MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	M00553750
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device has been disposed of 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
Note: this report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that a hot axios stent was to be implanted to treat a pancreatic walled-off necrosis (won) during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the distal flange of the stent deployed prematurely and was not fully in the collection.The device was removed from the patient with the stent still partially deployed on the delivery system.The physician attempted to place a cold axios stent, but the same issue occurred.A different device was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: AXIOS
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8518220
• Report Number: 3005099803-2019-01873
• Device Sequence Number: 1465779
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: 08714729904632
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: Health Professional
• Device Model Number: M00553750
• Device Catalogue Number: 50271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1