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 Stenosis (2263); Restenosis (4576)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510(k) #: p100022/s027.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Haine et al 2019  comparison between interwoven nitinol and drug eluting stents for endovascular treatment of femoropopliteal artery disease.The analysis period from a tertiary vascular referral centre ((b)(6)) ranged between august 2012 and august 2016.To enroll in the analysis patients had to be treated by implantation of either an ins or des for any lesion located within the entire femoropopliteal segment (including p1 to p3).A retrospective, single centre analysis using hospital based patient data from a prospectively collected series of consecutive cases was conducted to compare the cd-tlr rate between an ins (supera) and a des (zilver ptx) stent over a 12 month follow up period.Treatment was performed by four experienced operators according to institutional standards including digital sub-traction angiography (dsa) prior to any manoeuvre as well as before termination of the intervention to assess procedural success and to rule out visible macro-embolisation.Vessel preparation to reference diameter using plain old balloon angioplasty (poba) prior to stent placement as well as post-dilation of the stented segment were performed as standard.Cd-tlr was 18% (95% ci; 8%-27%) in the des group at 12 months follow up.Cd-tlr was defined as target lesion revascularisation performed for target lesion diameter stenosis >50% and either evidence of clinical or functional ischaemia (e.G.Recurrent/progressive intermittent claudication, critical limb ischaemia) or recurrence of the clinical syndrome for which the initial procedure was performed.Cd-tlr occurs in the absence of protocol directed surveillance ultrasound or angiography.1.5 devices used per procedure x 77 procedures = 115.5 devices.18% of 115 = 21 devices.

Manufacturer Narrative

Pma/510(k) #p100022/s027.Device evaluation: the unknown device of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation ¿ n/a.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 restenosis of the stented artery 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, smoking, coronary artery disease (cad), renal insufficiency, diabetes, history of ischemic stroke or transient ischemic attack, history of vascular surgery, history of lower limb amputation and rutherford classifications between 1 and 6.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.Summary: complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• 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: 11020097
• MDR Text Key: 226628242
• Report Number: 3001845648-2020-00954
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 10/25/2019
• Event Location: Hospital
• Date Manufacturer Received: 11/17/2020
• 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 Sex: Male