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 Problems Ischemia (1942); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #p100022/s001.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The long-term clinical performance of the zilver ptx stent for femoropopliteal lesions is unclear.A single-center retrospective study was conducted on 101 limbs of 83 patients with zilver ptx stents placed between (b)(6) 2012 and (b)(6) 2013.Target lesion revascularization avoidance rate (ff-tlr) 10 years after treatment, major adverse limb event avoidance rate (ff-male), and major amputation-free survival rate (afs) were the endpoints.Ff-tlr, ff-male, and afs were 60%, 54%, and 57%.Long-term clinical results were reasonable.This file will capture 43% of 83 patients were affected by amputation = 36 patients/devices.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 06-dec-2023.

Manufacturer Narrative

Pma/510(k) # p100022/s027 device evaluation the zilver ptx drug-eluting peripheral stent devices of rpn and lot numbers unknown 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.This complaint is related to (b)(4) and (b)(4) and was raised from a single-center retrospective study that was conducted on 101 limbs of 83 patients with zilver ptx stents placed between (b)(6) 2012 and (b)(6) 2013.This complaint will capture 43% of 83 patients were affected by amputation = 36 patients/devices 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.Manufacturing records prior to distribution all zilver ptx drug-eluting peripheral 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 review historical data was not reviewed as the lot number is unknown.Ifu/label review the japanese packaging insert c-ci1502m06 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.This lists ischemia requiring intervention (bypass or amputation of toe, foot, or leg) as a potential adverse event.There is no evidence to suggest the user did not follow the japanese packaging insert.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 have likely been attributed to patients¿ pre existing conditions.From the information available, it is known that the study was to determine the clinical performance of the zilver ptx device on patients with femoropopliteal lesions.As previously noted, ischemia requiring intervention (bypass or amputation of toe, foot, or leg) is listed as a potential adverse event in the japanese packaging insert.Confirmation of complaint the complaint is confirmed based on customer and/or rep testimony.Summary according to the initial reporter, the long-term clinical performance of the zilver ptx stent for femoropopliteal lesions is unclear.A single-center retrospective study was conducted on 101 limbs of 83 patients with zilver ptx stents placed between july 2012 and april 2013.Confirmed quantity of 36 devices, confirmed used.According to the initial reporter, amputation occurred in 36 patients over the 10 year period of the study.Long-term clinical results were reasonable investigation findings conclude a possible root cause could have likely been attributed to patients¿ pre existing conditions as it is known that the patients had femoropopliteal lesions.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 17204572
• MDR Text Key: 317919306
• Report Number: 3001845648-2023-00501
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• 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: 05/25/2023
• 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