BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICAST COVERED STENT

    MDR report key: 11513791 · Received March 18, 2021

    Report

    Report Number
    3011175548-2021-00305
    Event Type
    Death
    Date Received
    March 18, 2021
    Report Date
    August 23, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION: D9, H6 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 29 PATIENTS (17%) HAD MAJOR ADVERSE EVENTS, FOUR TARGET VESSELS WITH RUPTURES WERE APPROACHED THROUGH FENESTRATIONS, THREE OF THE FOUR PATIENTS WITH RA RUPTURE DEVELOPED ACUTE KIDNEY INJURY POSTOPERATIVELY AND ONE PATIENT WITH RA RUPTURE DIED TWO MONTHS AFTER THE PROCEDURE FROM AN UNKNOWN CAUSE, HOWEVER CONSIDERING THE DESIGN OF THE STUDY, NO DEATHS WITHIN 30 DAYS, NO DIFFERENCE BETWEEN THE GROUPS IN OCCURRENCE OF MAJOR ADVERSE EFFECTS AND THE FACT THAT INCORPORATION OF SMALLER THEN 4.0 MM IN DIAMETER RAS DURING F-BEVAR IS TECHNICALLY FEASIBLE (92% TECHNICAL SUCCESS) BUT IS ASSOCIATED WITH A SIGNIFICANT RISK OF RA RUPTURE AND KIDNEY LOSS, ONE CAN INFER THAT THE GETINGE¿S ICAST¿ BALLOON EXPANDABLE COVERED 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

    RECEIVED AN ARTICLE: KARKKAINEN, J. E. (2020). OUTCOMES OF SMALL RENAL ARTERY TARGETS IN PATIENT TREATED BY FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR. EUROPEAN JOURNAL OF ENDOVASCULAR SURGERY, 910-917. PURPOSE: TO EVALUATE RENAL RELATED OUTCOMES IN PATIENTS WHO HAD INCORPORATION OF A SMALL RENAL ARTERY (RA) DURING FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR (F-EVAR). METHOD: A TOTAL OF 215 CONSECUTIVE PATIENTS ENROLLED IN A PROSPECTIVE F-BEVAR TRIAL WERE REVIEWED. CONCLUSION: INCORPORATION OF <4.0 MM RAS DURING F-BEVAR IS ASSOCIATED WITH LOWER TECHNICAL SUCCESS, HIGHER RISK OF ARTERIAL DISRUPTION AND KIDNEY LOSS, AND LOWER PATENCY RATES AT ONE YEAR. PER THE ARTICLE DEATHS OCCURRED WITHIN THE STUDY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416779 ICAST COVERED STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death