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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 05/12/2023

Event Type  Injury  

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

Zilverpass: the cook zilver ptx drug-eluting stent versus bypass surgery for the treatment of femoropopliteal tasc c&d lesions.Patients in the zilver ptx arm were treated by placement of the zilver ptx drug-eluting stent (cook), according to standard procedures based on the instructions for use.The only pre-treatment allowed prior to placement of the zilver ptx drug-eluting stent (cook) is standard pta.Diameter measurements must be performed of the healthy vessel proximal and distal to the previously stented area.Diameter selection of the zilver ptx drugeluting stent (cook) should result in minimal oversizing.The target lesion needed to be completely covered by using as few stents possible.Post-dilatation could be performed according to the instructions of use.A total of 220 study subjects were enrolled.Five sites in belgium, four sites in germany, two sites in italy and two sites in brazil.This complaint will capture events potentially occurring in belgium.The below summary of patients required device revision or replacement: 1 patient had occlusion/thrombosis.5 patients had ischemia.2 patients had occlusion.5 patient had restenosis.Intervention for all patients included stent replacement.35 patients female: 78 patients male.Average age 70 years.

Event Description

Supplemental report is being submitted due to the completion of the investigation on (b)(6) 2024.

Manufacturer Narrative

Pma/510(k) # p100022/s027.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 was created from the pmcf study ¿zilverpass¿.It is related to 410553 410557, 410560, 410564, 410565, 410733, 410737, 410740, 410742, 410743,410744, 410745, 410746, 410747, 410748, 410749, 410754, 410755 410757 and captures 13 events requiring device revision or replacement in belgium.Manufacturing records 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.Instructions for use and label there is no evidence to suggest the user did not follow the ifu.It should be noted that the instructions for use (ifu0017) lists the following as potential adverse events: -occlusion -arterial thrombosis -restenosis of the tented artery.-ischemia requiring intervention.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to pre-existing conditions of peripheral artery disease (pad) with a stenotic or occlusive de novo lesion located in the femoropopliteal arteries.Risk factors for pad include age, obesity, nicotine abuse, hypertension, hyperlipidemia, diabetes and family history.Occlusion is listed as a known potential adverse event within the ifu.Diabetes, high blood pressure and peripheral arterial disease are all risk factors for developing arterial occlusion.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.According to input form medical affairs, "there is no evidence within the study to suggest any device malfunction or deterioration in device characteristics, and patient¿s pre-existing conditions would have contributed to the aes post procedure." as previously noted, arterial thrombosis, restenosis of the stented artery, ischemia requiring intervention and occlusion are listed as known potential adverse events within the ifu.Confirmation of complaint: complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation: the complaint was raised from pmcf study ¿zilverpass and captures 13 events requiring device revision or replacement in belgium.Confirmed quantity of 13 patients, confirmed used.According to medical input, the patients would have required require intervention/additional procedures due to these occurrences.Intervention for occlusion included: thrombus aspiration + des + pta thrombolysis + pta + stenting intervention for restenosis included: thrombolysis dcb + stent thrombolysis + stent, dcb + viabahn, des intervention for ischemia included: thrombolysis + stent + dcb dcb + stenting, thrombolysis + pta + stenting, thrombolysis + pta + stenting intervention for occlusion/thrombosis included: thrombolysis dcb + stent.Investigation findings conclude a possible root cause could be attributed to the patients pre existing conditions/characteristics.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PACLITAXEL-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: 18002063
• MDR Text Key: 326452841
• Report Number: 3001845648-2023-00801
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/12/2023
• Event Location: Hospital
• Date Manufacturer Received: 09/27/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male