BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 6621243 · Received June 8, 2017

    Report

    Report Number
    3001845648-2017-00214
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    March 1, 2017
    Report Date
    May 10, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002353098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 PMA/510(K) # P100022/S014 THE ZISV6-35-80-6.0-80-PTX DEVICE OF LOT NUMBER C1250965 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE TARGET LOCATION WAS CALCIFIED. THE COMPLAINT DEVICE WAS ADVANCED OVER A CORDIS EMERALD WIRE GUIDE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN DEPLOYING THE STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: 1. A SINGLE IMAGE PHOTOGRAPHED OFF AN ANGIOGRAPHY MONITOR IS PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE IMAGE DEMONSTRATES A RIGHT SFA STENT. THE STENT LENGTH WAS MEASURED ON THE IMAGE AT 60MM. THE ANGULATION AT WHICH THE PHOTOGRAPH WAS TAKEN FORESHORTENS THE STENT LENGTH ENOUGH TO MAKE ACCURATE STENT LENGTH MEASUREMENT OFF THE PHOTOGRAPH IMPOSSIBLE. 3. THE DISTAL TWO THIRDS OF THE STENT WERE IMPLANTED IN LONGITUDINAL COMPRESSION WITH A CONCERTINAED SEGMENT AT A CALCIFIED DISTAL SFA ATHEROMA. IMPRESSION : 1. IMPLANTATION IN LONGITUDINAL COMPRESSION WITH A SHORT SEGMENT OF CONCERTINAED STENT AT THE CALCIFIED PLAQUE IS CONFIRMED. THE LONGITUDINAL COMPRESSION WAS THE RESULT OF INADVERTENT FORWARD DELIVERY SYSTEM PRESSURE ON IMPLANTATION AND POSSIBLY STENT EXTRACTION. 2. CONCERTINAED STENT IS CAUSED BY INADVERTENT FORWARD DELIVERY SYSTEM PRESSURE AND USUALLY IS ASSOCIATED WITH AN ANTEGRADE APPROACH. DETAILS OF THE ACCESS WERE NOT PROVIDED. 3. STENT EXTRACTION OCCURS WHEN THE ATHEROMA CREATING THE STENOSIS STILL SIGNIFICANTLY FILLS THE LUMEN AND/OR IS HIGHLY IRREGULAR. THIS USUALLY OCCURS WHEN PRE-IMPLANTATION BALLOON PREP WAS TOO SMALL OR TOO QUICK TO SUFFICIENTLY REMODEL THE ATHEROMA. THE STENT CANNOT EXPAND TO NEAR ITS DESIGN DIAMETER BEFORE CONTACTING ATHEROMA. STENT ELEMENTS ARE TURNED ON END BY THE ATHEROMA AND SHORTEN THE STENT. THIS IN TURN EXTRACTS THE STENT FROM SHEATH. CALCIFIED ATHEROMA CAN REQUIRE PROLONGED ANGIOPLASTY TO REFERENCE VESSEL DIAMETER BEFORE THE VESSEL IS ADEQUATELY PREPPED FOR STENT IMPLANTATION. THE PRESENCE OF CALCIFIED ATHEROMA INCREASES THE PROBABILITY THAT PREIMPLANTATION BALLOON PREP WAS INSUFFICIENT. 4. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE OBSERVED. THE LESION DEMONSTRATED FOCAL CALCIFIED ATHEROMA. THE PRESENCE OF CALCIFIED ATHEROMA INCREASES THE PROBABILITY THAT PREIMPLANTATION BALLOON PREP WAS INSUFFICIENT. 5. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE CONCERTINAED SEGMENT INDICATES INADVERTENT FORWARD DELIVERY SYSTEM PRESSURE ON DEPLOYMENT. THE REMAINING COMPRESSED STENT SUPPORTS INADEQUATE PRE-IMPLANTATION BALLOON PREP. 6. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. EVIDENCE OF STENT EXTRACTION WAS OBSERVED. 7. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS RETURNED WITH THE STENT DEPLOYED. THERE WAS NO TACTILE DAMAGE ON THE OUTER SHEATH, DISTAL TIP OR THE COILS. THE HANDLE WAS OPENED, NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED INCORRECTLY. THE CUSTOMER COMPLAINT IS CONFIRMED, AS THE LONGITUDINAL COMPRESSION AND CONCERTINAING OF THE STENT WAS OBSERVED IN THE IMAGE REVIEW. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A DIFFICULT PATIENT ANATOMY, DEVICE HANDLING DURING THE PROCEDURE AND INSUFFICIENT PRE-DILATION OF THE LESION. FROM THE IMAGE REVIEW, A FOCAL CALCIFIED ATHEROMA WAS OBSERVED. THE PRESENCE OF CALCIFIED ATHEROMA INCREASES THE PROBABILITY THAT PREIMPLANTATION BALLOON PREPARATION WAS INSUFFICIENT. THE STENT WAS OBSERVED TO BE CONCERTINAED IN THE IMAGE REVIEW, SUGGESTING FORWARD PRESSURE ON THE DELIVERY SYSTEM DURING IMPLANTATION. THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE LONGTITUDINAL STENT COMPRESSION OBSERVED IN THE IMAGE REVIEW. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS 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 C1250965. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PLACEMENT OF ZILVER PTX STENT: IR PLACED THE STENT. HOWEVER, AFTER PLACEMENT THE STENT DID NOT COVER THE FULL LESION AS MEASURED. THE MEASURED THE STENT, NOW BEING 60MM AND NOT 80MM. COULD NOT CONFIRM WHETHER IR HAD FIXED THE DISTAL PART INITIALLY DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403884 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002353098

    Patients

    Seq Age Sex Outcome Treatment
    1