BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 7036387 · Received November 16, 2017

    Report

    Report Number
    3001845648-2017-00548
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    September 14, 2017
    Report Date
    November 16, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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/S001. INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2012: TWO PTX STENTS WERE PLACED IN THE PROXIMAL RIGHT SFA. ON (B)(6) 2017: RESTENOSIS WAS CONFIRMED IN THE OVERLAPPED SITE. ON (B)(6) 2017: STENT FRACTURE (TYPE II) WAS CONFIRMED IN THE ZIV6-35-125-6.0-120-PTX AT THE OVERLAPPED SITE. ON (B)(6) 2017: PTA WAS PERFORMED AND THE PATIENT RECOVERED. <UPDATED BASED ON NEW INFORMATION RECEIVED ON 10/NOV/2017> ON (B)(6) 2012: TWO PTX STENTS WERE PLACED IN THE PROXIMAL RIGHT SFA. (PLEASE REFER TO PRODUCT INFORMATION - NOTES FOR PRODUCT AND LOT#S.) ON (B)(6) 2017: RESTENOSIS WAS CONFIRMED AT THE POINT WHERE TYPE II STENT FRACTURE OF ZIV6-35-125-6.0-120-PTX WAS OBSERVED ON THE OVERLAP. ON (B)(6) 2017: PTA WAS PERFORMED AND THE PATIENT RECOVERED. THIS REPORT RELATES TO THE RESTENOSIS EVENT AT THE OVERLAPPED SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) #P100022/S001. THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. THIS REPORT RELATES TO THE RESTENOSIS EVENT AT THE OVERLAPPED SITE. AS 2 STENTS ARE SUSPECTED TO BE INVOLVED IN THIS EVENT A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE ALSO REPORT # 3001845648-2017-00549. THE STENT FRACTURE REPORTED WAS ALSO INVESTIGATED IN A SEPARATE REPORT - REFERENCE ALSO REPORT # 3001845648-2017-00550. THIS INVESTIGATION DEALS WITH THE RESTENOSIS OF ZIV6-35-125-6.0-40-PTX STENT OF LOT NUMBER C771051 NOTED ON THE 14-SEPT-2017 THE ZIV6-35-125-6.0-40-PTX STENT OF LOT NUMBER C771051 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE PATIENT HAD THE FOLLOWING PRE-EXISTING CONDITIONS AT THE TIME OF THE PROCEDURE: HYPERTENSION, DIABETES (TYPE II) AND EVER SMOKED (CURRENT SMOKER). 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: A SINGLE, VERY LIMITED QUALITY X-RAY IMAGE OF THE RIGHT THIGH IS PROVIDED, ALONG WITH THE COMPLAINT REPORT. THE IMAGE DEMONSTRATES ZILVER STENTS SPANNING AT LEAST 24CM FROM THE PROXIMAL SFA THROUGH THE ADDUCTOR CANAL. A SHORTER STENT WAS LIKELY OVERLAPPED WITH THE MORE SUPERIOR STENT IN THE PROXIMAL SFA. DEFINITE IDENTIFICATION OF ALL STENTS WAS NOT POSSIBLE BECAUSE OF LIMITED IMAGE QUALITY. AN ACUTE BEND TO THE LEFT LOCATED JUST SUPERIOR TO THE OVERLAP OF WHAT LIKELY WERE TWO 12CM LONG ZILVER STENTS HAD AN ARROW DRAWN FROM IT. THIS LIKELY INDICATED THE REPORTED STENT FRACTURE LOCATION. THE LIMITED IMAGE QUALITY PRECLUDES CONFIRMATION OF A TYPE I OR II FRACTURE. ALTHOUGH A FRACTURE COULD CERTAINLY BE PRESENT, ACUTE BENDING WITHOUT FRACTURE IS ALSO POSSIBLE. A TYPE ILL FRACTURE IS UNLIKELY WHILE TYPE IV AND V FRACTURES WERE NOT PRESENT. LUMEN COMPROMISE FROM KINK, FRACTURE, OR EXTERNAL COMPRESSION WAS NOT EVIDENT ON THE X-RAY. IMPRESSION: A STENT FRACTURE CANNOT BE CONFIRMED BECAUSE STENT ELEMENTS CANNOT BE RESOLVED BY THE LIMITED QUALITY IMAGE. THE ACUTE BEND COULD BE SECONDARY TO A TYPE II FRACTURE, AS REPORTED, HOWEVER ACUTE BENDING WITHOUT FRACTURE IS ALSO POSSIBLE. BECAUSE LUMEN COMPROMISE WAS NOT EVIDENT ON X-RAY, RESTENOSIS FROM KINK, FRACTURE, OR EXTERNAL COMPRESSION IS EXCLUDED. RE-STENOSIS ON THE BASIS OF NEOINTIMAL HYPERPLASIA IS NOT CONFIRMED BECAUSE NEOINTIMAL HYPERPLASIA CANNOT BE EVALUATED BY X-RAY. THE LONG STENTED LENGTH INCREASED THE POSSIBILITY OF ZILVER STENT FRACTURE. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. LUMEN COMPROMISE WAS NOT EVIDENT ON X-RAY, AND SO RESTENOSIS FROM KINK, FRACTURE, OR EXTERNAL COMPRESSION IS EXCLUDED. RE-STENOSIS ON THE BASIS OF NEOINTIMAL HYPERPLASIA IS NOT CONFIRMED BECAUSE NEOINTIMAL HYPERPLASIA CANNOT BE EVALUATED BY X-RAY. THEREFORE THIS COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. RESTENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (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 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 ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THIS TIME. IT MAY BE NOTED THAT THE PACKAGING INSERT LISTS RESTENOSIS OF THE STENTED ARTERY AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH PLACEMENT OF THIS DEVICE. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE PACKAGING INSERT FOR 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. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER C771051. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C771051. INTERVENTION OF PTA WAS PERFORMED AND THE PATIENT RECOVERED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR ANY POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: ON (B)(6) 2012: TWO PTX STENTS WERE PLACED IN THE PROXIMAL RIGHT SFA. ON (B)(6) 2017: RESTENOSIS WAS CONFIRMED IN THE OVERLAPPED SITE. ON (B)(6) 2017: STENT FRACTURE (TYPE II) WAS CONFIRMED IN THE ZIV6-35-125-6.0-120-PTX AT THE OVERLAPPED SITE. ON (B)(6) 2017: PTA WAS PERFORMED AND THE PATIENT RECOVERED. UPDATED BASED ON NEW INFORMATION RECEIVED ON 10/NOV/2017: ON (B)(6) 2012: TWO PTX STENTS WERE PLACED IN THE PROXIMAL RIGHT SFA. (PLEASE REFER TO PRODUCT INFORMATION - NOTES FOR PRODUCT AND LOT#S.) ON (B)(6) 2017: RESTENOSIS WAS CONFIRMED AT THE POINT WHERE TYPE II STENT FRACTURE OF ZIV6-35-125-6.0-120-PTX WAS OBSERVED ON THE OVERLAP. ON (B)(6) 2017: PTA WAS PERFORMED AND THE PATIENT RECOVERED. THIS REPORT RELATES TO THE RESTENOSIS EVENT AT THE OVERLAPPED SITE. AS 2 STENTS ARE SUSPECTED TO BE INVOLVED IN THIS EVENT A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE ALSO REPORT # 3001845648-2017-00549. THE STENT FRACTURE REPORTED WAS ALSO INVESTIGATED IN A SEPARATE REPORT - REFERENCE ALSO REPORT # 3001845648-2017-00550.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818822 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002513416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention