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

Catalog Number ZISV6-35-125-6-120-PTX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s014 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Occurrence: during stent placement the thumbwheel jammed, when the dr tried to force it, that is when it snapped.It was 50% deployed.Then the dr.Tried pulling it, and that is when it deployed, the stent was elongated.No additional steps were needed and no harm to patient.Patient outcome: no patient impact reported sg 15feb2024 patient/event info - notes: 3.32 are images of the device or procedure available? no 3.33 at what stage of the procedure did the complaint occur? stent placement.3.34 details of access sheath used (name, fr size, length)? terumo destination 7fr 45cm 3.35 what was the target location for the stent? distal sfa 3.36 was the product inspected for kinks or damage before use? yes 3.37 was the device used percutaneously? yes 3.38 was the device flushed through both flushing port before the procedure, as per ifu? yes 3.39 was pre-dilation performed ahead of placement of the stent? yes with a 5mm sterling balloon.3.40 was post-dilation performed after the placement of the stent? yes 3.41 details of the wire guide used (name, diameter, hyrdophyllic)? terumo.018 glidewire advantage 3.42 did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? n/a, tortuous, calcified, altered 3.43 was resistance encountered when advancing the wire guide to the target location? yes 3.44 was resistance encountered when advancing the delivery system to the target location? no 3.45 how did the physician deal with this resistance? after crossing the occlusion the dr pre-dilated the area with a 5 mm balloon 3.46 was the approach ipsilateral or contralateral? contralateral ¿ if contralateral, was the bifurcation angle steep? unknown 3.47 did the tip of the delivery system cross the target location? yes 3.48 was the delivery system tracked around a tight angle in the patient anatomy? yes 3.49 was the delivery system damaged/kinked/twisted during deployment? not on the inside, but the outside the thumbwheel was broken while the dr was rolling it back.3.50 was the handle pulled towards the hub during deployment? no 3.51 was the delivery system pushed during deployment? yes 3.52 was the stent deployed smoothly / without resistance? no ¿ if no, please detail any difficulty experienced during deployment: sfa stent stuck, there was resistance.3.53 what artery was the stent placed in? sfa 3.54 was the stent fully deployed from the delivery system prior to removal of the delivery system? no 3.55 did the patient have any pre-existing conditions? yes ¿ if yes, please specify:tortuous iliac, calcium in sfa, 3.56 did the patient require any additional procedures as a result of this event? no 3.57 what intervention (if any) was required? none 3.58 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a 3.59 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18886259
• MDR Text Key: 337444702
• Report Number: 3001845648-2024-00092
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)251102(10)C2131236
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C2131236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2024
• Event Location: Hospital
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male