MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Model Number G57449

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

A patient of undisclosed gender and age underwent an undisclosed procedure in which the zilver vena venous self-expanding stent, g57449, was used.The stent was deployed in a tight lesion.When deployed the stent stretched to 200 cm from a 160cm length.When it deployed it went into the tissue tract of the patient.The patient was transferred from the facility to the hospital with an emergent procedure.As per clinical specialist at cook inc received 19-nov-21: the doctor did not observe the stent detach from the delivery catheter (rushing) and pulled the stent and stretched it.The patient had to go to the hospital for emergency removal of the stent.This file will capture the user error of an incorrect size access sheath used.A 9fr access sheath was used instead of a 7fr.Per manufacture request this file was opened in relation to pr341184- stent stretched when deployed, to capture the user error of an incorrect size access sheath used (b)(6) 2023.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) # p200023.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 investigation on 13-dec-2023.

Manufacturer Narrative

Pma/510(k) #p200023.Device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.The zvt7-35-80-16-140 device of lot number c1771926 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.The file is related to (b)(4) and was raised to capture the incorrect size access sheath used.Manufacturing records: prior to distribution all zvt7 devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for zvt7-35-80-16-140 of lot number c1771926 did not reveal any discrepancies that could have contributed to this complaint issue.An nc (gen-111) was noted on the work order, however this was subsequently scrapped and would not have attributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/or label: it should be noted that the instructions for use, ifu0091, states the following: ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.There is evidence to suggest that the customer did not follow the instructions for use.Image review : an image was not returned for evaluation.Root cause review: a definitive root cause of the user not reading or following the instructions for use has been determined.From the additional questions it is known that an 9fr access sheath was used with the device.As previously noted, the ifu states ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary: according to the initial reporter a patient of undisclosed gender and age underwent an undisclosed procedure in which the zilver vena venous self-expanding stent, g57449, was used.This file will capture the user error of an incorrect size access sheath used.A 9fr access sheath was used instead of a 7fr.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience adverse effects due to this occurrence.The use of a larger size access sheath would not have contributed to the adverse event reported in (b)(4).Investigation findings conclude a definitive root cause of use error was established.The user has not complied with the requirements of the ifu.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: STENT, ILIAC VEIN
• 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: 17276915
• MDR Text Key: 318554121
• Report Number: 3001845648-2023-00543
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)231029(10)C1771926
• 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,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1771926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2021
• Event Location: Hospital
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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 Outcome(s): Required Intervention