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

Model Number	M00553750
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	Sore Throat (2396)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was disposed 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on february 9, 2021 that a cold axios stent was to be implanted to treat a stricture transduodenal to the second portion of the duodenum during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.During the procedure, the handle of the axios stent was not locked on the scope.During stent deployment, the stent was deployed distally and a portion of the inner sheath was detached from the delivery system.Grasping forceps were used to remove the stent and the broken inner sheath inside the patient.The procedure was completed with another cold axios stent.During a routine follow-up, the patient reported of sore throat.In the physician's assessment, retrieval of the broken inner sheath could have caused irritation on the patient's throat.No interventions to address the patient's sore throat were reported and the patient was reported to be fully recovered.Note: it was reported that stent was attempted to be placed to treat a stricture in the duodenum during an esophagogastroduodenoscopy (egd) procedure.The axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocyst >= 6 cm in size and a walled-off necrosis >= 6 cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.The device is not indicated to treat a stricture in the duodenum.Note: it was reported that the hot axios delivery system was not locked on the scope.The hot axios stent and delivery system instructions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

• 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: 11409029
• Report Number: 3005099803-2021-00861
• Device Sequence Number: 3976400
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: 08714729904632
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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 Model Number: M00553750
• Device Catalogue Number: 5375
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/04/2021
• 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