MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Catalog Number UNKNOWN

Device Problems Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/18/2023

Event Type  Injury  

Event Description

Zhang 2023, single-stage endovascular thrombectomy and stenting as the first-line strategy in the treatment of phlegmasia cerulea dolens caused by iliac vein lesions.Retrievable vena cava filters (vcfs) (optease, cordis, the netherlands) were then placed via contralateral femoral vein access.A 6-f or 8-f sheath was placed as per the selected suction catheter diameter via the vein below the knee.First, angiography was performed to confirm dvt and observe the extent of thrombus involvement.Initial rhyolitic thrombectomy (rt) was performed using an angiojet solenttm-omni or zelantetm thrombectomy catheter (boston scientific, marlborough).A power pulse lytic model was performed using 0.20 x 10^6 units of urokinase for approximately 20 min, then changing to the standard rt mode; this sequence was repeated 2-3 times if significant residual thrombus remained on subsequent venograms.Next, the deep vein patency and ivl were evaluated by frontal and lateral venography.For residual thrombus, a 10-f optease retrieval catheter (cordis, rainham) was used for manual aspiration thrombectomy (mat), as per the reported procedure.After thrombus removal, self-expandable stents, such as smart (cordis, miami, florida), luminexx (bard, murray hill, new jersey), or zilver vena (cook, limerick, ireland) were implanted for severe ivls.For those with thrombus clearance rate of less than 80%, a unifuse thrombolytic catheter (merit, new york) was used for assisted catheter-directed thrombolysis (cdt) treatment.Two cases experienced stent compression with secondary thrombosis and the symptoms were relieved after additional endovascular intervention.Patient outcome: symptoms were relieved after additional endovascular intervention.Require intervention/additional procedures s=4.Patient/event info - notes: thirteen patients were diagnosed with pcd, 8 male and 5 female, with a mean age of 51.5.

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

Pma/510(k) # p200023.Device evaluation the zvt7 device of rpn and lot number unknown, involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.This complaint was raised from literature paper zhang 2023, single-stage endovascular thrombectomy and stenting as the first-line strategy in the treatment of phlegmasia cerulea dolens caused by iliac vein lesions.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.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.Historical data review: historical data was not reviewed as the lot number is unknown.Ifu/label review: it should be noted that instructions for use (ifu0047) lists restenosis or thrombosis of the stented vein as a possible adverse event.There is no evidence to suggest the user did not follow the ifu.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to external compression caused by a possible difficult patient anatomy.It is possible that tortuosity of the anatomy may have placed compressive stress on the stent, causing the stent to become compressed.The stent compression could have in turn led to secondary thrombosis.As previously noted, restenosis or thrombosis of the stented vein is listed in the ifu as a known potential adverse event.Confirmation of complaint: complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation: according to the initial reporter, this complaint was raised from literature paper zhang 2023, single-stage endovascular thrombectomy and stenting as the first-line strategy in the treatment of phlegmasia cerulea dolens caused by iliac vein lesions where there was two cases in this study that experienced stent compression with secondary thrombosis.Confirmed quantity of (b)(4) devices, confirmed used.According to the initial reporter, the symptoms were relieved after additional endovascular intervention.Investigation findings conclude that a possible root cause could be attributed to a possible difficult patient anatomy.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 15-nov-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: 17078654
• MDR Text Key: 316801083
• Report Number: 3001845648-2023-00451
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2023
• Event Location: Hospital
• Date Manufacturer Received: 05/09/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male