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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Stenosis (2263)

Event Date 03/11/2021

Event Type  Injury  

Event Description

Cronan et al 2021 - endovascular management of nutcracker syndrome in an adolescent patient population.The purpose of this study was to investigate the technical feasibility, efficacy and safety of left renal vein stenting in adolescents with nutcracker syndrome.Materials and methods we conducted a retrospective review of electronic medical records and imaging archives to identify adolescents undergoing endovascular stenting for nutcracker syndrome.We reviewed patient demographics including age, gender, presenting symptoms and diagnostic imaging findings.We compared pre- and post-stent deployment intravascular ultrasound (ivus) and venography and evaluated patient symptoms in clinic up to 6 months following stent placement.Following institutional review board approval, we conducted a retrospective electronic medical record and imaging archive review to identify all adolescents who underwent endovascular stenting of the left renal vein from (b)(6) 2016 to (b)(6) 2019 self-expandable stents were selected in most cases because of their superior accuracy in deployment location and ability to supply adequate radial force to the surrounding vascular structures.At the time of initial procedure, eight zilver (cook medical, bloomington, in) stents were used in seven patients (four 12×60-mm stents, three 14×60-mm stents one 14×40-mm stent), and five venovo (bard, new providence, nj) stents were deployed in three patients (three 14×40 mm and two 14×60 mm).Zilver stents were placed prior to availability of venovo stents because the deployment was more precise with the zilver delivery system than with the wallstent (boston scientific, marlborough, ma).Noncompliant angioplasty balloons (conquest or atlas; bard) were used in a variety of sizes ¿ 14×40 mm, 14×20 mm and 12×40 mm ¿ to ensure full expansion of the stent.Further evaluation of the stent with ivus demonstrated intra-stent stenosis measuring 44% and 52% luminal narrowing, respectively, despite only a slight caliber narrowing at the time of the initial stent placement (fig.2).This complaint will capture the intra-stent stenosis.It will also capture the off label use of zilver vena stent for endovascular stenting of the left renal vein.As per ifu0091-8,¿ zilver vena venous stent is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.¿ patient outcome : stent revisions to increase the radial force and relieve the external compression were necessary in these patients: one received an additional wallstent (14×40 mm) and the other received two additional 14×40-mm zilver stents (fig.2)both patients tolerated the procedure well, were discharged home the same day, and returned to their respective sports and activity level following 6 months of anti-platelet treatment and with no further recurrence of hematuria.

Manufacturer Narrative

Pma 510k #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 investigation on 15-sep-2023.

Manufacturer Narrative

Pma 510k #p200023.Device evaluation: the device evaluation could not be completed as the devices involved in this complaint were not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to pr (b)(4)/ mdr ref#3001845648-2023-00484 and pr (b)(4)/ mdr#3001845648-2023-00486 and it was created from the attached article ¿cronan et al 2021- endovascular management of nutcracker syndrome in an adolescent patient population this complaint was opened to capture the off label use in 02 cases and intra stent stenosis.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation document review: prior to distribution all zilver vena venous self-expanding stent stent devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data was not reviewed as the lot number is unknown.There is evidence to suggest the user did not follow the ifu.Instructions for use (ifu0091) states the following: ¿ zilver vena venous stent is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.¿ from the article we know that the stents were placed endovascularly stenting of the left renal vein.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause of off label use can be concluded.From the article we know that the stents were placed endovascularly stenting of the left renal vein.As per the ifu zilver vena venous stent is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction it should be noted that, as the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function.As per (b)(4), rev006, section 5.3 table 1 - off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from the attached article ¿cronan et al 2021- endovascular management of nutcracker syndrome in an adolescent patient population.According to the initial reporter, the device was used off label in 02 cases where an adverse event related to this off label use of intra stent stenosis was reported.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER VENA VENOUS 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: 17171392
• MDR Text Key: 317819322
• Report Number: 3001845648-2023-00485
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2021
• Event Location: Hospital
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 16 YR
• Patient Sex: Male