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

Model Number	M00553670
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The axios stent 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 july 22, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the pancreas for pseudocyst drainage during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, the second flange of the axios stent could not be deployed.The axios stent was removed from the patient partially deployed on the delivery system and another axios stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on july 22, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the pancreas for pseudocyst drainage during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, the second flange of the axios stent could not be deployed.The axios stent was removed from the patient partially deployed on the delivery system and another axios stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of axios stent partially deployed.Block h10: an axios stent and electrocautery enhanced delivery system were returned for analysis.The stent was received fully covered by the outer sheath and undeployed.The delivery system was returned in original position.Visual examination of the returned device found the outer sheath kinked at the luer section.Functional inspection was performed and the stent was able to be deployed without problems.No other problems were noted to the stent and delivery system.The investigation concluded that the observed failure of outer sheath kinked was likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, and/or the technique used by the user, limited the performance of the device and contributed to the kink noted on the outer sheath.The reported event of stent partially deployed was not confirmed.Based on the available information, there is not enough information to confirm the reported event of stent partially deployed as the stent first flange was received fully covered by the outer sheath and undeployed; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED 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: 15201174
• Report Number: 3005099803-2022-04444
• Device Sequence Number: 2162500
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: 08714729979333
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192043
• 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): 09/12/2022

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 Expiration Date: 08/18/2023
• Device Model Number: M00553670
• Device Catalogue Number: 5367
• Device Lot Number: 0027858881
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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
• Patient Sex: Unknown