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

Model Number	M00553740
Medical Device Problem Codes	Use of Device Problem (1670); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported to boston scientific corporation that a hot axios stent was to be implanted in the esophagus during a stent placement procedure performed on (b)(6) 2019.According to the complainant, after the stent was fully deployed, the stent failed to expand.He stent was removed from the patient using forceps, and a second hot axios stent was placed to complete the procedure.There were no patient complications reported as a result of this event.Note: the hot axios stent was being implanted in the esophagus; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.

• 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: 9572309
• Report Number: 3005099803-2019-06465
• Device Sequence Number: 13546700
• Product Code: PCU
• UDI-Device Identifier: 08714729904625
• UDI-Public: 08714729904625
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/09/2020

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: 08/15/2020
• Device Model Number: M00553740
• Device Catalogue Number: 5374
• Device Lot Number: 0022521396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/09/2020
• 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