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

Model Number G57447

Device Problem Migration (4003)

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

Event Date 12/03/2021

Event Type  Injury  

Event Description

Reported by the dm on behalf of the customer via email, we had multiple product issues in a case this morning with dr.(b)(6).We used two different bentson wires that each got easily kinked and stuck in the catheters despite being wet and appropriately prepped.The bentson wires were the same part number (g01290) however they were from different lots.In the same case we also had an issue with a zilver vena stent 16x60 (g57447) lot c1847299 which was successful deployed however after post dilation with a boston xxl 16x60 balloon upon removal of the balloon (which on angio appeared to be deflated) the stent was pulled down into the external/common femoral vein.In an attempt to re-expand the second stent which was pulled back the doctor deployed a zilver vena 14x60 (g57444) lot c1841687 which successfully opened and anchored the vena stent that had been dragged back by the xxl balloon.A third zilver vena had to be placed (16x100 g57448 lot c1850657) in the intended area of compression in the common iliac vein because the stent was dragged into the external/ common).The patient was fine and no secondary procedures were necessary.

Manufacturer Narrative

Pma #: p200023.Common name: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma #: p200023.Common name: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Reported by the dm on behalf of the customer via email, we had multiple product issues in a case this morning with dr.(b)(6).We used two different bentson wires that each got easily kinked and stuck in the catheters despite being wet and appropriately prepped.The bentson wires were the same part number (g01290) however they were from different lots.In the same case we also had an issue with a zilver vena stent 16x60 (g57447) lot c1847299 which was successful deployed however after post dilation with a boston xxl 16x60 balloon upon removal of the balloon (which on angio appeared to be deflated) the stent was pulled down into the external/common femoral vein.In an attempt to re-expand the second stent which was pulled back the doctor deployed a zilver vena 14x60 (g57444) lot c1841687 which successfully opened and anchored the vena stent that had been dragged back by the xxl balloon.A third zilver vena had to be placed (16x100 g57448 lot c1850657) in the intended area of compression in the common iliac vein because the stent was dragged into the external/ common).The patient was fine and no secondary procedures were necessary.

Manufacturer Narrative

Device evaluation the zvt7-35-80-16-60 device of lot number c1847299 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Three (3) attempts for additional information with the standard list of questions were made to the customer but there was no response.Document review prior to distribution zvt7-35-80-16-60 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 zvt7-35-80-16-60 of lot number c1847299 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has or 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 c1847299.There is no evidence to suggest the user did not follow the ifu0091-8.Stent migration is listed as a known potential adverse event in the ifu root cause review a definitive root cause could not be determined from the available information.A possible root could be attributed to that the balloon did not fully deflate, hence upon removal of the balloon the stent migrated.The description of event indicates that upon removal of the balloon (which on angio appeared to be deflated) the stent was pulled down.It should be noted that stent migration is listed as a known potential adverse event within the instructions for use.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient was fine, and no secondary procedures were necessary.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report being submitted due to completion of investigation on 01-apr-2022.

• 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: 13051514
• MDR Text Key: 285434908
• Report Number: 3001845648-2021-00887
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574479
• UDI-Public: (01)10827002574479(17)240706(10)C1847299
• 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
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57447
• Device Catalogue Number: ZVT7-35-80-16-60
• Device Lot Number: C1847299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2021
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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