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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism/Embolus (4438)

Event Date 11/21/2022

Event Type  Injury  

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%.There was 1 case of distal embolization in the long des group, which was managed with endovascular embolectomy.Distal embolization in the long des group, which was managed with endovascular embolectomy.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.

Manufacturer Narrative

Device evaluation: the device evaluation could not be completed as the device involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This complaint was opened to capture 01 case of distal embolism.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 no evidence to suggest the user did not follow the ifu.Instructions for use lists embolism as a potential adverse event.Root cause review: a definitive root cause could not be determined.A possible root cause could be attributed to known potential complications.As per ifu, embolism is listed as a potential adverse event in the instructions for use.As per clinical input ¿require intervention/additional procedures to prevent permanent impairment/damage¿.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, there was 1 case of distal embolization in the long des group, which was managed with endovascular embolectomy.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 27-feb-23.

• 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: 16004281
• MDR Text Key: 305708111
• Report Number: 3001845648-2022-00900
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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?: No
• 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: 10/19/2022
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2022
• 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: 71 YR
• Patient Sex: Male