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

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/06/2022

Event Type  Injury  

Event Description

Hofmann 2022 - 12- month endpoint results from the evaluation of the zilver vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (vivo clinical study).Two-view venography was performed to assess the study lesion characteristics (e.G., location, minimum lumen diameter [mld]) and to assist with stent sizing.Intravascular ultrasound (ivus) was not considered standard of care during study design development and was not required per the protocol.Mld was determined using two venography projections, based on diameter measurements of the narrowest point in the treated segment of vein (the stented segment and 1 cm additional cranial and caudal to the stent).Venographic measurements used a calibration source (either intravascular calibration device(s) or an external calibrated device).Pre-dilation of the vessel and post-stent dilatation were recommended.Stents were recommended to be oversized by 2-4 mm relative to the surrounding vasculature, the expanded balloon diameter used for predilatation, or the standard diameter of the vein to be stented.Stents were recommended to fully cover the lesion and extend into healthy tissue (caudally and cranially) by 5-10 mm.When multiple stents were required, stent overlap by at least 1 cm was recommended.Upon procedure completion, two-view venography was used to evaluate the lesion and stent placement characteristics.Technical success failure: one clinical migration of a 16 x 100 mm stent was identified at 6 months (x-ray and ultrasound); this event was not identified as a technical failure from radiographic migration (>1 cm stent movement with no clinical sequelae) at placement.The patient¿s indication for stent placement was iliac vein compressed by iliac artery not related to may-thurner syndrome.The cec adjudicated the clinical migration as technique-related, noting that the stent was undersized and likely fixated in the lesion temporarily to the common iliac vein prior to migration.The stent migrated to the pulmonary artery and required surgical removal.The patient reported atrial flutter 23 days after surgical removal, which was managed medically.The stent migrated to the pulmonary artery and required surgical removal.The patient reported atrial flutter 23 days after surgical removal, which was managed medically.243 patients, average age: 53 years, gender: female 170, male 73.

Manufacturer Narrative

Additional procode: qan.

• Brand Name: ZILVER VENA VENOUS SELF EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 16399390
• MDR Text Key: 310137427
• Report Number: 3005580113-2023-00025
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2023
• Distributor Facility Aware Date: 02/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• 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: 53 YR
• Patient Sex: Female