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

Model Number M00553650

Device Problems Difficult to Remove (1528); Connection Problem (2900)

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

Event Date 03/23/2022

Event Type  malfunction  

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 transgastric to pancreas to treat a fluid collection during an endoscopic ultrasound (eus), cystogastrostomy procedure performed on (b)(6) 2022.During the procedure, it was noted that the handle was not stable when it was locked to the scope.The stent was successfully deployed; however, there was difficulty removing the delivery system.The delivery system was able to be removed after repeating the deployment steps.The procedure was completed with the original stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device problem code a150207 captures the reportable event of delivery system difficult to remove.Block h10: a hot axios delivery system was returned for analysis; the stent was not returned.Visual examination of the returned device found the luer damaged and the inner sheath was kinked.No other problems with the stent and delivery system were noted.The reported event of handle connection issue was confirmed; the luer was damaged.The reported event of delivery system difficult to remove could not be confirmed because this failure 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 the reported events and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled, the technique used by the user and/ or normal procedural difficulties encountered, limited the performance of the device and contributed to the delivery system difficult to remove, handle connection issue and inner sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation on march 23, 2022 that a hot axios stent was to be implanted transgastric to pancreas to treat a fluid collection during an endoscopic ultrasound (eus), cystogastrostomy procedure performed on march 23, 2022.During the procedure, it was noted that the handle was not stable when it was locked to the scope.The stent was successfully deployed; however, there was difficulty removing the delivery system.The delivery system was able to be removed after repeating the deployment steps.The procedure was completed with the original stent.There were no patient complications reported as a result of 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: 14086208
• MDR Text Key: 289321186
• Report Number: 3005099803-2022-01918
• 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: K153088
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0028369969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Race: White