BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 19526611 · Received June 13, 2024

    Report

    Report Number
    3001845648-2024-00272
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    September 26, 2023
    Report Date
    September 12, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P200023 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P200023. THIS FILE WAS OPENED IN RESPONSE TO THE ATTACHED LITERATURE ARTICLE, MONTOYA 2023 - AZYGOS VEIN STENTING AS AN ALTERNATE ROUTE FOR INFERIOR VENA CAVA OBSTRUCTION. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE ZILVER VENA DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL 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. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTION FOR USE. THE DEVICE WAS PLACED IN THE AZYGOS VEIN WITH THE PROXIMAL LANDING IN THE SUPRAHEPATIC IVC. THE DEVICE IFU0091 STATES ¿THE ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC VENOUS OUTFLOW OBSTRUCTION¿. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS ESTABLISHED WAS ESTABLISHED. ACCORDING TO THE INFORMATION CONTAINED WITHIN THE FILE, THE STENT WAS PLACED IN ¿THE AZYGOS VEIN WITH THE PROXIMAL LANDING IN THE SUPRAHEPATIC IVC¿. THIS IS CONSIDERED OFF LABEL USE OF THE STENT AS THE DEVICE IFU STATES THAT THE INTENDED USE IS ¿IN THE ILIOFEMORAL VEINS¿. MEDICAL ADVISOR INPUT CONFIRMS THE OFF-LABEL USE OF THE DEVICE. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED MERALGIA PARESTHETICA, WHICH RESOLVED AFTER THREE MONTHS. MERALGIA PARESTHETICA IS A IS A NERVE CONDITION THAT CAUSES PAIN, NUMBNESS, OR TINGLING IN THE UPPER OUTER THIGH. ACCORDING TO THE ARTICLE, ¿THE MERALGIA PARESTHETICA WAS PROBABLY DUE TO STENT COMPRESSION INJURY AT THE AXIS SITE¿. MEDICAL ADVISOR INPUT SUPPORTS THAT THIS WAS DUE TO OFF-LABEL USE. 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 DEVICE WILL PERFORM OR FUNCTION. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/ CORRECTION: FOR ALL COMPLAINTS A RECOMMENDED ACTION WILL BE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS FILE WAS OPENED IN RESPONSE TO THE ATTACHED LITERATURE ARTICLE, MONTOYA 2023 - AZYGOS VEIN STENTING AS AN ALTERNATE ROUTE FOR INFERIOR VENA CAVA OBSTRUCTION. CONFIRMED QUANTITY OF (B)(4) DEVICE USED. ACCORDING TO THE INFORMATION IN THE FILE, THE PATIENT EXPERIENCED PAIN AND NUMBNESS WHICH RESOLVED AFTER THREE MONTHS. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA LITERATURE/ARTICLE: MONTOYA 2023 - AZYGOS VEIN STENTING AS AN ALTERNATE ROUTE FOR INFERIOR VENA CAVA OBSTRUCTION VENOGRAPHY VIA RIGHT INTERNAL JUGULAR VEIN ACCESS CONFIRMED SVC PATENCY AND AN ABSENT INFRAHEPATIC IVC. SUGGESTING THIS WAS IVC ATRESIA (IVCA). WE WERE UNABLE TO FIND AN ENTRY POINT TO THE IVC FROM BELOW AND CONFIRMED THAT THE MAIN RIGHT ILIOFEMORAL OUTFLOW WAS THROUGH THE AZYGOS VEIN. WE SUCCESSFULLY CROSSED THE AZYGOS VEIN USING A STIFF ANGLED GLIDEWIRE, SUPPORTED BY THE TRIFORCE PERIPHERAL CROSSING SET (COOK MEDICAL INC). THE TRIFORCE WAS ADVANCED USING AN 8F X 35-CM SHEATH (TERUMO LNTERVENTIONAL SYSTEMS) TELE­SCOPED THROUGH OUR PRIMARY GROIN ACCESS SHEATH (LLF X 11 CM). SYSTEMIC ANTICOAGULATION WAS ADMINISTERED AT THIS POINT. AFTER ENTERING A CHANNEL CONNECTED TO THE INTRA HEPATIC SEGMENT OF THE IVC. SERIAL BALLOON VENOPLASTY AND STENTING WERE PERFORMED. A ZILVER VENA STENT STACK (COOK MEDICAL INC). 14 X 140 MM. WAS PLACED IN THE AZYGOS VEIN WITH PROXIMAL LANDING IN THE SUPRA­HEPATIC IVC. OFF-LABEL USE: 14X140MM ZILVER VENA STENT STACK WAS PLACED IN THE AZYGOS VEIN WITH PROXIMAL LANDING IN THE SUPRAHEPATIC IVC MERALGIA PARESTHETICA: HIS ONLY COMPLAINT WAS MERALGIA PARESTHETICA THAT RESOLVED AFTER 3 MONTHS. THE MERALGIA PARESTHETICA WAS PROBABLY DUE TO STENT COMPRESSION OR INJURY AT THE AXIS SITE IN THE MID-THIGH. PATIENT OUTCOME: PER MEDICAL ADVISOR INPUT PAIN/DISCOMFORT S=2

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 12-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184235 ZILVER VENA VENOUS SELF-EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male