MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number G57433

Device Problems Fracture (1260); Use of Device Problem (1670)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p200023.Common name - qan.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations via phone conversation "the patient had two wall stents implanted 6 years ago and they needed to be re-ballooned and extended into the external iliac.The physician used a gladiator balloon to post-dilate and it ruptured circumferentially and it left foreign material in the patient's body.The physician attempted to remove it and could not and so they decided to capture the material with another wall stent (which they placed inside the previously placed wall stent).The physician needed to extend a bit lower to capture more of the foreign material that was still remaining - and because they had the stent across the inguinal ligament they chose to use the zilver ptx.They post-dilated with a 10mm diameter gladiator balloon.The physician did a final angiogram and believed the stent 'may' have had a fracture.It was ivust and it appeared to be fractured at the specific spot where the plastic of the balloon was." note: the zilver may have been just deformed, but not necessarily fractured.The dm wanted to report it.Did any unintended section of the device remain inside the patient¿s body? - no · please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? - no · please specify delay or any additional procedure(s) and provide details: has the complainant reported any adverse effects on the patient due to this occurrence? - no has the complainant reported that the product caused or contributed to the adverse effects? - no · please specify adverse effects and provide details.General questions for complaint occurring during use, request the following: where was the access site? - femoral vein what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.- no what was the target location for the stent? - accros the inguinal ligament ¿ was the target location severely calcified or tortuous? - no was the device flushed prior to use? - yes were there any difficulties deploying the stent? - no was the stent fully deployed before removing the delivery system from the patient? - yes what other devices were used in the procedure? - see event description ¿ please provide manufacturer, model, brand, and size if possible.- see event description were any additional procedures necessary as a result of this event? - no can any photos, images, or reports of the procedure or device be provided? - the dm is going to try and obtain imaging.If the event involves thombosis, restenosis, and/or occlusion, request the following: - per dm, n/a if the event involved claudication / pain, request the following: - per dm, n/a if the event involves sheath separation, request the following: - per dm, n/a if the event involves stent shortening, request the following: - per dm, n/a if the event involving deployment difficulties, request the following: - per dm, n/a if the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: - per dm, n/a.

Manufacturer Narrative

Pma/510(k) # p200023.Common name - qan.Product code - qan.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 user error confirmed on (b)(6) 2022 by clinical advisor.Follow up mdr required to capture a code.

Manufacturer Narrative

Pma/510(k) # p200023.Common name - qan.Product code - qan.Device evaluation.The zvt7-35-80-12-60 device of lot number c1782059 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Prior to distribution zvt7-35-80-12-60 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 zvt7-35-80-12-60 of lot number c1782059 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 c1782059.It should be noted that the instructions for use are ifu0091-7.There is evidence to suggest the user did not follow the ifu.The user used the device in a situation other than specified within the instructions for use.A definite root cause of user error was identified from the available information, as the user used a stent to capture the balloon material against the vessel wall.The user used the device in a situation other than specified within the instructions for use.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 VENA VENOUS SELF-EXPANDING STENT
• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11848302
• MDR Text Key: 281515833
• Report Number: 3001845648-2021-00399
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574332
• UDI-Public: (01)10827002574332(17)231130(10)C1782059
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

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: 11/30/2023
• Device Model Number: G57433
• Device Catalogue Number: ZVT7-35-80-12-60
• Device Lot Number: C1782059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 04/26/2021; 04/26/2021
• Supplement Dates FDA Received: 02/14/2022; 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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
• Patient Age: 44 YR
• Patient Sex: Female