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

Model Number	M00537410
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001); Thrombosis/Thrombus (4440)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporters city: (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that after an endoscopic retrograde cholangiopancreatography (ercp) procedure was performed, an advanix rx pancreatic stent was used for pancreatitis prevention.The event date was not reported.After the procedure, the patient complained of abdominal pain and an emergency erp was performed.The advanix rx pancreatic stent penetrated into the pancreatic duct, and up to the pancreatic parenchyma.The stent was removed immediately, a new stent was placed, and pancreatic duct drainage was performed.Portal vein thrombosis was observed, and direct oral anticoagulant (doac) was administered for about a month.The patient recovered and was discharged after a month and a half.
Additional Manufacturer Narrative
Block b1: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporters city: (b)(6).Block h6: imdrf device code a0104 captures the reportable event of migrated into the pancreatic duct.Upon review of the reported incident "portal vein thrombosis (pvt) was observed" and no additional or clarifying information was obtained despite good faith efforts, at this time, it is determined that the pvt is not likely related to the advanix rx pancreatic stent as development of a pvt is a chronic process of prolonged inflammation.Therefore, imdrf patient code, thrombosis/thrombus, e0514 and imdrf impact code, medication required, f2303 have been removed.Additionally, imdrf impact code, addition surgery, f1901 has been corrected with unexpected medical intervention, f23.
Event or Problem Description
It was reported to boston scientific corporation that after an endoscopic retrograde cholangiopancreatography (ercp) procedure was performed, an advanix rx pancreatic stent was used for pancreatitis prevention.The event date was not reported.After the procedure, the patient complained of abdominal pain and an emergency erp was performed.The advanix rx pancreatic stent penetrated into the pancreatic duct, and up to the pancreatic parenchyma.The stent was removed immediately, a new stent was placed, and pancreatic duct drainage was performed.Portal vein thrombosis was observed, and direct oral anticoagulant (doac) was administered for about a month.The patient recovered and was discharged after a month and a half.

• Brand Name: ADVANIX PANCREATIC STENT KIT
• 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: 15723073
• Report Number: 3005099803-2022-06335
• Device Sequence Number: 19582174
• Product Code: FGE
• UDI-Device Identifier: 08714729856405
• UDI-Public: 08714729856405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 01/12/2023

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 Model Number: M00537410
• Device Catalogue Number: 3741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown