MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF-EXPANDING STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	ZIB6-80-12.0-40
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k)#: k182980 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Device tracking form received from cinc regulatory indicating patient is deceased.Procedure indicates to have dm contact physician to confirm if the device caused/contributed to the death.The physician indicated: the patient had a type a dissection complicated by mesenteric, renal and peripheral arterial malperfusion.I did a tevar, dissection stent and left renal artery stent.Ct surgery delayed fixing the type of dissection because the patient was still on anticoagulants.We feel she retrograde, dissected, even more ruptured.They had nothing to do with the stent per se.Patient expired.
Additional Manufacturer Narrative
Pma/510(k)#: (b)(4).Device evaluation the zilver 635 biliary self-expanding stent device of rpn zib6-80-12.0-40 device and lot number c2161924 involved in this complaint was not returned.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.The file is related to pr (b)(4) and pr (b)(4) and captures the abnormal use of the device - uncovered stent being used in a tevar procedure.Abnormal use complaints are considered to be beyond any further reasonable means of interface-related risk control by the manufacturer.It is unknown how the device will function outside of its intended use.Manufacturing records prior to distribution all zilver zib devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for lot number c2161924 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use/label it should be noted that the instructions for use ifu0042 states the following: intended use: the zilver 518 and 635 biliary stents are intended for palliation of malignant neoplasms in the biliary tree¿.There is evidence to suggest that the customer did not follow the instructions for use.From the information provided, it is known that the device was used in a tevar (thoracic endovascular aortic repair), dissection stent and left renal artery stent procedure.Image review an image was not returned for evaluation.Root cause review a definitive root cause of abnormal use was determined from the available information.From the information that was provided, it is known that the zib6-80-12.0-40 device was used in a tevar, dissection stent and left renal artery stent procedure.Thoracic endovascular aortic repair (tevar) procedure involves the placement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the aortic artery.While it is not clear where the zib had been deployed from the physician¿s feedback, as per clinical input, the zibs were used off-label.Zib is uncovered stent.The zib device was used during a tevar, dissection stent and left renal artery stent procedure.The user has not complied with the requirements of the ifu with respect to the intended use, indications for use or contraindications of the device.Confirmation of complaint complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary according to the initial reporter, this file was raised to capture the use of the zib6-80-12.0-40 device in a tevar, dissection stent and left renal artery stent procedure.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient is deceased.As per clinical input, the patient death seems to be related to ¿delayed fixing the type dissection because the patient was still on anticoagulants¿, which was irrelevant to zibs.As per information provided by the clinical specialist ¿the patient had a type a dissection complicated by mesenteric, renal and peripheral arterial malperfusion.We feel she retrograde, dissected, even more ruptured.They had nothing to do with the stent per se.It was not the result of the devices used¿.Investigation findings conclude a definitive root cause of abnormal use was determined.The user has not complied with the requirements of the ifu with respect to the intended use, indications for use or contraindications of the device.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on (b)(6) 2024.

• Brand Name: ZILVER 635 BILIARY SELF-EXPANDING STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• 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: 20449099
• Report Number: 3001845648-2024-00604
• Device Sequence Number: 15577657
• Product Code: FGE
• UDI-Device Identifier: 10827002362298
• UDI-Public: (01)10827002362298(17)270412(10)C2161924
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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 Catalogue Number: ZIB6-80-12.0-40
• Device Lot Number: C2161924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2024
• 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 Age: 73 YR
• Patient Sex: Female