BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4203316 · Received October 23, 2014

    Report

    Report Number
    3001845648-2014-00198
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    November 25, 2013
    Report Date
    September 24, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513454
    PMA / PMN Number
    P100022/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZILVER PTX DEVICE INVOLVED IN THIS COMPLAINT IS AS FOLLOWS: ZIV6-35-125-6.0-120-PTX OF LOT NUMBER C777371. THE STENT WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE PATIENT PRESENTED WITH THE FOLLOWING PRE-EXISTING CONDITIONS; CORONARY ARTERY DISEASE, HYPERTENSION, DIABETES (TYPE II), EVER SMOKED BUT NOT A CURRENT SMOKER. IMAGES RELATING TO THIS EVENT WERE RECEIVED AND REVIEWED AS FOLLOWS: IMAGE FINDINGS: ANGIOGRAPHY FROM THE (B)(6) 2013 INTERVENTION IS PROVIDED. NO IMAGING FROM THE INITIAL IMPLANTATION (B)(6) 2012 IS PROVIDED. NUMEROUS ANGIOGRAMS WITH CARBON DIOXIDE AS CONTRAST ARE PROVIDED. THREE ZILVER PTX STENTS HAVE BEEN PLACED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY FROM JUST INFERIOR THE SFA ORIGIN TO 5CM SUPERIOR THE MEDIAL FEMORAL CONDYLE SUPERIOR MARGIN. EACH STENT OVERLAPS THE OTHER APPROXIMATELY 1CM. THE MOST INFERIOR STENT HAS BEEN PLACED THROUGH A WALLSTENT AT THE ADDUCTOR CANAL. THE STENTED LENGTH IS 31.5CM. A FOCAL MODERATE TO SEVERE SMOOTH STENOSIS WAS PRESENT IN THE MID-STENT APPROXIMATELY 1.5 CM SUPERIOR THE DISTAL STENT. THE STENOSIS WAS PRIMARILY ALONG THE INNER MEDIAL ASPECT OF THE STENT. THE LATERAL SIDE OF THE STENOSIS WAS CAUSED BY STENT STRUTS PROJECTING INTO THE LUMEN. DESPITE EFFACEMENT, THIS PART OF THE STENOSIS RECOILED AFTER THE FIRST TWO OR THREE ANGIOPLASTIES. ONLY AFTER A THIRD ANGIOPLASTY WAS IMMEDIATE RECOIL ELIMINATED. THREE-VESSEL RUNOFF WAS PRESENT TO THE PROXIMAL CALF. THE CALF WAS NOT IMAGED DISTALLY. IMPRESSION: THE SMOOTH INTRA-STENT STENOSIS IS CONSISTENT WITH NEOINTIMAL HYPERPLASIA. THE STENOSIS WAS ASSOCIATED WITH AN ADJACENT STENT DEFORMITY. THE NEOINTIMAL HYPERPLASIA LIKELY REPRESENTS VASCULAR REACTION TO THE HIGHER FLOW VELOCITIES GENERATED AT THE FOCAL STENT DEFORMITY. GIVEN THAT THIS WAS THE SECOND RE-INTERVENTION, ANY DEFORMITY FROM THE ORIGINAL LESION PLAQUE SHOULD HAVE RESOLVED UNLESS IT WAS HEAVILY CALCIFIED. SINCE NO CALCIFICATION WAS PRESENT, THIS STENOSIS WAS MOST LIKELY CAUSED BY A KINK IN THE ARTERY AND NOT PERSISTENT ATHEROMATOUS PLAQUE. GIVEN THE LENGTH OF THE STENT SEGMENT, KINKING IN THE MID PORTION OF THE VESSEL IS NOT SURPRISING. WITHOUT PROVIDING ADDITIONAL SUPPORT WITH A SECOND STENT, IT IS NOT SURPRISING THAT THE STENOSIS RECURRED AND WILL LIKELY AGAIN RECUR. IT MAY BE NOTED THAT RE-STENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PTA AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS (OR AMPLIFIES) TO THE RESTENOSIS PROCESS. AS PER INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE, RESTENOSIS OF THE STENTED ARTERY IS NOTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. FROM INFORMATION PROVIDED THE PATIENT RECOVERED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ZIV6-35-125-6.0-120-PTX X 2 AND ZIV6-35-125.7.0-120-PTX X 1 WERE PLACED IN THE RIGHT SFA. ON (B)(6) 2013, RESTENOSIS WAS CONFIRMED ONLY IN ONE STENT THAT WAS PLACED MIDDLE OF THE THREE STENTS. PTA WAS PERFORMED. (THIS EVENT WAS PREVIOUSLY INVESTIGATED IN 2013). ON (B)(6) 2013, RESTENOSIS WAS CONFIRMED AT PLUS OR MINUS 5MM OF ONE ZIV6-35-125-6.0-120-PTX PLACED IN THE MOST DISTAL SIDE. THEN, RESTENOSIS WAS TREATED WITH A CUTTING BALLOON. ON (B)(6) 2013, THE PATIENT RECOVERED. THIS REPORT RELATES TO THE ZIV6-35-125-6.0-120-PTX DEVICE PLACED IN THE MOST DISTAL SIDE WHERE RESTENOSIS WAS CONFIRMED ON THE (B)(6) 2013 AND WAS TREATED WITH A CUTTING BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678218 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C777371 10827002513454

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention