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

Model Number G57447

Device Problems Off-Label Use (1494); Migration (4003)

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

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"access was right and left femoral vein, and jugular vein with 18fr x 35cm cook sheaths in both the ij & right femoral vein.There was an 8 fr sheath in the left femoral vein.The patient had a 10-year-old celet ivc filter in that was removed prior to placing stents.Once removed, the physician uses ivus to measure the ivc which measured a 14.2mm diameter.He decided to place a 16x60 zilver vena in the ivc right at the confluence from the right femoral vein.Then followed that stent with two 14x140 stents in the common iliac veins.These were all placed from the femoral vein access.The physician used ivus again to confirm placement.He then had to retrieve a piece of filter that had broken off in the liver during the ivc filter retrieval and realized the zilver vena stent that was placed in the ivc had migrated up higher in the ivc.He did mention it could have been dragged up from the catheter he was using to retrieve the piece of ivc filter.The physician tried pushing the stent down with a large snare then decided it needed to come out.He used the large snare from both above and below through the 18fr sheaths to snare and remove the zilver vena stent from the patient.The stent did fracture in 3 pieces but they were able to retrieve all pieces of the stent.The patient did great, no additional surgeries were needed and the final images looked good.I have attached pictures of the initial stents, the migrated stent, the removed stent, and the final image." this file will capture "stent migration", an additional file has been created to capture stent fracture.

Event Description

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

Manufacturer Narrative

Common name - qan.Product code - qan.Pma/510(k) # p200023.Device evaluation: the zvt7-35-80-16-60 device of lot number c1792883 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Prior to distribution zvt7-35-80-16-60 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 c1792883 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 c1792883.It should be noted that the instructions for use (ifu0091-7) states the following: ¿indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction¿.There is evidence to suggest the user did not follow the ifu.A definitive root cause of off label use was identified from the available information.This device was used in the inferior vena cava while the instructions for use, ifu0091-7, state that the stent is ¿¿indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction¿.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.However the patient did experience a delay in procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Correction mdr being submitted as the investigation wording has been altered to include reference to imaging review of related file (b)(4) (mdr ref# 3001845648-2021-00691).See below: device evaluation: the zvt7-35-80-16-60 device of lot number c1792883 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation -n/a.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 c1792883 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 c1792883.It should be noted that the instructions for use (ifu0091-7) states the following: ¿indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction¿.There is evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: impression: 1.The complaint of zvt7-35-80-16-60 fracture during snare removal is confirmed.An image of the removed fractured stent was provided.2.The three provided images were consistent with the complaint report narrative.The zvt7-35-80-16-60 had been implanted in a the distal ivc.It then migrated to the juxta renal and intrahepatic ivc.Its repositioning or removal was necessary as it would have covered the renal veins.The zvt7-35-80-16-60 was likely displaced by the catheter inserted to remove a celect filter leg from a right inferior accessory hepatic vein.3.The zvt7-35-80-16-60 was likely not oversized to the ivc.4.Civ stents were not inserted into the zvt7-35-80-16-60.Root cause review: a definitive root cause of off label use was identified from the available information.This device was used in the inferior vena cava while the instructions for use, ifu0091-7, state that the stent is ¿¿indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction¿.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.However the patient did experience a delay in procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Correction mdr being submitted as the investigation wording has been altered to include reference to imaging review of related file (b)(4) (mdr ref# 3001845648-2021-00691).

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 12517674
• MDR Text Key: 272854234
• Report Number: 3001845648-2021-00690
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574479
• UDI-Public: (01)10827002574479(17)240119(10)C1792883
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: G57447
• Device Catalogue Number: ZVT7-35-80-16-60
• Device Lot Number: C1792883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2021
• Event Location: Hospital
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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 Age: 58 YR
• Patient Sex: Male