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

Model Number M00553550

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

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on august 30, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted to the pancreas for pseudocyst drainage during an endoscopic ultrasound (eus) guided pseudocyst drainage procedure performed on (b)(6) 2022.During the procedure, the first flange of the axios stent was deployed, but did not expand and moved out of its position while pushing back the axios delivery system.The axios stent was removed from the patient partially deployed.The procedure was not completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: 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

(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 to the pancreas for pseudocyst drainage during an endoscopic ultrasound (eus) guided pseudocyst drainage procedure performed on (b)(6) 2022.During the procedure, the first flange of the axios stent was deployed, but did not expand and moved out of its position while pushing back the axios delivery system.The axios stent was removed from the patient partially deployed.The procedure was not completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: 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.Imdrf device code a1502 captures the reportable event of stent first flange difficult to position.Block h10: an axios delivery system was returned for analysis; the stent was not returned.Visual examination of the returned device found the outer sheath kinked in two sections.Functional inspection was performed by moving the catheter lock by sliding it to the right, then the catheter control hub was moved up and down.The catheter passes through the luer without resistance.Also, the stent hub was move down to the second and fourth position without any problem.No other problems were noted to the delivery system.The investigation concluded that the observed failure of outer sheath kinked was likely due to factors encountered during the procedure.It may be that 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 outer sheath kinked.A labeling review was performed and, from the information available, this device was used in a manner inconsistent per the instructions for use (ifu) / product label.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." the reported event of stent first flange failure to expand cannot be confirmed; the stent was not returned.The reported event of stent first flange difficult to position cannot be confirmed as this occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported events.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: 15459105
• MDR Text Key: 306440374
• Report Number: 3005099803-2022-05444
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0028958915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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