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 08/22/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Liu 2022 midterm outcomes of endovascular therapy for tasc ii d femoropopliteal lesions with critical limb ischemia: a retrospective analysis.Fifty seven limbs of 54 patients with cli due to tasc ii d femoropopliteal lesions who underwent evt at the first hospital of hebei medical university were retrospectively analysed in a single-centre, observational study.The patient characteristics, endovascular procedural details, freedom from target lesion revascularization (tlr), patency rates, ulcer healing rate, and limb salvage rate were accessed.57 limbs of 54 patients referred for evt of tasc ii d femoropopliteal lesions with cli were included in this observational, single-arm, single-institution, prospective study.Male, n (%) 41 (75.9).Age (years, mean ± sd) 68.2 ± 8.2.Access to the target lesion was determined using a 6 f 45- cmelong sheath (fortress, biotronik, dresden, germany), crossing over the aortic bifurcation, or using a 6 f 16-cmelong sheath (radifocus, terumo corporation, hanoi, vietnam) via an antegrade approach.After sheath placement, unfractionated 100 iu/kg heparin was administered by injection.A 0.035-inch hydrophilic guidewire (150 cm, radifocus, terumo corporation) crossed through the culprit lesions.The target vessel was first opened in the true lumen and a subintimal technique was used if this failed.To reduce damage, a balloon with a diameter 1 mm narrower than the target vessel was chosen.Predilation with small balloon catheter was performed for 2 min to limit the risk of dissection.Using a stent sizing selected to a 1:1 ratio to the normal artery segment diameter and extending at least 10 mm past the lesion proximally and distally.Adjacent stents were overlapped by 1 cm maximum.A radiopaque ruler was used to measure the length of the stented segment.Four types of nitinol self-expanding stents were implanted: protege everflex (ev3, plymouth, minnesota), aston pulsar (biotronik, berlin, german), lifestent (bard peripheral vascular, tempe, arizona), and zilver flex (cook, limerick, ireland).The routinely post dilated balloon after stenting was performed within the stented segment.In case of a percutaneous approach, groin closure was accomplished by manual compression or by using a vascular closure device (2-mm perclose proglide, abbott vascular, diegem, belgium).The complaint captures occurrences of restenosis and occlusion requiring surgery intervention patient outcome: require intervention/additional procedures.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Device evaluation: the zilver flex devices of lot numbers and rpns unknown, involved in this complaint, were implanted into the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.This complaint was raised from literature paper liu 2022 midterm outcomes of endovascular therapy for tasc ii d femoropopliteal lesions with critical limb ischemia: a retrospective analysis.It is related to (b)(4) and captures 25 occurrences of restenosis and occlusion requiring surgical intervention.The device evaluation could not be completed as the devices or photographic evidence of the devices were not returned for evaluation.With the information provided, a document-based investigation was conducted.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 a potential adverse event of this device.There is no evidence to suggest the user did not follow the instructions for use 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 anatomy.From the information available, it is known that a univariate analysis was done and it revealed that the predictors of restenosis or occlusion were the longer lesions and the presence of more complex lesions.As previously mentioned, restenosis of the stented artery is listed as a potential adverse event of this device in the ifu.Confirmation of complaint: complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation: according to the initial reporter, this complaint was raised from literature article ¿liu 2022 midterm outcomes of endovascular therapy for tasc ii d femoropopliteal lesions with critical limb ischemia: a retrospective analysis¿ fifty seven limbs of 54 patients with cli due to tasc ii d femoropopliteal lesions who underwent evt at the first hospital of hebei medical university were retrospectively analysed in a single-centre, observational study.The patient characteristics, endovascular procedural details, freedom from target lesion revascularization (tlr), patency rates, ulcer healing rate, and limb salvage rate were accessed.The complaint captures 25 occurrences of restenosis and occlusion requiring surgical intervention.Confirmed quantity of 25 devices, confirmed used.According to the initial reporter, there was 25 occurrences of restenosis and occlusion that required surgery.Reinterventions included evt, surgical bypass, rotational atherectomy, implanted with covered stents and a paclitaxel coated balloon.Investigation findings conclude possible root causes could be attributed to the patients anatomy, the lesion length and the presence of more complex lesions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 09-jan-2024.

• 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: 17245339
• MDR Text Key: 318285366
• Report Number: 3001845648-2023-00519
• 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: 01/09/2024

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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 01/26/2024
• 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: 69 YR
• Patient Sex: Male