BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM ICAST COVERED STENT

    MDR report key: 6004353 · Received October 6, 2016

    Report

    Report Number
    1219977-2016-00216
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 4, 2016
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    UDI-DI
    00650862854190
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS: THE ICAST WAS REMOVED FROM THE PACKAGING AND INSPECTED TO DETERMINE THE CAUSE OF THE COMPLAINT. THE DELIVERY SYSTEM WAS INSPECTED FOR DAMAGE. THERE WAS SIGNIFICANT DAMAGE TO THE SHAFT APPROXIMATELY 30CM FROM THE MANIFOLD OF THE DEVICE. THE SHAFT HAD COMPRESSED IN A SECTION APPROXIMATELY 15CM LONG. THIS TYPE OF DAMAGE IS DUE TO EXCESSIVE PUSHING FORCE. NO OTHER DAMAGE WAS OBSERVED. THE STENT WAS IN GOOD CONDITION AND SHOWED NO SIGNS OF DAMAGE INDICATING THAT THE DISTAL END OF THE CATHETER WAS NOT IN CONTACT WITH A BLOCKAGE. THE STENT WAS IN PERFECT CONDITION AND WAS FIRMLY CRIMPED BETWEEN THE TWO RADIO OPAQUE MARKER BANDS. THE DIAMETER OF THE CRIMPED STENT WAS MEASURED AND WAS 2.4MM. THIS DIAMETER IS IN LINE WITH THE CRIMPED STENT DIAMETERS OF THE QUALITY INSPECTION SAMPLES AND IS INDICATIVE OF A PROPERLY CRIMPED STENT. TO DETERMINE THE FUNCTIONALITY OF THE ICAST COVERED STENT SYSTEM THE CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THE STENT DEPLOYED TO NOMINAL INFLATION PRESSURE (8ATM). THE INTRODUCER SHEATH USED IN THE CASE HAS NOT BEEN RETURNED. THERE IS A POSSIBILITY THAT THE SHEATH KINKED DURING THE PROCEDURE AS IT APPEARS THAT THE COMPRESSION OF THE CATHETER SHAFT WAS LOCALIZED TO ONLY ONE LOCATION 30CM FROM THE MANIFOLD OF THE DEVICE. IF THE STENT OR TIP OF THE CATHETER HAD MADE CONTACT WITH AN OBSTRUCTION IT WOULD BE LIKELY THAT THERE WOULD BE SIGNS OF DAMAGE AT THESE LOCATIONS. THERE WERE NO SIGNS OF DAMAGE AT THE STENT OR DISTAL TIP OF THE CATHETER. ENGINEERING SUMMARY: A FULL REVIEW OF THE CATHETER LOT HISTORY RECORDS FOR THE DEVICE 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. CONCLUSION: BASED ON THE DETAILS OF THE EVENT AND THE SUCCESSFUL LOT QUALIFICATION TEST DATA, ATRIUM CAN FIND NO FAULT WITH THE DEVICE AND OR LOT OF STENT DELIVERY SYSTEMS IN QUESTION. IT IS POSSIBLE THAT THE SHEATH KINKED DURING THE PROCEDURE BUT CANNOT BE CONFIRMED. CLINICAL EVALUATION: THERE ARE SEVERAL POSSIBILITIES THAT CAN CAUSE A DELIVERY CATHETER TO BUCKLE INCLUDING BUT NOT LIMITED TO ATTEMPTING TO ADVANCE THROUGH A TIGHT ANGLE IN THE ANATOMY, AN INCORRECTLY SIZED SHEATH FOR THE PRODUCT OR INCORRECT PREPARATION OF THE PRODUCT. IT WAS REPORTED THAT THE PHYSICIAN MET RESISTANCE WHILE ADVANCING THE CATHETER INTO THE SHEATH. IF THE SHEATH WAS TOO SMALL THE DELIVERY CATHETER WOULD BE TIGHT PASSING THROUGH IT AND COULD CAUSE DAMAGE TO THE CATHETER AND DISLODGEMENT OF THE STENT. THE INSTRUCTIONS FOR USE WARN THAT SPECIAL CARE SHOULD BE TAKEN TO ENSURE THAT THE APPROPRIATE SIZE DEVICE AND ACCESSORIES ARE SELECTED PRIOR TO INTRODUCTION. THE IFU ALSO STATES DO NOT USE THIS PRODUCT WHERE FULL EXPANSION OF THE BALLOON DILATATION CATHETER CANNOT BE ACHIEVED DURING PRE-DILATION OR WHERE OBSTRUCTIONS CANNOT BE DILATED SUFFICIENTLY TO ALLOW PASSAGE OF THE DELIVERY CATHETER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA DATE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STENT WAS BEING PUSHED THROUGH THE SHEATH IT BECAME BENT. THE STENT WAS WITHDRAWN FROM THE PATIENT PRIOR TO DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660924 ATRIUM ICAST COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICAL CORPORATION 85419 241082 00650862854190

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention