BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 11775266 · Received May 5, 2021

    Report

    Report Number
    3001845648-2021-00365
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Report Date
    June 2, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL 510(K) NUMBER'S P100022/S026, P100022/S014, P100022/S027 OR P100022/S001. DEVICE EVALUATION: THE ZISV6 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE "TOMOI 2015" COMPLAINT FILES PR (B)(4)(EMDR 3001845648-2021-00364) , PR (B)(4)AND PR (B)(4) (EMDR 3001845648-2021-00366) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) WAS OPENED TO INVESTIGATE MALAPPOSED STRUTS. DOCUMENT REVIEW 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: AS PER THE JAPANESE PACKAGING INSERT (C-CI1502M06) WHICH ACCOMPANIES THIS DEVICE IT INFORMS THE USER ABOUT THE "POTENTIAL DEFECTS AND ADVERSE EVENTS THAT MAY OCCUR IN USE OF THIS DEVICE INCLUDE, BUT ARE NOT LIMITED TO: STENT MALAPPOSITION." THE JAPANESE PACKAGING INSERT (C-CI1502M06) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PACKAGING INSERT. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE PATIENT¿S PRE-EXISTING CONDITION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENTS WERE TREATED FOR SUPERFICIAL FEMORAL ARTERY LESIONS AND ALL PATIENTS EXHIBITED INTERMITTENT CLAUDICATION (RUTHERFORD CATEGORY 3). IT IS POSSIBLE THAT PATIENT PRE-EXISTING CONDITIONS CAUSED AND/OR CONTRIBUTED TO STENT MALAPPOSITION. AS MENTIONED ABOVE STENT MALAPPOSITION IS A KNOWN INHERENT RISK OF ENDOVASCULAR STENTING AND IS LISTED IN THE PACKAGING INSERT AS A POTENTIAL ADVERSE EVENT. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER MEDICAL ADVISOR THE PATIENT OUTCOME IS UNKNOWN; UNLIKELY TO HAVE REQUIRED CLINICAL INTERVENTION WITHIN STUDY PERIOD. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 02-JUNE-2022.

    Additional Manufacturer Narrative · 1

    POTENTIAL 510(K) NUMBER'S: P100022/S026, P100022/S014, P100022/S027 OR P100022/S001. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    TOMOI, 2015, ZILVER PTX AND ¿VASCULAR RESPONSE AFTER ZILVER PTX STENT IMPLANTATION FOR SUPERFICIAL FEMORAL ARTERY LESIONS: SERIAL OPTICAL COHERENCE TOMOGRAPHY FINDINGS AT 6 AND 12 MONTHS.¿ PURPOSE:TO COMPARE THE VASCULAR RESPONSE AFTER PACLITAXEL-COATED NITINOL DRUG-ELUTING STENT (ZILVER PTX) IMPLANTATION FOR SUPERFICIAL FEMORAL ARTERY LESIONS AFTER 6 AND 12 MONTHS USING OPTICAL COHERENCE TOMOGRAPHY (OCT). SERIAL OCT EXAMINATIONS WERE PERFORMED IN 5 PATIENTS (4 MEN; MEAN AGE 78.4±6.8 YEARS) WITH 9 ZILVER PTX STENTS AT 6- AND 12-MONTH FOLLOW-UP. THE OCT EXAMINATION WAS PERFORMED WITH A FREQUENCY DOMAIN SYSTEM (C7-XR; ST. JUDE MEDICAL, ST. PAUL, MN, USA) USING A 4.5-F GUIDING CATHETER (PARENT PLUS 45; MEDIKIT, TOKYO, JAPAN) AS A SHEATH VIA THE BRACHIAL ARTERY APPROACH. THE STENT WAS IMAGED USING AN AUTOMATIC PULLBACK DEVICE THAT MOVED THE OCT CATHETER AT 20 MM/S; DIGITAL IMAGES WERE CAPTURED AT AN ACQUISITION RATE OF 100 FRAMES PER SECOND. STRUT MALAPPOSITION WAS DEFINED AS DETACHMENT FROM THE VESSEL WALL >215 ¿M FOR THE ZILVER PTX (STENT STRUT THICKNESS 200 ¿M + THE OCT RESOLUTION LIMIT OF 15 ¿M). THE PERCENTAGE OF MALAPPOSED STRUTS WERE SIMILAR (0.2% VS. 0.2%) AT 6 AND 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671460 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 78 YR Male Required Intervention