BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 9360586 · Received November 22, 2019

    Report

    Report Number
    3001845648-2019-00622
    Event Type
    Injury
    Date Received
    November 22, 2019
    Report Date
    November 22, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THIS FILE IS RELATED TO (B)(4). THIS FILE WAS OPENED TO INVESTIGATE THE OCCURRENCE OF IN-STENT RESTENOSIS (ISR). THE ZIB6-40-8-6.0 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZIB6-40-8-6.0 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040-6) STATES THE FOLLOWING: ¿THE STENT HAS NOT BEEN DESIGNED TO INHIBIT TUMOR INGROWTH. TISSUE MAY GROW THROUGH THE STENTS¿. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER. IMPRESSION: 1. BECAUSE IMAGING OF THE COMPLAINT STENT WAS NOT PROVIDED, CONFIRMATION OF PREMATURE STENT DEPLOYMENT CANNOT BE CONFIRMED. 2. THE IMAGING DEMONSTRATES STENT IMPLANTATION THROUGH A 2CM STENOSIS LOCATED JUST INFERIOR A PRE-EXISTING STENT. THE NEWLY IMPLANTED STENT REPRESENTED THE SECOND STENT IN COMPLAINT REPORT. BECAUSE IT WAS SUBJECTIVELY STRETCHED, THE 7CM LONG STENT LIKELY WAS AN 8X60MM STENT. 3. CONSTRAINT OF THE SUCCESSFULLY IMPLANTED STENT BY THE 2CM LONG STENOSIS DEMONSTRATED THAT THE STENOSIS WAS AT LEAST MODERATE TO SEVERE AND PERSISTENT. IT HAD THE POTENTIAL TO SIGNIFICANTLY RESIST SHEATH ADVANCEMENT RELATIVE TO INNER CANNULA ADVANCEMENT. THIS COULD HAVE CAUSED THE COMPLAINT STENT TO PREMATURELY DEPLOY. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENT HAD PANCREATIC CANCER AND OBSTRUCTIVE JAUNDICE. IT IS POSSIBLE THAT THE PATIENT¿S PRE-EXISTING CONDITION CONTRIBUTED TO THE EVENT OF RESTENOSIS. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S). ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED AN ADDITIONAL STENT AS A RESULT OF THIS EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    RELATED TO (B)(4), THIS ADDITIONAL PR WAS OPENED TO CAPTURE RESTENOSIS IN THE STENT THAT HAD BEEN PREVIOUSLY PLACED IN THE PATIENT. WE ARE UNABLE TO OBTAIN ANY FURTHER INFORMATION DUE TO THE DOCTOR REFUSE TO PROVIDE MORE INFORMATION THAT OCCURRED A LONG TIME AGO. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS RESTENOSIS OCCURRED CAUSING BILIARY OBSTRUCTION AND UNDER THE ASSUMPTION THE ADDITIONAL PROCEDURE WAS REQUIRED AS A RESULT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    RELATED TO PR278130, THIS ADDITIONAL PR WAS OPENED TO CAPTURE RESTENOSIS IN THE STENT THAT HAD BEEN PREVIOUSLY PLACED IN THE PATIENT. WE ARE UNABLE TO OBTAIN ANY FURTHER INFORMATION DUE TO THE DOCTOR REFUSE TO PROVIDE MORE INFORMATION THAT OCCURRED A LONG TIME AGO. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS RESTENOSIS OCCURRED CAUSING BILIARY OBSTRUCTION AND UNDER THE ASSUMPTION THE ADDITIONAL PROCEDURE (PR 278130) WAS REQUIRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155963 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention