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

Model Number	M00534650
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that an advanix biliary stent was implanted, along with three other stents, in the common bile duct to treat a biliary stenosis due to liver transplant during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2021.According to the complainant, on (b)(6) 2021, during emergent follow-up, it was noticed that the advanix biliary stent had migrated outside the papilla.Reportedly, on (b)(6) 2021, the migrated stent was successfully removed from the duodenum using a snare and a new stent was not implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter state: initial reporter fax: block h6: device code a010402 captures the reportable event of stent migration.Block h10: the returned advanix biliary stent was analyzed, and a visual evalaution noted that the stent got blackened, and was kinked near the proximal barb.The delivery system was not returned for analysis.The reported issue of 'stent migration' could not be functionally or visually verified.No other issues with the device were noted.The reported event of stent migration was not confirmed.Based on the provided and collected information, the stent migrated and it was retrieved with a snare, it is likely that the stent was caught by the snare and it applied compression force with the loop to the stent resulting in kinking the device, and likely the stent got blackened as a result of being implanted for some days within the anatomy.The investigation conclusion code for the observed damage on the stent (kinked) will be documented as adverse event related to procedure.Since the reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions), the investigation conclusion code for the reported event will be documented as known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that an advanix biliary stent was implanted, along with three other stents, in the common bile duct to treat a biliary stenosis due to liver transplant during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6), 2021.According to the complainant, on (b)(6), 2021, during emergent follow-up, it was noticed that the advanix biliary stent had migrated outside the papilla.Reportedly, on (b)(6), 2021, the migrated stent was successfully removed from the duodenum using a snare and a new stent was not implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11366850
• Report Number: 3005099803-2021-00685
• Device Sequence Number: 11024502
• Product Code: FGE
• UDI-Device Identifier: 08714729787204
• UDI-Public: 08714729787204
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 09/01/2022
• Device Model Number: M00534650
• Device Catalogue Number: 3465
• Device Lot Number: 0025952633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/24/2021
• 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