MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM

Model Number	M00553680
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number; therefore, the device manufacture date is unknown at this time.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150101, captures the reportable event of stent first flange failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was intended to be implanted in the bile duct to facilitate drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the physician attempted to deploy the first flange, but it did not fully open.Although the initial steps (1 and 2) were completed, the distal flange failed to open.The procedure was completed by replacing and using another device.There were no patient complications reported as a result of this event.The patient is expected to fully recover.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was intended to be implanted in the bile duct to facilitate drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the physician attempted to deploy the first flange, but it did not fully open.Although the initial steps (1 and 2) were completed, the distal flange failed to open.The procedure was completed by replacing and using another device.There were no patient complications reported as a result of this event.The patient is expected to fully recover.
Additional Manufacturer Narrative
Block h11 corrective action statement has been updated.Block d4, h4: the complainant was unable to provide the complaint device lot number; therefore, the device manufacture date is unknown at this time.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Block h7 and h9: added type of remedial action and the correction/removal reporting # information.Block h11: boston scientific is initiating a removal of certain sizes of the axios stent and electrocautery enhanced delivery system (6mm x 8mm, 8mm x 8mm and 20mm x 10mm) manufactured since march 1, 2025.This action is being taken due to increased reports of stent deployment and expansion issues with these configurations.These issues only occur at the time of stent delivery and are expected to be noticed by the physician.Patients who have been treated with a successfully implanted axios stent should continue to follow standard of care and are not affected by this issue.A letter was sent out to materials managers/health care professionals on 19-dec-2025 to immediately stop further distribution or use of any affected 6mm x 8mm, 8mm x 8mm and 20mm x 10mm axios stent and electrocautery enhanced delivery system.The letter indicates to remove these devices from inventory and segregate them in a secure location until they can be returned to boston scientific.The referenced axios stent and electrocautery enhanced delivery system met all specifications prior to final approval for distributions/sale.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number; therefore, the device manufacture date is unknown at this time.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Block h7 and h9: added type of remedial action and the correction/removal reporting # information.Block h11: the axios stent and electrocautery enhanced delivery system was included in an affected batch listed in the letter to materials managers/health care professionals associated with 97507023-fa.Boston scientific initiated a corrective and preventative action (capa) investigation to further analyze an increase in axios stent and electrocautery enhanced delivery system complaints associated with stent deployment and expansion issues.The referenced axios stent and electrocautery enhanced delivery system met all specifications prior to final approval for distributions/sale.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was intended to be implanted in the bile duct to facilitate drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the physician attempted to deploy the first flange, but it did not fully open.Although the initial steps (1 and 2) were completed, the distal flange failed to open.The procedure was completed by replacing and using another device.There were no patient complications reported as a result of this event.The patient is expected to fully recover.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was intended to be implanted in the bile duct to facilitate drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the physician attempted to deploy the first flange, but it did not fully open.Although the initial steps (1 and 2) were completed, the distal flange failed to open.The procedure was completed by replacing and using another device.There were no patient complications reported as a result of this event.The patient is expected to fully recover.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number; therefore, the device manufacture date is unknown at this time.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Block h11: investigation summary: based on the available information, boston scientific was able to confirm the reported event of stent first flange failure to expand with testing of the product return.The device was returned for analysis partially deployed.Stent partially deployed is noted within the ifu as a possible adverse event associated with the use of the device.A kink was observed near the luer.No further handle or sheath damages were noted.When fully deployed, the proximal flange and saddle were slow to expand.At the end, the stent was able to fully expand to its designed shape once placed in a warm water bath.Stent expansion rates can be affected by compression, time, temperature, and humidity.Larger stents expand more slowly due to greater compression in the catheter.All sizes can be affected, but higher compression temporarily reduces opening until the stent reaches its intended shape.Device history record: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: one hot axios delivery device was returned for analysis partially deployed.It was noted that the stent was attempted to be deployed, as the handle is in 2nd position of deployment and the distal flange fully expanded.A kink was observed near the luer.No further handle or sheath damages were noted.Xray images observed the proximal of the stent near the ro marker.Indicating the stent was shifted proximal to the sheath.No other damages were noted.The stent was attempted to be deployed; no resistance was felt when retracting the slider.When fully deployed, the proximal flange and saddle were slow to expand.No stent braid twists and folds were noted.The stent was able to fully expand to its designed shape once placed in a warm water bath.Risk review: a risk review was completed and confirmed that the event of "stent first flange failure to expand" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, stent partially deployed is noted within the ifu as a possible adverse event associated with the use of the device.Investigation conclusion: taking all available information into consideration, the investigation concluded that the most probable cause is cause linked to device but unable to trace more specifically.Boston scientific is initiating a removal of certain sizes of the axios stent and electrocautery enhanced delivery system (6mm x 8mm, 8mm x 8mm and 20mm x 10mm) manufactured since march 1, 2025.This action is being taken due to increased reports of stent deployment and expansion issues with these configurations.These issues only occur at the time of stent delivery and are expected to be noticed by the physician.Patients who have been treated with a successfully implanted axios stent should continue to follow standard of care and are not affected by this issue.A letter was sent out to materials managers/health care professionals on 19-dec-2025 to immediately stop further distribution or use of any affected 6mm x 8mm, 8mm x 8mm and 20mm x 10mm axios stent and electrocautery enhanced delivery system.The letter indicates to remove these devices from inventory and segregate them in a secure location until they can be returned to boston scientific.The referenced axios stent and electrocautery enhanced delivery system met all specifications prior to final approval for distributions/sale.

• Brand Name: AXIOS?
• Common Device Name: GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23783432
• Report Number: 3005099803-2025-06680
• Device Sequence Number: 14734824
• Product Code: QXH
• UDI-Device Identifier: 00191506008086
• UDI-Public: (01)00191506008086
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150692
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/22/2026

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: M00553680
• Device Catalogue Number: M00553680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 12/19/2025; 03/31/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/14/2026; 01/14/2026; 04/22/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005099803-12192025-004-
• Patient Sequence Number: 1
• Patient Sex: Unknown