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 Problem 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)(6).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.The 2-year freedom from tlr was 87.5% ± 4.5% with a total of 7 reinterventions in the commercial zilver ptx arm of the xpedite clinical study.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 cover 7 events of tlr and 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/510(k) # p100022/s027.This file was created from pmcf study to capture tlr (target lesion revascularisation) and loss of patency.This file is related to pr (b)(4) / mdr#3001845648-2023-00607 "worsening rutherford classification(germany)", (b)(4) / mdr#3001845648-2023-00608 "loss of patency(germany)" and (b)(4) / mdr#3001845648-2023-00699 "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 instructions for use/label: it may be noted that the instructions for use (ifu0117) lists restenosis of the stented artery 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.A possible root cause could be attributed to the patients pre existing conditions.From the information provided it is known that the patients suffered from peripheral arterial disease (pad).Baseline characteristics and pre-existing comorbid conditions in the patients involved in the study included smoking, heart disease, vascular disease, renal and urinary insufficiency.It is possible that these pre-existing conditions caused and/or contributed to this event.Stent restenosis is defined as the narrowing or blockage of a previously implanted stent in a blood vessel.This condition can occur after a successful procedure, where a stent is placed to keep the vessel open and restore blood flow.However, in some cases, the inner lining of the blood vessel may grow back over the stent, leading to the stent to become narrowed or completely blocked again.This can occur due to progression of a patients pre-existing condition.From the article it is known that the patients involved in the study had baseline characteristics/pre-existing conditions which included smoking, heart disease, vascular disease, renal insufficiency, dialysis required, critical ischemia and claudication some of which are known predictors of restenosis.The progression of these baseline characteristics/pre-existing conditions potentially led to the compression or narrowing of the vessel which could have exerted pressure on the stent, leading the stent to possibly becoming distorted or impaired or weakened due to this pressure and thus not being able to maintain patency of the vessel.It should also be noted that restenosis is a common adverse event of endovascular procedures and is listed as a known potential adverse event within the ifu.Restenosis 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 surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.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 similar events.Summary: file was created from pmcf study to capture loss of patency and tlr (target lesion revascularisation).Confirmed quantity of 7 devices, confirmed used.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/underlying conditions, restenosis of the stented artery as a known potential adverse event.The progression of these baseline characteristics/pre-existing conditions potentially led to the compression or narrowing of the vessel which could have exerted pressure on the stent, leading the stent to possibly becoming distorted or impaired or weakened due to this pressure and thus not being able to maintain patency of the vessel.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for similar events.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 29-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: 17486599
• MDR Text Key: 320662473
• Report Number: 3001845648-2023-00606
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 05/16/2024
• 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