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

Model Number M00553650

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

Patient Problems Edema (1820); No Code Available (3191)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the stent 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 august 20, 2020 that a hot axios stent has been implanted in a transgastric position to treat a pancreatic cyst during a hot axios placement procedure performed on (b)(6) 2020.According to the complainant, on (b)(6) 2020, the patient experienced edema which was noted all around the patient's stomach.On (b)(6) 2020, ultrasonic endoscopy was performed and a double pigtail was implanted; however, the drainage failed.A second hot axios stent was placed to drain the largest edema.Reportedly, the first hot axios stent remains implanted.There was no reported issue with the stent and it is unknown whether there is a relationship between the stent and the edema.The patient's current condition was reported to be stable and will undergo follow-up observation.

• Brand Name: AXIOS
• 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: 10515160
• MDR Text Key: 206510473
• Report Number: 3005099803-2020-03845
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• 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): Required Intervention