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

Model Number M00553550

Device Problems Device-Device Incompatibility (2919); Activation Failure (3270)

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

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a hot axios stent was to be implanted transduodenal to gallbladder to treat cholecystitis during an endoscopic ultrasound-guided gallbladder drainage (eus-gbd) procedure performed on (b)(6) 2022.During the procedure, a 19ga needle was used to puncture through the duodenum and into the gallbladder.The guidewire was passed through the 19ga needle and then the axios stent was advanced through the guidewire; however, it was noted that the coating of the guidewire was stripped off by the axios.The axios stent was removed with the guidewire and another guidewire was attempted to be used.The stent was re-inserted; however, the coating stripped off the guidewire again.The physician deployed the first flange of the stent in the gallbladder; however, the first flange failed to expand.The stent was removed partially deployed on the delivery system.The physician created another puncture transgastric to the gallbladder and another axios stent was used to complete the procedure without the aid of a 19ga needle or guidewire.The first puncture site was closed using a clip.There were no patient complications due to this event.

Manufacturer Narrative

Block h6: medical device problem code a150101 captures the reportable event of stent first flange failure to expand.Block h10: a hot axios stent and delivery system were returned for analysis.The stent was returned partially deployed and the first flange was fully expanded.The deployment hub was returned in position "2".Visual examination of the returned device found the sheath kinked next to the luer lock.Functional evaluation was performed; the stent was deployed and the guidewire was inserted and withdrew without problems.No other problems with the stent and delivery system were noted.The investigation concluded that the observed failure of sheath kinked was likely due to factors encountered during the procedure.It may be that using excessive force or forcing the device against significant resistance, limited the performance of the device and contributed to the sheath kinked.The reported event of stent first flange failure to expand could not be confirmed; the stent first flange was returned fully expanded.The reported event of device interaction with other device could not be confirmed because this failure occurred during the procedure and could not be functionally/visually verified.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation on march 23, 2022 that a hot axios stent was to be implanted transduodenal to gallbladder to treat cholecystitis during an endoscopic ultrasound-guided gallbladder drainage (eus-gbd) procedure performed on (b)(6) 2022.During the procedure, a 19ga needle was used to puncture through the duodenum and into the gallbladder.The guidewire was passed through the 19ga needle and then the axios stent was advanced through the guidewire; however, it was noted that the coating of the guidewire was stripped off by the axios.The axios stent was removed with the guidewire and another guidewire was attempted to be used.The stent was re-inserted; however, the coating stripped off the guidewire again.The physician deployed the first flange of the stent in the gallbladder; however, the first flange failed to expand.The stent was removed partially deployed on the delivery system.The physician created another puncture transgastric to the gallbladder and another axios stent was used to complete the procedure without the aid of a 19ga needle or guidewire.The first puncture site was closed using a clip.There were no patient complications due to this event.

• 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: 14112435
• MDR Text Key: 289273750
• Report Number: 3005099803-2022-01937
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0028072038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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