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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Restenosis (4576)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Rabellino et al 2022 ¿ ¿novel common femoral artery lesion classification in patients undergoing endovascular revascularization¿ all procedures were performed in a dedicated hybrid angiography laboratory.Generally, patients underwent a ¿¿crossover¿¿ approach over the aortic bifurcation through a retrograde contralateral femoral puncture with a dedicated 6f long sheath (45 cm) or via brachial approach with a dedicated 6f long sheath (90 cm).After sheath placement heparin was administered at 100 iu/kilogram.Digital subtraction angiography (dsa) was initially used to assess and classify lesions.Following dsa and identification of targeted lesions, a hydrophilic 0.035-inch wire was used for crossing, following the standard percutaneous transluminal angioplasty (pta) technique, followed by self-expandable nitinol stent implantation.A variety of stents were used to treat lesions: smart (cordis, (b)(4)) 14.41%; complete (medtronic, (b)(4)) 16.74%; zilver flex (cook medical, (b)(4)) 15.5%, everflextm (medtronic, (b)(4)) 19.4%; epictm (boston scientific, (b)(4)) 17.28% and prote´ge´ gps (medtronic, minneapolis, mn) 16.67%.Restenosis: target lesion revascularization were performed in three patients.The one patient in rutherford iv at fu, was later on screened with ct scan and had a patent cfa stent from index procedure, with a new significant ipsilateral lesion in the popliteal artery.In this patient, we performed antegrade puncture of the cfa stent for access with no reported complications.Off-label: use in common femoral artery and deep femoral artery.

Manufacturer Narrative

Pma/510(k) # 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 was created from the attached journal article ref.Att.¿rabellino_2022 highlighted.Pdf¿.Pr 381297 has been created to capture 06 cases of off label use with no adverse event reported.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.It should be noted that the instructions for use states ¿the product is intended for use in the iliac, superficial femoral artery (sfa) and above-the-knee popliteal artery¿.It should also be noted that the ifu lists restenosis of the stented artery as a potential adverse event.There is evidence to suggest the user did not follow the ifu.There is 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 of off label use can be concluded based on the information provided.The information for use states that the device is intended for use in the iliac, superficial femoral artery and above-the-knee popliteal artery however from the information provided the target location was the common femoral artery and deep femoral artery.The off-label use of the stent may have caused or contributed to the restenosis as it¿s unknown how the device will perform outside of its intended 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 rabellino et al ¿novel common femoral artery lesion classification in patients undergoing endovascular revascularization¿.According to the initial reporter, 03 patients experienced restenosis requiring revascularisation as a result of this occurrence.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 07-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: 15127575
• MDR Text Key: 296847243
• Report Number: 3001845648-2022-00472
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 01/04/2023
• 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: 73 YR
• Patient Sex: Male