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 Off-Label Use (1494)

Patient Problems Stenosis (2263); Restenosis (4576)

Event Date 02/13/2018

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

Shintaku 2019 the efficacy of drug-eluting stent for recurrent central venous restenosis in a patient undergoing hemodialysis.Balloon angioplasty was performed using a conventional balloon catheter (10 mm ¿ 4 cm).One des (8 mm ¿ 4 cm; zilver ptx) was carefully deployed at the in-stent restenosis to keep the entry of the cephalic arch open, followed by additional dilation using a conventional balloon catheter (8 mm ¿ 8 cm).Then, the cephalic arch stenosis was dilated using the same balloon catheter from the cephalic vein.Good outflow through the stented segment and cephalic arch with only partial filling of the collateral veins were observed.This complaint was opened to capture the residual narrowing was recognized, one des (zilver ptx; 8 mm ¿ 8 cm) was deployed from the subclavian vein to the axillary vein to deter the outflow of the cephalic arch (figure 4(b)).Although additional implantation of a second des was required 14.6 months after the first des placement, freedom from tlr extended from 4.4 months to more than 8.6 months.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation: the device of unknown rpn and 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.Lab evaluation ¿ n/a.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 all ptx devices are subject to visual 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 the instructions for use (ifu0117-5) states the following: flow restrictions remaining after stent deployment (e.G., residual proximal or distal stenosis or dissection, or poor distal outflow) may increase the risk of stent thrombosis.Inflow and outflow should be assessed at the procedure completion and additional measures considered (e.G., additional pta, adjunctive stenting, or distal bypass) if necessary, to maintain food inflow and outflow.The ifu also states that potential adverse events that may occur include arterial thrombosis.The ifu also states that ¿the zilver ptx drug-eluting peripheral stent is intended for use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4mm to 7mm.¿ there is evidence to suggest the user did not follow the ifu.The japanese packaging insert c-ci1502m02 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.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patients previous pre-existing conditions.Patients with moderate to severe intermittent claudication or clti with rest pain or minor tissue stenotic or occlusive de novo lesion in the femoropopliteal arteries suitable for both endovascular therapy and bypass surgery were included in the study.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, 1 patient experienced stent thrombosis.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Device evaluation: the device of unknown rpn and 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 all ptx devices are subject to visual 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 the instructions for use (ifu0117-5) states the following: flow restrictions remaining after stent deployment (e.G., residual proximal or distal stenosis or dissection, or poor distal outflow) may increase the risk of stent thrombosis.Inflow and outflow should be assessed at the procedure completion and additional measures considered (e.G., additional pta, adjunctive stenting, or distal bypass) if necessary, to maintain food inflow and outflow.The ifu also states that potential adverse events that may occur include arterial thrombosis.The ifu also states that ¿the zilver ptx drug-eluting peripheral stent is intended for use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4mm to 7mm.¿ there is evidence to suggest the user did not follow the ifu.The japanese packaging insert c-ci1502m02 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.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patients previous pre-existing conditions.Patients with moderate to severe intermittent claudication or clti with rest pain or minor tissue stenotic or occlusive de novo lesion in the femoropopliteal arteries suitable for both endovascular therapy and bypass surgery were included in the study.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, 1 patient experienced stent thrombosis.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted as a correction report annex g code updated.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 10830006
• MDR Text Key: 218498327
• Report Number: 3001845648-2020-00862
• 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,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2018
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2020
• 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: 60 YR
• Patient Sex: Male