BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 4701397 · Received April 14, 2015

    Report

    Report Number
    3001845648-2015-00080
    Event Type
    Injury
    Date Received
    April 14, 2015
    Report Date
    March 16, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) P2100022 AND S001. (B)(4). THIS INVESTIGATION ADDRESSES RESTENOSIS THAT OCCURRED IN A ZIV6-35-125-7-100-PTX DEVICE WHICH REMAINS IMPLANTED IN THE PT. IT IS THEREFORE NOT AVAILABLE FOR EVAL. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE AVAILABLE IMAGES WERE FORWARDED FOR INDEPENDENT REVIEW WHOM CONFIRMED RESTENOSIS ON THE AVAILABLE IMAGES. RESTENOSIS IS A COMMON ADVERSE EFFECT 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 TO OR AMPLIFIES THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT SURFACE OF THE ZILVER PTX STENT WAS COATED WITH THE DRUG (PACLITAXEL) TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. ACCORDING TO INDEPENDENT REVIEWER, NEOINTIMAL HYPERPLASIA EXTENDED THROUGHOUT THE STENTS. IT CAN BE NOTED THAT NEOINTIMAL HYPERPLASIA IS THE MAJOR CAUSE OF RESTENOSIS THAT OCCURS AFTER INTERVENTIONS SUCH AS STENTING OR ANGIOPLASTY. IT CAN BE THEREFORE STATED THAT IT IS VERY UNLIKELY THAT THE EVENT COULD HAVE OCCURRED DUE TO ZILVER PTC MALFUNCTION. ACCORDING TO INSTRUCTIONS FOR USE FOR THIS DEVICE, RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. PRIOR TO DIST ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF RELEVANT MFG RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. BASED ON THE IMAGE REVIEW, THE CUSTOMER COMPLAINT WAS CONFIRMED AS RESTENOSIS HAS BEEN IDENTIFIED ON THE AVAILABLE IMAGES. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AND THE TREATING PHYSICIAN RECOMMENDED THE PT FOR BYPASS. QUAL ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT UNDERWENT TURBOHAWK ATHERECTOMY &BALLOON ANGIOPLASTY PERFORMED IN THE LEFT SFA FROM THE RIGHT FEMORAL APPROACH. THE LEFT SF AND 80% STENOSIS AT THE ADDUCTOR CANAL WITH 3-VESSEL RUNOFF. ALL LESIONS ON THE LEFT WERE REDUCED TO A 20% RESIDUAL STENOSIS WITH ATHERECTOMY AND ADJUNCTIVE BALLOON ANGIOPLASTY. ON (B)(6) 2014, A DUPLEX STUDY SUGGESTED THERE WAS MORE THAN 50% STENOSIS IN LEFT SFA. THE DEVICE DID REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THIS REPORT ADDRESSED THE SECOND DEVICE REPORTED. AN ADD'L SEPARATE REPORT WILL BE SUBMITTED IN RELATION TO THE FIRST AND THIRD DEVICE REPORTED- REPORT REFERENCE NUMBER:3001845648-2015-00079 AND 3001845648-2015-00081.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249059 ZILVER PTX 35 DRUG-ELUTING STENT STENT, SUPERFICIAL FEMERAL ARTERY, DRUG-ELUTION NIU COOK IRELAND LTD C965345

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR