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

Model Number	G38481
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	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The shaft was kinked and they were not able to advance a.018 wire to exit the tip.They had to use another g38481 to finish the procedure.If contralateral, was the bifurcation angle steep? did not get into the patient, tried to load the.018¿ wire through the zilver ptx 6 mm x 100 mm outside of body wouldn't advance, there was a kink in shaft the drs.Tried to straighten it out with forceps.What was the access site chosen? common femoral.Details of the access sheath used (name, fr size, length)? raabe 6 fr x 55 cm.What approach was used to access the target site? contralateral, no.What was the target location for the stent? sfa, stent did not enter vascular.What artery was the stent placed in? proximal sfa to proximal popliteal.Another zilver ptx 6 mm x 100 mm was placed not the kinked shaft one.It was also from the same lot number.What disease pathology was being treated? mixed plaque.Did the stent delivery system cross the target location? no, used another zilver ptx stent- 6 mm x 100 mm that crossed using the same.018¿ wire what was the access site chosen? common femoral had no baring on the wire initialing not passing through the wire lumen of stent.Was the patient's anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other (if other, please specify) no, some calcium, still had no baring with kink in wire lumen.Were any other defects (other than the complaint issue) observed on the delivery system prior to return? no.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions e1/f5 - phone number: (b)(6).

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: 24774894
• Report Number: 3001845648-2026-00118
• Device Sequence Number: 20349965
• Product Code: NIU
• UDI-Device Identifier: 10827002384818
• UDI-Public: (01)10827002384818(17)271125(10)C2384265
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P100022/S014
• 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): 05/12/2026

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: G38481
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Device Lot Number: C2384265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2026
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2026
• 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