MAUDE Adverse Event Report: COOK MEDICAL IRELAND ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	G38483
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event: per rep - (b)(6) 2024 - the distal tip of the deployment device separated from the rest of the deployment device.They said that the stent deployed successfully.When they tried to remove the deployment system the from sheath, it got stuck and eventually separated inside sheath.It was all removed with the sheath.The procedure had been successfully completed with the device in question.Patient/event info - notes: prefix ziv6-ptx/zisv6-ptx.3.60 are images (e.G.Angiography, us etc.) of the device and/or procedure available? n/a, yes, no -yes 3.61 was the device flushed before the procedure, as per ifu? n/a, yes, no -yes 3.62 were there any issues with flushing of the device? n/a, yes, no -no 3.63 details of the access sheath used (name, fr size,length)? -unkr 3.64 details of the wire guide used (name, diameter, hydrophillic)? -unkr, not hydrophylic 3.65 what approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other -unkr please specify for other: if contralateral, was the bifurcation angle steep? n/a, yes, no 3.66 what was the target location for the stent? -sfa 3.67 what artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other -unkr please specify for other: 3.68 was the wire guide removed from the patient prior to advancing the delivery system? n/a, yes, no -unkr 3.69 if removed, was the wire guide wiped prior to advancement of the delivery system? n/a, yes, no -unkr 3.70 did the stent delivery system cross the target location? n/a, yes, no -yes 3.71 was pre-dilation performed ahead of placement of the stent? n/a, yes, no -yes 3.72 was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other -unkr if other, please specify: 3.73 was resistance encountered when advancing the wire guide? n/a, yes, no -unkr 3.74 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no -no 3.75 was resistance encountered when deploying the stent? n/a, yes, no -no 3.76 how did the physician deal with any resistance encountered? -n/a 3.77 was the stent fully deployed in the patient before removing the delivery system? n/a, yes, no -yes 3.78 after deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other -no if other, please specify: 3.79 was post-dilation performed after the placement of the stent? n/a, yes, no -yes 3.80 did any portion of the device break off? n/a, yes, no -yes if yes, please state what part: -delivery system 3.81 when did the device break? n/a, prep, advancement, deployment, withdrawal, after removal -withdrawal 3.82 thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? n/a, yes, no -yes 3.83 thumbwheel only ¿ was the retraction sheet being held during deployment.N/a, yes, no -unkr 3.84 did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? n/a, yes, no -unkr if yes, was the stent partially deployed? n/a, yes, no if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed 3.85 if removed, did any part of the stent fracture during removal of the delivery system? n/a, yes, no -n/a 3.86 was the delivery system kinked or twisted during advancement or deployment? n/a, yes, no -no 3.87 please advise if and when any damage was observed on the; 3.87.1 wireguide n/a, yes, no -n/a prior to use, during use, post procedure 3.87.2 delivery system n/a, yes, no -yes prior to use, during use, post procedure -withdrawal if yes, please specify (e.G.Kinked or twisted): -separated 3.88 what intervention (if any) was required? -no 3.89 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day -no 3.90 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no -no please specify if yes.
Additional Manufacturer Narrative
Pma/510(k) # p100022/s026.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 24-jan-2025.
Additional Manufacturer Narrative
Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.A photo was received which revealed a section of the distal inner catheter to be broken and detached from the device.Manufacturing records: prior to distribution, all zisv6-35-125-6-140-ptx devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for zisv6-35-125-6-140-ptx device of lot number c2139578 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: a review of the manufacturing records for the zisv6-35-125-6-140-ptx device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2139578.Instructions for use and label: the notes section of the instructions for use (ifu0118), which accompanies this device instructs the user under precautions "this product is intended for use by physicians trained and experienced in diagnostic and interventional vascular techniques." under the precautions section of the ifu the user is advised "following stent deployment, if resistance is met during the withdrawal of the delivery system, carefully remove the delivery system and wire guide as a unit.If resistance is still encountered during the removal of the delivery system and wire guide as a unit, remove the wire guide, delivery system and introducer sheath together as a unit." there is no evidence to suggest that the customer did not follow the instructions for use.(ifu0118) 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 is that a difficult patient anatomy may have resulted in the formation of a small kink on the delivery system and/or wire guide.It is possible that the presence of a kink may have contributed to the difficulty removing the delivery system post stent deployment, as confirmed by additional information in the patient/event info - notes as a kink would have created friction between the distal inner and wire guide.This may have resulted in the user having to apply additional force to remove the device which may have led to the distal inner breaking/separated.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, deployment device separated.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined from the available information.A possible root cause is that a difficult patient anatomy may have resulted in the formation of a small kink on the delivery system and/or wire guide.It is possible that the presence of a kink may have contributed to the difficulty removing the delivery system post stent deployment, as confirmed by additional information in the patient/event info - notes as a kink would have created friction between the distal inner and wire guide.This may have resulted in the user having to apply additional force to remove the device which may have led to the distal inner breaking/separated.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK MEDICAL IRELAND; cook medical ireland; o'halloran rd; limerick
• Manufacturer (Section G): COOK MEDICAL IRELAND; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 19748484
• Report Number: 3001845648-2024-00387
• Device Sequence Number: 21086429
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)251204(10)C2139578
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100022/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2025
• Device Model Number: G38483
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C2139578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown