MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZIV5-18-125-9-40

Device Problem Off-Label Use (1494)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

Foreshortened 40 to 30, the drs approx measurement.Patient outcome: no patient impact reported sg 12jan2024 patient/event info - notes: the following information has been received via phone call on 12jan2024.Sg 12jan2024 3.32 are images of the device or procedure available? no 3.33 at what stage of the procedure did the complaint occur? removing the introducer.3.34 details of access sheath used (name, fr size, length)? bmx penumbra 3.35 what was the target location for the stent? intracranial vessel 3.36 was the product inspected for kinks or damage before use? unknown 3.37 was the device used percutaneously? yes 3.38 was the device flushed through both flushing port before the procedure, as per ifu? n/a 3.39 was pre-dilation performed ahead of placement of the stent? n/a 3.40 was post-dilation performed after the placement of the stent? n/a 3.41 details of the wire guide used (name, diameter, hyrdophyllic)? n/a 3.42 did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? focal stenosis 3.43 was resistance encountered when advancing the wire guide to the target location? no 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? n/a 3.46 was the approach ipsilateral or contralateral? ipsilateral 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? 3.49 was the delivery system damaged/kinked/twisted during deployment? no 3.50 was the handle pulled towards the hub during deployment? no 3.51 was the delivery system pushed during deployment? n/a 3.52 was the stent deployed smoothly / without resistance? n/a ¿ if no, please detail any difficulty experienced during deployment: n/a 3.53 what artery was the stent placed in? unknown 3.54 was the stent fully deployed from the delivery system prior to removal of the delivery system? yes 3.55 did the patient have any pre-existing conditions? yes ¿ if yes, please specify: idiopathic intracranial hypertension 3.56 did the patient require any additional procedures as a result of this event? no 3.57 what intervention (if any) was required? n/a 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)? n/a.

Manufacturer Narrative

Pma/510(k) # p050017/s002 and s003 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: ZILVER 518 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• 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: 18666959
• MDR Text Key: 334885688
• Report Number: 3001845648-2024-00043
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• 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: 01/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ZIV5-18-125-9-40
• Device Lot Number: C2082304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2024
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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: Female