BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 11468607 · Received March 12, 2021

    Report

    Report Number
    3011175548-2021-00288
    Event Type
    Injury
    Date Received
    March 12, 2021
    Report Date
    August 25, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: NOTE: THE USE OF THE DEVICE MAY BE RELATED TO AN OFF-LABEL USE OF THE ICAST¿ BALLOON EXPANDABLE COVERED STENT, WHICH MEANS THAT THE USE HAS NOT BEEN APPROVED OR CLEARED BY THE FOOD AND DRUG ADMINISTRATION (FDA) AS SAFE OR EFFECTIVE. GETINGE¿S ICAST¿ COVERED STENT IS FDA 510(K) CLEARED FOR THE TREATMENT OF TRACHEOBRONCHIAL STRICTURES PRODUCED BY MALIGNANT NEOPLASMS. ALTHOUGH TWO PATIENTS WHO HAD PROGRESSION OF CKD STAGE (5%) REQUIRED RESTENTING FOR RENAL STENT STENOSIS, HOWEVER CONSIDERING THE DESIGN OF THE STUDY, EXCELLENT TECHNICAL SUCCESS RATE (100%), LOW 30-DAY MORTALITY (1.1%) AND THE FACT THAT FREQUENCY OF AKI WAS NOT AFFECTED BY THE PRE-EXISTING CKD, ONE CAN INFER THAT THE GETINGE¿S ICAST¿ BALLOON EXPANDABLE COVERED BRIDGING STENTS PERFORMED AS EXPECTED. H3 OTHER TEXT: PRODUCT NOT RETURNED.

    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: KHOURY, M. E. (2019). FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR IN PATIENTS WITH CHRONIC KIDNEY DISEASE. JOURNAL OF VASCULAR SURGERY, 66-72. PURPOSE: THE PURPOSE OF THIS STUDY WAS TO ASSESS RENAL PERIOPERATIVE OUTCOMES AND RENAL FUNCTION DETERIORATION AFTER FENESTRATED-BRANCHED ENDOVASCULAR ANEURYSM REPAIR (F/BEVAR) IN PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD). METHOD: THE STUDY INCLUDED 186 PATIENTS WHO UNDERWENT F/BEVAR BETWEEN 2013 AND 2018 FOR SUPRARENAL JUXTARENAL AND TYPE I TO TYPE IV TAAAS. CONCLUSION: F/BEVAR IS AN EFFECTIVE AND SAFE PROCEDURE FOR PATIENTS WITH COMPLEX ABDOMINAL AORTIC ANEURYSMS AND TAAAS, EVEN AMONG PATIENTS WITH CKD. PER THE ARTICLE ADVERSE EVENTS INCLUDE ACUTE KIDNEY INJURY AND RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372865 ICAST COVERED STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention