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

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Vomiting (2144)

Event Date 09/24/2018

Event Type  Death  

Manufacturer Narrative

The exact date of death and date of the event are unknown.The provided date of death and event date were chosen as a best estimate based on the information provided by the complainant.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(6).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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a hot axios stent was successfully implanted in a transgastric position to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) procedure performed on an unknown date.According to the complainant, following the procedure, the patient's fluid collection was not shrinking.The patient was referred to a second physician to potentially have a second axios stent placed to facilitate further drainage.However, before the patient was seen by the second physician, the patient died sometime between (b)(6) 2018.Reportedly, the patient was vomiting blood prior to their death.The physician suspected that the bleeding came from the pseudocyst and that there may have been an aneurysm within the pseudocyst that the axios stent was placed within.The complainant reported that there was no deficiency of the axios stent.Attempts by boston scientific to obtain additional information regarding the patient's cause of death and the relationship between the axios stent and the patient's death 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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7990858
• MDR Text Key: 124548889
• Report Number: 3005099803-2018-60866
• Device Sequence Number: 1
• Product Code: PCU
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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