MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number UNKNOWN

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

Patient Problems Stenosis (2263); Restenosis (4576)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Falkowski et al 2020 (zilver ptx) ¿ ¿assessment of mortality and factors affecting outcome of use of paclitaxel-coated stents and bare metal stents in femoropopliteal pad¿.Paclitaxel-coated stents (zilver® ptx®, cook medical) and standard, self-expanding, non-coated stents (zilver® flex, cook medical) were used for treatments.Arteriography of the lower limbs was performed from contralateral puncture.A vascular introducer was installed (cordis®, contralateral).Using the feature ¿road map¿, the transition was made by means of a guide (terumo medical, stiff 0.035).A balloon catheter adapted to the diameter of the vessel and the length of the lesion was then introduced (cordis®, boston¿, medtronic¿), and pta was performed according to generally accepted principles.The stent was selected for the width of the vessel and the length of the stenosis in such a way that the diameter of the stent was 1 mm larger than the diameter of the treated vessel, and the stent covered the change over the entire length.Stents (40¿140 mm long) were used with diameters 5¿8 mm and delivery system 125 cm.After implantation, postdilation was performed with a balloon catheter.Restenosis: in the bms group, there were 6 cases of narrowing and 2 occlusions.After 36 months (±1 month), 64 patients with restenosis underwent duplex ultrasonography and 36 underwent ct.A total of 2 patients with restenosis only underwent ct.In the bms group there were 37 cases of narrowing and 9 occlusions.This file will capture the 8 cases of restenosis @ 6 months in the bms group which were potentially device related, as per clinical input.7 of these patients also required tlr.

Event Description

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

Manufacturer Narrative

Pma/510(k) # (b)(4).Device evaluation the zfv6 device of unknown rpn and lot number involved in this complaint 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 zfv6 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.It should be noted that restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0058-4).There is no evidence to suggest the user did not follow the ifu.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 conditions, the stent placement procedure and/or the stent itself.From the available information it is known that patients who were enrolled in the study were classified between 2-5 on the rutherford scale.Patient pre-existing conditions included obstruction/stenosis, hypertension, diabetes mellitus, myocardial infarction, stroke, dyslipidemia, chronic kidney disease and coronary artery disease (cad).It is possible that patient pre-existing conditions caused and/or contributed to the events of restenosis requiring additional intervention and/or procedures.As mentioned above restenosis of the stented artery is listed as a known potential adverse event within the ifu.However, there is no evidence within the journal article to suggest any device malfunction or deterioration in device characteristics.Summary the complaint is confirmed based on customer testimony.According to the initial reporter 08 patients in the bms group experienced restenosis at 6 months.07 of these patients required target lesion revacsularisation (tlr).Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10821978
• MDR Text Key: 217960600
• Report Number: 3001845648-2020-00847
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR