BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 15127575 · Received July 29, 2022

    Report

    Report Number
    3001845648-2022-00472
    Event Type
    Injury
    Date Received
    July 29, 2022
    Date of Event
    January 21, 2022
    Report Date
    December 7, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S006. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. ¿RABELLINO_2022 HIGHLIGHTED.PDF¿. PR 381297 HAS BEEN CREATED TO CAPTURE 06 CASES OF OFF LABEL USE WITH NO ADVERSE EVENT REPORTED. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER FLEX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE-THE-KNEE POPLITEAL ARTERY¿. IT SHOULD ALSO BE NOTED THAT THE IFU LISTS RESTENOSIS OF THE STENTED ARTERY AS A POTENTIAL ADVERSE EVENT. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE INFORMATION FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY AND ABOVE-THE-KNEE POPLITEAL ARTERY HOWEVER FROM THE INFORMATION PROVIDED THE TARGET LOCATION WAS THE COMMON FEMORAL ARTERY AND DEEP FEMORAL ARTERY. THE OFF-LABEL USE OF THE STENT MAY HAVE CAUSED OR CONTRIBUTED TO THE RESTENOSIS AS IT¿S UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF ITS INTENDED USE. IT SHOULD ALSO BE NOTED THAT THE IFU LISTS RESTENOSIS OF THE STENTED ARTERY AS A POTENTIAL ADVERSE EVENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER RABELLINO ET AL ¿NOVEL COMMON FEMORAL ARTERY LESION CLASSIFICATION IN PATIENTS UNDERGOING ENDOVASCULAR REVASCULARIZATION¿. ACCORDING TO THE INITIAL REPORTER, 03 PATIENTS EXPERIENCED RESTENOSIS REQUIRING REVASCULARISATION AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    RABELLINO ET AL 2022 ¿ ¿NOVEL COMMON FEMORAL ARTERY LESION CLASSIFICATION IN PATIENTS UNDERGOING ENDOVASCULAR REVASCULARIZATION¿ ALL PROCEDURES WERE PERFORMED IN A DEDICATED HYBRID ANGIOGRAPHY LABORATORY. GENERALLY, PATIENTS UNDERWENT A ¿¿CROSSOVER¿¿ APPROACH OVER THE AORTIC BIFURCATION THROUGH A RETROGRADE CONTRALATERAL FEMORAL PUNCTURE WITH A DEDICATED 6F LONG SHEATH (45 CM) OR VIA BRACHIAL APPROACH WITH A DEDICATED 6F LONG SHEATH (90 CM). AFTER SHEATH PLACEMENT HEPARIN WAS ADMINISTERED AT 100 IU/KILOGRAM. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS INITIALLY USED TO ASSESS AND CLASSIFY LESIONS. FOLLOWING DSA AND IDENTIFICATION OF TARGETED LESIONS, A HYDROPHILIC 0.035-INCH WIRE WAS USED FOR CROSSING, FOLLOWING THE STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TECHNIQUE, FOLLOWED BY SELF-EXPANDABLE NITINOL STENT IMPLANTATION. A VARIETY OF STENTS WERE USED TO TREAT LESIONS: SMART (CORDIS, (B)(4)) 14.41%; COMPLETE (MEDTRONIC, (B)(4)) 16.74%; ZILVER FLEX (COOK MEDICAL, (B)(4)) 15.5%, EVERFLEXTM (MEDTRONIC, (B)(4)) 19.4%; EPICTM (BOSTON SCIENTIFIC, (B)(4)) 17.28% AND PROTE´GE´ GPS (MEDTRONIC, MINNEAPOLIS, MN) 16.67%. RESTENOSIS: TARGET LESION REVASCULARIZATION WERE PERFORMED IN THREE PATIENTS. THE ONE PATIENT IN RUTHERFORD IV AT FU, WAS LATER ON SCREENED WITH CT SCAN AND HAD A PATENT CFA STENT FROM INDEX PROCEDURE, WITH A NEW SIGNIFICANT IPSILATERAL LESION IN THE POPLITEAL ARTERY. IN THIS PATIENT, WE PERFORMED ANTEGRADE PUNCTURE OF THE CFA STENT FOR ACCESS WITH NO REPORTED COMPLICATIONS. OFF-LABEL: USE IN COMMON FEMORAL ARTERY AND DEEP FEMORAL ARTERY

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-DEC-2022 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343112 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention