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

Catalog Number UNKNOWN

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Type  Injury  

Event Description

One patient had a device deficiency reported during the procedure.In the patient¿s medical record, the stent was noted as defective (no further description), and another stent was placed astride the first one to cover it.Additionally, this is of one of the two patients for whom technical success was not achieved.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.510k: k163018.

Manufacturer Narrative

Pma/510(k) # k163018.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the receipt of additional information.Cc form received 26-aug-22: mdr (b)(4): device issue (biliary stent): first stent not at the exact place.((b)(4) the site entered the ae as follows, ¿second prosthesis astride the first one which was not at the exact place¿.Site assessed event as not related to the study stent, however, stated that the event was due to a device deficiency and only noted the following, ¿defective device¿.Patient outcome: the site marked ¿no treatment¿ on the crf; however, it appears that treatment would be considered placement of the second stent ¿astride the first¿ stent (per procedure form, 2nd stent was placed both side-by-side and through the wall of another stent ((b)(4)).The event was considered resolved (patient recovered/stabilized).This file will capture the first stent device deficiency (not at the exact place) and ther requirement for an additional stent.

Event Description

Supplemental report is being submitted due to the completion of the investigation on (b)(6) 2023.

Manufacturer Narrative

Pma/510(k) # (b)(4).Device evaluation 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.Lab evaluation ¿ n/a document review prior to distribution all zib6-40-10-4.0 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 was not reviewed as the lot number is unknown.It should be noted that the instructions for use (ifu0040) lists stent migration as a potential adverse event.There is no evidence to suggest the user did not follow the ifu.There is no evidence to suggest that the customer did not follow the label.Image review an image was not returned for evaluation.Root cause review a definitive root cause could not be determined however a possible root cause could be attributed to known potential complications.The ifu lists stent migration as a potential adverse event.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, a second stent was required to be placed as a result of the original stent not being at the exact place.It is unclear from the information provided if the placement of the second stent occurred during the initial procedure or it this required a second procedure.Risk assessment is based on the requirement for a second procedure as a conservative assessment.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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 15310896
• MDR Text Key: 298783248
• Report Number: 3001845648-2022-00590
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 36 KG