BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 19526356 · Received June 13, 2024

    Report

    Report Number
    3001845648-2024-00271
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    June 22, 2023
    Report Date
    September 12, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ¿COMPARTMENT SYNDROME BOTH LEGS¿. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE ZFV6-125-7-10.0 DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: THERE IS NO EVIDENCE THAT THE USER DID NOT FOLLOW THE IFU/LABEL. 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 DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE OF PROCEDURAL COMPLICATIONS WAS DETERMINED. AS PER MEDICAL ADVISOR INPUT, ¿THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS COMPLICATION, IT WAS DUE TO THE PROCEDURE¿. MEDICAL ADVISOR INPUT ALSO STATES THAT THE EVENT MEETS THE CRITERIA OF AN EXPECTED AND FORESEEABLE SIDE EFFECT. THE PATIENT EXPERIENCED COMPARTMENT SYNDROME IN BOTH LEGS, WHICH IS COVERED BY ¿WORSENED CLAUDICATION/REST PAIN¿, LISTED AS A KNOWN 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 CONTINUE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS FILE WAS OPENED IN RESPONSE TO A PCMF STUDY REPORTING ¿COMPARTMENT SYNDROME BOTH LEGS¿. CONFIRMED QUANTITY OF 01 DEVICE USED. ACCORDING TO INFORMATION CONTAINED WITHIN THE FILE ¿PATIENT HAD COMPARTMENT SYNDROME IN BOTH LEGS: TREATED WITH FASCIOTOMY: RESOLVED WITH SEQUELAE ON (B)(6) 2023-FOOT DORSY PALSI¿. A POSSIBLE ROOT CAUSE OF PROCEDURAL COMPLICATIONS WAS ESTABLISHED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: (B)(6) 2023 PATIENT HAD A ZFV6 DEVICE PLACED IN LEFT STUDY LEG, ILLIAC LESION (B)(6) 2023 PATIENT DISCHARGED ADVERSE EVENT NOTED DURING PROCEDURE AND DISCHARGE DATE 22-JUN-2023 PATIENT HAD COMPARTMENT SYNDROME IN BOTH LEGS: TREATED WITH FASCIOTOMY: RESOLVED WITH SEQUELAE 03-JUL-2023 FOOT DORSY PALSI. PER STUDY SITE, NOT RELATED TO STUDY DEVICE, CAUSAL RELATIONSHIP TO STUDY PROCEDURE. PATIENT OUTCOME: RESOLVED WITH FOOT DORSY PALSI.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 12-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937800 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention