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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

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 13-002.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.1 patient experienced a worsening rutherford classification by 2 classes or more.Insufficient information available per medical affairs input likely requiring intervention/additional procedures.Patient info: 64.9% (37/57) men with a mean age of 69.3 ± 8.9 years (range 49-84 years).

Manufacturer Narrative

Pma/510(k) # p100022/s027.This file was created from pmcf study to capture worsening rutherford classification.This file is related to (b)(4) "tlr (germany)", (b)(4) "loss of patency(germany)" and (b)(4) "loss of patency (new zealand)".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: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all 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.Review historical data: n/a.Instructions for use/label: it may be noted that the instructions for use (ifu0117) lists worsened claudication/rest pain as a known potential adverse event.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/underlying conditions, worsened claudication/rest pain is a known potential adverse event.As per medical advisor input "pre-existing conditions" was noted as a possible root cause peripheral arterial disease (pad) was listed as pre existing conditions.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: for all complaints a recommended action will be to continue to monitor for similar events.Summary: file was created from pmcf study to capture worsening rutherford classification.Confirmed quantity of 1 device, confirmed used.Patient outcome, insufficient information available per medical affairs input likely requiring intervention/additional procedures.Investigation findings conclude that a possible root cause could be attributed to patient pre-existing/underlying conditions, worsened claudication/rest pain is a known potential adverse event.Complaint is confirmed based on customer and/or rep testimony.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 on 22-apr-2024.

• 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: 17486728
• MDR Text Key: 320661448
• Report Number: 3001845648-2023-00607
• 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
• Report Date: 04/22/2024

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