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

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.

• 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 Key: 16504924
• MDR Text Key: 310949925
• Report Number: 3005099803-2023-01176
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• 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 Date: 08/23/2023
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0030004253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/07/2023; 05/31/2023
• Supplement Dates FDA Received: 04/21/2023; 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: Asian