BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 3890636 · Received June 3, 2014

    Report

    Report Number
    3001845648-2014-00093
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 6, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ZIV6-35-125-6-80-PTX (ZILVER PTX) DEVICES OF LOT NUMBER C973653 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE STENTS WERE SUCCESSFULLY IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE ZILVER PTX DEVICES WERE IMPLANTED IN THE (B)(6) Y/O WHITE FEMALE WITH A HISTORY OF CORONARY ARTERY DISEASE, PAST MYOCARDIAL INFARCTION, HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND SMOKING (QUIT). IT MAY BE NOTED THAT ACCORDING TO COMPLAINT INFORMATION, THE PHYSICIAN INDICATED THAT THE EVENT WAS "DEFINITELY" RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICE. IN ADDITION, THE FOLLOWING INFORMATION WAS PROVIDED BY THE MEDICAL SCIENCE OFFICER IN RELATION TO THIS COMPLAINT: "RETROPERITONEAL BLEEDS ARE AN UNCOMMON BUT WELL-RECOGNIZED COMPLICATION OF FEMORAL ARTERY ACCESS. THEY ARE TYPICALLY ASSOCIATED WITH A NEEDLE STICK TOO PROXIMAL ON THE FEMORAL ON THE ARTERY (IT'S DIFFICULT TO APPLY PRESSURE AND OBTAIN HEMOSTASIS IN HIGH STICKS) OR A NEEDLE STICK THROUGH THE POSTERIOR WALL OF THE ARTERY. A PATIENT ON ANTICOAGULANTS IS ALSO AT HIGHER RISK OF RETROPERITONEAL BLEED. I DON'T THINK THE ZILVER PTX IN ANY WAY CONTRIBUTED TO THIS EVENT... I'M NOT SURE THE BLEEDING STARTED ONE DAY POST-PROCEDURE; THAT MAY BE WHEN IT WAS RECOGNIZED. THE BLEEDING MAY HAVE BEEN ONGOING SINCE THE PROCEDURE; RETROPERITONEAL BLEEDS MAY NOT ALWAYS BE READILY APPARENT UNTIL MUCH BLOOD HAS BEEN LOST." BASED ON THE PHYSICIAN'S COMMENTS AS WELL ON THE CLINICAL INPUT IT IS UNLIKELY THAT THE RETROPERITONEAL BLEED WAS CAUSED BY THE ZILVER PTX DEVICES. AS INDICATED ABOVE, RETROPERITONEAL BLEEDS ARE COMPLICATION OF FEMORAL ARTERY ACCESS AND ARE TYPICALLY ASSOCIATED WITH A NEEDLE STICK TOO PROXIMAL ON THE FEMORAL ON THE ARTERY OR A NEEDLE STICK THROUGH THE POSTERIOR WALL OF THE ARTERY. HOWEVER, AS THE CONDITION OF USE CANNOT BE REPLICATED A DEFINITIVE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. SINCE THERE IS NO EVIDENCE TO SUGGEST THAT RETROPERITONEAL BLEED DID NOT OCCUR THE EVENT IS CONFIRMED BASED ON CUSTOMER TESTIMONY, HOWEVER, THIS COMPLAINT IS NOT RELATED TO THE ZILVER PTX DEVICES. ZILVER PTX INSTRUCTION FOR USE INCLUDES THE FOLLOWING INFORMATION: "THE USE OF THIS DRUG-ELUTING PERIPHERAL STENT CARRIES THE RISKS ASSOCIATED WITH PERIPHERAL ARTERY STENTING, INCLUDING VASCULAR COMPLICATIONS, AND/OR BLEEDING EVENTS." IN ADDITION, HEMATOMA/HEMORRHAGE IS LISTED AS 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 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. IT MAY BE NOTED THAT ALTHOUGH THE EVENT WAS NOT DIRECTLY RELATED TO THE ZILVER PTX DEVICES AND THE IMPLANTED STENTS PERFORMED AS INTENDED, A RETROPERITONEAL BLEEDING OCCURRED AS A RESULT OF THE PROCEDURE. ON (B)(6) 2014 (14 DAYS POST-PROCEDURE), THE PATIENT DIED. THE CAUSE OF DEATH HAS NOT BEEN REPORTED AND THE SITE HAS BEEN QUERIED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PRE-DILATED. TWO STENTS WERE IMPLANTED AND DILATATION PERFORMED FOLLOWING STENT DEPLOYMENT. THE NEXT DAY ON (B)(6) 2014, THE PATIENT EXPERIENCED A HEMATOMA AT THE ACCESS SITE WHICH REQUIRED INTERVENTION. THE STUDY LESION WAS NOT INVOLVED. THE PHYSICIAN STATED THE EVENT WAS DEFINITELY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICE. TREATMENT INCLUDED, REPEAT ANGIOGRAPHY AND PLACEMENT OF A COVERED STENT, FLUID MANAGEMENT AND MULTIPLE UNITS OF BLOOD PRODUCTS. PATIENT DIED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324871 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C973653

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention