MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/19/2015

Event Type  Injury  

Event Description

Oberto et al 2015 ¿ comparison of sfa lesion treatment with zilver ptx in diabetics vs.Non-diabetics: 2-year clinical and functional results.¿ background: prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting niti¬nol stent (zilver ptx), and focused in particular on the treatment of complex lesions and/or diabetic patients.Between may 2010 and march 2012, 67 patients (78% males) were treated by zilver ptx, because of stenosis or occlusions of the superficial femoral artery in one of two centers.Stage renal disease).One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4).All patients had successful stent placement.The des evaluated in the study was the zilver ptx nitinol stent (cook medical, (b)(4) usa), which incorporates a self-expanding, flexible nitinol stent platform with a 3 g/mm2 polymer-free coating of paclitaxel on its outer surface.Stents were placed at least 1 cm below the sfaorigin and above the medial femoral epicondyle to fully cover the target lesion(s).Pre-dilatation and post dilatation were at the physician¿s discretion, with residual stenosis <30% required for procedural success.The same antiplatelet regimen was recommended for all patients.Conclusions: the use of zilver ptx is safe and effective in the treatment of sfa lesions.In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in dand non-d, suggesting a particularly favorable activity of ptx in a subpopulation of diabetics.Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.This complaint was opened to capture no stent patency at 24 months.Primary patency, evaluated by kaplan-meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months.Require intervention/additional procedures to prevent permanent impairment/damage.8 patients required reintervention at 24m including 3 major amputations.

Manufacturer Narrative

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

Event Description

Final mdr being submitted due to completion of investigation on 18-may-2022.

Manufacturer Narrative

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.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).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, diabetes, smoking, renal insufficiency and rutherford classification 4.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.From the literature it is known that patients required intervention/additional procedures to prevent permanent impairment/damage.8 patients required reintervention at 24m including 3 major amputations.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: 13416352
• MDR Text Key: 289325859
• Report Number: 3001845648-2022-00049
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 06/15/2022
• 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 Sex: Male