BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER DRUG-ELUTING SELF-EXPANDING STENT

    MDR report key: 5722310 · Received June 14, 2016

    Report

    Report Number
    3001845648-2016-00154
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    September 1, 2012
    Report Date
    June 13, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001. ADDITIONAL INFORMATION RELATING TO THIS COMPLAINT HAS BEEN REQUESTED. THE INVESTIGATION OF THIS EVENT IS STILL PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001. THE STENTS WERE IMPLANTED IN THE PATIENTS AND ARE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ACCORDING TO INFORMATION PROVIDED, PTX STENTS WERE USED TO TREAT CEPHALIC ARCH STENOSIS IN AV FISTULA PATIENTS AS PART OF A RANDOMIZED CLINICAL STUDY. THE RESULTS OF THE STUDY WERE PRESENTED AND DESCRIBED STENT-RELATED COMPLICATIONS. ACCORDING TO INFORMATION PROVIDED IN THE PRESENTATION SLIDES, THERE WAS ONE CASE OF STENT FRACTURE WITH AXILLARY VEIN STENT PROTRUSION AT 3 MONTHS. FURTHER INFORMATION AVAILABLE ON SLIDE 31, STATED THAT THE LESION WAS FIRST TREATED WITH A 7MM CONQUEST BALLOON WHICH RESULTED IN 10% RESIDUAL STENOSIS. 1X 8MM DES (ZILVER PTX) STENT WAS IMPLANTED. THE PATIENT PRESENTED HIGH VENOUS PRESSURE AT 3 MONTHS, POSSIBLY ASSOCIATED WITH CENTRAL VEIN STENOSIS. THE PATIENT RECEIVED 4 MONTHLY STENT AND CENTRAL ANGIOPLASTIES AND WAS AGREED FOR RE-STENTING AFTER 30 MONTHS. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. FROM INFORMATION AVAILABLE ON SLIDE 13, OF THE PATIENTS WHO RECEIVED PTX STENTS, 67% WERE DIABETIC, 100% SUFFERED FROM HYPERTENSION AND HEART DISEASE AND 17% HAD A HISTORY OF TOBACCO USE. IT CAN BE NOTED THAT USE OF THE DEVICE IN THE CEPHALIC VEINS IS CONSIDERED OFF LABEL USE. AS PER THE INSTRUCTIONS FOR USE PROVIDED WITH ALL ZILVER PTX DEVICES, THE ZILVER PTX DRUG ELUTING PERIPHERAL STENT IS INTENDED FOR USE IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ABOVE-THE-KNEE FEMOROPOPLITEAL ARTERIES. IT IS POSSIBLE THAT OFF LABEL USE COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT FRACTURE. HOWEVER, DUE TO LIMITED INFORMATION AND AS THE CONDITIONS OF USE CANNOT BE REPLICATED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE RPN AND LOT NUMBER OF THE DEVICE INVOLVED IN THIS OCCURRENCE IS UNKNOWN. THEREFORE, A REVIEW OF THE RELEVANT DOCUMENTATION CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. BASED ON INFORMATION PROVIDED IN THE PRESENTATION SLIDES, THE PATIENT RECEIVED ADDITIONAL ANGIOPLASTIES AND WAS AGREED FOR RE-STENTING AT 30 MONTHS. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS REPORT COMES VIA (B)(4) WHERE (B)(6) (MEDICAL STUDENT) PRESENTED (IN A SCIENTIFIC SESSION) THE RESULTS FROM A (B)(6) STUDY (FROM SEPTEMBER 2012 THROUGH MARCH 2014) AT (B)(6) HOSPITAL USING THE ZILVER PTX STENT TO TREAT CEPHALIC VEIN STENOSES IN AV FISTULA PATIENTS AS ONE ARM OF A (B)(6) STUDY. THE ZILVER PTX STENT IS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY. THE STUDY INCLUDED 28 PATIENTS, INCLUDING NINE THAT WERE TREATED WITH THE ZILVER PTX STENT. THE PRESENTER DESCRIBED STENT-RELATED COMPLICATIONS. NO FURTHER/SPECIFIC DETAILS HAVE BEEN RECEIVED. THE COOK REP WAS UNABLE TO REACH THE PRESENTER AFTER THE PRESENTATION AND AT THE TIME OF THIS REPORT THE REP WAS STILL TRYING TO REACH THE PRESENTER AND OBTAIN ADDITIONAL INFORMATION. NOTE ONE REPORT SUBMITTED AS THE SPECIFICS ON MULTIPLE PATIENTS ARE NOT KNOWN DUE TO NATURE OF THE ORIGIN OF THIS EVENT.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SENT DUE TO THE CONCLUSION INTO THE INVESTIGATION OF THIS EVENT. NOTE ALSO ADDITIONAL INFORMATION WAS RECEIVED RELATING TO THIS EVENT THAT CLARIFIED THE EVENT DESCRIPTION APPLICABLE TO THIS REPORT. PREVIOUSLY ONE REPORT WAS SUBMITTED DUE TO THE ORIGIN OF THE INFORMATION AND NO SPECIFICS RECEIVED RELATING TO SPECIFIC EVENTS. THIS REPORT COMES VIA (B)(6) WHERE (B)(6) (MEDICAL STUDENT) PRESENTED (IN A SCIENTIFIC SESSION) THE RESULTS FROM A SINGLE-CENTER, RANDOMIZED STUDY (FROM SEPTEMBER 2012 THROUGH MARCH 2014) AT (B)(6) HOSPITAL USING THE ZILVER PTX STENT TO TREAT CEPHALIC VEIN STENOSES IN AV FISTULA PATIENTS AS ONE ARM OF A PROSPECTIVE, RANDOMIZED CLINICAL STUDY. IT CAN BE NOTED THAT THE ZILVER PTX STENT IS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY. THE PURPOSE OF THE STUDY WAS TO ASSESS THE EFFICIENCY OF DRUG-ELUTING STENT OR STENT GRAFT PLACEMENT AFTER ANGIOPLASTY COMPARED TO BALLOON ANGIOPLASTY ALONE. THE STUDY INCLUDED 28 PATIENTS, INCLUDING 11 THAT WERE TREATED WITH THE ZILVER PTX STENT. AS PER THE INFORMATION OBTAINED FROM THE PRESENTATION SLIDES, COMPLICATIONS INCLUDED GASTROINTESTINAL HEMORRHAGE, STENT PROTRUSION INTO AXILLARY VEIN AND STENT FRACTURE. THIS REPORT RELATES TO THE REPORTED COMPLICATION OF 'STENT FRACTURE' AND THE RESULTING INTERVENTIONS ASSOCIATED WITH THIS COMPLICATION. NO FURTHER SPECIFICS OUTSIDE OF THE ATTACHED PRESENTATION HAVE BEEN RECEIVED. NOTE ADDITIONAL REPORTS WILL BE SUBMITTED RELATING TO OTHER SPECIFICALLY STATED COMPLICATIONS IN THE PRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379271 ZILVER DRUG-ELUTING SELF-EXPANDING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention