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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Zilver vascular final pmcf report mdr-2058_3rd party vendor (fivos and the society for vascular surgery (svs) patient safety organization).Methods: in order to evaluate the cook medical bare metal zilver vascular ses, vqi peripheral vascular intervention (pvi) registry data for procedures performed between (b)(6) 2023 by physicians participating in the vqi pvi registry were analyzed.All consecutive pvi procedures for treatment of chronic peripheral arterial disease were selected.This file will capture long term outcomes: occlusion of target lesion.Patient outcome: require intervention/additional procedures s=4.Patient/event info: total number of procedures = 1674; total number of patients = 1596 (male = 1032), avg age = 68.2 yrs.

Manufacturer Narrative

Pma/510(k) # p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma 510k #p050017/s006 this file was created from the attached zilver vascular final pmcf report mdr-2058_3rd party vendor (fivos and the society for vascular surgery (svs) patient safety organization) to capture the adverse event occlusion of target lesion this file is related to pr 416831, pr 416834 and pr 416835.Device evaluation the zilver vascular self-expanding stent of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records prior to distribution all zilver 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.Instructions for use/label there is no evidence to suggest the user did not follow the ifu.It should be noted that restenosis of the stented artery is listed in d00052328 rba0013 overall risk/ benefit analysis as a potential adverse event of using the device.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 patient's pre-existing condition of chronic peripheral arterial disease.One-year freedom from occlusion of target lesion 97.6% ± 0.4% of cook zilver vascular self expanding stents significantly benefited patients.As previously noted, restenosis of the stented artery is listed d00052328 rba0013 overall risk/ benefit analysis as a potential adverse event of using the device and is a known adverse event of peripheral vascular intervention procedures that can be caused by chronic peripheral arterial disease.Confirmation of complaint complaint is confirmed based on customer and/or rep testimony.Summary this file was created from a pmcf study.In order to evaluate the cook medical bare metal zilver vascular ses, vqi peripheral vascular intervention (pvi) registry data for procedures performed between january 2017 and april 2023 by physicians participating in the vqi pvi registry were analyzed.All consecutive pvi procedures for treatment of chronic peripheral arterial disease were selected.Confirmed quantity of 28 devices, confirmed used.According to the initial reporter, the device was used in 28 cases.All patients would have required intervention/additional procedures.Investigation findings conclude a possible root cause of patients pre existing conditions.Occlusion of target lesion is a known adverse event of peripheral vascular intervention procedures that can be caused by chronic peripheral arterial disease.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplement report being submitted due to the completion of the investigation on (b)(6) 2024.

• Brand Name: ZILVER 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: 18363909
• MDR Text Key: 330990281
• Report Number: 3001845648-2023-00936
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/08/2023
• 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: 68 YR
• Patient Sex: Male