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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

Product code: qan 510(k): p200023 (b)(4) investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Amato, 2020, zilver vena: 'combined nutcracker and ehlers-danlos syndromes: a case report' a (b)(6) year-old woman presented with low back and pelvic pain.Following the diagnosis of nutcracker syndrome, she underwent endovascular treatment with renal vein stent placement; however, the patient continued to complain of pain.Further examinations revealed left renal vein compression by the portal vein.The patient underwent a second procedure; however, improvement was temporary, and her pain returned.Further investigation revealed previously undetected nephroptosis and hyperelasticity.A diagnosis of ehlersedanlos syndrome made, possibly explaining the mobility of viscera and unusual compression of the left renal vein by the portal vein.(b)(4) is capturing off-label use of the zilver vena due to placement in the left renal vein.

Manufacturer Narrative

Product code: qan.510(k): p200023.Device evaluation: the two zilver vena venous self expanding stents (zvt7) of unknown lot numbers involved in this complaint were implanted in the patients and not available for evaluation.With the information provided a document-based investigation was conducted.Document review: as the lot numbers of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zilver vena venous self expanding stents are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is evidence to suggest the user did not follow the instructions for use ((b)(4)).The instructions for use state the following: intended use: the zilver vena venous stent is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.According to the literature the patient underwent endovascular treatment with renal vein stent placement.Root cause review: a definitive root cause of off label use was identified from the available information.According to the literature the patient underwent endovascular treatment with renal vein stent placement.The zilver vena venous stent is intended for use in the iliofemoral veins.It is not possible to state how the device will perform when used outside of its validated state.Summary: complaint is confirmed based on customer testimony.According to the literature the patient underwent a second procedure; however, improvement was temporary, and her pain returned.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr report being submitted due to completion of the investigation on 30-jul-21.

• Brand Name: ZILVER VENA VENOUS SELF EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11658404
• MDR Text Key: 280550119
• Report Number: 3001845648-2021-00304
• 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
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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?: No
• Distributor Facility Aware Date: 02/17/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 47