MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00532210
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation (bsc) that an advanix biliary stent was successfully implanted during a liver transplant procedure due to hilar stenosis performed on (b)(6) 2023.On (b)(6) 2023, the patient experienced post bleeding sphincterotomy.The physician then noticed that the stent had migrated into the jejunum.The migrated advanix biliary stent was successfully removed using a rat tooth device and a new stent was placed with a non-bsc device.There were no patient complications reported as a result of this event.Additional information received confirmed that there was no relationship between the to the advanix biliary stent and the post bleeding sphincterotomy.
Additional Manufacturer Narrative
Imdrf device code a010402 captures the reportable event of stent migration.Patient code f23 captures the reportable event of unexpected medical intervention.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16464537
• Report Number: 3005099803-2023-01023
• Device Sequence Number: 12028004
• Product Code: FGE
• UDI-Device Identifier: 08714729786993
• UDI-Public: 08714729786993
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: M00532210
• Device Catalogue Number: 3221
• Device Lot Number: 0027145417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown