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 Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 02/04/2022

Event Type  Injury  

Event Description

Saaya et al 2022 - a prospective randomized trial on endovascular recanalization with stenting versus remote endarterectomy for the superficial femoral artery total occlusive lesions.Patients were randomized using a sealed envelope method.In the first ei group, there were 119 patients who received endovascular recanalization and stenting of sfa.In the second re group, there were 119 patients who received semiclosed endarterectomy for sfa.All reconstructions were unilateral.For the ei group, ipsilateral or contralateral approaches were used, depending on the clinical situation.If the ipsilateral antegrade access to sfa failed, we attempted the contralateral approach crossing sfa.Recanalization with a hydrophilic 0.035-inch guide was performed.Anticoagulant (heparin sulfate 150 u/kg) was introduced before starting the procedure.After recanalization and balloon angioplasty of the sfa, we performed stenting with self-expanding nitinol stents (protege everflex, zilver flex stent [bms], absolute pro, abbott).If necessary, several stents were implanted, but no more than three.The overlap of the stents was approximately 5-10 mm.Stent implantation was not performed in the middle or distal third of the popliteal artery.This complaint was opened to capture loss of patency in ei group; restenosis (47) and reocclusion (39).In 21 (25%) cases in the ei group, conservative therapy was effective and reinterventions were avoided.Endovascular reinterventions were performed in 65 (75%) cases in the ei group (58% pta of sfa and 42% pta with stenting of sfa).

Manufacturer Narrative

Likely pma/510(k) # for zilver flex 35 vascular self-expanding stent: p050017/s006.The investigation is in progress and a follow up mdr will be submitted.

Manufacturer Narrative

Likely pma/510(k) # for zilver flex 35 vascular self-expanding stent: p050017/s006.Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4) and it was created from the attached journal article.(b)(4) was opened to capture the 21 cases of restenosis or occlusion where conventional therapy was effective and intervention was avoided.Lab evaluation ¿ n/a.Document review: prior to distribution all zilver flex devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data was not reviewed as the lot number is unknown.It should be noted that the instructions for use lists restenosis of the stented artery as a potential adverse event.There is no evidence to suggest the user did not follow the ifu.There is no evidence to suggest that the customer did not follow the label.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 patient pre-existing conditions.From the article it is known that patient baseline characteristics included risk factors for restenosis/occlusion including arterial hypertension, coronary heart disease, diabetes mellitus, obesity and tobacco use.It should also be noted that the ifu lists restenosis of the stented artery as a potential adverse event.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from literature paper saaya et al ¿a prospective randomized trial on endovascular recanalization with stenting versus remote endarterectomy for the superficial femoral artery total occlusive lesions¿.According to the initial reporter, 65 patients underwent reintervention as a result of restenosis or re-occlusion.As per medical advisor input ¿require intervention/additional procedures to prevent permanent impairment/damage¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation on 09-dec-2022 and an update to the investigation conclusions.

• 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
• 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: 15111562
• MDR Text Key: 296662660
• Report Number: 3001845648-2022-00473
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 01/05/2023
• 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