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

Model Number	G38480
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: p100022/s014 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Per rep - (b)(6) 2021 - the stent would not cross the lesion after successful angioplasty.They attempted to cross, in and out of the body, 4 or 5 times.They were able to cross the lesion with 2 different 4 mm balloons.The wire used was a.035 glide wire advantage from terumo.It has not yet been confirmed if they were able to complete the procedure.
Event or Problem Description
Final mdr cancellation report being submitted due to completion of the investigation on (b)(6)2021 and reassessment of file to be no longer reportable as this event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.
Additional Manufacturer Narrative
Pma/510(k) #: p100022/s014.Final mdr cancellation report being submitted due to completion of the investigation on (b)(6)2021 and reassessment of file to be no longer reportable as this event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.The zisv6-35-125-6-80-ptx device of lot number c1800844 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Prior to distribution zisv6-35-125-6-80-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 zisv6-35-125-6-80-ptx of lot number c1800844 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 c1800844.It should be noted that the instructions for use (ifu0118-6) states the following: if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device.There is evidence to suggest the user did not follow the ifu.The user error encountered of '' they attempted to cross , in and out of the body , 4 or 5 times '' is a possible result of the failure mode stent not crossing the lesion therefore can be captured in this complaint.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.It is possible that difficulty patient anatomy caused resistance when attempting to cross the lesion.The complaint is confirmed based on customer testimony.The patients outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11937736
• Report Number: 3001845648-2021-00435
• Device Sequence Number: 3856800
• Product Code: NIU
• UDI-Device Identifier: 10827002384801
• UDI-Public: (01)10827002384801(17)230107(10)C1800844
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: G38480
• Device Catalogue Number: ZISV6-35-125-6-80-PTX
• Device Lot Number: C1800844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2021
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown