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

Model Number	G38416
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As initially reported to customer relations: a 75-year-old female patient underwent a lower extremity angiogram procedure in which the zilver ptx 35 drug-eluting stent, g38416, was used.The thumbwheel became difficult to turn, the shaft corkscrewed, and the stent would not deploy.The device was removed, and the physician did not stent over that area.The physician used three additional zilver stents and stented above this area.Are images (e.G., angiography, us etc.) of the device and/or procedure available? district manager is unsure if images are available.Was the device flushed before the procedure, as per ifu? yes were there any issues with flushing of the device? no details of the wire guide used (name, diameter, hydrophilic)? glidewire advance.035 what approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other (please specify for other; if contralateral, was the bifurcation angle steep? contralateral what was the target location for the stent? distal sfa what artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other (please specify for other) distal sfa was the wire guide removed from the patient prior to advancing the delivery system? no if removed, was the wire guide wiped prior to advancement of the delivery system? n/a did the stent delivery system cross the target location? yes was pre-dilation performed ahead of placement of the stent? yes was the patient's anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other (if other, please specify) tortuous and calcified was resistance encountered when advancing the wire guide? yes when crossing lesion was resistance encountered when advancing the delivery system to the target location? yes, this is when the difficulty occurred was resistance encountered when deploying the stent? stent did not deploy how did the physician deal with any resistance encountered? device was removed and three additional stents used to stent above this area.Was the stent fully deployed in the patient before removing the delivery system? n/a after deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other (if other, please specify) n/a was post-dilation performed after the placement of the stent? n/a did any portion of the device break off? no when did the device break? n/a, prep, advancement, deployment, withdrawal, after removal.N/a thumbwheel only - was the distal end of the stability sheath inside the access sheath? district manager was unsure thumbwheel only - was the retraction sheet being held during deployment.District manager unsure did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? no l if yes, was the stent partially deployed? n/a l if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a if removed, did any part of the stent fracture during removal of the delivery system? n/a was the delivery system kinked or twisted during advancement or deployment? no please advise if and when any damage was observed on the; l wireguide n/a, yes, no l prior to use, during use, post procedure l delivery system n/a, yes, no l prior to use, during use, post procedure l if yes, please specify (e.G., kinked or twisted) what intervention (if any) was required? no was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G., kink)? no.
Additional Manufacturer Narrative
Device evaluation: 1 unit of lot c2332950 of zisv6-35-125-5-140-ptx was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 12 january 2026.Observations from the lab evaluation were as follows; device returned with red safety button pressed in deployed position.Strain relief noted to be twisted, with outer sheath bent directly below strain relief.Device returned with severe curvatures noted along delivery system.Crinkling/bunching noted at approx.25cms - 39cms and 51cms - 64 cms from white distal tip.Device handle examined and no issues observed.Biological matter noted above white distal tip.Device flushes with resistance.Abundance of biological matter observed.0.035 inch wire guide attempted to be passed through device.Unable to pass beyond crinkling/bunching observed at 25cms - 39cms from white distal tip.Attempted to deploy the stent.Delivery system broke directly at strain relief.Unable to deploy the stent.During deployment attempt excessive resistance was encountered causing the strain relief to become warped leading to the metal proximal inner breaking and protruding out through the stability sheath.The reported failure was observed.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 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the notes section of the instructions for use, ifu0118 which accompanies this device states the following; "sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Inspect the product to ensure no damage has occurred¿ and ¿upon removal from package, inspect the product to ensure no damage has occurred".There is no evidence to suggest that the user did not follow the instructions for use or label (ifu0118).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As per one of the answers to the additional questions the patient¿s anatomy was tortuous and calcified.A possible root cause can be attributed to difficult patient anatomy.The tortuous and calcified anatomy would have increased mechanical stress during device navigation and deployment which would cause excessive bending, strain, and deformation of the delivery system, leading to the severe curvatures, crinkling and twisting observed during the lab evaluation resulting in the stent not being able to be deployed.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 22-jan-26.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23768232
• Report Number: 3001845648-2025-00627
• Device Sequence Number: 9750520
• Product Code: NIU
• UDI-Device Identifier: 10827002384160
• UDI-Public: (01)10827002384160(17)270610(10)C2332950
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100022/S027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Model Number: G38416
• Device Catalogue Number: ZISV6-35-125-5-140-PTX
• Device Lot Number: C2332950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female