MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ PANCREATIC STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00536460
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was removed from a patient during a stent removal procedure performed on (b)(6) 2016 as part of the (b)(6) clinical study.On (b)(6) 2016 the patient underwent the study stent placement procedure.A biliary sphincterotomy was performed prior to stent placement as well as a pancreatic sphincterotomy.The patient underwent balloon dilation and had an additional pancreatic plastic stent placed (non-study stent).Contrast was injected into the pancreatic duct from the main pancreatic duct and side branches.The pancreatic duct was dilated 4mm.The stent indwell duration was 4 weeks.According to the complainant, on (b)(6) 2016, the patient¿s advanix pancreatic stent was reported to have experienced a partial proximal migration.The advanix pancreatic stent was removed from the patient earlier than planned using a grasper.A non-bsc plastic pancreatic stent was placed and the procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX¿ PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6152756
• Report Number: 3005099803-2016-03738
• Device Sequence Number: 509112
• Product Code: FGE
• UDI-Device Identifier: 08714729857402
• UDI-Public: (01)08714729857402(17)20160222(10)0017231552
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2016

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: 02/22/2016
• Device Model Number: M00536460
• Device Catalogue Number: 3646
• Device Lot Number: 0017231552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2016
• Initial Report FDA Received Date: 12/07/2016
• 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: 48 YR