MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Tomoi, 2015, zilver ptx and vascular response after zilver ptx stent implantation for superficial femoral artery lesions: serial optical coherence tomography findings at 6 and 12 months.Purpose: to compare the vascular response after paclitaxel-coated nitinol drug-eluting stent (zilver ptx) implantation for superficial femoral artery lesions after 6 and 12 months using optical coherence tomography (oct).Serial oct examinations were performed in 5 patients (4 men; mean age 78.4¿6.8 years) with 9 zilver ptx stents at 6- and 12-month follow-up.The oct examination was performed with a frequency domain system (c7-xr; t.Jude medical, st.Paul, mn, usa) using a 4.5-f guiding catheter (parent plus 45; medikit, tokyo, japan) as a sheath via the brachial artery approach.The stent was imaged using an automatic pullback device that moved the oct catheter at 20 mm/s; digital images were captured at an acquisition rate of 100 frames per second.In-stent restenosis (isr) was found in only 1 of 5 lesions at 1 year.

Manufacturer Narrative

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.This file was created from the journal article "tomoi 2015" complaint files (b)(4) (report reference number 3001845648-2021-00364), (b)(4) (report reference number 3001845648-2021-00365) and (b)(4) (report reference number 3001845648-2021-00366) were opened as a result of this paper.This file (b)(4) was opened to investigate in-stent restenosis.As the rpn and lot number of the complaint stent is 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.The japanese packaging insert which accompanies this device informs the user about the "potential significant adverse events that may occur in use of this device include, but are not limited to: restenosis or occlusion of the stented artery." the japanese packaging insert supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.There is no evidence to suggest that the customer did not follow the packaging insert.A definitive root cause could not be determined from the available information.A possible root cause could be attributed the patient¿s pre-existing condition.From the information provided it is known that the patients were treated for superficial femoral artery lesions and all patients exhibited intermittent claudication (rutherford category 3).It is possible that patient pre-existing conditions caused and/or contributed to in-stent restenosis.As mentioned above restenosis is a known inherent risk of endovascular stenting and is listed in the packaging insert as a potential adverse event.However, there is no evidence within the journal article to suggest any device malfunction or deterioration in device characteristics.Therefore, it is more likely that patient pre-existing conditions caused or contributed to in-stent restenosis.Summary: complaint is confirmed based on customer testimony.From the information provided it is unknown whether the patient experienced any adverse effects due to this occurrence.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.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11775265
• MDR Text Key: 264475727
• Report Number: 3001845648-2021-00364
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2021
• 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: 78 YR
• Patient Sex: Male