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

Catalog Number UNKNOWN

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

Patient Problems Aneurysm (1708); Hematoma (1884); Pseudoaneurysm (2605)

Event Date 09/17/2021

Event Type  Injury  

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

Pinto et al 2021 ¿ ¿endovascular management of transplant renal artery stenosis: early and mid-term results¿.In cases of more significant stenosis, artery pre-dilation with balloon angioplasty is performed.Different types of stents are used according to the affected artery and availability: self-expanding stents zilver flex¿ (cook medical, (b)(4)) and absolut pro¿ (abbott vascular, (b)(4)) are used in the external iliac arteries.Angioplasty with self-expandable stent placement in the external iliac artery (2/13) in two.There were two access-related complications: a groin hematoma that was surgically drained and a common femoral artery false aneurism treated with eco-guided thrombin embolization.

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.Lab evaluation ¿ n/a.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 ¿arterial aneurysm¿ and ¿hematoma/haemorrhage¿ as potential adverse events.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 however a possible root cause could be attributed to known potential complications of the procedure.As per medical advisor input ¿haematoma and pseudoaneurysm formation are known complications of arterial vascular stent placement¿.It should be noted that the ifu lists arterial aneurysm and hematoma as potential adverse events.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from literature paper pinto et al ¿endovascular management of transplant renal artery stenosis: early and mid-term results¿.According to the initial reporter, there were 02 access-related complications: 01 groin hematoma that was surgically drained and 01 common femoral artery false aneurism treated with eco-guided thrombin embolization.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 11nov2022.

Manufacturer Narrative

(b)(4).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.Lab evaluation ¿ n/a 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 ¿arterial aneurysm¿ and ¿hematoma/haemorrhage¿ as potential adverse events.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 however a possible root cause could be attributed to known potential complications of the procedure.As per medical advisor input ¿haematoma and pseudoaneurysm formation are known complications of arterial vascular stent placement¿.It should be noted that the ifu lists arterial aneurysm and hematoma as potential adverse events.Summary the complaint is confirmed based on customer testimony.The complaint was raised from literature paper pinto et al ¿endovascular management of transplant renal artery stenosis: early and mid-term results¿.According to the initial reporter, there were 02 access-related complications: 01 groin hematoma that was surgically drained and 01 common femoral artery false aneurism treated with eco-guided thrombin embolization.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This supplemental report is being submitted to an update to the imdrf coding on (b)(6) 2024.

• Brand Name: ZILVER FLEX 35 BILIARY 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: 15111594
• MDR Text Key: 296661876
• Report Number: 3001845648-2022-00476
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 09/17/2021
• Event Location: Hospital
• Date Manufacturer Received: 06/28/2022
• 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): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female