BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 5313152 · Received December 21, 2015

    Report

    Report Number
    3001845648-2015-00295
    Event Type
    Injury
    Date Received
    December 21, 2015
    Date of Event
    September 7, 2015
    Report Date
    March 4, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# P100022/S001. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C780031 WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT WAS CONFIRMED THAT IMAGES WOULD NOT BE AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. AVAILABLE INFORMATION STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING HYPERTENSION AND WAS A PREVIOUS SMOKER. RESTENOSIS 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 TO (OR AMPLIFIES) THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. IT CAN BE THEREFORE STATED THAT IT IS VERY UNLIKELY THAT THE REPORTED RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. DUE TO LACK OF IMAGING NO OTHER COMMENTS CAN BE MADE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH PLACEMENT OF THIS DEVICE. 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. ACCORDING TO INFORMATION PROVIDED PTA WAS PERFORMED AND THE PATIENT RECOVERED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    PMA/510(K)# P100022/S001. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C780031 WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: ¿FINDINGS: SECONDARY INTERVENTION ANGIOGRAPHY PERFORMED 3 YEARS POST IMPLANTATION IS PROVIDED WITH THE COMPLAINT REPORT. THE STENTS WERE IMPLANTED IN THE RIGHT SFA FROM THE SFA ORIGIN THROUGH THE ADDUCTOR CANAL. THE 6X120MM STENTS HAD BEEN PLACED FROM THE DISTAL SFA THROUGH THE PROXIMAL SFA WITH THE 7X40MM SPANNING THE FINAL SEGMENT OF THE PROXIMAL SFA TO THE ORIGIN. THE ENTIRE STENTED LENGTH WAS 26.5CM. THE STENTS WERE FULLY EXPANDED TO THEIR DESIGN DIAMETERS. THE RIGHT LEG INFLOW WAS PROVIDED THROUGH A LEFT TO RIGHT FEM-FEM BYPASS. THE ENTIRE STENTED LENGTH WAS OCCLUDED UP TO THE FINAL 36.5MM OF THE DISTAL STENT. THE OCCLUSION WAS RAPIDLY CROSSED WITH A WIRE AND THEN TREATED WITH ANGIOPLASTY. DEFORMATION OF THE ANGIOPLASTY BALLOON DURING INFLATION DEMONSTRATED THAT THE SEVERE NEOINTIMAL HYPERPLASIA HAD DEVELOPED FROM THE MID DISTAL STENT THROUGH THE ENTIRE MID STENT. MODERATE NEOINTIMAL HYPERPLASIA WAS DEMONSTRATED IN THE SAME FASHION IN THE PROXIMAL 7X40MM STENT. THE ANGIOPLASTY WAS REPEATED A SECOND TIME WITH IMPROVEMENT TO LESS THAN 30%RESIDUAL DIAMETER STENOSIS. THE POPLITEAL ARTERY WAS NEARLY OCCLUDED BY A SMALL EMBOLISM DURING THE ANGIOPLASTY. THIS WAS DISPLACED DISTALLY OCCLUDING THE TIBIAL PERONEAL TRUNK. THE FINAL IMAGING DEMONSTRATED A WIRE, EITHER PART OF AN EMBOLECTOMY DEVICE OR A DISTAL PROTECTION DEVICE, IN THE MID POSTERIOR TIBIAL ARTERY. IMAGING OF FULLY RESTORED CALF RUNOFF WAS NOT PROVIDED. DESPITE THE EMBOLISM THE ANTERIOR TIBIAL ARTERY WHICH CONSTITUTED THE DOMINANT RUNOFF VESSEL TO THE RIGHT FOOT REMAINED PATENT IN TO THE FOOT. IMPRESSION: SEVERE DISTAL AND MID 6X120MM STENT AND MODERATE PROXIMAL 7X40MM STENT NEOINTIMAL HYPERPLASIA WAS CONFIRMED ALONG WITH A MINIMAL AMOUNT OF THROMBUS. STENT PATENCY WAS CHALLENGED BY THE LONG STENTED LENGTH AND THE RIGHT LEG INFLOW LIMITATION. THE RIGHT ILIAC ARTERY WAS OCCLUDED AND THE RIGHT LEG HAD TO SHARE LEFT LEG INFLOW THROUGH A LEFT TO RIGHT FEM-FEM BYPASS. DISTAL RUNOFF WAS COMPROMISED DURING SUCCESSFUL STENT ANGIOPLASTY BY EMBOLIC OCCLUSION TO THE TIBIAL PERONEAL TRUNK. WHETHER THIS WAS RESOLVED CANNOT BE DETERMINED. