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

Catalog Number ZIB6-40-10-6.0

Device Problems Fracture (1260); Device-Device Incompatibility (2919)

Patient Problems Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k182980.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Stents used: g37276 lots c1860575 x 2 + c1861710 x 1 the dr deployed 10mm x 60mm stents on both sides during a ptc procedure, although unfortunately this did not create patency initially as the tumour was very stiff, so i post-dilated the stents simultaneously with 6mm x 40mm balloons on each side.Disappointingly one of the stents fractured in this process, so i chose to restent the fractured section and extend both stents into the duodenum.I used one of the few wallflex stents we had in stock to reline the fractured stent and a zilver to extend the non-fractured side.At this point the biliary drainage was poor, probably from spasm at the ampulla, so i again gently dilated the new stents to 6mm.The newly deployed zilver stent again fractured during this dilatation, despite the use of a balloon much smaller than the stent diameter.Updated information received from the rep on (b)(6) 2023 in verbatim jil01: i failed to inform you that only 1 of the stents fractured upon post dilatation and i will confirm the lot# to you on friday when i meet with the dr.I am also collecting imaging from him to send in for investigation.These stents were also consignment stock so we would not need to replace these.We may need to credit that 1 that fractured after investigation although lets wait to see what the investigation uncovers from the scans.I did tick adverse event, however that was in relation to the notes made by the dr with regards to the poor drainage.Patient outcome: no unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.Note from the rep: i did tick adverse event, however that was in relation to the notes made by the dr with regards to the poor drainage.

Event Description

Supplemental report is being submitted due to the completion of a image review completed on 12-jun-2023 and the completion of the investigation 07-jul-2023.

Manufacturer Narrative

Pma/510(k) # k182980 device evaluation the zib6-40-10-6.0 device of c1861710 lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records review prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review the review of the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and label it should be noted that the instructions for use is ifu0040.There is no evidence to suggest that the customer did not follow the instructions for use or label.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: impression 1.The complaint of zib6-40-10-6.0 is confirmed.The right biliary duct zib6-40-10-6.0 and cbd zib6-40-10-6.0 fractured during post deployment angioplasty.Each stent was implanted alongside an additional stent.Localized overstretching from enmeshment of the adjacent stents and fixation in the fibrotic tumor was likely responsible.2.The right duct stent was likely enmeshed in the left duct stent.Each was also anchored in fibrotic tumour.The stent elements just inferior the stenosis would have nonuniformly ovexpanded just inferior the stenosis.3.Cdb zib6-40-10-6.0 and matching wallflex stent stretching was consistent with localised zib6-40-10-6.0 enmeshment in the wallflex stent.Wallflex stents elongate with compression.Cbd zib6-40-10-6.0 angioplasty would have compressed and elongated the adjacent wallflex stent.Any cbd zib6-40-10-6.0 stent elements enmeshed in the wallflex stent would have pulled inferiorly during angioplasty.The locally overstretched elements fractured.Root cause analysis a definitive root cause could not be determined however a possible root cause can be attributed to overstretching of the stent based on the imaging review.From the imaging review it was observed that each stent was implanted alongside an additional stent and anchored in fibrotic tumour.During balloon dilation, it is possible that the stent would have been pulled and overstretched due to enmeshment in the adjacent stent and fixation in the fibrotic tumour, leading to stent fracture of the overstretched segment of the stent.Confirmation of complaint complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation according to the initial reporter, following the deployment of 01 zib6-40-10-6.0 stent in the biliary tree, the stent fractured during balloon dilation.No additional procedure was required as a result of this occurrence.Investigation findings conclude a possible root cause of localised overstretching from enmeshment in the adjacent stent and fixation in the fibrotic tumour as observed in the imaging review.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 SELF-EXPANDING BILIARY STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• 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: 16991090
• MDR Text Key: 315825075
• Report Number: 3001845648-2023-00391
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002372761
• UDI-Public: (01)10827002372761(17)240827(10)C1861710
• Combination Product (y/n): N
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIB6-40-10-6.0
• Device Lot Number: C1861710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2023
• Event Location: Hospital
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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