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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 M00553540
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2022
Event Type  Injury  
Event Description
It was reported to boston scientific corporation on (b)(6) 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the gallbladder during a gallbladder drainage procedure performed on (b)(6) 2022.The patient was multimorbid and high-risk patient.During the procedure, the stent was fully deployed; however, the second flange did not release from the scope, and the tip became detached which resulted in the endoscope breaking which will be sent for repair.The device was removed, and a surgery was performed to suture the puncture site in the duodenal bulb and to remove the gallbladder.In the physician's assessment, there was a relationship between the surgery and the axios stent.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the gallbladder during a gallbladder drainage procedure performed on (b)(6) 2022.The patient was multimorbid and high-risk patient.During the procedure, the stent was fully deployed; however, the second flange did not release from the scope, and the tip became detached which resulted in the endoscope breaking which will be sent for repair.The device was removed, and a surgery was performed to suture the puncture site in the duodenal bulb and to remove the gallbladder.In the physician's assessment, there was a relationship between the surgery and the axios stent.
 
Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent first flange difficult to position.Imdrf device code a0501 captures the reportable event of tip detached.Block h10: an axios delivery system was returned for analysis.Visual examination of the returned device found the black marker damaged in the distal section, the outer sheath was bent, and the tip was detached and was not returned.No other problems were noted to the delivery system.Taking all available information into consideration, the investigation concluded that the reported event and observed failures were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, the technique used by the physician and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the reported event and the observed failures.The reported event of stent first flange difficult to position cannot be confirmed because this happened during the procedure and there is no bjective evidence or descriptive conditions to confirm the reported events.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
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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 Key15807828
MDR Text Key303759379
Report Number3005099803-2022-06701
Device Sequence Number1
Product Code PCU
Combination Product (y/n)N
Reporter Country CodeGM
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 01/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00553540
Device Catalogue Number5354
Device Lot Number0030160153
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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