MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number	G43782
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: p050017 s002 and s003.
Event or Problem Description
As initially reported to customer relations via phone conversation: a patient of undisclosed gender and age underwent a standard angio procedure in which the zilver 518 vascular self-expanding stent, g43782, was used.The flexor part disattached from the handle therefore the stent was not deployed.As the other g43782 the customer had was the same lot number and it was not trusted by the customer they used a different size of a zilver 518 to complete the procedure with no further complications.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no did the patient require any additional procedures due to this occurrence? no if yes, please describe.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.
Additional Manufacturer Narrative
Pma/510(k) #: p050017 s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental follow-up report is being submitted due to the receipt and evaluation of the complaint device.Device evaluated on (b)(6) 2021: "separation of outer sheath from handle.".
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Device evaluation: the ziv5-18-125-8-60 device of lot number c1787927 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 28th july 2021.On evaluation of the device, separation of the outer sheath from the handle was observed at the distal end of handle, just below the white cap.The device could not be flushed.A 0.018 inch wire guide could not pass through the device.Blood was observed on distal end of inner catheter.Document review: prior to distribution ziv5-18-125-8-60 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 ziv5-18-125-8-60 of lot number c1787927 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 c1787927.It should be noted that the instructions for use (ifu0043-9) states the following: ¿the zilver vascular stent is intended for use as an adjunct to percutaneous transluminal angioplasty (pta) in the treatment of symptomatic vascular disease of the iliac arteries¿.There is evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause of off- label use was identified from the available information.The user used this device for the treatment of a lesion on the sfa.This is considered off label use.Summary: 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 518 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12065400
• Report Number: 3001845648-2021-00521
• Device Sequence Number: 4111282
• Product Code: NIO
• UDI-Device Identifier: 10827002437828
• UDI-Public: (01)10827002437828(17)240105(10)C1787927
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2021

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: 01/05/2024
• Device Model Number: G43782
• Device Catalogue Number: ZIV5-18-125-8-60
• Device Lot Number: C1787927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 05/28/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/25/2021; 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1