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 Reocclusion (1985); Stenosis (2263); Restenosis (4576)

Event Date 12/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Tsujimura 2020 ¿clinical outcomes of polymer-free, paclitaxel-coated stents versus 1 stent grafts in 2 peripheral arterial disease patients with femoropopliteal artery lesions.¿ objective: zilver ptx polymer-free, paclitaxel-coated stents and viabahn stent grafts are effective for the treatment of femoropopliteal lesions.The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease (pad) in real-world settings.Procedure: after insertion of a 6- or 7-fr sheath, an intra-arterial bolus of 5000 iu of heparin was injected and supplemented, as required, to maintain an active clotting time of > 200 seconds.A 0.035-, 0.018-, or 0.014-inch guidewire was used to cross the lesion.After the wire was passed, balloon angioplasty was performed at the discretion of each operator.Two types of devices were used: zilver ptx stents and viabahn stent grafts.The device size was chosen to be 1 mm larger than the reference vessel diameter.Post-dilation was performed as necessary at the discretion of each operator.Restenosis was defined as recurrence of 50% diameter stenosis determined by angiography or a peak systolic velocity ratio > 2.4 on duplex ultrasonography.A series of sensitivity analyses revealed that zilver ptx stents had a higher risk of restenosis and lower risk of stent thrombosis than viabahn stent grafts.This file was opened to capture 121 cases of restenosis in the zilver ptx and 120 target lesion reinterventions within both groups (unknown qty of zilver ptx patients).

Event Description

The investigation was concluded on the (b)(6) 2022, this supplement report is being submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.The zisv6 devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.As the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the japanese packaging insert (c-ci1502m06) which accompanies this device it informs the user about the "potential significant adverse events that may occur in use of this device include, but are not limited to: restenosis or occlusion of the stented artery." the japanese packaging insert (c-ci1502m06) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.There is no evidence to suggest that the customer did not follow the packaging insert.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing conditions included hypertension, hyperlipidemia, diabetes, renal failure, coronary artery disease (cad) and rutherford classifications between 1 and 6.Restenosis of the stented artery is also listed as a known potential adverse event within the packaging insert 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.Complaint is confirmed based on customer testimony.The patient¿s outcome is unknown.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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11344371
• MDR Text Key: 232520182
• Report Number: 3001845648-2021-00134
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2020
• Event Location: Hospital
• Date Manufacturer Received: 01/22/2021
• 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: 74 YR
• Patient Sex: Male