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

Model Number	M00537290
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Perforation (2001); No Code Available (3191)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was placed in the bile duct of a patient during an endoscopic biliary drainage procedure.The exact implant date was not reported, however, the stent was reported to have been indwell for approximately one month.According to the complainant, on (b)(6) 2020 the advanix pancreatic stent was noted to have migrated out of the bile duct, causing a perforation of the colon.The patient required additional open surgery to treat the perforation.The migrated stent was explanted from the patient and the patient's condition at the conclusion of the surgery was reported to be stable.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10367446
• Report Number: 3005099803-2020-03128
• Device Sequence Number: 16865919
• Product Code: FGE
• UDI-Device Identifier: 08714729856887
• UDI-Public: 08714729856887
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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 Expiration Date: 12/22/2020
• Device Model Number: M00537290
• Device Catalogue Number: 3729
• Device Lot Number: 0024014290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/05/2020
• 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: Required Intervention
• Patient Age: 84 YR