LIKELY INCLUDE BUT ARE NOT LIMITED TO, THE PATIENT¿S SEVERE THORACOABDOMINAL TRAUMA WITH CONCOMITANT INJURIES AND FREQUENT THROMBUS-RELATED COMPLICATIONS, AVAILABILITY OF QUALIFIED TRAUMA TEAM AND VASCULAR SURGEON AND NECESSITY OF MULTIPLE REOPERATIONS DUE TO HIGH-BURDEN TRAUMA OR NATURAL PATIENTS¿ GROWS AND DEVELOPMENT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE: GOUVEIA E MELO, R. (2019). CLINICAL ASPECTS AND PRESENT CHALLENGES OF THE SEAT BELT AORTA. JOURNAL OF VASCULAR SURGERY, 994-1004. PURPOSE: TO CREATE A DECISION ALGORITHM BY REVIEWING OUR CURRENT EXPERIENCE AND ANALYZING THE PRESENTATION AND MANAGEMENT OF OUR PATIENTS WITH A SEAT BELT AORTA. METHOD: A RETROSPECTIVE ANALYSIS OF ALL CONSECUTIVE PATIENTS ADMITTED WITH THE DIAGNOSIS OF SEAT BELT AORTA FROM 2008-2018. CONCLUSION: SEAT BELT AORTA IS A DEADLY CONDITION, FREQUENTLY ASSOCIATED WITH BLUNT THORACOABDOMINAL TRAUMA WITH CONCOMITANT INJURIES PER THE ARTICLE ADVERSE EVENTS INCLUDED INSTENT RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281111 ADVANTA V12 COVERED STENT STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention