BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 2980488 · Received February 22, 2013

    Report

    Report Number
    1219977-2013-00008
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 26, 2010
    Report Date
    February 26, 2010
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #1 (MDR# 1219977-2012-00050) WAS NOT RETURNED FOR EVALUATION. DEVICE # 2 WAS RETURNED FOR EVALUATION. COMPONENTS RETURNED TO INCLUDED A 7MMX38MMX80CM BALLOON CATHETER (DEVICE#2), A 7 FRENCH TERUMO DESTINATION INTRODUCER SHEATH AND A SET OF FILMS. NO OTHER DETAILS WERE PROVIDED. A REVIEW OF THE INFORMATION PROVIDED INDICATED DIFFICULTY IN ACHIEVING ACCESS TO THE RIGHT ILIAC WITH THE DEVICE. WHILE THE 6X38MM BALLOON CATHETER WAS NOT INCLUDED, THE 7X38MM BALLOON CATHETER EXHIBITED THE USUAL CRIMP IMPRESSIONS ON BOTH THE BALLOON AND THE CATHETER SHAFT INDICATING A PROPER CRIMP. AN ASSESSMENT OF THE INTRODUCER SHOWED A SLIGHT KINK APPROXIMATELY 6CM FROM THE DISTAL TIP. IT IS UNKNOWN WHEN THE INTRODUCER WAS KINKED OR IF IT WAS PRESENT DURING THE CLINICAL CASE. BASED ON THE FLOW ANOMALY OBSERVED AT BIFURCATE, IT IS CONCEIVABLE THAT THE INTRODUCER WAS CONSTRICTED WHICH MAY EXPLAIN THE DIFFICULTY IN GAINING ACCESS WITH BOTH A 7X38MM AND A SMALLER PROFILE 6X38MM DEVICE. A REVIEW OF THE LOT QUALIFICATION DATA COMPLETED BY QUALITY CONTROL PRIOR TO SHIPMENT YIELDED NO ANOMALIES. ATRIUM REVIEWS ALL COMPLAINTS INDEPENDENTLY AND TAKES EACH ONE VERY SERIOUSLY HOWEVER OUTSIDE OF THE CALCIFIED VESSEL IT IS DIFFICULT TO RE-ENACT THE EXACT CONDITIONS EXPERIENCED DURING THE CLINICAL PROCEDURE. BASED ON THE PROCEDURAL INFORMATION PROVIDED AS WELL AS NO ISSUES OBSERVED WITH EITHER THE DATA RETAINED IN QUALITY CONTROL OR THE OBSERVATIONS RECORDED, ATRIUM CAN FIND NO FAULT WITH THE MANUFACTURING PROCESS OR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    DEVICE #2: THE STENT CAME OFF OF CATHETER DURING PROCEDURE. TREATMENT OF RIGHT ILIAC OCCLUSION. ACCESS ON LEFT SIDE - CONTRALATERAL APPROACH TO TREAT RIGHT ILIAC. THE DOCTOR NOTICED THE STENT HAD COME OFF AFTER HE HAD CROSSED OVER THE BIFURCATION (HE HAD PASSED THE STENT IN THE SHEATH OVER THE BIFURCATION). HE WAS ABLE TO GET THE STENT BACK TO THE LEFT ILIAC WHERE HE DEPLOYED THE STENT IN THE LEFT COMMON ILIAC. DEVICE #1 (REF. MDR 1219977-2012-00050): HE NEXT TRIED A 6X38 STENT AND ALSO LOST THE STENT AS HE CROSSED OVER. THE STENT WAS RETRIEVED AND REMOVED FROM THE PATIENT. THE PATIENT RECEIVED NO TREATMENT ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77616 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP. 85404 10504644

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7 FRENCH TERUMO DESTINATION INTRODUCER SHEATH