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 Problems Perforation of Vessels (2135); Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Restenosis (4576)

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

Xpedite: paclitaxel-coated peripheral stents used in the treatment of femoropopliteal stenoses (cip identification: (b)(6)).This international, multicenter, prospective, randomized controlled clinical study will compare the performance of two investigational paclitaxel coatings to the paclitaxel coating on the commercially-available zilver® ptx® drug-eluting peripheral stent (zilver ptx stent) in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery.A total of (b)(4) paclitaxel-eluting stents were placed in (b)(4) lesions during the study.Table 2.4-1 reports the number of stents implanted per patient.This file will capture (b)(6) patients with adverse events treated by surgical intervention:- ae id # (patient id + event #) ¦ event description ¦ event treatment (as reported by site) (b)(6) ¦ vascular - embolism distal to study lesion ¦ thrombo-aspiration (b)(6) ¦ vascular - embolism distal to study lesion ¦ aspiration (b)(6) ¦ vascular - embolism distal to study lesion ¦ percutaneous/medical - thrombectomy/thrombolysis/other- heparin i.V.(b)(6) ¦ vascular - other - reperfusion injury ¦ medical - vimovo (b)(6) ¦ vascular embolism distal to study lesion ¦ percutaneous thrombolysis; aspiration (b)(6) ¦ vascular injury caused by study procedure or secondary intervention perforation ¦ percutaneous - bare balloon (b)(6) ¦ vascular injury caused by study procedure or secondary intervention - perforation ¦ external compression bandage (b)(6) ¦ vascular thrombosis ¦ percutaneous - thrombectomy (b)(6)¦ vascular embolism distal to study lesion ¦ percutaneous - bare balloon; medical - prostavasin (b)(6) ¦ vascular - other - embolus at the proximal edge of the stent and the profunda femoral artery.¦ percutaneous - thrombolysis (b)(6) ¦ vascular embolism distal to study lesion ¦ percutaneous - bare balloon/drug-eluting stent/thrombectomy/thrombolysis; change of medication(s) (b)(6) ¦ vascular thrombosis ¦ percutaneous - bare balloon/drug-eluting balloon/bare stent/drug-eluting stent (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - drug-eluting balloon/drug-eluting stent/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/drug-eluting balloon/thrombectomy; change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/bare stent/stent graft (b)(6) ¦ vascular - occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/drug-eluting balloon (b)(6) ¦ vascular - occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon (b)(6) ¦ vascular - occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/drug-eluting balloon (b)(6) ¦ vascular- occlusion/restenosis requiring intervention ¦ percutaneous- drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/bare stent (b)(6) ¦ vascular - occlusion/restenosis requiring intervention ¦ percutaneous - atherectomy/drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical atherectomy/bare balloon/bare stent/heparin (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/bare stent/heparin 5000 iu (b)(6) ¦ vascular thrombosis ¦ surgical - intraoperative thrombectomy by fogarty balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/cutting balloon/drug- eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - rotational thrombectomy (b)(6) ¦ vascular thrombosis ¦ percutaneous - bare balloon/thrombolysis; change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous atherectomy/ drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - atherectomy/drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/ drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous drug-eluting balloon/scoring balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/drug-eluting balloon (b)(6) ¦ vascular - other - occlusion of sfa right after 0,5 cm.The middle sfa is monophasically filled ¦ surgical - femoro-popliteal, supragenual bypass with 6 mm prothesis (b)(6) ¦ vascular thrombosis ¦ percutaneous bare balloon/bare stent/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous atherectomy/ drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - cutting balloon/drug-eluting balloon/bare stent/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - drug-eluting balloon; change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ surgical/percutaneous/medical amputation (4th toe)/ bare balloon/drug-eluting balloon/antibiotic(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/ drug-eluting balloon/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/drug-eluting stent (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/ drug-eluting balloon (b)(6) ¦ vascular thrombosis ¦ percutaneous - thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical drug- eluting balloon/thrombectomy/change of medication(s)/heparin (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous atherectomy/bare balloon/drug-eluting balloon/vascular tacks (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous drug-eluting balloon/drug-eluting stent (b)(6) ¦ vascular thrombosis ¦ percutaneous/other - thrombectomy/thrombolysis/insertion of lyse catheter with 10mg rtpa bolus (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical drug- eluting balloon/thrombectomy/scoring balloon angioplasty.Implantation of 8 vascular tacks/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous drug-eluting balloon/thrombectomy (b)(6) ¦ vascular - occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/drug-eluting balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/cutting balloon/drug- eluting stent/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/drug-eluting balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous - bare balloon/drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical drug- eluting balloon/bare stent/thrombectomy/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/drug-eluting balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous cutting balloon/drug-eluting balloon/bare stent/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/cutting balloon/bare stent (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/drug-eluting balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/bare stent/thrombectomy (b)(6) ¦ vascular thrombosis ¦ percutaneous bare balloon/bare stent/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical drug- eluting balloon/bare stent/ scoring balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous atherectomy/drug-eluting balloon (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous drug-eluting stent/scoring balloon (b)(6) ¦ vascular thrombosis ¦ percutaneous/medical drug- eluting balloon/thrombectomy/change of medication(s) (b)(6) ¦ vascular thrombosis ¦ percutaneous bare balloon/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical atherectomy/drug-eluting balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/other bare balloon/drug-eluting balloon 1370154uns004 ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/drug-eluting balloon/other/change of medication(s) (b)(6) ¦ vascular thrombosis ¦ percutaneous atherectomy/drug-eluting balloon/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical bare balloon/drug-eluting balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/drug-eluting balloon/bare stent/thrombectomy (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical drug-eluting balloon/thrombectomy/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous/medical cutting balloon/drug-eluting balloon/change of medication(s) (b)(6) ¦ vascular occlusion/restenosis requiring intervention ¦ percutaneous bare balloon/cutting balloon/drug-eluting balloon/bare stent (b)(6) ¦ vascular occlusion/restenosis s requiring intervention ¦ percutaneous bare balloon/bare stent percutaneous - bare balloon s=3.Percutaneous - bare balloon; medical - prostavasin s=3.Percutaneous - thrombolysis s=3.Percutaneous - thrombectomy s=3.Thrombo-aspiration s=3.Embolism aspiration s=3.Thrombectomy etc.S=3.Intraoperative - thrombectomy s=4.Percutaneous - thrombectomy s=4.Require intervention/additional procedures s=4.Total number of patients = (b)(4), male = 121; mean age = 68.2 yrs.

• 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: 18343038
• MDR Text Key: 330660945
• Report Number: 3001845648-2023-00920
• 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
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male