BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 11515752 · Received March 18, 2021

    Report

    Report Number
    3011175548-2021-00329
    Event Type
    Injury
    Date Received
    March 18, 2021
    Report Date
    October 20, 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

    ARTICLE REVIEWED: EL-SABAWI ET AL. 2020. TRANSCATHETER CLOSURE OF CORONARY ARTERY FISTULA: A 21-YEAR EXPERIENCE. J ENDOVASC THER; 27(6):902-909. THE SUBJECT ARTICLE IS A SINGLE-CENTER RETROSPECTIVE REVIEW OF 45 PATIENTS WHO UNDERWENT TRANSCATHETER CLOSURE OF 56 CORONARY ARTERY FISTULAS (CAFS) FROM 1997 TO 2018. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE OUTCOMES OF TRANSCATHETER CORONARY ARTERY FISTULA (CAF) CLOSURE AND TO IDENTIFY ANATOMIC/PROCEDURAL FACTORS THAT MAY IMPACT OUTCOMES. THE SUBJECT ARTICLE IS A SINGLE-CENTER RETROSPECTIVE REVIEW OF 45 PATIENTS WHO UNDERWENT TRANSCATHETER CLOSURE OF 56 CORONARY ARTERY FISTULAS (CAFS) FROM 1997 TO 2018. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE OUTCOMES OF TRANSCATHETER CORONARY ARTERY FISTULA (CAF) CLOSURE AND TO IDENTIFY ANATOMIC/PROCEDURAL FACTORS THAT MAY IMPACT OUTCOMES. 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: ALTHOUGH 8 (17.8%) PATIENTS HAD COMPLICATIONS, INCLUDING DEVICE MIGRATION IN THREE, INTRACRANIAL HEMORRHAGE FROM ANTICOAGULATION IN ONE, AND MYOCARDIAL INFARCTION (MI) IN FOUR (MI WAS A RESULT OF COVERED STENT THROMBOSIS IN 2 PATIENTS OR STAGNATION OF FLOW AFTER CLOSURE OF LARGE DISTAL CAF), HOWEVER CONSIDERING THE DESIGN OF THE STUDY, 89.3% OF TECHNICAL SUCCESS RATE, SURVIVAL AT 1 YEAR AT 97.8%, THE FACT THAT BOTH PATIENTS WITH MI HAD SUCCESSFUL PLACEMENT OF DRUG-ELUTING STENTS RESTORING MYOCARDIAL FLOW AND NOTING POTENTIAL RISKS AND COMPLICATIONS THAT MAY OCCUR WITH IMPLANTATION OF THE STENTS, 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: EL-SABAWI, B. E. (2020). TRANSCATHETER CLOSURE OF CORONARY ARTERY FISTULA: A 21-YEAR EXPERIENCE. CATHETER CARDIOVASCULAR INTERVENTION, 311-319. PURPOSE: TO EVALUATE THE OUTCOMES OF TRANSCATHETER CORONARY ARTERY FISTULA (CAF) CLOSURE AND TO IDENTIFY ANATOMIC/PROCEDURAL FACTORS THAT MAY IMPACT OUTCOMES. METHOD: ALL PATIENTS WHO UNDERWENT TRANSCATHETER CAF CLOSURE AT (B)(6) CLINIC FROM 1997-2018 WERE RETROSPECTIVELY REVIEWED. CONCLUSION: TRANSCATHETER CAF CLOSURE ISI ASSOCIATED WITH A FAVORABLE ACUTE PROCEDURAL SUCCESS AND COMPLICATION RATE IN SELECTED PATIENTS. PER THE ARTICLE ADVERSE EVENTS INCLUDED HEMORRHAGE, THROMBOSIS AND RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414912 ICAST COVERED STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention