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

Model Number	M00534270
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2021.During a routine follow up procedure, performed on (b)(6) 2021, it was noticed that the stent had migrated proximally.The patient was brought back for a third and final procedure for stent removal from hilar area.The migrated advanix biliary stent was successfully retrieved with an extractor balloon.There was no new stent implanted to the patient.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.Block h6: medical device problem code a010402 captures the reportable event of stent migration.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent presented a color variation, the stent was damaged close to the proximal tip.The naviflex delivery system was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it is most likely that the user manipulation, technique applied during the procedures and/or even tortuous anatomy could have contributed on this problem through the time that it was placed, once the stent was damaged it is possible that migration was due to the damage presented.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was impanted during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2021.During a routine follow up procedure, performed on (b)(6) 2021, it was noticed that the stent had migrated proxinally.The patient was brought back for a third and final procedure for stent removal from hilar area.The migrated advanix biliary stent was successfully retrieved with an extractor balloon.There was no new stent implanted to the patient.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 12859433
• Report Number: 3005099803-2021-05954
• Device Sequence Number: 19912763
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: 08714729787365
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 04/19/2023
• Device Model Number: M00534270
• Device Catalogue Number: 3427
• Device Lot Number: 0027168620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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