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 Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 06/29/2022

Event Type  Injury  

Event Description

(b)(6), 2023 ¿ bare-metal stent in dysfunctional hemodialysis access: an assessment of circuit patency according to access type and stent location.All procedures were performed on an outpatient basis.Avf or avg were cannulated with an 18-gauge needle after local anesthesia, and a 6¿8 fr sheath (terumo, tokyo, japan or cook, bloomington, in, usa) was introduced into the outflow vein of the arm over a 0.035-inch guidewire (terumo, tokyo, japan).Venography was performed to assess the circuit for stenosis or occlusion.Once the lesion was identified, angioplasty was performed using a balloon catheter with balloon diameters ranging from 5 mm to 16 mm.The diameter of the balloon was 0%¿10% larger in relation to the diameter of the adjacent vessel segment.A self-expanding nitinol bms was deployed in the dilated lesion when any of the following indications were met: 1) elastic recoil resulting in residual stenosis of more than 30% after angioplasty, 2) early restenosis developing within 1 month after treatment, 3) flow-limiting dissection, or 4) vessel rupture.The diameter of stents was equal to or larger than the diameter (up to 30%) of the angioplasty balloon, ranging from 5 to 20 mm.One of the following stents was used: s.M.A.R.T.Stent (cordis corp, fremont, ca, usa), absolute pro stent (abbott vascular, santa clara, ca, usa), and zilver flex stent (cook).Patients received aspirin 100 mg (astrix cap, boryung pharmaceutical co., seoul, korea) and clopidogrel 75 mg (plavix tab, handok, seoul, korea) once a day for 3 months following treatment.Patient info: 159 patients (95 males, 64 females; mean age, 64.1 years).This complaint was opened to capture off label use and major complications.Zilver flex devices placed 18 brachiocephalic vein, 51 cephalic arch, 40 upper arm vein, 10 juxta-anastomotic vein, 7 arteriovenous (av) anastomosis, and 33 graft-vein (gv) anastomosis.Per ifu0058-4 zilver flex devices are intended for use in iliac, superficial femoral artery (sfa) and above-the-knee popliteal artery.One case of graft infection resulting in surgical removal of graft.Two cases of thrombosis in aneurysmal fistula.One case of postprocedural bleeding requiring a surgical operation.Patient outcome: surgical intervention.

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

Supplement report being submitted due to the completion of the investigation on 10aug2023.

Manufacturer Narrative

Pma 510k #p050017/s006.Device evaluation: the device evaluation could not be completed as the devices involved in this complaint were not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4), bare-metal stent in dysfunctional hemodialysis access: an assessment of circuit patency according to access type and stent location this complaint was opened to capture the off label use and major adverse events in 04 cases.Lab evaluation : the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation document review: prior to distribution all zilver flex 35 vascular self-expanding stent 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.There is evidence to suggest the user did not follow the ifu.Instructions for use (ifu0058) states the following: ¿zilver flex devices are intended for use in iliac, superficial femoral artery (sfa) and above-the-knee popliteal artery.¿ from the article we know that the stents were placed 18 brachiocephalic vein, 51 cephalic arch, 40 upper arm vein, 10 juxta-anastomotic vein, 7 arteriovenous (av) anastomosis, and 33 graft-vein (gv) anastomosis.It should also be noted that infection is listed as a potential adverse event in the ifu.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause of off label use can be concluded.From the article we know that the stents were placed in 18 brachiocephalic vein, 51 cephalic arch, 40 upper arm vein, 10 juxta-anastomotic vein, 7 arteriovenous (av) anastomosis, and 33 graft-vein (gv) anastomosis.Per the ifu, ¿zilver flex devices are intended for use in iliac, superficial femoral artery (sfa) and above-the-knee popliteal artery.¿ it should be noted that, as the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function.Off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.This complaint also captures potential infection.As per ifu, infection is listed as a potential adverse event of this device.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from the article ¿lee 2023, bare-metal stent in dysfunctional hemodialysis access: an assessment of circuit patency according to access type and stent location.According to the initial reporter, the device was used off label in 04 cases where an adverse event requiring surgical intervention related to this off label use was reported.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: 17223235
• MDR Text Key: 318078693
• Report Number: 3001845648-2023-00522
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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: 06/29/2022
• Event Location: Hospital
• Date Manufacturer Received: 05/31/2023
• 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: 64 YR
• Patient Sex: Male