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

Model Number	G38491
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations: the shaft of the stent delivery system broke while advancing in through pedal access.I do not have the product available to send back.The product made patient contact, but no patient was harmed, and the case was successfully completed.No patient was harmed, and the case was successfully completed.Per the clinical specialist: my answers are below in red.I answered these the best i could after speaking with staff.Sounds like it was difficult to cross and quite a bit of force might¿ve been used to try and put the delivery up.1.Contact at facility and contact info: na 2.What was the date of the occurrence? (b)(6) 2025.3.Will the facility be reporting this to a government agency (fda, competent authority, etc.) no.4.Is an acknowledgment letter (formal notification of the complaint being received) required? no.5.Is any account action needed (credit, no charge replacement, no action, investigation results, etc.¿)? no.6.Lot: c2216599.7.Gpn: g38491.8.What type of procedure was being performed? angiogram.9.Can you provide any patient information (age, weight, gender, preexisting conditions)? 10.Are images (e.G.Angiography, us etc.) of the device and/or procedure available? n/a, yes, no.11.Was the device flushed before the procedure, as per ifu? yes.12.Were there any issues with flushing of the device? no.13.Details of the access sheath used (name, fr size, length)? 6x45.14.Details of the wire guide used (name, diameter, hyrdophyllic)? v18 300cm.15.What approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other.Pedal access.A.B.If contralateral, was the bifurcation angle step? 16.What was the target location for the stent? sfa.17.What artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p (proximal popliteal), other.A.Please specify for other: it was not placed.A new stent was opened.18.Was the wire guide removed from the patient prior to advancing the delivery system? unknown.19.If removed, was the wire guide wiped prior to advancement of the delivery system? unknown.20.Did the stent delivery system cross the target location? i do not think so 21.Was predilation performed ahead of placement of the stent? unknown.22.Was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other.Sounds like it might¿ve been calcified and was hard to cross a.If other, please specify: 23.Was resistance encountered when advancing the wire guide? 24.Was resistance encountered when advancing the delivery system to the target location? 25.Was resistance encountered when deploying the stent? 26.How did the physician deal with any resistance encountered? 27.Was the stent fully deployed in the patient before removing the delivery system? 28.After deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other a.If other, please specify: 29.Was post dilation performed after the placement of the stent? 30.Did any portion of the device break off? a.If yes, please state what part: 31.When did the device break? n/a, prep, advancement, deployment, withdrawal, after removal 32.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? 33.Thumbwheel only ¿ was the retraction sheet being held during deployment.34.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? a.If yes, was the stent partially deployed? i.If yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? 35.If removed, did any part of the stent fracture during removal of the delivery system? no 36.Was the delivery system kinked or twisted during advancement or deployment? yes, it kinked while advancing it.37.Please advise if and when any damage was observed on the.38.Wireguide a.Prior to use, during use, post procedure none.39.Delivery system a.Prior to use, during use, post procedure none b.If yes, please specify (e.G.Kinked or twisted): 40.What intervention (if any) was required? na.41.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.A different stent was placed same day.42.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.A.Please specify if yes.43.If not with the device in question, how was the procedure performed and/or finished? a new zilver ptx was placed.44.Did the patient require any additional interventions/procedures or experience any adverse effects due to this event? no.
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.Manufacturing records: prior to distribution, all zisv6-35-125-7-140-ptx devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for zisv6-35-125-7-140-ptx device of lot number c2216599 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and label: the precautions section of the instructions for use (ifu0118), which accompanies this device instructs the user "this product is intended for use by physicians trained and experienced in diagnostic and interventional vascular techniques.Standard techniques for interventional vascular procedures should be employed" there is 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 be attributed to use error.As per information reported in the file, the user attempted to gain access with the delivery system via pedal access.Input received from our medical advisor stated that it is not common practice to try and gain access through the foot to place a ptx stent, hence why there is a contralateral or ipsilateral route in case it doesn¿t work in one leg.Additionally, engineering input confirmed that the device has never been tested via pedal access and this is not the normal practice for implanting a stent above the knee.This use error would have contributed to the shaft of the delivery system breaking.Use error 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/rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, the shaft of the stent delivery system broke while advancing in through pedal access.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not suffer any adverse effects.Investigation findings conclude that a definitive root cause could be attributed to use error.As per information reported in the file, the user attempted to gain access with the delivery system via pedal access.Input received from our medical advisor stated that it is not common practice to try and gain access through the foot to place a ptx stent, hence why there is a contralateral or ipsilateral route in case it doesn¿t work in one leg.Additionally, engineering input confirmed that the device has never been tested via pedal access and this is not the normal practice for implanting a stent above the knee.This use error would have contributed to the shaft of the delivery system breaking.Use error 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.

• 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: 21376078
• Report Number: 3001845648-2025-00066
• Device Sequence Number: 8623663
• Product Code: NIU
• UDI-Device Identifier: 10827002384917
• UDI-Public: (01)10827002384917(17)260821(10)C2216599
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 06/27/2025

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: 08/21/2026
• Device Model Number: G38491
• Device Catalogue Number: ZISV6-35-125-7-140-PTX
• Device Lot Number: C2216599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown