BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 10869324 · Received November 19, 2020

    Report

    Report Number
    3001845648-2020-00878
    Event Type
    Injury
    Date Received
    November 19, 2020
    Report Date
    December 9, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S001. DEVICE EVALUATION: THE ZISV6 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. AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZISV6 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 OCCLUSION IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE (IFU0117-5). THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/UNDERLYING CONDITIONS. FROM THE LITERATURE ARTICLE IT IS KNOWN THAT PATIENT HAD A HIGH PREVALENCE OF DIABETES AND CORONARY ARTERY DISEASE. OTHER UNDER LYING CONDITIONS INCLUDED ATRIAL FIBRILLATION, HYPERLIPIDAEMIA , CHRONIC RENAL INSUFFICIENCY, HYPERTENSION AND HISTORY OF SMOKING. OCCLUSION IS ALSO LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE IFU AND IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES THAT CAN BE CAUSED BY OBSTRUCTION TO THE VESSEL (E.G. DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND/OR STENTING). COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT¿S OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P100022/S001. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    STERN, 2020, ZILVER PTX AND PACLITAXEL EXPOSURE AND LONG-TERM MORTALITY OF PATIENTS TREATED WITH THE ZILVER PTX DRUG-ELUTING STENT. FROM AN INSTITUTIONAL DATABASE, WE RETROSPECTIVELY IDENTIFIED ALL PATIENTS TREATED WITH THE ZILVER PTX STENT BETWEEN 2013 AND 2015. THIS REPRESENTS THE INITIAL TWO-YEAR PERIOD FOLLOWING APPROVAL BY THE FDA. DEMOGRAPHIC AND COMORBIDITY INFORMATION WAS COLLECTED AT BASELINE. PROCEDURAL AND DEVICE INFORMATION WERE RECORDED AT THE TIME OF PROCEDURE, INCLUDING NUMBER OF STENTS PLACED AND LESION LENGTH. THE INITIAL EXPOSURE DOSE OF PACLITAXEL WAS CALCULATED USING THE MANUFACTURERS INFORMATION ON AMOUNT OF DRUG PER DEVICE. FOR THE PRIMARY OUTCOME OF OVERALL MORTALITY, PATIENTS OR THEIR FAMILIES WERE PERSONALLY CONTACTED BY TELEPHONE TO DETERMINE IF THEY ARE CURRENTLY ALIVE OR DEAD. SECONDARY OUTCOMES EVALUATED INCLUDED PATENCY WITH AND WITHOUT REINTERVENTION. WHEN PACLITAXEL COATED DEVICES (INCLUDING BOTH ADDITIONAL STENTS AND DRUG-COATED BALLOONS) WERE USED IN REINTERVENTION, THIS WAS ADDED TO DETERMINE AN INDIVIDUALS TOTAL LIFETIME PACLITAXEL EXPOSURE DOSE. SIXTY-FOUR PATIENTS WERE TREATED WITH ZILVER PTX DURING THE STUDY PERIOD. THIS INCLUDES 15 PATIENTS WHO UNDERWENT STAGED, BILATERAL INTERVENTIONS, FOR A TOTAL OF 79 LIMBS TREATED. ONE OF THE MAJOR ADVANTAGES OF OUR STUDY, HOWEVER, IS THAT WE WERE ABLE TO ACCOUNT FOR SUBSEQUENT REINTERVENTIONS USING PACLITAXEL AND FACTOR THIS INTO THE LIFETIME EXPOSURE DOSE. THESE ARE REAL PATIENTS WHO PRESENTED BACK WITH RESTENOSIS OR OCCLUSION AND WERE OFTEN TREATED WITH DCBS. THIS COMPLAINT IS CONSERVATIVELY CAPTURING 15 CASES OF RE-OCCLUSION AS THE PAPER DOES NOT SPECIFY HOW MANY PATIENTS REQUIRED INTERVENTION FOR THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331080 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention