BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4350903 · Received December 16, 2014

    Report

    Report Number
    3001845648-2014-00330
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    November 12, 2013
    Report Date
    January 13, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002513454
    PMA / PMN Number
    P100022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INDEPENDENT IMAGE REVIEW RECEIVED IN RELATION TO MDR REPORT REF #3001845648-2014-00271, 00272 AND 00273 WHICH WERE INITIALLY SUBMITTED FOR REPORTS OF OCCLUSION ALSO INDICATED ONE INCIDENT OF STENT FRACTURE HAD OCCURRED WITH A ZIV6-35-125-6.0-120-PTX DEVICE. NO INFO WAS RECEIVED PRIOR TO THIS IMAGE REVIEW THAT INDICATED A STENT FRACTURE HAD OCCURRED. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVAL (THE STENT REMAINS IMPLANTED IN THE PT). WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES RELATING TO THIS EVENT WERE RECEIVED AND REVIEWED. IMAGE FINDINGS INCLUDED A NEW STEP-OFF ALONG THE MID SFA PTX STENT PROXIMAL RIGHT LATERAL MARGIN WAS CONSISTENT WITH A TYPE 1 STENT FRACTURE. THE FRACTURE WAS NOT ASSOCIATED WITH INCREASED NEO-INTIMAL HYPERPLASIA, KINKING, OR AN ACUTE BEND. MINIMAL LUMEN NARROWING WAS DEMONSTRATED MID STENT-NEO-INTIMAL HYPERPLASIA AFTER ANGIOPLASTY. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON THE CUSTOMER TESTIMONY AND ON THE IMAGING PROVIDED AS TYPE 1 STENT FRACTURE WAS CONFIRMED. IT MAY BE NOTED THAT STENT STRUT FRACTURE IS A KNOWN POTENTIAL ADVERSE EFFECT OF THE USE 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 MFG RECORDS FOR LOT #C780022 REVEALED NO ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT REPORT. ACCORDING TO INFO PROVIDED, THE PHYSICIAN WAS NOT AWARE OF THE STENT FRACTURE AND DOES NOT PLAN ANY ACTION RELATING TO THE STENT FRACTURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PT REPORTED AS OCCURRING AS A RESULT OF THIS SPECIFIC EVENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001. AN INDEPENDENT IMAGE REVIEW RECEIVED IN RELATION TO MDR REPORT REF # 3001845648-2014-00271, 3001845648-2014-00272& 3001845648-2014-00273 WHICH WERE INITIALLY SUBMITTED FOR REPORTS OF OCCLUSION ALSO INDICATED ONE INCIDENT OF STENT FRACTURE HAD OCCURRED WITH A ZIV6-35-125-6.0-120-PTX DEVICE. NO INFORMATION WAS RECEIVED PRIOR TO THIS IMAGE REVIEW THAT INDICATED A STENT FRACTURE HAD OCCURRED. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C780022 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMPRESSION: THE STEP OFF ALONG THE MID ZILVER STENT PROXIMAL RIGHT LATERAL MARGIN WAS AGAIN DEMONSTRATED AND UNCHANGED. THIS CORRELATES WITH THE RELATED COMPLAINT REPORT. GIVEN THE STABILITY, THE DEFORMITY IS MOST CONSISTENT WITH A TYPE I FRACTURE THAT REMAINS CLINICALLY INSIGNIFICANT. NO SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT ANATOMY WAS OBSERVED. NO SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WAS OBSERVED. RELATIVE TO THE USE IF THE DEVICE, LONG STENTED LENGTH INCREASED THE RISK OF FRACTURE FROM CONFORMATIONAL CHANGES DURING HIP FLEXION. NO SIGNIFICANT FINDINGS WERE OBSERVED RELATIVE TO THE DEVICE DESIGN OR PERFORMANCE. THE STENT FRACTURE WAS STABLE AND PREVIOUSLY UNRELATED TO THE PRIOR THROMBOSIS.¿ THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS IMAGING REVEALED STENT DEFORMITY CONSISTENT WITH A TYPE I STENT FRACTURE. ACCORDING TO THE IMAGING REVIEW A STEP OFF ALONG THE MID ZILVER STENT PROXIMAL RIGHT LATERAL MARGIN WAS AGAIN DEMONSTRATED AND UNCHANGED SINCE THE FIRST IMAGING REVIEW. GIVEN THE STABILITY, THE DEFORMITY IS MOST CONSISTENT WITH A TYPE I FRACTURE THAT REMAINS CLINICALLY INSIGNIFICANT. THE LONG STENT LENGTH INCREASED THE RISK OF STENT FRACTURE. IT CAN BE NOTED THAT THE STENT FRACTURE WAS UNRELATED TO THE PRIOR THROMBOSIS COMPLAINT. STENT STRUT FRACTURE IS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE 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 FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ACCORDING TO INFORMATION PROVIDED THE PHYSICIAN WAS NOT AWARE OF THE STENT FRACTURE AND DOES NOT PLAN ANY ACTION RELATING TO THE STENT FRACTURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON THE (B)(6) 2012, TWO ZIV6-35-125-6.0-120-PTX DEVICES OF LOT # C778925 AND C780022 AND ONE ZIV6-35-125-7.0-40-PTX DEVICE OF LOT #C772908 WERE IMPLANTED IN THE RIGHT SFA OF THE PT. AN INDEPENDENT IMAGE REVIEW RECEIVED IN RELATION TO MDR REPORT REF # 3001845648-2014-00271, 00272 AND 00273 WHICH WERE INITIALLY SUBMITTED FOR REPORTS OF OCCLUSION ALSO INDICATED ONE INCIDENT OF STENT FRACTURE HAD OCCURRED WITH A ZIV6-35-125-6.0-120-PTX DEVICE. NO INFO WAS RECEIVED PRIOR TO THIS IMAGE REVIEW THAT INDICATED A STENT FRACTURE HAD OCCURRED. THE INFO RECEIVED INDICATES NO ACTION HAS BEEN TAKING SPECIFICALLY RELATING TO THE STENT FRACTURE. AS OF (B)(6) 2014, NO FURTHER ADVERSE EFFECTS TO THE PT HAD BEEN REPORTED AS OCCURING. AS TWO ZIV6-35-125-6.0-120-PTX DEVICES WERE IMPLANTED IN THE PT AND IT IS NOT POSSIBLE TO CONFIRM WHICH ONE IN PARTICULAR HAD FRACTURED, TWO REPORTS HAVE BEEN SUBMITTED FOR EACH SUSPECT DEVICE LOT NUMBER. NOTE HOWEVER, THE IMAGE REVIEW RECEIVED CONFIRMS ONLY ONE STENT FRACTURE HAS OCCURRED. REFERENCE ALSO DIRECTLY RELATED MDR REPORT REF #3001845648-2014-00329.

