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

Model Number M00553570

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematemesis (4478)

Event Date 02/12/2021

Event Type  Death  

Manufacturer Narrative

Exact date unknown, event occurred on (b)(6) 2021 or (b)(6) 2021.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 patient expired and the stent remains implanted; 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 march 08, 2021 that a hot axios stent was implanted to create patency for a short benign radiation stricture in the proximal esophagus.The axios stent placement was performed on (b)(6) 2021.Reportedly, cautery was not used and a puncture was not created.During the procedure, the axios stent was successfully deployed with "perfect placement".However, 3 or 4 days after the stent placement procedure the patient passed away; the patient was found at home, deceased and there was evidence of hematemesis.No autopsy was performed.In the physician's assessment, it is unknown if there was a relationship between the patient's death/patient complications and the axios stent.The cause of death was not provided to bsc.Note: it was reported that the axios stent was intended to be placed to create patency for a short benign radiation stricture in the esophagus.However, per the hot axios stent and electrocautery- enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with >= 70 % fluid content.The hot axios stent is not indicated to be implanted in the esophagus.The physician also indicated that it was known that this is not an indicated use.The physician did note that there was no alleged issue or malfunction of the axios device.

• 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: 11594843
• MDR Text Key: 243114035
• Report Number: 3005099803-2021-01296
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00553570
• Device Catalogue Number: 5357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2021
• 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