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

Model Number	M00553750
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code a0401 captures the reportable event of handle break for stomach/duodenal stricture indication.The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an axios stent and delivery system was to be implanted to treat a stricture during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, the inner components of the axios stent deployment hub broke.The procedure was completed using another axios stent.There were no patient complications reported as a result of this event.It was reported that the axios stent was to be implanted to treat a stricture during an esophagogastroduodenoscopy (egd) procedure.However, per the axios stent and delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and 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.
Event or Problem Description
It was reported to boston scientific corporation on june 13, 2022 that an axios stent and delivery system was to be implanted to treat a duodenal stricture during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, the inner components of the axios stent deployment hub broke.The procedure was completed using another axios stent.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was to be implanted to treat a duodenal stricture during an esophagogastroduodenoscopy (egd) procedure.However, per the axios stent and delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and 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.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of handle break for stomach/duodenal stricture indication.Block h10: an axios stent and delivery system were returned for analysis.The stent was returned fully covered by the outer sheath and undeployed.The delivery system was returned in position "4".Visual examination of the returned device found the outer sheath detached at the luer section.No other problems were noted to the stent and delivery system.It was reported that the axios stent was to be implanted to treat a stricture during an esophagogastroduodenoscopy (egd) procedure.A product labeling review was performed and from the information available, this device was used in a manner inconsistent per the instructions for use (ifu) / product label.The ifu states, "the axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall." the axios stent is not indicated to be placed to treat a stricture.He reported event of handle break was not confirmed as the handle was returned in good conditions and no damages were noted.The observed failure of outer sheath detached could have been perceived by the physician as handle break, and was likely due to factors encountered during the procedure.It may be that the characteristics of the lesion, how the device was handled, the technique used by the user and/or normal procedural difficulties encountered during the procedure, limited the performance of the device.Therefore, contributing to the detachment of the outer sheath.Based on the available information, the investigation concluded that the reported event and observed failures were likely due to factors encountered during the procedure.Therefore, the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: AXIOS STENT AND DELIVERY SYSTEM
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14950389
• Report Number: 3005099803-2022-03712
• Device Sequence Number: 14849472
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: 08714729904632
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 01/24/2024
• Device Model Number: M00553750
• Device Catalogue Number: 5375
• Device Lot Number: 0028731505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown