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 Obstruction/Occlusion (2422)

Event Date 10/16/2021

Event Type  Injury  

Event Description

Marples 2021, prophylactic paclitaxel-eluting stent placement does not improve covered femoropopliteal stent patency.We performed a retrospective case¿control study to further investigate the method of prophylactic deployment of paclitaxel-eluting zilver-ptx (ptx) (cookmedical, bloomington, in) stents at themargins of viabahn (vbn) stents (w.L.Gore and associates, flagstaff, az) to improve rates of edge restenosis and patency.The lesion was assessed with angiography, and predilation was used if required.In the study group, zilver ptx-eluting stents were deployed before vbn stent insertion (fig 1), extending 10 mm from both the proximal and distal edge.The control group received the vbn stent only.Patients received dual antiplatelet therapy for 6 months postoperatively followed by a single agent thereafter.In patients taking an oral anticoagulant (eg, warfarin) preoperatively, this was continued postoperatively in combination with a single antiplatelet agent.Note off label use: a viabahn covered stent was deployed inside the zilver ptx stent.Per the ifu precautions section, overlapping stent use is only recommended when the stents are of similar composition.The covered stent is constructed with a reinforced expanded polytetrafluoroethylene(eptfe) liner and, thus, is dissimilar in composition.In the vbn+ ptx group, two limbs experienced occlusions at 8 and 15 months, respectively.One occlusion was managed with surgical bypass and the other with thrombolysis.This file will capture 2 instances of occlusion and off label use.Mean age: 78 years.10 male and 15 female patients.

Manufacturer Narrative

Pma/510(k) # p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to an update to the description of events 'confirmation received 09-jan-2023 that the off label use relates to prophylactic use' and the completion of the investigation on the 19-jan-2023.

Manufacturer Narrative

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.It should be noted that this file is related to another complaint files.For details of the other investigation please refer to pr (b)(4) (report reference number (b)(4) ).It should be noted that this file is related to another complaint files.For details of the other investigation please refer to pr (b)(4) (report reference number (b)(4) ).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.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.¿.There is evidence to suggest the user did not follow the ifu.From the article it is known that the device was placed prophylactically and used to prevent restenosis developed at the proximal and distal edges of the viabahn stent in this study which is not the intended use of this device.Root cause review: a definitive root cause of off label use can be concluded.From the article it is known that the stents were placed prophylactically and used to prevent restenosis developed at the proximal and distal edges of the viabahn stent.The ifu states ¿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¿.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.Summary: the complaint is confirmed based on customer testimony.There were no adverse events reported as a result of this occurrence.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: 16003287
• MDR Text Key: 305684823
• Report Number: 3001845648-2022-00892
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P100022
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Female