MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022/s014 (specific rpn is unknown).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Arendt 2021, comparison of anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease between 2002 and 2016, 59 venous stents were placed in 51 patients for the treatment of nonthrombotic lower extremity venous disease.Zilver ptx stents (cook medical, bloomington, indiana) and palmaz genesis stents (cordis) were placed in 1 patient each.A majority (94%) of the stents were placed in the left common iliac vein, followed by the left external iliac vein (14%).Two (4%) patients had stents placed in the left common femoral vein, whereas 1 (2%) patient had a stent placed in the right common iliac vein.Note off label use: per the ifu, zilver ptx is only indicated for use in the above-the-knee femoropopliteal arteries.There were 5 patients with minor bleeding adverse effects (eg, heavy menses or access site hematoma).Of the 5 patients who experienced the minor bleeding adverse effects, 1 was on concurrent antiplatelet therapy because of a history of acute coronary syndrome.No major bleeding or thrombotic adverse effects were experienced by patients in either group.This file will capture off label use of a ptx device and potential bleeding.Access site haematoma likely treated conservatively ie.Medical treatment or monitoring.45 female and 6 male patients.Subtherapeutic cohort average age 40.Therapeutic average age 48.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 21-feb-2023.

Manufacturer Narrative

Pma/510(k) # p100022/s014 (specific rpn is unknown).Device evaluation: the zilver ptx drug eluting peripheral stent device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file will capture off label use of a ptx device and potential bleeding.Lab evaluation : the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review: prior to distribution all zilver ptx drug-eluting peripheral stent 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.There is evidence to suggest the user did not follow the ifu.It should be noted that the instructions for use (ifu0117) states the following: ¿the zilver ptx drug eluting peripheral stent is intended for use in the treatment of symptomatic vascular disease of the above the knee femoro-popliteal arteries.¿.From the article we know that the stents were placed in the left common iliac vein, the left external iliac vein, the left common femoral vein and the right common iliac vein which these are not the intended use of this device.It should also be noted that hematoma/hemorrhage is listed as a potential adverse event in the ifu.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause of off label use can be concluded.From the article it is known that stents were placed in patients for the treatment of non thrombotic lower extremity venous disease.Stents were placed in the left common iliac vein, the left external iliac vein, the left common femoral vein and the right common iliac vein.Per the ifu, zilver ptx is only indicated for use in the above-the-knee femoropopliteal arteries.It should be noted that, as the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function.Off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.This complaint also captures potential bleeding.As per ifu, hematoma/hemorrhage is listed as a potential adverse event of this device.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from the attached journal article arendt 2021, comparison of anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease.According to the initial reporter, the device was used off label in 01 case with possible bleeding reported.As per medical advisor input ¿access site haematoma likely treated conservatively i.E.Medical treatment or monitoring¿.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX DRUG ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 15995986
• MDR Text Key: 305611141
• Report Number: 3001845648-2022-00877
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 08/22/2022
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2022
• 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