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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2022

Event Type  malfunction  

Event Description

De boer 2022, medium term outcomes of deep venous stenting in the management of venous thoracic outlet syndrome.Stents are placed across stenotic lesions, extending to and from non-diseased portions of the subclavian or axillary vein, with intraluminal balloons used to assist with the determination of appropriate stent diameters.Patients comprising the present cohort were commenced on lifelong antiplatelet therapy (either aspirin or clopidogrel) following placement of stents.A total 45 first rib resections were performed for vtos over the study period, with deep venous stents subsequently placed in 30 (66.7%) of these affected limbs.Four patients suffered bilateral lesions.Among the 30 procedures included in the cohort, a total of 33 stents were placed in the axillary and subclavian veins.Off the 33 stents placed 17 stents were cook zilver vena.Off label use placement in the subclavian or axillary vein per ifu0091-8 zilver vena stents are indicated for use in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.Patient/event info - notes: patient info: patient age was 48 +/- 12 years (range 21 - 66 years).Thirty seven per cent of patients were male.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.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 review: prior to distribution all zilver vena 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.Instructions for use and label: 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 of symptomatic venous outflow obstruction¿.There is evidence to suggest the user did not follow the ifu or label.Image review: an image was not returned for evaluation.Root cause analysis: definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.The instructions for use states that the device is intended for use in the iliofemoral veins however from the information provided, the target location was the subclavian or axillary vein.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: the complaint was raised from literature paper de boer et al ¿medium term outcomes of deep venous stenting in the management of venous thoracic outlet syndrome¿.The paper reported the off label use of 17 zilver vena stents in the subclavian or axillary veins.There were no adverse effects reported as a result of this occurrence.Investigation findings conclude a definitive root cause of off label use in the subclavian or axillary veins.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This supplemental report is being submitted due to completion of the investigation on the 22-jun-2023.

• 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: 17049745
• MDR Text Key: 316933611
• Report Number: 3001845648-2023-00438
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2022
• 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: 48 YR
• Patient Sex: Female