BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 17169482 · Received June 21, 2023

    Report

    Report Number
    3001845648-2023-00486
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    March 11, 2021
    Report Date
    September 15, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K #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 510K# P200023 DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICES INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) / MDR REF#3001845648-2023-00484 AND (B)(4) / MDR REF#3001845648-2023-00485 AND IT WAS CREATED FROM THE ATTACHED ARTICLE ¿CRONAN ET AL 2021- ENDOVASCULAR MANAGEMENT OF NUTCRACKER SYNDROME IN AN ADOLESCENT PATIENT POPULATION THIS COMPLAINT WAS OPENED TO CAPTURE THE OFF LABEL USE IN 01 CASE AND MILD COMPRESSION OF THE ZILVER STENT . LAB EVALUATION THE DEVICE 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 VENOUS SELF-EXPANDING STENT STENT 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. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. INSTRUCTIONS FOR USE (IFU0091) STATES THE FOLLOWING: THIS COMPLAINT WILL CAPTURE THE MILD COMPRESSION OF THE ZILVER STENT. IT WILL ALSO CAPTURE THE OFF LABEL USE OF ZILVER VENA STENT FOR ENDOVASCULAR STENTING OF THE LEFT RENAL VEIN. AS PER IFU0091,¿ ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION.¿ 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 WE KNOW THAT THE STENTS WERE PLACED ENDOVASCULARLY STENTING OF THE LEFT RENAL VEIN. AS PER THE IFU 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. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM THE ATTACHED ARTICLE ¿CRONAN ET AL 2021- ENDOVASCULAR MANAGEMENT OF NUTCRACKER SYNDROME IN AN ADOLESCENT PATIENT POPULATION ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS USED OFF LABEL IN 01 CASE WHERE AN ADVERSE EVENT RELATED TO THIS OFF LABEL USE OF AND MILD COMPRESSION OF THE ZILVER STENT . COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    CRONAN ET AL 2021 - ENDOVASCULAR MANAGEMENT OF NUTCRACKER SYNDROME IN AN ADOLESCENT PATIENT POPULATION. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE TECHNICAL FEASIBILITY, EFFICACY AND SAFETY OF LEFT RENAL VEIN STENTING IN ADOLESCENTS WITH NUTCRACKER SYNDROME. MATERIALS AND METHODS WE CONDUCTED A RETROSPECTIVE REVIEW OF ELECTRONIC MEDICAL RECORDS AND IMAGING ARCHIVES TO IDENTIFY ADOLESCENTS UNDERGOING ENDOVASCULAR STENTING FOR NUTCRACKER SYNDROME. WE REVIEWED PATIENT DEMOGRAPHICS INCLUDING AGE, GENDER, PRESENTING SYMPTOMS AND DIAGNOSTIC IMAGING FINDINGS. WE COMPARED PRE- AND POST-STENT DEPLOYMENT INTRAVASCULAR ULTRASOUND (IVUS) AND VENOGRAPHY AND EVALUATED PATIENT SYMPTOMS IN CLINIC UP TO 6 MONTHS FOLLOWING STENT PLACEMENT. FOLLOWING INSTITUTIONAL REVIEW BOARD APPROVAL, WE CONDUCTED A RETROSPECTIVE ELECTRONIC MEDICAL RECORD AND IMAGING ARCHIVE REVIEW TO IDENTIFY ALL ADOLESCENTS WHO UNDERWENT ENDOVASCULAR STENTING OF THE LEFT RENAL VEIN FROM JANUARY 2016 TO DECEMBER 2019. SELF-EXPANDABLE STENTS WERE SELECTED IN MOST CASES BECAUSE OF THEIR SUPERIOR ACCURACY IN DEPLOYMENT LOCATION AND ABILITY TO SUPPLY ADEQUATE RADIAL FORCE TO THE SURROUNDING VASCULAR STRUCTURES AT THE TIME OF INITIAL PROCEDURE, EIGHT ZILVER (COOK MEDICAL, BLOOMINGTON, IN) STENTS WERE USED IN SEVEN PATIENTS (FOUR 12×60-MM STENTS, THREE 14×60-MM STENTS ONE 14×40-MM STENT), AND FIVE VENOVO (BARD, NEW PROVIDENCE, NJ) STENTS WERE DEPLOYED IN THREE PATIENTS (THREE 14×40 MM AND TWO 14×60 MM). ZILVER STENTS WERE PLACED PRIOR TO AVAILABILITY OF VENOVO STENTS BECAUSE THE DEPLOYMENT WAS MORE PRECISE WITH THE ZILVER DELIVERY SYSTEM THAN WITH THE WALLSTENT (BOSTON SCIENTIFIC, MARLBOROUGH, MA). NONCOMPLIANT ANGIOPLASTY BALLOONS (CONQUEST OR ATLAS; BARD) WERE USED IN A VARIETY OF SIZES ¿ 14×40 MM, 14×20 MM AND 12×40 MM ¿ TO ENSURE FULL EXPANSION OF THE STENT . A THIRD PATIENT EXPERIENCED WORSENING FLANK AND PELVIC PAIN AT HER 1-MONTH FOLLOW-UP. DURING HER FIRST PROCEDURE, SHE HAD ALSO UNDERGONE LEFT GONADAL VEIN EMBOLIZATION FOR PELVIC CONGESTION SYNDROME. ABDOMEN/PELVIS WAS PERFORMED AT 1 MONTH TO EVALUATE THE SUCCESS OF THE GONADAL VEIN EMBOLIZATION AS WELL AS THE LEFT RENAL VEIN STENT. THE CT DEMONSTRATED MILD COMPRESSION OF THE ZILVER STENT. THIS COMPLAINT WILL CAPTURE THE MILD COMPRESSION OF THE ZILVER STENT. IT WILL ALSO CAPTURE THE OFF LABEL USE OF ZILVER VENA STENT FOR ENDOVASCULAR STENTING OF THE LEFT RENAL VEIN. AS PER IFU0091-8,¿ ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION.¿ PATIENT OUTCOME: STENT REVISION WAS PERFORMED WITH A 14×40- MM WALLSTENT. THE PATIENT REQUIRED A 48-H ADMISSION FOR PAIN CONTROL FOLLOWING THE STENT REVISION AND EXPERIENCED ONGOING PELVIC PAIN AT FOLLOW-UP; THIS ULTIMATELY REQUIRED REFERRAL TO PAIN MANAGEMENT FOR FURTHER EVALUATION. TEN PATIENTS UNDERWENT 13 PROCEDURES WITHIN THE STUDY TIME PERIOD (FIGS. 1 AND 2). AVERAGE AGE WAS 16 YEARS (RANGE 12¿ 20 YEARS) WITH SIX MALES AND FOUR FEMALES (TABLE 1).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 15-SEP-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287880 ZILVER VENA VENOUS SELF-EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN
    252059 ZILVER VENA VENOUS SELF-EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Required Intervention