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 07/13/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Falkowski et al 2020 (zilver ptx) ¿ ¿assessment of mortality and factors affecting outcome of use of paclitaxel-coated stents and bare metal stents in femoropopliteal pad¿.Paclitaxel-coated stents (zilver® ptx®, cook medical) and standard, self-expanding, non-coated stents (zilver® flex, cook medical) were used for treatments.Arteriography of the lower limbs was performed from contralateral puncture.A vascular introducer was installed (cordis®, contralateral).Using the feature ¿road map¿, the transition was made by means of a guide (terumo medical, stiff 0.035).A balloon catheter adapted to the diameter of the vessel and the length of the lesion was then introduced (cordis®, boston¿, medtronic¿), and pta was performed according to generally accepted principles.The stent was selected for the width of the vessel and the length of the stenosis in such a way that the diameter of the stent was 1 mm larger than the diameter of the treated vessel, and the stent covered the change over the entire length.Stents (40¿140 mm long) were used with diameters 5¿8 mm and delivery system 125 cm.After implantation, postdilation was performed with a balloon catheter.Restenosis: in the des group, there were 3 cases of narrowing and 1 occlusion.After 36 months (±1 month), 64 patients with restenosis underwent duplex ultrasonography and 36 underwent ct.A total of 2 patients with restenosis only underwent ct.In the des group there were 16 cases of narrowing and 4 occlusions.This file will capture the 4 cases of restenosis @ 6 months in the des group which were potentially device related, as per clinical input.4 of these patients also required tlr.

Manufacturer Narrative

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.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.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, dyslipidaemia, diabetes, smoking, coronary artery disease (cad), renal insufficiency, history of ischemic stroke or transient ischemic attack, history of vascular surgery and rutherford classifications between 2 and 5.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

Final mdr being submitted due to completion of investigation on (b)(6) 2021.

• 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
• MDR Report Key: 10821453
• MDR Text Key: 218913242
• Report Number: 3001845648-2020-00846
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR