BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 20438354 · Received October 14, 2024

    Report

    Report Number
    3001845648-2024-00598
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Report Date
    October 25, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002362397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K182980. DEVICE EVALUATION: THE ZILVER 635 BILIARY SELF-EXPANDING STENT DEVICE OF RPN ZIB6-125-12.0-40 DEVICE AND LOT NUMBER C2057254 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE FILE IS RELATED TO (B)(4) AND CAPTURES THE ABNORMAL USE OF THE DEVICE - UNCOVERED STENT BEING USED IN A TEVAR PROCEDURE. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. MANUFACTURING RECORDS PRIOR TO DISTRIBUTION ALL ZILVER ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER C2057254 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE/LABEL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE IFU0042 STATES THE FOLLOWING: INTENDED USE: THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION PROVIDED, IT IS KNOWN THAT THE DEVICE WAS USED IN A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR), DISSECTION STENT AND LEFT RENAL ARTERY STENT PROCEDURE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION THAT WAS PROVIDED, IT IS KNOWN THAT THE ZIB6-125-12.0-40 WAS USED IN A TEVAR, DISSECTION STENT AND LEFT RENAL ARTERY STENT PROCEDURE. THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE INVOLVES THE PLACEMENT OF A COVERED STENT (A METAL MESH TUBE WITH A LAYER OF FABRIC) INTO THE WEAKENED AREA OF THE AORTIC ARTERY. WHILE IT IS NOT CLEAR WHERE THE ZIB HAD BEEN DEPLOYED FROM THE PHYSICIAN¿S FEEDBACK, AS PER CLINICAL INPUT, THE ZIBS WERE USED OFF-LABEL. ZIB IS UNCOVERED STENT. THE ZIB DEVICE WAS USED DURING A TEVAR, DISSECTION STENT AND LEFT RENAL ARTERY STENT PROCEDURE. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE, INDICATIONS FOR USE OR CONTRAINDICATIONS OF THE DEVICE. CONFIRMATION OF COMPLAINT COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY ACCORDING TO THE INITIAL REPORTER, THIS FILE WAS RAISED TO CAPTURE THE USE OF THE ZIB6-125-12.0-40 DEVICE IN A TEVAR, DISSECTION STENT AND LEFT RENAL ARTERY STENT PROCEDURE. CONFIRMED QUANTITY OF (B)(4) DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT IS DECEASED. AS PER CLINICAL INPUT, THE PATIENT DEATH SEEMS TO BE RELATED TO ¿DELAYED FIXING THE TYPE OF DISSECTION BECAUSE THE PATIENT WAS STILL ON ANTICOAGULANTS¿, WHICH WAS IRRELEVANT TO ZIBS. AS PER INFORMATION PROVIDED BY THE CLINICAL SPECIALIST ¿THE PATIENT HAD A TYPE A DISSECTION COMPLICATED BY MESENTERIC, RENAL AND PERIPHERAL ARTERIAL MAL PERFUSION. WE FEEL SHE RETROGRADE, DISSECTED, EVEN MORE RUPTURED. THEY HAD NOTHING TO DO WITH THE STENT PER SE. IT WAS NOT THE RESULT OF THE DEVICES USED¿. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE, INDICATIONS FOR USE OR CONTRAINDICATIONS OF THE DEVICE.

    Description of Event or Problem · 0

    DEVICE TRACKING FORM RECEIVED FROM CINC REGULATORY INDICATING PATIENT IS DECEASED. PROCEDURE INDICATES TO HAVE DM CONTACT PHYSICIAN TO CONFIRM IF THE DEVICE CAUSED/CONTRIBUTED TO THE DEATH. THE PHYSICIAN INDICATED: THE PATIENT HAD A TYPE A DISSECTION COMPLICATED BY MESENTERIC, RENAL AND PERIPHERAL ARTERIAL MALPERFUSION I DID A TEVAR, DISSECTION STENT AND LEFT RENAL ARTERY STENT CT SURGERY DELAYED FIXING THE TYPE DISSECTION BECAUSE THE PATIENT WAS STILL ON ANTICOAGULANTS WE FEEL SHE RETROGRADE, DISSECTED, EVEN MORE RUPTURED THEY HAD NOTHING TO DO WITH THE STENT PER SE. PATIENT OUTCOME: PATIENT EXPIRED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-OCT-24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208313 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C2057254 10827002362397

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female