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

Catalog Number ZISV6-35-125-6.0-140-PTX

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s026.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Upon opening the packaging of the device, damage was noted in the inner catheter tip.Therefore, another device was used instead.Additional information: 1 for complaints observed during device preparation, ask: 1-1 was the package damaged? no.1-2 how was the device stored? vertically.

Manufacturer Narrative

Pma/510(k) # p100022/s026 device evaluation the zisv6-35-125-6.0-140-ptx device of lot number c1799221 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review prior to distribution zisv6-35-125-6.0-140-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl a review of the manufacturing records for zisv6-35-125-6.0-140-ptx of lot number c1799221 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1799221.It should be noted that the instructions for use (ifu0122) states the following: ''inspect the product to ensure no damage has occurred'' there is no evidence to suggest the user did not follow the ifu.The japanese packaging insert (b)(4) 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 root cause review a possible root cause of damage during transport or storage was identified.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to completion of invetsigation on 25-may-23.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: 13889405
• MDR Text Key: 297740717
• Report Number: 3001845648-2022-00175
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002354187
• UDI-Public: (01)10827002354187(17)230111(10)C1799221
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Catalogue Number: ZISV6-35-125-6.0-140-PTX
• Device Lot Number: C1799221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/22/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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