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

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); 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

Common name: (b)(6).Pma/510(k) # p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 24-mar-2023 and an update to the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # p200023.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.This file is related to pr (b)(4) ( emdr ref.- 3001845648-2023-00116 ), pr (b)(4) ( emdr ref.- 3001845648-2023-00117 ), pr (b)(4) ( emdr ref.- 3001845648-2023-00118 ), pr (b)(4) ,( emdr ref.- 3001845648-2023-00198 ), pr (b)(4) ( emdr ref.- 3001845648-2023-00197 ), pr (b)(4) ( emdr ref.- 3001845648-2023-00196 ) and it was created from the attached journal article.This complaint captures the possibility that the event occurred in the us while pr (b)(4) captures the possibility that the event occurred in taiwan.Lab evaluation ¿ n/a.Document 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 was not reviewed as the lot number is unknown.It should be noted that the instructions for use states: ¿selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration.It is important to select the appropriate stent size after a complete diagnostic evaluation.¿ it should also be noted that stent migration is listed as a potential adverse event in the ifu.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 review a definitive root cause could be attributed to the user not reading or following the instructions for use.From the article it is known that the stent selected was undersized which led to stent migration.As previously noted, the instructions for use states ¿selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration.It is important to select the appropriate stent size after a complete diagnostic evaluation.¿ summary the complaint is confirmed based on customer testimony.The complaint was raised from literature paper hofmann et al ¿12-month endpoint results from the evaluation of the zilver vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction¿.According to the initial reporter, the user error of selecting the incorrect stent size led to stent migration into the pulmonary artery, which resulted in surgical removal of the stent.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 16397020
• MDR Text Key: 309885151
• Report Number: 3001845648-2023-00119
• 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: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2022
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2023
• 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: 53 YR
• Patient Sex: Female