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

Model Number M00553650

Device Problems Use of Device Problem (1670); Positioning Problem (3009); Activation Failure (3270); Poor Visibility (4072)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2023

Event Type  Death  

Manufacturer Narrative

Block a4: the patient's weight is 52.8 kg.Block h6: imdrf device code a1502 captures the reportable event of the stent positioning issue.Imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f19 captures the surgical intervention to remove the stent.Imdrf impact code f2301 captures the additional device to close the puncture site.

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 gallbladder for gallbladder drainage during the axios-guided drainage of the gallbladder procedure performed on (b)(6) 2023.The physician was using the eus method of deployment, where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1-to-1 fashion.During the procedure, the first flange was successfully deployed; however, the second flange did not completely expand, and it moved distally toward the end of the sheath.The entire stent ended up being lodged between the wall of the gallbladder and the abdominal wall.The puncture site was clipped, and the patient was sent to the operating room (or) to surgically remove the stent.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent and electrocautery- enhanced delivery system was used for the drainage of the gallbladder.Per the axios stent and electrocautery-enhanced delivery system directions for use (dfu), the axios stent and electrocautery-enhanced delivery system 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 that are adherent to the gastric or bowel wall.The stent is not indicated for the drainage of the gallbladder.

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 gallbladder for gallbladder drainage during the axios-guided drainage of the gallbladder procedure performed on (b)(6) 2023.The physician was using the eus method of deployment, where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1-to-1 fashion.During the procedure, the first flange was successfully deployed; however, the second flange did not completely expand, and it moved distally toward the end of the sheath.The entire stent ended up being lodged between the wall of the gallbladder and the abdominal wall.The puncture site was clipped, and the patient was sent to the operating room (or) to surgically remove the stent.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent and electrocautery- enhanced delivery system was used for the drainage of the gallbladder.Per the axios stent and electrocautery-enhanced delivery system directions for use (dfu), the axios stent and electrocautery-enhanced delivery system 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 that are adherent to the gastric or bowel wall.The stent is not indicated for the drainage of the gallbladder.Additional information received on (b)(6) 2023.It was further reported the proximal flange was mis-deployed between the gallbladder and duodenal wall.The physician was unable to recover the stent and the patient then underwent the removal surgery.It was also reported that the patient passed away two weeks post-axios stent placement procedure.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Blocks b2, b5, h1, and h6 (impact codes) have been updated based on the additional information received on (b)(6) 2023.Block a4: the patient's weight is 52.8 kg.Block h6: imdrf device code a1502 captures the reportable event of the stent positioning issue.Imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f19 captures the surgical intervention to remove the stent.Imdrf impact code f2301 captures the additional device to close the puncture site.Imdrf impact code f02 capture the reportable of event of patient's death.

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 gallbladder for gallbladder drainage during the axios-guided drainage of the gallbladder procedure performed on (b)(6) 2023.The physician was using the eus method of deployment, where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1-to-1 fashion.During the procedure, the first flange was successfully deployed; however, the second flange did not completely expand, and it moved distally toward the end of the sheath.The entire stent ended up being lodged between the wall of the gallbladder and the abdominal wall.The puncture site was clipped, and the patient was sent to the operating room (or) to surgically remove the stent.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent and electrocautery- enhanced delivery system was used for the drainage of the gallbladder.Per the axios stent and electrocautery-enhanced delivery system directions for use (dfu), the axios stent and electrocautery-enhanced delivery system 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 that are adherent to the gastric or bowel wall.The stent is not indicated for the drainage of the gallbladder.***additional information received on september 29, 2023*** it was further reported the proximal flange was mis-deployed between the gallbladder and duodenal wall.The physician was unable to recover the stent and the patient then underwent the removal surgery.It was also reported that the patient passed away two weeks post-axios stent placement procedure.No further information has been obtained despite good faith efforts.***additional information received on october 27, 2023*** it was further reported that perforation had occurred because the stent's second flange did not completely open.

Manufacturer Narrative

Blocks b2, b5, e4, g2, and h6 (patient codes and impact codes) have been updated based on the additional information received on october 27, 2023.Block a4: the patient's weight is 52.8 kg.Block g2: report source: medwatch report mw5146877 block h6: imdrf device code a1502 captures the reportable event of the stent positioning issue.Imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f19 captures the surgical intervention to remove the stent.Imdrf impact code f2301 captures the additional device to close the puncture site.Imdrf impact code f02 captures the reportable of event of patient's death.Imdrf patient code e2114 captures the reportable patient complication of perforation.Imdrf impact code f08 captures the reportable event of patient hospitalization or prolonged hospitalization.

• 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: 17895188
• MDR Text Key: 325238146
• Report Number: 3005099803-2023-05367
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN230019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0031948183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 09/29/2023; 10/27/2023
• Supplement Dates FDA Received: 10/19/2023; 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention; Death
• Patient Age: 85 YR