    Description of Event or Problem · 1

    THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: ON THE (B)(6) 2012 TWO ZIV6-35-125-6.0-120-PTX DEVICES OF LOT # C778925 & C780022 AND ONE ZIV6-35-125-7.0-40-PTX DEVICE OF LOT # C772908 WERE IMPLANTED IN THE RIGHT SFA OF THE PATIENT. AN INDEPENDENT IMAGE REVIEW RECEIVED IN RELATION TO MDR REPORT REF # 3001845648-2014-00271, 3001845648-2014-00272& 3001845648-2014-00273 WHICH WERE INITIALLY SUBMITTED FOR REPORTS OF OCCLUSION ALSO INDICATED ONE INCIDENT OF STENT FRACTURE HAD OCCURRED WITH A ZIV6-35-125-6.0-120-PTX DEVICE. NO INFORMATION WAS RECEIVED PRIOR TO THIS IMAGE REVIEW THAT INDICATED A STENT FRACTURE HAD OCCURRED. THE INFORMATION RECEIVED INDICATES NO ACTION HAS BEEN TAKING SPECIFICALLY RELATING TO THE STENT FRACTURE. AS OF THE 25.JAN.2014 NO FURTHER ADVERSE EFFECTS TO THE PATIENT HAD BEEN REPORTED AS OCCURRING. AS TWO ZIV6-35-125-6.0-120-PTX DEVICES WERE IMPLANTED IN THE PATIENT AND IT IS NOT POSSIBLE TO CONFIRM WHICH ONE IN PARTICULAR HAD FRACTURED, TWO REPORTS HAVE BEEN SUBMITTED FOR EACH SUSPECT DEVICE/LOT #. NOTE HOWEVER THE IMAGE REVIEW RECEIVED CONFIRMS ONLY ONE STENT FRACTURE HAS OCCURRED. REFERENCE ALSO DIRECTLY RELATED MDR REPORT REF # 3001845648-2014-00329.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826610 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C780022 10827002513454

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR