BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 19740169 · Received July 15, 2024

    Report

    Report Number
    3001845648-2024-00370
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 8, 2024
    Report Date
    September 18, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002518770
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS FILE WAS OPENED IN RESPONSE TO A PCMF STUDY, REPORTING A ¿COMPLETELY OCCLUDED STUDY STENT¿. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE ZFV6-80-6-8.0 DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER C2006115 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL: THERE IS NO EVIDENCE TO SUGGEST THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. RESTENOSIS OF THE STENTED ARTERY IS A KNOWN SIDE EFFECT OF THE DEVICE. IFU0058 STATES ¿POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO: ABRUPT STENT CLOSURE, ALLERGIC REACTION TO NITINOL, AMPUTATION, ANGINA/CORONARY ISCHEMIA, ARRYTHMIA, ARTERIAL ANEURYSM, ARTERIAL RUPTURE, ARTERIOVENOUS FISTULA, ATHEROEMBOLIZATION (BLUE TO SYNDROME), DEATH, EMBOLISM, FEVER, HEMATOMA/HEMORRHAGE, HYPERSENSITIVITY REACTIONS, HYPOTENSION /HYPERTENSION, INFECTION/ABSCESS FORMATION AT ACCESS SITE, INTIMAL INJURY/DISSECTION, ISCHEMIA REQUIRING INTERVENTION (BYPASS OR AMPUTATION OF TOE, FOOT OR LEG), MYOCARDIAL INFARCTION, PSEUDOANEURYSM FORMATION, PULMONARY EMBOLISM, RENAL FAILURE, RESTENOSIS OF THE STENTED ARTERY, SEPTICEMIA/BACTEREMIA, STENT MALPOSITION, STENT MIGRATION, STENT STRUT FRACTURE, STROKE, SPASM, TISSUE NECROSIS, WORSENED CLAUDICATION/REST PAIN¿. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. ACCORDING TO THE INFORMATION CONTAINED WITHIN THE FILE, PATIENT PRE-EXISTING CONDITIONS INCLUDE DIABETES MELLITUS AND PERIPHERAL ARTERIAL DISEASE (PAD), AND THE PATIENT IS A CURRENT SMOKER. ALL OF THESE ARE KNOWN RISK FACTORS FOR DEVELOPING STENT OCCLUSION. STENT OCCLUSION OCCURS WHEN AN IMPLANTED STENT BECOMES BLOCKED DUE TO THE FORMATION OF A BLOOD CLOT WITHIN OR AROUND THE STENT. THIS COULD LEAD TO THE ARTERIES BECOMING NARROWED. THESE NARROWED ARTERIES COULD LEAD TO PRESSURE BEING EXERTED ON THE STENT AS THE NARROWING PROGRESSES. THIS CAN ALSO OCCUR DUE TO PROGRESSION OF A PATIENT'S PRE-EXISTING CONDITION. PERIPHERAL ARTERY DISEASE (PAD), ALSO KNOWN AS PERIPHERAL ARTERIAL DISEASE, IS A COMMON CONDITION WHERE NARROWED ARTERIES REDUCE BLOOD FLOW TO THE ARMS OR LEGS. SPECIFICALLY, IT AFFECTS THE PERIPHERAL ARTERIES THAT CARRY BLOOD AWAY FROM THE HEART TO OTHER PARTS OF THE BODY. THE MOST PREVALENT TYPE OF PAD IS LOWER-EXTREMITY PAD, WHICH RESULTS IN REDUCED BLOOD FLOW TO THE LEGS AND FEET. PAD IS A RISK FACTOR FOR DEVELOPING RESTENOSIS. DIABETES MELLITUS IS A CHRONIC DISEASE THAT OCCURS EITHER WHEN THE PANCREAS DOES NOT PRODUCE ENOUGH INSULIN OR WHEN THE BODY CANNOT EFFECTIVELY USE THE INSULIN IT PRODUCES. INSULIN IS A HORMONE THAT REGULATES BLOOD GLUCOSE. HYPERGLYCAEMIA, ALSO CALLED RAISED BLOOD GLUCOSE OR RAISED BLOOD SUGAR, IS A COMMON EFFECT OF UNCONTROLLED DIABETES AND OVER TIME LEADS TO SERIOUS DAMAGE TO MANY OF THE BODY'S SYSTEMS, ESPECIALLY THE NERVES AND BLOOD VESSELS. THIS IS A KNOWN EFFECT. OCCLUSION IS LISTED AS A KNOWN ADVERSE EFFECT IN THE DEVICE CER, (B)(4) REV008, AND RESTENOSIS OF THE STENTED ARTERY IS A LISTED POTENTIAL ADVERSE EVENT IN THE DEVICE IFU. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/ CORRECTION: FOR ALL COMPLAINTS A RECOMMENDED ACTION WILL BE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS FILE WAS OPENED IN RESPONSE TO A PCMF STUDY, REPORTING A ¿COMPLETELY OCCLUDED STUDY STENT¿. CONFIRMED QUANTITY OF 01 DEVICE USED. ACCORDING TO THE INFORMATION IN THE FILE, THE PATIENT REQUIRED SURGICAL INTERVENTION. A POSSIBLE ROOT CAUSE OF PRE-EXISTING CONDITIONS WAS DETERMINED. OCCLUSION IS LISTED AS A KNOWN ADVERSE EFFECT IN THE DEVICE CER AND RESTENOSIS OF THE STENTED ARTERY IS LISTED AS A KNOWN ADVERSE EFFECT IN THE DEVICE IFU.

    Description of Event or Problem · 0

    COMPLETELY OCCLUDED STUDY STENT IN PROXIMAL AFS BUT ALSO COMPLETE OCCLUSION OF DISTAL PREEXISTING STENTS IN MID/DISTAL AFS AND POLITEAL ARTERY. PT. PRESENTED AT THE ER WITH CLAUDICATIO/PAIN AT 100M WALKING DISTANCE, WITH WORSENING DURING THE LAST FEW DAYS. DUS SHOWED NO FLOW IN THE STUDY LEG RIGHT (AFS AND POPLITEAL ARTERY). PT. WAS ADMITTED, INTRAARTERIAL LYSIS THERAPY WAS STARTED ON (B)(6) ,2024 AND SUCCESSFULLY COMPLETED THE FOLLOWING DAY. RESOLVED ON (B)(6) 2024.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497450 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD C2006115 10827002518770

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention