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 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #p100022/s014.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Soga 2020a ¿japanese patients treated in the imperial randomized trial comparing eluvia and zilver ptx stents¿.A total 33 zilver ptx stents were used to treat 28 patients.Lesion predilation with an uncoated balloon catheter was common, with 89.3% (25/28) of patients having it performed in the d zilver ptx groups.All stents were dilated with a balloon post-deployment.At discharge, 94.6% (53/56) of patients treated with eluvia were on dual antiplatelet therapy with acetylsalicylic acid and one of clopidogrel, prasugrel, or ticlopidine.Dual therapy continued for 92.9% (52/56) at 1 month, 76.8% (43/56) at 6 months, and 58.2% (32/55) at 12 months for patients treated with eluvia, and the proportions were similar for patients treated with zilver ptx (supplementary table 1).Acetylsalicylic acid use (alone or in dual therapy) was reported for 85.7% (48/56) at 6 months and 78.2% (43/55) at 12 months.Clopidogrel was the most commonly used p2y12 receptor inhibitor, with 89.3% (50/56) of patients receiving it at discharge and 69.1% (38/55) continuing at 12 months (alone or in combination with acetylsalicylic acid).The proportions of patients on the respective antiplatelet therapies were similar for the zilver ptx group (supplementary table 1).100% patency not observed at 12 months, the observed primary patency rate was 84.6% (22/26) for zilver.A total of 4 patients were noted where 100% patency was not observed.This complaint was opened to capture the 2 patients where 100% patency was not observed.Reference (b)(4) for inclusion of the remaining two patients involved.

Event Description

Final mdr being submitted due to completion of the investigation on 24-sept-21.

Manufacturer Narrative

Pma/510(k) #p100022/s014.Device evaluation: the zisv6 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, hyperlipidemia, diabetes, smoking, coronary artery disease (cad), renal insufficiency, history of vascular surgery and rutherford classifications rutherford classifications that is specified to be 2, 3 or 4.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.

• 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: 10820609
• MDR Text Key: 218912875
• Report Number: 3001845648-2020-00851
• 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
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/05/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR