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

Model Number	M00536660
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted and 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 a commercial bsc plastic stent was implanted in pancreatic duct of the patient on (b)(6) 2016 as part of (b)(6).On (b)(6) 2016 an advanix pancreatic stent was implanted in the patient.During the placement procedure, prophylactic nsaids were administered via rectal indomethacin.A prior biliary sphincterotomy and pancreatic sphincterotomy were performed.A previously placed pancreatic stent was removed at the time of the procedure.In addition to stent placement the following were also conducted: pancreatic stone extraction (other than by eswl), balloon sweep, and balloon dilation.Contrast was injected into the pancreatic duct the entire length of main pancreatic duct into tail of pancreas.The pancreatic duct was dilated 8mm, and the intended duration of indwell is greater than 8 weeks.On (b)(6) 2016 during a planned stent removal procedure, the bsc plastic stent was removed from the patient using a snare, grasper, and other (no specifics reported).It was reported that the stent had experienced a complete proximal migration which was not desired by the site.Additionally, the stent was difficult to remove from the patients duct.The stent was removed after a balloon dilation of the papilla with a grasper and the procedure was completed by placing a non-bsc stent.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: 6099115
• Report Number: 3005099803-2016-03343
• Device Sequence Number: 16483859
• Product Code: FGE
• UDI-Device Identifier: 08714729857600
• UDI-Public: (01)08714729857600(17)20170531(10)18663113
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: M00536660
• Device Catalogue Number: 3666
• Device Lot Number: 18663113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR