MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

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

Patient Problems Stenosis (2263); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations via phone conversation "the stent restenosis and required subsequent recanalization." patient outcome: did any unintended section of the device remain inside the patient¿s body? - no.Please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? - see event description.Please specify delay or any additional procedure(s) and provide details: has the complainant reported any adverse effects on the patient due to this occurrence? - none reported.Has the complainant reported that the product caused or contributed to the adverse effects? - none reported.Please specify adverse effects and provide details.

Manufacturer Narrative

Device evaluation: the unknown rpn zilver ptx drug eluting peripheral stent of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.Several attempts were made to obtain additional information regarding this device.However, no response has been received to date.With the information provided, a document-based investigation was conducted.As the rpn and lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.  as per the instructions for use, ifu0118-6, which accompanies this device it informs the user "potential adverse events that may occur include, but are not limited to, the following: restenosis of the stented artery".There is not sufficient evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.Typically the most likely root cause is attributed to patient pre-existing/underlying conditions.Although the patient pre-existing/underlying conditions are unknown we know that restenosis of the stented artery is a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.  summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the user had to subsequently place another stent inside the occluded stent.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.

• Brand Name: UNKNOWN
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11342029
• MDR Text Key: 241444291
• Report Number: 3001845648-2021-00120
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention