BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM ICAST COVERED STENT

    MDR report key: 6208275 · Received December 28, 2016

    Report

    Report Number
    1219977-2016-00259
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    UDI-DI
    00650862854534
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ENGINEERING INVESTIGATION: THE DETAILS STATE THE FOLLOWING: "AS PART OF THE (B)(6) STUDY BEING CONDUCTED BY COOK, INC., THE FOLLOWING EVENT WAS NOTED: THE DATE OF STENT PLACEMENT WAS (B)(6). ON FOLLOW UP AN ANGIOGRAM AN OCCLUSION OF THE LEFT RENAL (IN-STENT) WAS OBSERVED. A RIGHT TRANSFEMORAL BILATERAL SELECTIVE CATHETERIZATION OF THE RENAL ARTERY, RIGHT RENAL ANGIOGRAM WAS PERFORMED. IT WAS REPORTED THAT "VARIOUS SMALL HYDROPHILIC WIRES WERE TRIED ACROSS THE AREA OF THE LEFT RENAL STENT OCCLUSION UNSUCCESSFULLY. TO DATE, THE OCCLUSION IN THE LEFT RENAL STENT REMAINS." A FULL REVIEW OF THE CATHETER LOT HISTORY RECORDS FOR THE DEVICES IN QUESTION WAS PERFORMED. THE RECORDS INDICATE THAT THIS LOT OF CATHETERS PASSED ATRIUMS FINAL LOT QUALIFICATION TESTING. THIS INSPECTION REQUIRES THAT THE CATHETER LOT MUST PASS THE FOLLOWING: ABILITY OF THE STENT AND DELIVERY SYSTEM TO BE PASSED THROUGH THE LABELED INTRODUCER SHEATH. ABILITY TO DEPLOY THE STENT AT NOMINAL PRESSURE (8ATM). ABILITY TO WITHDRAW THE DEFLATED BALLOON CATHETER BACK THROUGH THE LABELED INTRODUCER SHEATH. ABILITY OF THE DELIVERY SYSTEM TO WITHSTAND 5 INFLATE/DEFLATE CYCLES AT THE RATED BURST PRESSURE (12ATM) WITHOUT LEAKS OR FAILURES. BALLOON BURST TESTING. THE BALLOON MUST BURST OVER THE RATED BURST PRESSURE SPECIFIED ON THE LABEL (12ATM). RESULT: ALL QUALITY INSPECTION SAMPLES PASSED THIS FINAL INSPECTION WITHOUT ANY NON-CONFORMANCES NOTED DURING THE FINAL LOT QUALIFICATION TESTING. AS NONE OF THE PERTINENT INFORMATION WAS PROVIDED NOR IMAGES OF THE STENT BLOCKAGE, ATRIUM CANNOT CONFIRM THE PRESENCE OF THE OCCLUSION. OTHER IMPORTANT DETAILS NOT PROVIDED INCLUDED THE DISEASE STATE OF THE RENAL ARTERY PRIOR TO THE PROCEDURE AND IF THE PATIENT FOLLOWED THE RECOMMENDED POST-OPERATIVE INSTRUCTIONS INCLUDING ANTI-THROMBIN/ANTI-PLATELET THERAPY. TO DATE THERE ARE ONLY 5 INSTANCES WHERE COMPLAINTS WERE MADE REGARDING THROMBUS FORMATION OR RESTENOSIS. A 5 YEAR REVIEW IN THE COMPLAINT HISTORY ONLY SHOWED 5 COMPLAINTS; THIS IS VERY MINIMAL IN REGARDS TO THE UNITS SOLD IN THE LAST 5 YEARS FOR THE ICAST PRODUCT LINE. THE TOTAL AMOUNT OF DEVICES SOLD IN THE U.S. LAST 5 YEARS WAS (B)(4). (B)(4). CONCLUSION: BASED ON THE DETAILS OF THE EVENT AND THE SUCCESSFUL LOT QUALIFICATION TEST DATA, ATRIUM CAN FIND NO FAULT WITH THE LOT OF STENT DELIVERY SYSTEMS IN QUESTION. CLINICAL EVALUATION: RESTENOSIS OR REOCCLUSION IS A NARROWING OF AN ARTERY RESULTING IN RESTRICTED BLOOD FLOW. THIS PERTAINS TO AN ARTERY THAT HAS BECOME NARROWED BY DISEASE, HAS RECEIVED TREATMENT TO CLEAR THE BLOCKAGE AND SUBSEQUENTLY THE VESSEL HAS BECOME RE-NARROWED EITHER AS A RESULT OF PROGRESSIVE DISEASE, IMPROPER SIZING OF THE STENT OR NONCOMPLIANCE WITH THE RECOMMENDED ANTIPLATELET/ANTITHROMBIN REGIMEN THAT IS PRESCRIBE POST PROCEDURE. RESTENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES. PATIENTS WITH SEVERE VASCULAR DISEASE REQUIRING INTERVENTION HAVE A HIGHER RISK OF IN-STENT RESTENOSIS. NO INFORMATION ABOUT THE PATIENT'S SYMPTOMS OR DISEASE STATE WAS PROVIDED. THERE WAS NO REPORT OF RE-INTERVENTION. IT WAS REPORTED, HOWEVER, THAT "THE OCCLUSION IN THE LEFT RENAL STENT REMAINS." THE INSTRUCTIONS FOR USE WARN OF ADVERSE EVENTS INCLUDING, BUT NOT LIMITED TO "MISPLACEMENT, MIGRATION AND OCCLUSION." IT WARNS THAT "NATIVE LUMEN DIMENSIONS MUST BE ACCURATELY MEASURED, NOT ESTIMATED."

    Description of Event or Problem · 1

    AS PART OF THE (B)(6) STUDY BEING CONDUCTED BY COOK, INC., THE FOLLOWING EVENT WAS NOTED: THE DATE OF STENT PLACEMENT WAS (B)(6) 2016. ON FOLLOW UP AN ANGIOGRAM AN OCCLUSION OF THE LEFT RENAL (IN-STENT) WAS OBSERVED. A "RIGHT TRANSFEMORAL BILATERAL SELECTIVE CATHETERIZATION OF THE RENAL ARTERY, RIGHT RENAL ANGIOGRAM" WAS PERFORMED. IT WAS NOTED THAT "VARIOUS SMALL HYDROPHILIC WIRES WERE TRIED ACROSS THE AREA OF THE LEFT RENAL STENT OCCLUSION UNSUCCESSFULLY". TO DATE, THE OCCLUSION IN THE LEFT RENAL STENT REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860336 ATRIUM ICAST COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICAL CORPORATION 85453 234626 00650862854534

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention