BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 11376683 · Received February 24, 2021

    Report

    Report Number
    3011175548-2021-00214
    Event Type
    Injury
    Date Received
    February 24, 2021
    Report Date
    November 21, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE REVIEWED: BALABAN, ET AL. (2020). SUCCESSFUL MANAGEMENT OF A RARE AND FATAL COMPLICATION OF CARDIAC CATHETERIZATION: ABDOMINAL COMPARTMENT SYNDROME. ANATOL J CARDIOL, 23: 183-91. THE SUBJECT ARTICLE IS A CASE REPORT OF 55 YEAR OLD MALE PATIENT WHO UNDERGONE DIAGNOSTIC CORONARY ANGIOGRAPHY 1 WEEK AGO AND PRESENTED TO THE HOSPITAL WITH RETROPERITONEAL HEMATOMA (RPH). THIS COMPLAINT IS BASED ON INFORMATION FOUND WITHIN A ARTICLE/LITERATURE REVIEW. THERE WAS NO PRODUCT THAT WAS AVAILABLE FOR EVALUATION, THEREFORE A DEVICE EVALUATION COULD NOT BE CONDUCTED AND THE COMPLAINT CANNOT BE CONFIRMED. THE AUTHOR OF THE ARTICLE DID NOT REPORT ANY MAJOR ADVERSE PATIENT EFFECTS AS RESULT OF THIS EVENT. 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. ATTEMPTS TO OBTAIN THE DEVICE LOT INFORMATION WAS CONDUCTED BUT UNSUCCESSFUL. THE HAZARDOUS SITUATION/HARM IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THERE WAS NO EVIDENCE WITHIN THE ARTICLE THAT THE DEVICE WAS THE CAUSE OF THE REPORTED EVENT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND, THEREFORE NO ESCALATION TO CAPA PROCESS IS REQUIRED. CONCLUSION: CONSIDERING THAT GETINGE¿S ADVANTA V12TM BALLOON EXPANDABLE COVERED STENT WAS SUCCESSFULLY IMPLANTED TO TREAT PATIENT FEMORAL EXTRAVASATION, ONE CAN INFER THAT DEVICE PERFORMED AS EXPECTED. THE AUTHORS DO NOT ATTRIBUTE DEVELOPMENT OF ABDOMINAL COMPARTMENT SYNDROME TO THE IMPLANTED STENT. H3 OTHER TEXT : NOT AVAILABLE FOR RETURN.

    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

    ARTICLE RECEIVED: BALABAN, I. E. (2020). SUCCESSFUL MANAGEMENT OF A RARE AND FATAL COMPLICATION OF CARDIAC CATHETERIZATION: ABDOMINAL COMPARTMENT SYNDROME. ANATOL JOURNEY OF CARDIOLOGY, 183-191. PURPOSE: ACOS CAN BE CAUSED BY RETROPERITONEAL BLEEDING WITH INCREASING INTRAABDOMINAL PRESSURE. METHOD: A CASE REPORT. CONCLUSION: OCCURRENCE OF RPH AFTER INTERVENTIONAL PROCEDURES TO THE FEMORAL ARTERY IS UNCOMMON, AND RPH CAN BE COMPLICATED BY ACOS. PER THE ARTICLE ADVERSE EVENTS INCLUDED ABDOMINAL COMPARTMENT SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272383 ADVANTA V12 COVERED STENT STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention