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

Model Number M00553650

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

The complainant indicated that the device remains implanted 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a hot axios stent was successfully implanted to treat a pancreatic cyst during an endoscopic ultrasound (eus) guided cyst drainage procedure performed on an unknown date.According to the complainant, upon departure from the hospital, the patient was involved in a vehicle accident.The patient returned to the hospital for evaluation.Imaging was performed, and it was noticed that a vessel was in close proximity to the stent.The physician and surgeon considered embolization of the vessel but decided upon observation only without embolization.Several weeks later, the patient presented to the emergency room with abdominal pain.While in the emergency room, the patient hemorrhaged, and the emergency room staff were unable to resuscitate the patient.The patient expired in the emergency room.The clinical cause of the patient's death was reported to be gastrointestinal bleed.The relationship between the axios stent and the patient's death and/or bleeding is unknown.However, it was reported that the source of the bleed was adjacent to the axios stent.Attempts by boston scientific to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: AXIOS STENT AND DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7674272
• MDR Text Key: 113557566
• Report Number: 3005099803-2018-02166
• 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: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: M00553650
• Device Lot Number: 21769982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2018
• 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