MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; Stent, iliac vein

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problems Dyspnea (1816); Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Zilver vena product code: qan.510 k: p200023.

Event Description

Pathmarajah, 2021.¿ ¿chronic occlusion mimicking agenesis of the inferior vena cava in patients with iliofemoral deep vein thrombosis.¿ a 25-year-old man was admitted to the hospital with an extensive left iliofemoral dvt.He had a history of a traumatic pretibial wound washout and splint immobilization of the same leg 2 weeks earlier.His medical history included fibromyalgia and chronic pain.He did not have a personal or family history of thrombophilia and was not taking any regular medications.He had presented with acute pain and swelling in his left groin, with associated dyspnea and chest tightness.A duplex venous ultrasound revealed fresh thrombus in the left common femoral vein with proximal extension into the common iliac vein.The diagnostic venogram revealed occlusion of the ivc from the infrahepatic area to the junction of the iliac veins with prominent paravertebral collateral veins, both common iliac veins were occluded at the origin, with stenosis of the left external iliac and femoral veins.Both iliac veins and the ivc were recanalized, predilated with a balloon, and stented (sinus venous and sinus xl; pyramed, belrose, new south wales, australia; and zilver vena; cook medical australia, eight mile plains, queensland, australia) ranging from 14 to 25 mm based on the size of the vessel, with good flow obtained through the reconstructed veins.The patient continued warfarin therapy postoperatively.The 6-month follow-up review showed significant improvement in his pts.Off-label use: zilver vena stent placement in inferior vena cava.

Manufacturer Narrative

Zilver vena product code: qan.510 k: p200023.Device evaluation: the unknown device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver vena devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use, ifu0047, states the following: ¿the zilver vena venous stent is intended for use in the iliofemoral veins for the treatment for symptomatic venous outflow obstruction¿.There is evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause of off label use was identified from the available information.Based on the available information, it is known that the zvt7 device was used in the inferior vena cava.As per ifu, the zvt7 device is intended for use in the iliofemoral veins.Therefore, use of the zvt7 device in the inferior vena cava is considered off label.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.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to completion of investigation on 05-aug-2022.

• 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: 14590287
• MDR Text Key: 301850162
• Report Number: 3001845648-2022-00341
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 09/01/2022
• 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 Age: 25 YR
• Patient Sex: Male