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

Model Number M00553540

Device Problem Positioning Problem (3009)

Patient Problem Peritonitis (2252)

Event Date 06/18/2021

Event Type  Death  

Manufacturer Narrative

(b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a hot axios stent was to be implanted transduodenal to the gallbladder during an endoscopic ultrasound (eus) guided gallbladder drainage procedure performed on (b)(6) 2021.During the procedure, the physician had difficulty deploying the stent because of low echographic visibility due to bleeding in the gallbladder which resulted in the stent being fully deployed in the duodenum.The stent was removed from the patient using forceps and another axios stent was implanted to complete the procedure.Later in the week after the hot axios implantation, the patient passed away due to a biliary leak.Reportedly, the patient was unable to undergo surgery due to other pathologies.In the physician's assessment, the axios stent deployed in an incorrect position did contribute to the biliary leak that led to patient's death.Additionally, the patient's comorbidity of severely extended cancer contributed to patient's death.

• Brand Name: AXIOS STENT AND 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: 12254768
• MDR Text Key: 264361391
• Report Number: 3005099803-2021-03856
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: M00553540
• Device Catalogue Number: 5354
• Device Lot Number: 0026776814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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): Death; Required Intervention