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

Model Number M00553660

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  Injury  

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 transgastric to the jejunum during an axios gastrojejunostomy procedure performed on (b)(6) 2022.During the procedure, the first flange of the axios stent was deployed; however, it did not fully expand.The axios stent was removed from the patient partially deployed and another axios stent was used to complete the procedure.There were no patient complications as a result of this event.Note: it was reported that the axios stent was placed for an axios gastrojejunostomy procedure.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.It was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery-enhanced delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failed to expand.Block h10: an axios stent and electrocautery enhanced delivery system were returned for analysis.Visual examination of the returned device found the stent partially deployed.The delivery system was returned in position "2".Functional inspection was performed; the catheter was able to pass through the luer without resistance.Also, the stent hub was able to be moved down to the second and fourth position and the stent was deployed without problems and the first flange was expanded without problems.No other problems were noted to the stent and delivery system.The reported event of stent first flange failure to expand could not be confirmed as the stent first flange expanded without problems.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the device was intended to be placed for an axios gastrojejunostomy procedure.The ifu states, "the hot 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 with >= 70% fluid content that are adherent to the gastric or bowel wall." the hot axios stent is not indicated to be placed to treat a walled-of-necrosis with >30% necrotic material.Furthermore, it was reported that the handle was rotated as the device was luer locked to the scope.The ifu states "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." taking all available information into consideration, the investigation concluded that the reported events and observed failure 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 events and observed failure.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation on october 06, 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the jejunum during an axios gastrojejunostomy procedure performed on (b)(6) 2022.During the procedure, the first flange of the axios stent was deployed; however, it did not fully expand.The axios stent was removed from the patient partially deployed and another axios stent was used to complete the procedure.There were no patient complications as a result of this event.Note: it was reported that the axios stent was placed for an axios gastrojejunostomy procedure.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.It was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery-enhanced delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

• 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: 15677817
• MDR Text Key: 302469642
• Report Number: 3005099803-2022-06316
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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 Expiration Date: 03/11/2023
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0029026554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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): Required Intervention