BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 21812537 · Received April 10, 2025

    Report

    Report Number
    3001845648-2025-00179
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 14, 2025
    Report Date
    June 12, 2025
    Manufacturer
    COOK MEDICAL IRELAND
    Product Code
    NIO
    UDI-DI
    10827002438689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE RECEIPT OF ADDITIONAL INFORMATION ON 16 MAY 2025 THAT THE DESCRIPTION OF THE EVENT WAS INCORRECT AND THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE ORIGINAL REPORT INCORRECTLY INDICATED THAT THE STENT BECAME EXPOSED DURING INSERTION OUTSIDE THE PATIENT¿S BODY, DESPITE THE SAFETY LOCK BEING ENGAGED. AS A RESULT, THE PHYSICIAN USED A DEVICE FROM A DIFFERENT MANUFACTURER TO COMPLETE THE PROCEDURE (SPECIFIC DETAILS OF THE ALTERNATE DEVICE ARE UNAVAILABLE). THE CORRECT EVENT INVOLVED TREATMENT OF THE RIGHT ILIAC ARTERY ACCESSED VIA THE LEFT FEMORAL ARTERY. A ZIV6-35-80-10-80 STENT WAS INSERTED, BUT DEPLOYMENT AT THE TARGET LESION WAS UNSUCCESSFUL. AFTER REMOVING THE SAFETY TAB, THE PHYSICIAN ATTEMPTED DEPLOYMENT AGAIN AT THE STENOSIS SITE, BUT IT REMAINED UNSUCCESSFUL. THE STENT WAS THEN REMOVED FROM THE PATIENT¿S BODY, AND AN ATTEMPT TO DEPLOY IT OUTSIDE THE BODY RESULTED IN PARTIAL DEPLOYMENT, WHICH REQUIRED SIGNIFICANT FORCE.

    Description of Event or Problem · 0

    WHEN THE PHYSICIAN STARTED TO INSERT THE DELIVERY SYSTEM ALONG THE GW OUTSIDE THE PATIENT'S BODY, THE STENT BECAME EXPOSED (EXPANDED) EVEN THOUGH THE SAFETY LOCK WAS ENGAGED. HE COMPLETED THE PROCEDURE WITH ANOTHER MANUFACTURER'S DEICE (DETAIL UNKNOWN).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE RECEIPT OF ADDITIONAL INFORMATION ON 16 MAY 2025 THAT THE DESCRIPTION OF THE EVENT WAS INCORRECT AND THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE ORIGINAL REPORT INCORRECTLY INDICATED THAT THE STENT BECAME EXPOSED DURING INSERTION OUTSIDE THE PATIENT¿S BODY, DESPITE THE SAFETY LOCK BEING ENGAGED. AS A RESULT, THE PHYSICIAN USED A DEVICE FROM A DIFFERENT MANUFACTURER TO COMPLETE THE PROCEDURE (SPECIFIC DETAILS OF THE ALTERNATE DEVICE ARE UNAVAILABLE). THE CORRECT EVENT INVOLVED TREATMENT OF THE RIGHT ILIAC ARTERY ACCESSED VIA THE LEFT FEMORAL ARTERY. A ZIV6-35-80-10-80 STENT WAS INSERTED, BUT DEPLOYMENT AT THE TARGET LESION WAS UNSUCCESSFUL. AFTER REMOVING THE SAFETY TAB, THE PHYSICIAN ATTEMPTED DEPLOYMENT AGAIN AT THE STENOSIS SITE, BUT IT REMAINED UNSUCCESSFUL. THE STENT WAS THEN REMOVED FROM THE PATIENT¿S BODY, AND AN ATTEMPT TO DEPLOY IT OUTSIDE THE BODY RESULTED IN PARTIAL DEPLOYMENT, WHICH REQUIRED SIGNIFICANT FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665683 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO, STENT, ILIAC NIO COOK MEDICAL IRELAND G43868 C2080479 10827002438689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown