MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

Park 2022, long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: parade ii study.In both groups, predilation of the target lesion was performed prior to stent implantation.In the long des group, stents were implanted to extend 10mm proximally and distally from the margins of the target lesion with a luminal narrowing of > 50%.When multiple stents were required, margins of the stents overlapped by at least 10mm.In the spot des group, stents were implanted only in those segments with residual stenosis > 30% or a flow limiting dissection after repeated predilation.In cases of an optimal result after predilation (without significant residual stenosis or flow-limiting dissection), a single stent was implanted to cover the most stenotic segment or the proximal stump of the occlusion before predilation.In both groups, zilver ptx with a diameter of 5¿7mm was used for stenting at the fp target lesions.Postdilation with an up to 10% oversized balloon was performed when the residual stenosis was > 30%.Per table 2: in the long des group 7 devices were placed in an iliac lesion and 7 were placed btk.In the spot des group 9 devices were placed in an iliac lesion and 8 were placed btk.Note off label use: per the ifu, zilver ptx is only indicated for use in the above-the-knee femoropopliteal arteries¿.Mean patient age was 70.9 ± 8.6 years, and the majority (82.5%) of study participants were male.

Manufacturer Narrative

Pma/510(k) # p100022/s014.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 the completion of the investigation on 24-feb-2023.

Manufacturer Narrative

Device evaluation the device evaluation could not be completed as the devices involved in this complaint were not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to pr 382406, pr 382413, pr 382417, pr382420 and pr 382421 and it was created from the article ¿park 2022, long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: parade ii study¿.This complaint was opened to capture the off label use in 31 cases.Lab evaluation: the device 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 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.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 an iliac lesion and also below the knee for which these are not the intended use of this device.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 we know that the stents were placed in an iliac lesion and also below the knee.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.As per d00213689, rev006, section 5.3 table 1 - off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Summary the complaint is confirmed based on customer testimony.The complaint was raised from the attached article ¿park 2022, long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: parade ii study¿.According to the initial reporter, the device was used off label in 31 cases where no adverse event related to this off label use was reported.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING 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: 16004818
• MDR Text Key: 308390173
• Report Number: 3001845648-2022-00899
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 02/24/2023

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?: No
• 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: 10/19/2022
• 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 Age: 71 YR
• Patient Sex: Male