BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 19491908 · Received June 7, 2024

    Report

    Report Number
    3001845648-2024-00264
    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
    NIU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S027. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S027. A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT DUE TO COMPLETION OF THE INVESTIGATION ON 14-AUG-2024. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK/ LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. 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 WILL CAPTURE THE USER ERROR OF A NON-STANDARD ACCESS TECHNIQUE. THIS FILE IS RELATED TO (B)(4). DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE ZILVER PTX 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 IFU0122 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 OFF USER ERROR 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¿. MEDICAL ADVISOR INPUT INDICATES THAT THE ¿FEMORAL CUT DOWN TECHNIQUE¿ IS NOT A STANDARD ACCESS TECHNIQUE, ¿CUTDOWN TECHNIQUE IS AN OPEN PROCEDURE AND IS COMPLETELY DIFFERENT FROM THE STANDARD ACCESS TECHNIQUE¿. USER/USE RELATED COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. 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 WILL CAPTURE THE USER ERROR OF A NON-STANDARD ACCESS TECHNIQUE. CONFIRMED QUANTITY OF 02 DEVICES USED. NO ADVERSE EFFECTS TO THE PATIENTS WERE NOTED IN THIS STUDY. A DEFINITIVE ROOT CAUSE OF USER ERROR OF A NON-STANDARD ACCESS TECHNIQUE WAS DETERMINED.

    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 - PDES (ZILVER PTX) - ENDOVASCULAR DEVICES PLACED IN 5/80 LIMBS (48.7%). THIS COMPLAINT CAPTURES THE USER ERROR OF ZILVER PTX 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

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT DUE TO COMPLETION OF THE INVESTIGATION ON 14-AUG-2024. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK/ LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319752 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male