MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIO STENT, ILIAC

Catalog Number UNKNOWN

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

Patient Problems Reocclusion (1985); Obstruction/Occlusion (2422)

Event Date 12/05/2020

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

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.Reocclusion was defined as recurrence of occlusion in stent site determined by angiography or duplex ultrasonography, regardless of the cause.This file was opened to capture 50 re-occlusions in the ptx group and the requirement for target lesion reinterventions within both groups (unknown qty of zilver ptx patients).

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Pma/510(k) # p100022/s027.Device evaluation 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.Lab evaluation ¿ document review.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.It should be noted that occlusion is listed as a known potential adverse event within the instructions for use (ifu0117-5).There is no evidence to suggest the user did not follow the ifu.Image review ¿ n/a.Root cause review 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.Occlusion 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 obstruction to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Summary 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: NIO STENT, ILIAC
• 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: 11344379
• MDR Text Key: 241467419
• Report Number: 3001845648-2021-00133
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): Y
• 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: 01/11/2022

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?: 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
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/08/2022
• 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: 74 YR
• Patient Sex: Male