BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 12624441 · Received October 13, 2021

    Report

    Report Number
    3001845648-2021-00726
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 15, 2021
    Report Date
    January 28, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002574493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME - QAN. PRODUCT CODE - QAN. PMA/510(K) # P200023. DEVICE EVALUATION: THE ZVT7-35-80-16-140 DEVICE OF LOT NUMBER C1840532 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. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW : PRIOR TO DISTRIBUTION ZVT7-35-80-16-140 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ZVT7-35-80-16-140 OF LOT NUMBER C1840532 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1840532. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE ARE IFU0091-7. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW - N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENTS PRE-EXISTING CONDITION (CHRONIC OBSTRUCTION). THE NARROWED VESSEL MAY HAVE COMPRESSED THE STENT, WHICH MAY HAVE LED TO STENT FORESHORTENING. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA # - P200023 & COMMON NAME - QAN. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    INTERVENTION REQUIRING A 16X140 ZILVER VENA STENT. AFTER DEPLOYMENT OF STENT AND 140MM WERE MEASURED USING THE IVUS CATHETER THE STENT FORESHORTENED MISSING THE PROXIMAL LANDING MARK. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. 3.94 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A,YES,NO. 3.95 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO. ¿ IF YES, PLEASE SPECIFY: 3.96 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER. ¿ IF OTHER, PLEASE SPECIFY: 3.97 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? N/A, YES, NO. 3.98 WAS THE DEVICE USED PERCUTANEOUSLY? N/A,YES,NO. 3.99 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? 3.100 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER. ¿ IF OTHER, PLEASE SPECIFY: 3.101 WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? ¿ IF OTHER, PLEASE SPECIFY 3.102 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL. 3.103 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? N/A, YES, NO. 3.104 WHAT WAS THE TARGET LOCATION FOR THE STENT? 3.105 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 3.106 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? N/A,YES,NO. 3.107 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLIC)? 3.108 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? N/A, YES, NO. 3.109 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? N/A, YES, NO. 3.110 IF RESISTANCE WAS MET, HOW DID THE PHYSICIAN ADDRESS THIS? 3.111 DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? N/A,YES,NO. 3.112 DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? N/A,YES,NO 3.113 DID THE USER PUSH THE HUB DURING DEPLOYMENT? N/A, YES, NO. 3.114 DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? N/A, YES, NO. 3.115 WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? N/A, YES, NO. 3.116 WAS THE STENT FULLY DEPLOYED IN THE PATIENT? N/A, YES, NO. 3.117 WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? N/A, YES, NO. 3.118 WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A, YES, NO. 3.119 WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? N/A, YES, NO. 3.120 WHAT INTERVENTION (IF ANY) WAS REQUIRED? 3.121 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY 3.122 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO. ¿ PLEASE SPECIFY IF YES. 3.94 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES, 3.95 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? UNKNOWN. ¿ IF YES, PLEASE SPECIFY: 3.96 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) ANATOMY WAS NOT TORTUOUS. ¿ IF OTHER, PLEASE SPECIFY: 3.97 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 3.98 WAS THE DEVICE USED PERCUTANEOUSLY? YES. 3.99 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? COMMON FEMORAL VEIN 3.100 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER ¿ IF OTHER, PLEASE SPECIFY: 3.101 WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? IF OTHER, PLEASE SPECIFY-CHRONIC OBSTRUCTION NARROWING. 3.102 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? IPSILATERAL. 3.103 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES. 3.104 WHAT WAS THE TARGET LOCATION FOR THE STENT? CIV,EIV,CFV. 3.105 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)?10FR CORDIS,11CM. 3.106 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. 3.107 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLIC)? 035 JWIRE 3.108 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO. 3.109 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO. 3.110 IF RESISTANCE WAS MET, HOW DID THE PHYSICIAN ADDRESS THIS? 3.111 DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES. 3.112 DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? YES. 3.113 DID THE USER PUSH THE HUB DURING DEPLOYMENT? NO. 3.114 DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? YES. 3.115 WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? NO. 3.116 WAS THE STENT FULLY DEPLOYED IN THE PATIENT? YES. 3.117 WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? YES. 3.118 WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? YES. 3.119 WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? NO. 3.120 WHAT INTERVENTION (IF ANY) WAS REQUIRED? 3.121 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A. 3.122 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? N/A, NO. PLEASE SPECIFY IF YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526376 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD G57449 C1840532 10827002574493

    Patients

    Seq Age Sex Outcome Treatment
    1 Female