MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZFV6-125-7-20.0

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

Stent cannot be pushed over the via."as per cc form": stent cannot be pushed over the wire, second stent the same occurrence> switch on terumo wire, stent can pushed.Lab evaluation: 10th feb 2022 visual inspection: a kink is noted on the outer sheath just below the white connector cap.Functional inspection: a wire guide could not pass through the kink in the device.The device flushed as expected.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Cancellation mdr beinig submitted as no adverse effect to the patient was reported as occurring and the 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)¿.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Cancellation mdr being submitted as no adverse effect to the patient was reported as occurring and the 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 zfv6-125-7-20.0 device of lot number c1836651 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation.On evaluation of the device, a kink was noted on the outer sheath just below the white connector cap.A wire guide could not pass through the kink in the device.The device flushed as expected.Prior to distribution zfv6-125-7-20.0 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 zfv6-125-7-20.0 of lot number c1836651 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 c1836651.There is no evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to excessive pressure placed on the device while handling the device out of its original packaging and/or during device preparation stage.It is possible that the user may have kinked the device accidentally during this stage, which would have prevented the wire guide from passing through the device at the kink.It is not known if the user noticed the kink on the catheter and/or at what stage this damage occurred on the device.It is assumed that the device was not used off label.As per the information given by the facility, the device was used in the 'afs'.It is likely that the facility misspelled 'sfa' when filling out the cc form.The use of the zfv6 device in the sfa is on label.Three attempts were made to obtain more information from the customer through additional questions, which if answered, would have clarified if the device was used in the sfa and if the kink was noted by the physician prior to return of the device.However, the additional questions were not answered by the facility.Complaint is confirmed as the failure was verified in the laboratory.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.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• 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: 13706811
• MDR Text Key: 296898235
• Report Number: 3001845648-2022-00125
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002528557
• UDI-Public: (01)10827002528557(17)240609(10)C1836651
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZFV6-125-7-20.0
• Device Lot Number: C1836651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2022
• Event Location: Hospital
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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