BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 3893928 · Received June 11, 2014

    Report

    Report Number
    3001845648-2014-00102
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 2, 2014
    Report Date
    December 26, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022 AND S001. PLEASE NOTE THIS REPORT RELATES TO THE ZIV6-35-125-7.0-60-PTX OF LOT # C777742 WHICH WAS PLACED IN THE RIGHT LOWER SFA OF THE PT. PLEASE NOTE AN ADDITIONAL TWO REPORTS HAVE BEEN SUBMITTED IN RELATION TO THIS EVENT. REFERENCE REPORTS #3001845648-2014-00099 AND 3001845648-2014-00101. THIS INCIDENT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE INTERVENTION (PTA AND ADDITIONAL DEVICE PLACEMENT) CARRIED OUT AS A RESULT OF THE OCCURRENCE OF CRITICAL LIMB ISCHEMIA AND RE-STENOSIS WHILE A ZILVER PTX STENT WAS INDWELLING. THERE WERE NO ZILVER PTX DEVICES OF LOT NUMBERS C777742 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE STENTS WERE IMPLANTED IN THE PT AND ARE THEREFORE NOT AVAILABLE FOR EVALUATION. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. NO IMAGES WERE PROVIDED TO REVIEW AS PART OF THE COMPLAINT INVESTIGATION. RE-INTERVENTION OF THE RIGHT SFA WAS PERFORMED. THROUGH THE ANGIOGRAPHY, THIS ISCHEMIA WAS CONFIRMED TO HAVE ORIGINATED FROM A NEW STENOSIS FORM IN THE ARE DISTAL TO WHERE THE PTX STENT WAS PLACED, MEANING THE PTX PLACEMENT HAD NO RELATION TO THIS ISCHEMIA IN RIGHT SFA. ANGIOGRAPHY WAS ALSO CONDUCTED TO THE LEFT SFA, CONFIRMING THERE WAS A STENOSIS IN THE DISTAL PART OF THE PTX STENT. RE-INTERVENTION OF THE LEFT SFA WAS PERFORMED ON (B)(6) 2014. THE STENOSIS IN THE DISTAL PART OF THE PTX STENT WAS TREATED BY PTA AND A NEW STENT PLACEMENT. AS PER THE PHYSICIAN INVOLVED IN THE PROCEDURE; CRITICAL LIMB ISCHEMIA IN LEFT SFA HAD NO RELATION TO PTX STENTS PLACEMENT. ALTHOUGH THE STENOSIS IN THE DISTAL PART OF THE PTX STENT LED TO THE ISCHEMIA, THIS IS NOT A SPECIAL STENOSIS, BUT JUST TYPICAL ONE OFTEN SEEN AFTER STENT PLACEMENT. THERE WERE NO MALFUNCTIONS/DEFECTS/PROBLEMS IN THE PTX STENT ITSELF OR PTX STENT PLACEMENT. IT MAY BE NOTED THAT RE-STENOSIS 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 RE-STENOSIS PROCESS. AS PER INSTRUCTION FOR USE, RE-STENOSIS OF THE STENTED ARTERY IS NOTED AS A POTENTIAL ADVERSE EVENT 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. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THIS REPORT RELATES TO THE ZIV6-35-125-7.0-60-PTX OF LOT # C777742 WHICH WAS PLACED IN THE RIGHT LOWER SFA OF THE PATIENT. PLEASE NOTE AN ADDITIONAL TWO REPORTS HAVE BEEN SUBMITTED IN RELATION TO THIS EVENT. REFERENCE REPORTS # 3001845648-2014-00099 AND 3001845648-2014-00101. THIS INCIDENT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE INTERVENTION (PTA AND ADDITIONAL DEVICE PLACEMENT) CARRIED OUT AS A RESULT OF THE OCCURRENCE OF CRITICAL LIMB ISCHEMIA AND RE-STENOSIS WHILE A ZILVER PTX STENT WAS INDWELLING. THERE WERE NO ZILVER PTX DEVICES OF LOT NUMBERS C777742 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE STENTS WERE IMPLANTED IN THE PATIENT AND ARE THEREFORE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. NO IMAGES WERE PROVIDED TO REVIEW AS PART OF THE COMPLAINT INVESTIGATION. RE-INTERVENTION OF THE RIGHT SFA WAS PERFORMED. THROUGH THE ANGIOGRAPHY, THIS ISCHEMIA WAS CONFIRMED TO HAVE ORIGINATED FROM A NEW STENOSIS FORMED IN THE AREA DISTAL TO WHERE THE PTX STENT WAS PLACED, MEANING THE PTX PLACEMENT HAD NO RELATION TO THIS ISCHEMIA IN RIGHT SFA. ANGIOGRAPHY WAS ALSO CONDUCTED TO THE LEFT SFA, CONFIRMING THERE WAS A STENOSIS IN THE DISTAL PART OF THE PTX STENT. RE-INTERVENTION OF THE LEFT SFA WAS PERFORMED ON THE (B)(6) 2014. THE STENOSIS IN THE DISTAL PART OF THE PTX STENT WAS TREATED BY PTA AND A NEW STENT PLACEMENT. AS PER THE PHYSICIAN INVOLVED IN THE PROCEDURE; CRITICAL LIMB ISCHEMIA IN LEFT SFA HAD NO RELATION TO PTX STENTS PLACEMENT. ALTHOUGH THE STENOSIS IN THE DISTAL PART OF THE PTX STENT LED TO THE ISCHEMIA, THIS IS NOT A SPECIAL STENOSIS, BUT JUST TYPICAL ONE OFTEN SEEN AFTER STENT PLACEMENT. THERE WERE NO MALFUNCTIONS/DEFECTS/PROBLEMS IN THE PTX STENT ITSELF OR PTX STENT PLACEMENT. IT MAY BE NOTED THAT RE-STENOSIS 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 RE-STENOSIS PROCESS. AS PER INSTRUCTION FOR USE, RE-STENOSIS OF THE STENTED ARTERY IS NOTED AS A POTENTIAL ADVERSE EVENT 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. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS. 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. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ZILVER PTX STENT WERE PLACED IN THE RIGHT LOWER SFA AND LEFT UPPER SFA OF THE PT. AFTER THE PROCEDURE, THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL AND HAD BEEN FOLLOWED UP THERE. CRITICAL LIMB ISCHEMIA WAS OBSERVED (DATE UNK) IN BOTH SIDES OF LOWER LIMB OF THE PT WORSENED RUTHERFORD OF BOTH SIDES AND ULCERS ON BOTH SIDES WERE ALSO OBSERVED. RE-INTERVENTION OF THE RIGHT SFA WAS PERFORMED. THROUGH THE ANGIOGRAPHY, THIS ISCHEMIA WAS CONFIRMED TO HAVE ORIGINATED FROM A NEW STENOSIS FORMED IN THE AREA DISTAL TO WHERE THE PTX STENT WAS PLACED, MEANING THE PTX PLACEMENT HAD NO RELATION TO THIS ISCHEMIA IN RIGHT SFA. ANGIOGRAPHY WAS ALSO CONDUCTED TO THE LEFT SFA, CONFIRMING THERE WAS A STENOSIS IN THE DISTAL PART OF THE PTX STENT. RE-INTERVENTION OF THE LEFT SFA WAS PERFORMED. THE STENOSIS IN THE DISTAL PART OF THE PTX STENT WAS TREATED BY PTA AND A NEW STENT PLACEMENT. ON (B)(6) 2014, THE CONDITION OF THE PT WAS UNCHANGED; ALTHOUGH THE STENOSES IN BOTH SIDES DISAPPEARED BY PTA AND STENT PLACEMENT, ULCERS HAVE NOT BEEN CURED YET. THE PT HAVE NOT RECOVERED YET.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF CORRECTED INFORMATION IN RELATION TO THE PATIENTS' OUTCOME. ZILVER PTX STENTS WERE PLACED IN THE RIGHT LOWER SFA AND LEFT UPPER SFA OF THE PATIENT. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND HAD BEEN FOLLOWED UP THERE. CRITICAL LIMB ISCHEMIA WAS OBSERVED (DATE UNKNOWN) IN BOTH SIDES OF LOWER LIMB OF THE PATIENT WORSENED RUTHERFORD OF BOTH SIDES AND ULCERS ON BOTH SIDES WERE ALSO OBSERVED. RE-INTERVENTION OF THE RIGHT SFA WAS PERFORMED. THROUGH THE ANGIOGRAPHY, THIS ISCHEMIA WAS CONFIRMED TO HAVE ORIGINATED FROM A NEW STENOSIS FORMED IN THE AREA DISTAL TO WHERE THE PTX STENT WAS PLACED, MEANING THE PTX PLACEMENT HAD NO RELATION TO THIS ISCHEMIA IN RIGHT SFA. ANGIOGRAPHY WAS ALSO CONDUCTED TO THE LEFT SFA, CONFIRMING THERE WAS A STENOSIS IN THE DISTAL PART OF THE PTX STENT. RE-INTERVENTION OF THE LEFT SFA WAS PERFORMED. THE STENOSIS IN THE DISTAL PART OF THE PTX STENT WAS TREATED BY PTA AND A NEW STENT PLACEMENT. PLEASE NOTE THIS REPORT RELATES TO THE ZIV6-35-125-7.0-60-PTX OF LOT # C777746 WHICH WAS PLACED IN THE LEFT UPPER SFA OF THIS PATIENT. PLEASE NOTE AN ADDITIONAL TWO REPORTS HAVE BEEN SUBMITTED IN RELATION TO THIS EVENT. REFERENCE ALSO REPORTS # 3001845648-2014-0099 AND 3001845648-2014-00101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346127 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C777742

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention