MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Zilver ptx implanted, 12 cases of acute thrombosis post implant.Implant and date of occurrence is around 2015-2016.Patient outcome: acute thrombosis post implant.

Manufacturer Narrative

Device evaluation the zilver ptx 35 drug-eluting stent devices of unknown rpns and unknown lot numbers involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted manufacturing records prior to distribution all 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.Review historical data historical data was not reviewed as the lot number is unknown.Instructions for use/label there is no evidence to suggest that the customer did not follow the instructions for use (ifu0118).It should be noted that arterial thrombosis is listed as a potential adverse event related to the device in the instructions for use.Image review an image was not returned for evaluation.Root cause review a root cause could not be concluded from the limited information available.Possible root causes may be attributed to the patients underlying conditions or pre existing conditions.Numerous attempts were made to gain more information in regards to this complaint but no further information was available.Should more information become available at a later stage, the file can be re-assessed and updated accordingly.As previously mentioned, arterial thrombosis is listed as a potential adverse event related to the device in the instructions for use.Confirmation of complaint complaint is confirmed based on customer and/or rep testimony summary according to the initial reporter, zilver ptx implanted, 12 cases of acute thrombosis post implant.Implant and date of occurrence is around 2015-2016.Confirmed quantity of 12 devices, confirmed used.From the initial reporter, we do not know the patient outcome after the 12 instances of acute thrombosis post implant.Should more information become available at a later stage, the file can be re-assessed and updated accordingly investigation findings conclude definitive root cause could not be determined due to the limited information available.Should additional information become available the complaint will be reopened and updated accordingly.Possible root causes may be attributed to the patients underlying conditions or pre existing conditions.As previously mentioned, arterial thrombosis is listed as a potential adverse event related to the device in the instructions for use complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the (b)(6) 2023.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 17078573
• MDR Text Key: 316752045
• Report Number: 3001845648-2023-00448
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/10/2023
• 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