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 Problem Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Fransson, 2023, randomized clinical trial comparing drug eluting stent zilver ptx® versus bare metal stent zilver flex® for treatment of lesions in femoral and popliteal arteries in chronic limb threatening ischemia.Patients presenting with clti scheduled for endovascular treatment of fp lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to des or bms after lesion crossing.Primary endpoints were target lesion revascularization (tlr) at 12 and 24 months and primary patency at 12 and 24 months.Secondary endpoints were technical success (ts), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (sae) at 24 month and survival at five years.This file was opened to capture the occurrence of predischarge restenosis in the zilver flex group.Require intervention/additional procedures.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 01-dec-2023.

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 literature paper ¿fransson, 2023, randomized clinical trial comparing drug eluting stent zilver ptx® versus bare metal stent zilver flex® for treatment of lesions in femoral and popliteal arteries in chronic limb threatening ischemia.¿ it is related to (b)(4) (emdr 3001845648-2023-00476 ) and (b)(4) (emdr 3001845648-2023-00481) and captures 01 occurrence of predischarge restenosis in the bms zilver flex group.Manufacturing records 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.Instructions for use and label: it should be noted that the instructions for use (ifu0058) lists restenosis of the stented artery as potential adverse event.There is no evidence to suggest the user did not follow the ifu or label.Image review : an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patients pre existing condition.From the available information it is known that patients baseline characteristics included chronic limb threatening ischemia, lesions in the sfa and first part of the pa, diabetes mellitus, chronic kidney disease, active smoking, cardiovascular disease and cerebrovascular disease.It is possible that patients pre-existing conditions caused or contributed to the event of predischarge restenosis.As previously noted, restenosis of a stented artery is listed as known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by obstruction to the vessel.Confirmation of complaint: complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation the complaint was raised from literature paper ¿fransson, 2023, randomized clinical trial comparing drug eluting stent zilver ptx® versus bare metal stent zilver flex® for treatment of lesions in femoral and popliteal arteries in chronic limb threatening ischemia¿.According to the initial reporter, patients presenting with clti scheduled for endovascular treatment of fp lesions were randomly assigned by blinded envelopes1:1 in a single blinded, parallel group design to des or bms after lesion crossing.Primary endpoints were target lesion revascularization (tlr) at 12 and 24 months and primary patency at 12 and 24 months.Secondary endpoints were technical success (ts), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (sae) at 24 month and survival at five years.This file was opened to capture the occurrence of predischarge restenosis in the bms zilver flex group.Confirmed quantity of (b)(4) devices, confirmed used.According to the article, it is known that in hospital technical failures were by protocol subject to corrective retreatment before discharge at the discretion of the interventionist.As per clinical input, the patients would have required intervention/additional procedures.Investigation findings conclude a possible root cause of the patients pre existing conditions which included chronic limb threatening ischemia.As previously noted, restenosis of a stented artery is listed as known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by obstruction to the vessel.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
• 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: 17161743
• MDR Text Key: 317452204
• Report Number: 3001845648-2023-00480
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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?: 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/22/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 12/18/2023
• 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: 75 YR
• Patient Sex: Male