MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZFV6-125-6-12.0

Device Problem Off-Label Use (1494)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p050017/s006 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

After the stent was delivered to the lesion site, it was found that it could not be released, and the stent was replaced and the procedure continued patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: our distributor replied us the answers below, thanks.1.Are images of the device or procedure available? no 2.At what stage of the procedure did the complaint occur? stent placement 3.Details of access sheath used (name, fr size, length)? cordis¿s sheath ,718-212-55 ,55cm 4.What was the target location for the stent? renal artery 5.Was the product inspected for kinks or damage before use? yes, but no damage was observed 6.Was the device used percutaneously? no 7.Was the device flushed through both flushing port before the procedure, as per ifu? yes 8.Was pre-dilation performed ahead of placement of the stent? no 9.Was post-dilation performed after the placement of the stent? n/a, the stent could not released 10.Details of the wire guide used (name, diameter, hyrdophyllic)? abbott supercroe wire guide, diameter 0.014 11.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? no 12.Was resistance encountered when advancing the wire guide to the target location? no 13.Was resistance encountered when advancing the delivery system to the target location? no 14.How did the physician deal with this resistance? rotating the wire guide 15.Was the approach ipsilateral or contralateral? contralateral 16.If contralateral, was the bifurcation angle steep? no 17.Did the tip of the delivery system cross the target location? yes 18.Was the delivery system tracked around a tight angle in the patient anatomy? yes 19.Was the delivery system damaged/kinked/twisted during deployment? no 20.Was the handle pulled towards the hub during deployment? yes 21.Was the delivery system pushed during deployment? yes 22.Was the stent deployed smoothly / without resistance? no 23.If no, please detail any difficulty experienced during deployment: _ the stent is not released when placed 24.What artery was the stent placed in? renal artery 25.Was the stent fully deployed from the delivery system prior to removal of the delivery system? no,the stent is not released 26.Did the patient have any pre-existing conditions? renal artery stenosis 27.If yes, please specify: renal artery stenosis leads to high blood pressure 28.Did the patient require any additional procedures as a result of this event? no 29.What intervention (if any) was required? no 30.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure 31.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.

• Brand Name: ZILVER FLEX 35 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: 18695016
• MDR Text Key: 336433260
• Report Number: 3001845648-2024-00051
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Report Date: 01/15/2024

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: ZFV6-125-6-12.0
• Device Lot Number: C1909317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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