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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.510k p050017/s006.Product code: nio.

Event Description

The patients in this study received self-expanding stents, of which 64 were bare metal stents (b)(6) inc., (b)(6); zilver flex, cook medical, (b)(4) with some stent grafts (viabahn; gore medical, flagstaff, az, usa).Once the guidewire catheter had passed through the true vascular cavity, a percutaneous directional atherectomy was performed (see figure 5).A peripheral plaque excision system (silverhawk or turbohawk) was used to cut through the entire lesion along the preceding 0.035 cm guide wire, which was passed through the occluded segment into the distal outflow tract using the exchange technique.Guided by the roadmap, the cutting edge was aimed at the sclerosis plaque and pushed to excise the plaque slowly and uniformly.31 patients were diagnosed with >50% restenosis or re-occlusion.Evt was repeated on the 24 affected limbs of these patients.Eight cases of restenosis were recanalized by balloon dilation, and 13 cases were recanalized by balloon dilation and stent implantation.Four of the patients in our study were successfully recanalized with percutaneous directional atherectomy devices.Only 1 patient required an additional stent implantation.**file will capture a potential of 31 cases restenosis / reocclusion with intervention ¿ unconfirmed how many zilver flex stents were involved **.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 25-nov-2022.

Manufacturer Narrative

510k 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 pr 370583 (3001845648-2022-00479) 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 (ifu0058) 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 and/or known potential complications.From the article it is know that the patients risk factors for restenosis/occlusion included long history of smoking, arterial hypertension, diabetes mellitus, hyperlipoproteinemia, chronic renal failure, critical limb ischemia and tasc ii d lesions.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 yisheng lin et al ¿mid-term outcomes of endovascular treatment and risk factors for recurrence in patients with trans-atlantic-inter-society ii c/d femoropopliteal lesions¿.According to the initial reporter, 31 patients experience restenosis or reocclusion requiring intervention.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.

• 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 ; 061334440
• MDR Report Key: 15112430
• MDR Text Key: 296676461
• Report Number: 3001845648-2022-00478
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/25/2022

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2020
• 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: 12/20/2022
• 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