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

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.Annex g: g04122 - stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Fu, 2020, zilver vena and stent characteristics of 32 patients with early (<14 days) iliofemoral stent occlusion.Patients diagnosed with early in-stent thrombosis after iliofemoral stenting were reviewed in this retrospective analysis.Patients with a recurrence of symptoms or the detection of thrombus in stents within 14 days after stent implantation were included.Patients with stents placed below the orifice of the deep femoral vein were excluded.The main factor was suboptimal positioning: in eight cases of thrombosis, an insufficient stent length to cover the distally located pathology was identified and in three cases, an insufficient stent length to proximally locate the pathology was identified.These 11 patients received another stent after successful lysis.As there were 9 cook zilver vena devices used in this study, this file will capture 9 cases where the insufficient stent length was chosen.

Event Description

Final mdr being submitted due to completion of the investigation on 24-sept-21.

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.Device evaluation: the zilver vena venous self expanding stent (zvt-7) devices of unknown lot number involved in this complaint were implanted in the patients and was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver vena venous self expanding stent devices are subject to visual 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 ifu (ifu0047-5).The instructions for use state the following: stent sizing.1.Determine the proper stent size after complete diagnostic evaluation.The stent diameter should be at least 1mm larger than the estimated diameter of the target vein.Measure the total length of the obstructed vein to determine the length of the segment that requires the stent and the length of the stent needed.Stent from the most distal end of the lesion to the most proximal end of the lesion in a continuous fashion.Suboptimal positioning of the stent resulting in insufficient coverage of distal located pathology and insufficient coverage of proximally located pathology is cited in the paper as some of the underlying causes of thrombosis and intervention.Root cause review: a definitive root cause of user error was determined from the available information.The instructions for use require that the total length of the obstructed vein is measured to determine the length of the segment that requires the stent and the length of the stent needed.The study found that insufficient coverage of the pathology because of an incorrect stent size being used resulted in thrombosis and intervention.It should also be noted that thrombosis of the stented vein is listed in the instructions for use as a potential adverse event.Summary: the complaint is confirmed based on customer testimony.All patients received another stent after successful lysis complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER VENA VENOUS SELF EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• MDR Report Key: 11640250
• MDR Text Key: 261754444
• Report Number: 3001845648-2021-00291
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR