BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 19490005 · Received June 7, 2024

    Report

    Report Number
    3001845648-2024-00262
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    September 15, 2023
    Report Date
    July 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 THE ATTACHED LITERATURE ARTICLE, ZENUNAJ ET AL 2023, ENDOVASCULAR REVASCULARISATION VERSUS OPEN SURGERY WITH PROSTHETIC BYPASS FOR FEMORO-POPLITEAL LESIONS IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE THIS FILE CAPTURES THE OFF LABEL USE OF A CUT DOWN TECHNIQUE TO GAIN VASCULAR ACCESS. THIS FILE IS RELATED TO (B)(4), (B)(4), (B)(4), (B)(4) AND (B)(4). 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. 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. INSTRUCTIONS FOR USE AND/LABEL: THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTION FOR USE. THE DEVICE IFU0058 STATES ¿STANDARD TECHNIQUES FOR PLACEMENT OF AN ARTERIAL ACCESS SHEATH AND WIRE GUIDE SHOULD BE EMPLOYED DURING THE USE OF THE VASCULAR STENT¿. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE OF THE OFF LABEL USE OF A FEMORAL CUT DOWN TECHNIQUE WAS ESTABLISHED. THE INFORMATION IN THE FILE STATES THAT VASCULAR ACCESS WAS ACHIEVED IN TWO CASES USING A ¿FEMORAL CUT DOWN TECHNIQUE¿. THE DEVICE IFU STATES THAT ¿STANDARD TECHNIQUES FOR PLACEMENT OF AN ARTERIAL ACCESS SHEATH AND WIRE GUIDE SHOULD BE EMPLOYED DURING THE USE OF THE VASCULAR STENT¿. THE FEMORAL CUT DOWN TECHNIQUE IS NOT CONSIDERED A STANDARD ACCESS TECHNIQUE AND MEDICAL ADVISOR INPUT CONFIRMS OFF LABEL USE ¿YES, CUTDOWN TECHNIQUE IS AN OPEN PROCEDURE AND IS COMPLETELY DIFFERENT FROM THE STANDARD ACCESS TECHNIQUE¿ . THE DEVICE WAS USED OUTSIDE OF THEIR VALIDATED STATE AND/OR AGAINST THE INSTRUCTIONS PROVIDED IN THE IFU, IT IS NOT POSSIBLE TO PREDICT HOW THE DEVICE WILL PERFORM OR FUNCTION. AS PER (B)(4), REV006, SECTION 5.3 TABLE 1 - OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. 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 THE ATTACHED LITERATURE ARTICLE, ZENUNAJ ET AL 2023, ENDOVASCULAR REVASCULARISATION VERSUS OPEN SURGERY WITH PROSTHETIC BYPASS FOR FEMORO-POPLITEAL LESIONS IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE. THIS FILE CAPTURES THE OFF LABEL USE OF A CUT DOWN TECHNIQUE TO GAIN VASCULAR ACCESS. CONFIRMED QUANTITY OF 19 DEVICES USED. NO ADVERSE EFFECTS TO THE PATIENT WERE NOTED IN THIS STUDY. A DEFINITIVE ROOT CAUSE OF THE OFF LABEL USE OF A FEMORAL CUT DOWN TECHNIQUE WAS ESTABLISHED..

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: ZENUNAJ ET AL 2023 - ENDOVASCULAR REVASCULARISATION VERSUS OPEN SURGERY WITH PROSTHETIC BYPASS FOR FEMORO-POPLITEAL LESIONS IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE. IN THE ENDOVASCULAR GROUP, 52 PROCEDURES WERE PERFORMED PERCUTANEOUSLY BY PUNCTURING THE FEMORAL ARTERY UNDER ULTRASOUND GUIDANCE; HAEMOSTASIS WAS ACHIEVED USING A PERCUTANEOUS CLOSURE DEVICE (ANGIO-SEAL VIP, 6 FR; TERUMO MEDICAL CORPORATION, SOMERSET, NJ, USA). VASCULAR ACCESS WAS ACHIEVED IN THE REMAINING CASES USING THE FEMORAL CUT-DOWN TECHNIQUE. TWO DIFFERENT APPROACHES WERE USED IN THE ENDOVASCULAR GROUP BECAUSE OF RANDOMISATION IN ANOTHER STUDY, WHICH EVALUATED THE OUTCOMES BETWEEN THE TWO VASCULAR ACCESSES [11]. THE LENGTH OF THE TARGET LESION WAS 200 MM + 15 MM SD. THE FIRST-LINE STRATEGY USED IN THE ENDOVASCULAR GROUP WAS BALLOON ANGIOPLASTY; IN ALL CASES, NITINOL SELF EXPANDABLE STENTS WERE USED ONLY FOR RESIDUAL STENOSIS AND FLOW-LIMITING DISSECTIONS (TABLE 3). ALL THE ENDOVASCULAR PROCEDURES WERE PERFORMED BY A SINGLE VASCULAR SURGEON WHILE THE OPEN BYPASSES WERE PERFORMED BY EXPERIENCED VASCULAR SURGEONS. AS PER TABLE 3 - PBMS (ZILVER FLEX) - ENDOVASCULAR DEVICES PLACED IN 24/80 LIMBS (22.8%). THIS COMPLAINT CAPTURES THE USER ERROR OF ZILVER FLEX DEVICE - VASCULAR ACCESS - FEMORAL CUT-DOWN TECHNIQUE. PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO CONFIRMATION THAT THE DEVICE WAS USED OFF LABEL ON (B)(6) 2024 AND THE COMPLETION OF THE INVESTIGATION ON 13-AUG-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030582 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male