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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 M00553660
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Peritonitis (2252); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  Injury  
Manufacturer Narrative
Imdrf patient code e1024 captures the reportable event of peritonitis.Imdrf impact code f23 captures the reportable event of abdominal drain placement performed to address the complication.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.
 
Event Description
It was reported to boston scientific corporation on february 21, 2023, that an axios stent and electrocautery enhanced delivery system was implanted to treat gastric outlet obstruction on (b)(6) 2023, as part of the e7127 passage clinical trial.The patient was enrolled into the clinical trial on (b)(6) 2023.On (b)(6) 2023, the patient experienced peritonitis and the hospitalization was prolonged.A computed tomography (ct) scan was performed and the axios stent was noted to be patent.On (b)(6) 2023, abdominal drain placement was performed to address leakage of gastrointestinal contents.In the physician's assessment, the patient complication is possibly related to the device.Note: it was reported that the axios stent was implanted to treat a gastric outlet obstruction.However, per the axios stent and electrocautery-enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.The device is not indicated for the treatment of gastric outlet obstruction.
 
Manufacturer Narrative
Block b5 has been updated with the additional information received on march 07, 2023, and april 03, 2023.Block h6: imdrf patient code e1024 captures the reportable event of peritonitis.Imdrf impact code f23 captures the reportable event of abdominal drain placement performed to address the complication.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.
 
Event Description
It was reported to boston scientific corporation on february 21, 2023, that an axios stent and electrocautery enhanced delivery system was implanted to treat gastric outlet obstruction on (b)(6) 2023, as part of the e7127 passage clinical trial.The patient was enrolled into the clinical trial on (b)(6) 2023.During the procedure, the axios stent was implanted successfully.Post-dilation was not performed, and stent patency could be visualized.On (b)(6) 2023, six (6) days post stent implant, the patient experienced peritonitis and the hospitalization was prolonged.A computed tomography (ct) scan was performed and the axios stent was noted to be patent.On (b)(6) 2023, eight (8) days post stent implant, abdominal drain placement was performed to address leakage of gastrointestinal contents.Note: it was reported that the axios stent was implanted to treat a gastric outlet obstruction.However, per the axios stent and electrocautery-enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.The device is not indicated for the treatment of gastric outlet obstruction.***additional information received on march 07, 2023, and april 03, 2023*** it was reported that the patient complication noted was bacterial peritonitis which was resolved on (b)(6) 2023.In the physician's assessment, the patient complication is possibly related to the device and index procedure.
 
Manufacturer Narrative
Block b5 and h6 (patient codes and impact codes) have been updated with the additional information received on may 31, 2023.Block g2: e7127 passage clinical study.Block h6: imdrf patient code e1024 captures the reportable event of peritonitis.Imdrf impact code f23 captures the reportable event of abdominal drain placement performed to address the complication.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Block h10: g2 (report source) and h10 has been corrected.
 
Event Description
It was reported to boston scientific corporation on february 21, 2023, that an axios stent and electrocautery enhanced delivery system was implanted to treat gastric outlet obstruction on (b)(6), 2023, as part of the e7127 passage clinical trial.The patient was enrolled into the clinical trial on (b)(6), 2023.During the procedure, the axios stent was implanted successfully.Post-dilation was not performed, and stent patency could be visualized.On (b)(6), 2023, six (6) days post stent implant, the patient experienced peritonitis and the hospitalization was prolonged.A computed tomography (ct) scan was performed and the axios stent was noted to be patent.On (b)(6), 2023, eight (8) days post stent implant, abdominal drain placement was performed to address leakage of gastrointestinal contents.Note: it was reported that the axios stent was implanted to treat a gastric outlet obstruction.However, per the axios stent and electrocautery-enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.The device is not indicated for the treatment of gastric outlet obstruction.Additional information received on march 07, 2023, and april 03, 2023.It was reported that the patient complication noted was bacterial peritonitis which was resolved on march 01, 2023.In the physician's assessment, the patient complication is possibly related to the device and index procedure.Additional information received on may 31, 2023.It was reported that in the physician's assessment the bacterial peritonitis is not related to the device and the index procedure.
 
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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 Key16504924
MDR Text Key310949925
Report Number3005099803-2023-01176
Device Sequence Number1
Product Code PCU
UDI-Device Identifier08714729951179
UDI-Public08714729951179
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K163272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/23/2023
Device Model NumberM00553660
Device Catalogue Number5366
Device Lot Number0030004253
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2023
Initial Date FDA Received03/08/2023
Supplement Dates Manufacturer Received03/07/2023
05/31/2023
Supplement Dates FDA Received04/21/2023
06/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age75 YR
Patient SexMale
Patient RaceAsian
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