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 Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 05/12/2023

Event Type  Injury  

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 medication: 2 patients had occlusion.1 patient had thrombosis.1 patient had restenosis.1 patient had embolism/embolus.Treatment for occlusion included: thrombolysis + ptas (plasma thromboplastin antecedent).Treatment for thrombosis included: thrombolysis.Treatment for restenosis included: medication.Treatment for embolism/embolus included: anticoagulation.35 patients female: 78 patients male.Average age 70 years.

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 corrections to quantity updated from (b)(4) to (b)(4) to remove occlusions patients captured in (b)(4).Annex e code.

Manufacturer Narrative

Pma/510(k) # p100022/s027.This file was opened in response to the pmcf study, zilverpass ¿ 5 year report.This pr will capture complaints for three study patients requiring medication in belgium.This file is related to (b)(4).Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all 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.Instructions for use and/label: there is no evidence to suggest the user did not follow the ifu or label.It should be noted that thrombosis, restenosis and embolism/embolus are listed as known potential adverse effects in the device ifu0117.Potential adverse event that may occur include the following: allergic reaction to anticoagulant and or antithrombotic or contrast medium, allergic reaction to nickel, atheroembolization (blue toe syndrome), arterial aneurysm, arterial rupture, arterial thrombosis, arteriovenous fistula, death, dissection, embolism, fever, hematoma/hemorrhage, hypersensitivity reactions, infection, infection/abscess formation at access site, ischemia requiring intervention (bypass or amputation of toe, foot or leg), occlusion, pain/discomfort, pseudoaneurysm formation, renal failure, restenosis of the stented artery, stent embolization, stent malapposition, stent migration, stent fracture, vessel perforation or puncture, vessel spasm, worsened claudication/rest pain.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 stenotic or occlusive de novo lesion located in the femoropopliteal arteries.As previously noted, thrombosis, restenosis and embolism/embolus are listed as known potential adverse effects in the device ifu0117.Restenosis of the stented artery is 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.Occlusion, thrombosis, and embolism are listed as known potential adverse events within the ifu.All previously noted.Nicotine abuse and hypercholesterolemia were noted in the information from the study as prominent risk factors seen in the study patients, and are risk factors for developing occlusion, thrombosis and embolism.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: this file was opened in response to the attached pmcf study, zilverpass ¿ 5 year report.The cook zilver ptx drug-eluting stent versus bypass surgery for the treatment of femoropopliteal tasc c&d lesions.This pr will capture complaints for three study patients requiring medication in belgium.Confirmed quantity of (b)(4) devices used.According to the initial reporter, the device was used in three cases, where patients experienced thrombosis, restenosis and embolism/embolus.All five patients required medication.Treatment for thrombosis included: thrombolysis, treatment for restenosis included: medication, treatment for embolism/embolus included: anticoagulation.Investigation findings conclude a possible root cause of patients pre-existing conditions.Thrombosis, restenosis and embolism/embolus are listed as known potential adverse effects in the device ifu.As noted in the report, hypercholesterolemia and nicotine abuse are listed as prominent risk factors, and are risk factors for developing occlusion, thrombosis, embolism and restenosis.The report states that ¿all device and procedure related adverse events reported during this time period are considered anticipated¿.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 18-apr-2024.

Manufacturer Narrative

Pma/510(k) # p100022/s027.This file was opened in response to the attached pmcf study, zilverpass ¿ 5 year report.This pr will capture complaints for three study patients requiring medication in belgium.This file is related to prs, (b)(4).Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all 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.Instructions for use and/label: there is no evidence to suggest the user did not follow the ifu or label.It should be noted that thrombosis, restenosis and embolism/embolus are listed as known potential adverse effects in the device ifu0117.Potential adverse event that may occur include the following: allergic reaction to anticoagulant and or antithrombotic or contrast medium, allergic reaction to nickel, atheroembolization (blue toe syndrome), arterial aneurysm, arterial rupture, arterial thrombosis, arteriovenous fistula, death, dissection, embolism, fever, hematoma/hemorrhage, hypersensitivity reactions, infection, infection/abscess formation at access site, ischemia requiring intervention (bypass or amputation of toe, foot or leg), occlusion, pain/discomfort, pseudoaneurysm formation, renal failure, restenosis of the stented artery, stent embolization, stent malapposition, stent migration, stent fracture, vessel perforation or puncture, vessel spasm, worsened claudication/rest pain.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 stenotic or occlusive de novo lesion located in the femoropopliteal arteries.As previously noted, thrombosis, restenosis and embolism/embolus are listed as known potential adverse effects in the device ifu0117.Restenosis of the stented artery is 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.Occlusion, thrombosis, and embolism are listed as known potential adverse events within the ifu, as previously noted.Nicotine abuse and hypercholesterolemia were noted in the information from the study as prominent risk factors seen in the study patients, and are risk factors for developing occlusion, thrombosis and embolism.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: this file was opened in response to the attached pmcf study, zilverpass ¿ 5 year report.The cook zilver ptx drug-eluting stent versus bypass surgery for the treatment of femoropopliteal tasc c&d lesions.This pr will capture complaints for three study patients requiring medication in belgium.Confirmed quantity of 03 devices used.According to the initial reporter, the device was used in three cases, where patients experienced thrombosis, restenosis and embolism/embolus.All five patients required medication.Treatment for thrombosis included: thrombolysis, treatment for restenosis included: medication, treatment for embolism/embolus included: anticoagulation.Investigation findings conclude a possible root cause of patients pre-existing conditions.Thrombosis, restenosis and embolism/embolus are listed as known potential adverse effects in the device ifu.As noted in the report, hypercholesterolemia and nicotine abuse are listed as prominent risk factors, and are risk factors for developing occlusion, thrombosis, embolism and restenosis.The report states that ¿all device and procedure related adverse events reported during this time period are considered anticipated¿.

• 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: 18002062
• MDR Text Key: 326453133
• Report Number: 3001845648-2023-00802
• 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,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 09/27/2023; 09/27/2023
• Supplement Dates FDA Received: 04/09/2024; 05/03/2024
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Male