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

Model Number M00553650

Device Problem Activation Failure (3270)

Patient Problem Hematemesis (4478)

Event Date 08/08/2022

Event Type  malfunction  

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 implanted transgastric to pancreas to treat a pancreatic cyst during a pancreatic cyst drainage procedure performed on (b)(6) 2022.During the procedure, the distal flange of the axios stent was deployed; however, it did not fully expand.Somehow the distal flange of the axios stent fully opened.The axios stent was successfully implanted by pulling and pushing the axios delivery catheter and the procedure was completed.However, post procedure, it was noted that the patient vomited a considerable amount of blood.A computerized tomography (ct) scan was performed to check the reason for patient's hematemesis and no issues were found.The patient's condition following the procedure was reported to be fine.

Event Description

It was reported to boston scientific corporation on august 09, 2022 that an axios stent and electrocautery enhanced delivery system was implanted transgastric to pancreas to treat a pancreatic cyst during a pancreatic cyst drainage procedure performed on (b)(6) 2022.During the procedure, the distal flange of the axios stent was deployed; however, it did not fully expand.Somehow the distal flange of the axios stent fully opened.The axios stent was successfully implanted by pulling and pushing the axios delivery catheter and the procedure was completed.However, post procedure, it was noted that the patient vomited a considerable amount of blood.A computerized tomography (ct) scan was performed to check the reason for patient's hematemesis and no issues were found.The patient's condition following the procedure was reported to be fine.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of first flange of the axios stent failed to expand.Block h10: an axios electrocautery enhanced delivery system was received for analysis; the stent was not returned as it remained implanted.The device was received with the deployment hub in position 2.Visual inspection found the inner sheath bent.The catheter and the monopolar plug were inspected and no damages were found.No other issues were noted to the delivery system.The reported event of stent failure to expand could not be functionally/visually verified as the stent was not returned.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, minor or excessive bleeding requiring intervention is noted within the dfu as a potential complication associated with the use of the device.Vomiting and minor injury/ illness / impairment are consequence of the reported event of hemorrhage, minor.The damage noted to the inner sheath was most likely due to procedural factors encountered during the procedure.Handling and excessive manipulation of the device without enough care could have led to inner sheath kinked/bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• 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: 15342147
• MDR Text Key: 302063316
• Report Number: 3005099803-2022-04984
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153088
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0028394869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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