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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE Back to Search Results
Model Number M00553530
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the bile duct during a bile drainage procedure performed on (b)(6) 2023.During the procedure, the stent first flange did not expand.The axios stent was removed from the patient partially deployed, and another device was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
 
Manufacturer Narrative
H6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.
 
Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Block h10: an axios stent and electrocautery enhanced delivery system were received for analysis.The stent was received fully deployed and expanded.Visual examination of the returned device found the inner sheath kinked.A dimensional inspection was performed, and the stent was measured to be within specification.No other problems were noted with the stent and delivery system.The investigation concluded that the observed problem of inner sheath kinked 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 problem.The reported event of stent first flange failure to expand cannot be confirmed as the stent was received fully deployed and expanded.Based on the available information, there is not enough information to confirm the reported event of stent first flange failure to expand; 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.
 
Event Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the bile duct during a bile drainage procedure performed on (b)(6) 2023.During the procedure, the stent first flange did not expand.The axios stent was removed from the patient partially deployed, and another device was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
 
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Brand Name
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Type of Device
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 Key18540277
MDR Text Key333331652
Report Number3005099803-2024-00074
Device Sequence Number1
Product Code PCU
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K150692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00553530
Device Catalogue Number5353
Device Lot Number0030703499
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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