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

Model Number	M00532970
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Perforation (2001); No Code Available (3191)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the duodenum of a patient.Around mid (b)(6) the patient had the bsc plastic stent implanted.However, the exact implant date was not reported.On (b)(6) 2020 the patient returned for a planned computerized tomography (ct) scan for the patient's underlying pancreatic cancer.During the ct scan, it was noticed that the bsc plastic stent had migrated and eroded through the duodenal wall causing a perforation.The patient was sent to the endoscopy physician where the migrated stent was removed from the patient and the perforation was closed using an ovesco device.The patient was released from the hospital two days later in good condition.About a week later, the patient went to hospice due to their underlying cancer and not due to the bsc plastic stent.The patient passed away shortly afterwards.The exact date of death was not reported.The physician assessed that the patient's cause of death was due to the underlying cancer and was not related to the bsc plastic stent.

• 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: 11066333
• Report Number: 3005099803-2020-06314
• Device Sequence Number: 14126175
• Product Code: FGE
• UDI-Device Identifier: 08714729786887
• UDI-Public: 08714729786887
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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 Model Number: M00532970
• Device Catalogue Number: 3297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/23/2020
• 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: Hospitalization; Required Intervention