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

Model Number	M00553690
Medical Device Problem Codes	Difficult to Remove (1528); Human-Device Interface Problem (2949); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on august 18, 2021 that a hot axios stent was implanted in a transgastric position to treat a 7cm pancreatic fluid collection during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2021.During the axios removal procedure performed on (b)(6) 2021, it was noted that the stent migrated into the collection.The physician attempted to remove the stent using a rat tooth forceps; however, the stent was unable to be visualized due to tissue overgrowth and could not be removed.The physician then attempted to remove some of the tissue to expose the stent for removal; however, this was also unsuccessful.The patient was referred to surgery and a distal pancreatectomy was performed the same day to remove the stent.The patient experienced patient complications and was admitted to the hospital for the surgery to remove the stent and recovery.Reportedly, the patient is expected to fully recover.

• Brand Name: AXIOS
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12453618
• Report Number: 3005099803-2021-04679
• Device Sequence Number: 1194577
• Product Code: PCU
• UDI-Device Identifier: 00191506008093
• UDI-Public: 00191506008093
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: M00553690
• Device Catalogue Number: 5369
• Device Lot Number: 0027385403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention