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

Catalog Number ZFV6-80-6-8.0

Device Problems Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

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

Event Date 02/08/2022

Event Type  Injury  

Event Description

Access was difficult.Arteries were very occluded.Gained access and went up and over from left femoral artery into left iliac artery.Placed a zilver flex stent in right common iliac.Went thought the stent with a wire into the sfa.They sheath they used to go up and over, seemed to pusd on the placed stent and the stent did a u-turn and went into de external iliac a section of the device did not remain inside the patient¿s body.See below the patient did require any additional procedures due to this occurrence.Because the stent curled back on itself, the curled part was removed and the rest of the stent remained ( as i have been told) according to the initial reporter, the patient did not experience any adverse effects due to this occurrence are images of the device or procedure available? no.At what stage of the procedure did the complaint occur? occurred as the introducer was been moved through the stent that was placed in the right common iliac.Details of access sheath used (name, fr size, length)? i don¿t know.What was the target location for the stent? right superficial femoral artery was the product inspected for kinks or damage before use? don¿t know was the device used percutaneously? access gained through the left femoral artery.Was the device flushed through both flushing port before the procedure, as per ifu? yes.Was pre-dilation performed ahead of placement of the stent? don¿t know.Was post-dilation performed after the placement of the stent? don¿t know.Details of the wire guide used.I have provided details in the complaint form.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? difficult access, highly occluded.Was resistance encountered when advancing the wire guide to the target location? don¿t know.Was resistance encountered when advancing the delivery system to the target location? don¿t know.How did the physician deal with this resistance? don¿t know.Was the approach ipsilateral or contralateral? contralateral.If contralateral, was the bifurcation angle steep? n/a, yes, no.Did the tip of the delivery system cross the target location? n/a.Was the delivery system tracked around a tight angle in the patient anatomy? n/a.Was the delivery system damaged/kinked/twisted during deployment? n/a.Was the handle pulled towards the hub during deployment? n/a.Was the delivery system pushed during deployment? n/a.Was the stent deployed smoothly / without resistance? don¿t know.If no, please detail any difficulty experienced during deployment: what artery was the stent placed in? right common iliac.Was the stent fully deployed from the delivery system prior to removal of the delivery system? yes.Did the patient have any pre-existing conditions? don¿t know.If yes, please specify: did the patient require any additional procedures as a result of this event? yes.They had to perform an open procedure to remove the stent and insert a new one.What intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) #p050017/s006 device evaluation the zfv6-80-6-8.0 device of lot number c1887301 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review prior to distribution zfv6-80-6-8.0 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zfv6-80-6-8.0 of lot number c1887301 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1887301.It should be noted that the instructions for use ifu0058-4 states the following: ¿in relation to the lesion site, the distal area of narrowing should be stented first, followed by the proximal locations¿.There is evidence to suggest the user did not follow the ifu.Root cause review a definitive root cause of user error was identified from the available information.It is known that the user placed the proximal stent first, then crossed through this proximally placed stent in order to place a stent in the distal area of the lesion.This is considered user error, as per the instructions for use, ifu0058-4, ¿in relation to the lesion site, the distal area of narrowing should be stented first, followed by the proximal locations¿.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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 ; 061334440
• MDR Report Key: 13705862
• MDR Text Key: 291706363
• Report Number: 3001845648-2022-00121
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002518770
• UDI-Public: (01)10827002518770(17)241116(10)C1887301
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZFV6-80-6-8.0
• Device Lot Number: C1887301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2022
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Female