MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number G43858

Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged Prior to Use (2284)

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

Event Date 08/18/2022

Event Type  malfunction  

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.

Event Description

The device was to be used for evt in the left iliac artery by left groin approach.However, the stent got deployed spontaneously during preparation, so another ziv6-35-80-8-60 was used instead.There have been no adverse effects to the patient reported.Physician's comment: the stent was spontaneously deployed at the timing that i did not intend.Sales rep's comment: when the device was returned to me, i noticed that the safety lock was removed.Therefore, i assume that the stent got deployed at the timing that the physician did not intend.I told the physician not to remove the safetly lock until he is ready for deployment.Prefix ziv5/ziv6/ was the device used percutaneously? n/a - prior to patient contact, which artery was the stent to be placed in? n/a - prior to patient contact, was the approach ipsilateral or contralateral? (ipsilateral), if contralateral, was the bifurcation angle tight? where on the patient was the percutaneous access site? details of access sheath used (name, fr size, length)? was the device flushed through both flushing port before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hyrdophyllic)? terumo radifocus rf-ga35263.035 260cm hydrophilic.Was the patient's anatomy tortuous or calcified? (no).Was resistance encountered when advancing the wire guide or delivery system to the target location? n/a - prior to patient contact how did the physician deal with this resistance? was pre-dilation performed ahead of placement of the stent? yes.Was post-dilation performed after the placement of the stent? yes.Did the tip of the delivery system cross the target location? n/a - prior to patient contact.Are images of the device of procedure available? no.Did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? n/a - prior to patient contact.

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.

Event Description

Supplemental report is being submitted due to the completion of the lab evaluation on 18-nov-2022 and additional information received on 30-nov-2022.Additional information received on 30-nov-2022: "there was no damage and the safety lock was attached before use.However, it appears that the safety lock was removed at some point, but he doesn't seem to know when that was".

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation on 20-jan-23.

Manufacturer Narrative

Pma/510(k) # p050017/s002 and s003.Device evaluation: the ziv6-35-80-8-80 device of lot number c1774315 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 18 nov 2022.Refer to returned product section for lab attendance and notes.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device the following was noted: visual inspection; red safety lock not returned; stent is partially deployed on return.Functional inspection: stent was able to be deployed with no issue.No damage noted on the stent 0.035 inch wire guide passes through device with no issue.Device flushes with no issue.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records 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 for this work order.It should be noted that the instructions for use (ifu0043) states the following: ¿upon removal from package, inspect the product to ensure no damage has occurred¿ and ¿to deploy the stent remove the red safety lock¿.There is no evidence to suggest that the customer did not follow the instructions for use.The japanese packaging insert c-ci0909106 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to how the device was handled when being removed from the packaging.As per the rep ¿when the device was returned to me, i noticed that the safety lock was removed.Therefore, i assume that the stent got deployed at the timing that the physician did not intend.I told the physician not to remove the safety lock until he is ready for deployment.¿ the physician confirmed that the product was inspected before use and confirmed the presence of the red safety tab at this point.The physician has also said that he does not know when the safety lock was removed.(ref att (b)(4) query red safety lock removal reply).It is possible that the red safety lock was inadvertently displaced during preparation causing the spontaneous deployment.Summary: the complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.This was noticed during preparation, so the device did not make contact the patient.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 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: 15428859
• MDR Text Key: 306594033
• Report Number: 3001845648-2022-00643
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002438580
• UDI-Public: (01)10827002438580(17)231107(10)C1774315
• 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,Followup
• Report Date: 01/20/2023

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 Expiration Date: 11/07/2023
• Device Model Number: G43858
• Device Catalogue Number: ZIV6-35-80-8-80
• Device Lot Number: C1774315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 08/19/2022; 08/19/2022
• Supplement Dates FDA Received: 12/15/2022; 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2020
• 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