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT¿S ANATOMY WERE OBSERVED. INFLOW WAS LIMITED TO INFLOW THROUGH A FEM-FEM BYPASS. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE STENTS WERE USED TO TREAT THE ENTIRE SFA WITH A TOTAL STENTED LENGTH OF 26.5CM. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE. THE 6X120MM STENTS DEVELOPED SEVERE NEOINTIMAL HYPERPLASIA AND THE 7X40MM STENT DEVELOPED MODERATE NEOINTIMAL HYPERPLASIA. CAUSE OF ANY ADVERSE EFFECTS. THE TIBIAL PERONEAL TRUNK WAS OCCLUDED BY AN EMBOLISM LIBERATED DURING STENT ANGIOPLASTY.¿ THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS IMAGING REVEALED THAT NEOINTIMAL HYPERPLASIA DEVELOPED THROUGH THE STENTS. ACCORDING TO THE IMAGING REVIEW, DEFORMATION OF THE ANGIOPLASTY BALLOON DURING INFLATION DEMONSTRATED THAT SEVERE NEOINTIMAL HYPERPLASIA HAD DEVELOPED FROM THE MID DISTAL STENT THROUGH THE ENTIRE MID STENT AND MODERATE NEOINTIMAL HYPERPLASIA WAS DEMONSTRATED IN THE PROXIMAL 7X40MM STENT. A MINIMAL AMOUNT OF THROMBOSIS WAS ALSO CONFIRMED. STENT PATENCY WAS CHALLENGED BY THE LONG STENTED LENGTH AND THE RIGHT LEG INFLOW LIMITATION. THE RIGHT ILIAC ARTERY WAS OCCLUDED AND THE RIGHT LEG HAD TO SHARE LEFT LEG INFLOW THROUGH A LEFT TO RIGHT FEM-FEM BYPASS. DISTAL RUNOFF WAS ALSO COMPROMISED DURING STENT ANGIOPLASTY BY AN EMBOLIC OCCLUSION OF THE PERONEAL TRUNK. IN ADDITION, AVAILABLE INFORMATION STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING HYPERTENSION AND A HISTORY OF TOBACCO USE. RESTENOSIS 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 TO OR AMPLIFIES THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. BASED ON THE ABOVE, IT IS VERY UNLIKELY THAT THE REPORTED RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. IT MAY BE NOTED THAT RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH PLACEMENT OF THIS DEVICE. 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. ACCORDING TO INFORMATION PROVIDED PTA WAS PERFORMED AND 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: THREE ZILVER PTX STENTS WERE PLACED IN THE RIGHT SFA OF THE PATIENT. ON (B)(6) 2015: RESTENOSIS IN THE LESION WAS CONFIRMED. ON (B)(6) 2015: PTA WAS PERFORMED. AS THREE ZILVER PTX DEVICES ARE SUSPECTED AS INVOLVED IN THIS EVENT. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE ALSO REPORTS 3001845648-2015-00294 AND 3001845648-2015-00296.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SENT DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: ON (B)(6) 2012: THREE ZILVER PTX STENTS WERE PLACED IN THE RIGHT SFA OF THE PATIENT. ON (B)(6) 2015: RESTENOSIS IN THE LESION WAS CONFIRMED. ON (B)(6) 2015: PTA WAS PERFORMED. AS THREE ZILVER PTX DEVICES ARE SUSPECTED AS INVOLVED IN THIS EVENT. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE ALSO REPORTS 3001845648-2015-00294 AND 3001845648-2015-00296.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840046 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention