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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022/s014/s027/s026.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Xpedite: paclitaxel-coated peripheral stents used in the treatment of femoropopliteal stenoses.Study number (b)(4).The xpedite study is a pre-market, interventional, feasibility study comparing the currently available zilver® ptx® drug-eluting peripheral stent (technical file: itf054-csevs-dd) with two investigational paclitaxel drug coatings on the zilver® stent.All 57 patients in the commercial zilver ptx arm had a single de novo lesion; lesions were treated with a total of 93 commercial zilver ptx stents.Stent sizing and placement were determined by the sites during the index procedure.All commercial zilver ptx stents in the xpedite study were implanted using the thumbwheel delivery system.Primary patency was assessed using duplex ultrasound.The 2 year primary patency rate was 75.0% ± 5.9%, with a total of 14 failures in the commercial zilver ptx arm of the xpedite clinical study.This file will capture 7 events of loss of patency.Patient outcome: surgical intervention.Patient info: 64.9% (37/57) men with a mean age of 69.3 ± 8.9 years (range 49-84 years).

Manufacturer Narrative

Pma 510k # p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted as a correction updated pmcf report with breakdown of patients/country received 14-aug-2023.Xpedite: paclitaxel-coated peripheral stents used in the treatment of femoropopliteal stenoses.Study number (b)(4).The xpedite study is a pre-market, interventional, feasibility study comparing the currently available zilver® ptx® drug-eluting peripheral stent (technical file: itf054-csevs-dd) with two investigational paclitaxel drug coatings on the zilver® stent.All 57 patients in the commercial zilver ptx arm had a single de novo lesion; lesions were treated with a total of 93 commercial zilver ptx stents.Stent sizing and placement were determined by the sites during the index procedure.All commercial zilver ptx stents in the xpedite study were implanted using the thumbwheel delivery system.Primary patency was assessed using duplex ultrasound.The 2 year primary patency rate was 75.0% ± 5.9%, with a total of 15 failures in the commercial zilver ptx arm of the xpedite clinical study.This file will capture 6 events of loss of patency in germany.Surgical intervention.Patient info: 64.9% (37/57) men with a mean age of 69.3 ± 8.9 years (range 49-84 years).

Event Description

Supplemental report is being submitted due to the completion of the investigation on 01-mar-2024.

Manufacturer Narrative

Pma/510(k) # p100022/s027 this file was created from pmcf study to capture 6 events of restenosis/occlusion and loss of patency in germany this file is related to pr 403361, pr 403362 and pr 403703.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.Manufacturing records: prior to distribution all zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown instructions for use/label: it may be noted that the instructions for use (ifu0117) lists restenosis of the stented artery and occlusion as known potential adverse events.There is no evidence to suggest the user did not follow the instructions for use.Image review an image was not returned for evaluation.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/baseline characteristics.From the information provided, patients included in the study, had peripheral arterial disease and their baseline characteristics included hypertension, diabetes and smoking.These are all known predictors of restenosis.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.Occlusion is listed as a known potential adverse event within the ifu.Diabetes, high blood pressure and peripheral arterial disease are all risk factors for developing arterial occlusion.As per medical advisor input "pre-existing conditions" was noted as a possible root cause.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary: according to the initial reporter, this file was created from a pmcf study.The xpedite study is a pre-market, interventional, feasibility study comparing the currently available zilver® ptx® drug-eluting peripheral stent (technical file: itf054-csevs-dd) with two investigational paclitaxel drug coatings on the zilver® stent.All 57 patients in the commercial zilver ptx arm had a single de novo lesion; lesions were treated with a total of 93 commercial zilver ptx stents.Stent sizing and placement were determined by the sites during the index procedure.This file captures restenosis/occlusion and loss of patency in germany.Confirmed quantity of 6 devices, confirmed used.According to the initial reporter, patient outcome, as per information provided surgical intervention was required.As per medical advisor input "require intervention/additional procedures s=4".Investigation findings conclude that a possible root cause could be attributed to patient pre-existing/baseline characteristics.As previously noted, restenosis of the stented artery and occlusion are known potential adverse events.

• Brand Name: ZILVER PACLITAXEL-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: 17486857
• MDR Text Key: 320664239
• Report Number: 3001845648-2023-00608
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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
• Event Location: Hospital
• Date Manufacturer Received: 07/11/2023
• 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: 63 YR
• Patient Sex: Male