MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number	ZSO-7-10
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is pending.A follow up report will be submitted with the investigation conclusions.
Event or Problem Description
After confirming the occurrence of cbd stricture, the zso stent is mounted on the right and left hilar, respectively, and the procedure is terminated.The next day, the patient was x-rayed for follow-up and the stent was migrated.
Additional Manufacturer Narrative
The device involved in this complaint was not returned to (b)(4) for an evaluation therefore a documentation based investigation was carried out.The complaint was confirmed based on customer testimony.As the device was not returned to (b)(4) for evaluation a definitive root cause for this occurrence could not be conclusively determined.There is no evidence to suggest that this issue affects the entire lot # c1283075; upon review of complaints this failure mode has not occurred previously with this lot # c1283075.A review of the incoming quality control record for the component involved in this complaint did not reveal any discrepancies that could have contributed to this issue.Prior to distribution all zso-7-10 devices are subject to 100% inspection to ensure device integrity, these inspections and functional checks are outlined in internal procedures in place at (b)(4).Ifu0045-6 lists stent migration among the potential complications associated with biliary stent placement.The addition of flaps or pigtails (as with zso-7-10) to stents serves to prevent upward/ downward migration in the biliary duct due to peristalsis.A post implantation evaluation detected stent migration within 1 to 2 days of being implanted.A potential root cause of this occurrence may be attributed to patient anatomy.A potential root cause of this occurrence may be attributed to patient anatomy.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
After confirming the occurrence of cbd stricture, the zso stent is mounted on the right and left hilar, respectively, and the procedure is terminated.The stent was found to be disappeared during follow up check-up one month after procedure.

• Brand Name: ZIMMON BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6263044
• Report Number: 3001845648-2017-00015
• Device Sequence Number: 955655
• Product Code: FGE
• UDI-Device Identifier: 00827002217072
• UDI-Public: (01)00827002217072(17)191010(10)C1283075
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

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: ZSO-7-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention