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

Model Number	M00553740
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas during a transgastric fluid collection drainage procedure performed on (b)(6) 2024.During the procedure, the first flange was deployed but then the handle broke.The stent was removed from the patient partially deployed and another axios stent was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas during a transgastric fluid collection drainage procedure performed on (b)(6) 2024.During the procedure, the first flange was deployed but then the handle broke.The stent was removed from the patient partially deployed and another axios stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an axios stent and delivery system were received for analysis.Visual examination of the returned device found the stent fully covered by the outer sheath and undeployed.The monopolar plug was detached and was not returned.Functional inspection was performed, the catheter was unlocked by moving the catheter lock by sliding it to the right, then the catheter control hub was moved up and down.The catheter passed through the luer without resistance.Also, the stent hub was move down to the second and fourth position.The stent was able to be deployed without problem.No problems were noted to the stent and delivery system.Taking all available information into consideration, the investigation concluded that the observed damage of monopolar plug detached was likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the observed damage.The reported event of stent partially deployed cannot be confirmed as the stent 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, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent partially deployed is noted within the manufacturer's labeling as a known possible adverse event related to the use of the device.

• 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: 19034437
• Report Number: 3005099803-2024-01382
• Device Sequence Number: 15201627
• Product Code: PCU
• UDI-Device Identifier: 08714729904625
• UDI-Public: 08714729904625
• 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
• 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): 05/20/2024

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: M00553740
• Device Catalogue Number: 5374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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