BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 18444712 · Received January 4, 2024

    Report

    Report Number
    3001845648-2024-00014
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    April 12, 2013
    Report Date
    June 7, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K163018. DEVICE EVALUATION: 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. THIS FILE WAS RAISED FROM THE ATTACHED JOURNAL ARTICLE DUCREUT ET AL 2013 'LONG-TERM PATENCY OF VENOUS SINUS STENTS FOR IDIOPATHIC INTRACRANIAL HYPERTENSION' TO CAPTURE 22 INSTANCES OF OFF LABEL USE. LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) STATES THE FOLLOWING: "THE ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION" THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. FROM THE ARTICLE IT IS KNOWN THAT THE DEVICES WERE PLACED IN THE VENOUS SINUS AND WERE USED TO TREAT IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH) WHICH IS NOT THE INTENDED USE OF THIS DEVICE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED. FROM THE ARTICLE IT IS KNOWN THAT THE STENTS WERE PLACED IN THE VENOUS SINUS AND WERE USED TO TREAT IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH). AS PREVIOUSLY MENTIONED, THE IFU STATES ¿THE ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION¿. IT SHOULD BE NOTED THAT, AS THE DEVICE WAS USED OUTSIDE OF THEIR VALIDATED STATE AND/OR AGAINST THE INSTRUCTIONS PROVIDED IN THE IFU, IT IS NOT POSSIBLE TO PREDICT HOW THE DEVICES WILL PERFORM OR FUNCTION. AS PER (B)(4), REV006, SECTION 5.3 TABLE 1 - OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. CONFRIMATION 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 POTENTIAL SIMILAR EVENTS. SUMMARY: THE FILE WAS RAISED FROM THE ATTACHED JOURNAL ARTICLE DUCREUT ET AL 2013 'LONG-TERM PATENCY OF VENOUS SINUS STENTS FOR IDIOPATHIC INTRACRANIAL HYPERTENSION' TO CAPTURE 22 INSTANCES OF OFF LABEL USE. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS USED OFF LABEL IN VENOUS SINUS IN 22 CASES. NO ADVERSE EVENTS WERE REPORTED FOR THESE INSTANCES. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED. IT SHOULD BE NOTED THAT, AS THE DEVICE WAS USED OUTSIDE OF THEIR VALIDATED STATE AND/OR AGAINST THE INSTRUCTIONS PROVIDED IN THE IFU, IT IS NOT POSSIBLE TO PREDICT HOW THE DEVICES WILL PERFORM OR FUNCTION. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: DUCRUET,2013 ¿ LONG-TERM PATENCY OF VENOUS SINUS STENTS FOR IDIOPATHIC INTRACRANIAL HYPERTENSION. PROCEDURE: ALL PATIENTS UNDERWENT RETROGRADE VENOGRAPHY TO CONFIRM A >50% STENOSIS AND A TRANS-STENOSIS PRESSURE GRADIENT. FOLLOWUP CATHETER ANGIOGRAPHY WAS PERFORMED BEGINNING 3 MONTHS AFTER THE PROCEDURE. A TOTAL OF 36 STENTS WERE PLACED IN 30 PATIENTS. DUAL ANTIPLATELET MEDICATION WITH ACETYLSALICYLIC ACID 325 MG AND CLOPIDOGREL 75 MG DAILY WAS INITIATED 3 DAYS PRIOR TO TREATMENT. BOTH AGENTS WERE CONTINUED UNTIL 3 MONTHS AFTER PLACEMENT, AT WHICH POINT CLOPIDOGREL WAS DISCONTINUED. OFF LABEL: THIS COMPLAINT WILL CAPTURE REMAINING 22 DEVICES USED OFF LABEL FOR VENOUS SINUS STENTS FOR IDIOPATHIC INTRACRANIAL HYPERTENSION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-JUN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680425 UNKNOWN FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female