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 Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p200023; investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Shin, 2022, percutaneous extraction of colorectal cancer metastasis involving inferior vena cava using inari clottriever thrombectomy system under general anesthesia (institutional preference), access to the bilateral common femoral veins was obtained.Simultaneous bilateral iliocavography (fig.1d and e) demonstrated total occlusion of the ivc with innumerable ascending lumbar and paravertebral venous collaterals.Conventional recanalization, using hydrophilic wires and catheters, was performed from the common femoral veins to reach the right internal jugular vein.Angioplasty of the ivc was then performed with an 8-mm balloon.A 13-french clottriever sheath was placed via the right common femoral vein.A clottriever was then positioned with the coring element in the suprarenal ivc (fig.1f), and thrombectomy was performed with four passes.The clottriever sheath was then placed into the left common femoral vein.Under fluoroscopic and intravascular ultrasound-guidance, thrombectomy was again performed with four passes (fig.1g), and extracted thrombus was collected for pathologic analysis post-thrombectomy venography and intravascular ultrasound demonstrated chronic-appearing, flow-limiting luminal lesions throughout the ivc and bilateral iliocaval systems.Reconstruction was performed using two overlapping 16-mm × 80-mm zilver vena venous self-expanding stents (cook medical; bloomington, in) in the infrarenal ivc to the iliac confluence.Post-deployment angioplasty was performed using a 16-mm high-pressure balloon.Next, in a simultaneous double-barrel fashion, two 14-mm × 120-mm zilver vena venous self-expanding stents (cook medical) were deployed extending from the infra-renal ivc to the bilateral external iliac veins.Post-deployment angioplasty was performed with a 12-mm high-pressure balloon.A 12- mm × 90-mm wallstent (boston scientific; marlborough, ma) was then deployed extending from the left external iliac vein to the left common femoral vein.Post-deployment angioplasty was performed with a 12 mm high-pressure balloon.Post-reconstruction venography and intravascular ultrasound demonstrated brisk in-line flow along the entire stent constructs to the right atrium (fig.1h).This complaint captures off label use ¿ device used to recanalize a vein obstructed by a solid tumor localized within the lumen of the inferior vena cava.

Manufacturer Narrative

Pma/510(k) # p200023.This file was created from literature "shin_ds_2022" to capture off label use.Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution all zilver vena devices are subjected to a visual inspection and functional inspection to ensure device integrity.Review historical data: n/a.Instructions for use and/label: it should be noted that the instructions for use (ifu0091) states the following: "the zilver vena venous stent is 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 or label.As per medical advisor "yes, it was off-label use." image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of off label use can be concluded based on the information provided.The information for use states that the device is intended for use in the iliofemoral veins however from the information provided the device was used to recanalize a vein obstructed by a solid tumor localized within the lumen of the inferior vena cava , this is considered off label use.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer, device used to recanalize a vein obstructed by a solid tumor localized within the lumen of the inferior vena cava.Confirmed quantity of 04 devices, confirmed used.According to the initial reporter, patients outcome was unknown.Investigation findings conclude that a definitive root cause of off label use can be concluded based on the information provided.Complaint is confirmed based on customer and/or rep testimony.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 21-aug-23.

• 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: 17069368
• MDR Text Key: 316614240
• Report Number: 3001845648-2023-00442
• Device Sequence Number: 1
• Product Code: QAN
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2021
• Event Location: Hospital
• Date Manufacturer Received: 05/08/2023
• 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 Age: 60 YR
• Patient Sex: Male