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

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

Patient Problems Abdominal Pain (1685); Skin Inflammation/ Irritation (4545)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Report source: medwatch#: mw5113327.(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6) 2022, that an axios stent and electrocautery enhanced delivery system was implanted to treat a pancreatic fluid collection during a procedure performed on (b)(6) 2022.On an unknown date, post stent placement, the patient experienced abdominal pain four times after overeating or when eating certain foods.The pain was so intense that the patient had to be brought to the emergency room to receive treatment.During the visit, it was confirmed that the stent placement was intact and was draining the pancreatic fluid collection.The stent was scheduled to be removed on an unknown date.

Event Description

It was reported to boston scientific corporation on november 15, 2022, that an axios stent and electrocautery enhanced delivery system was implanted to treat a pancreatic fluid collection during a procedure performed on (b)(6) 2022.On an unknown date, post stent placement, the patient experienced abdominal pain four times after overeating or when eating certain foods.The pain was so intense that the patient had to be brought to the emergency room to receive treatment.During the visit, it was confirmed that the stent placement was intact and was draining the pancreatic fluid collection.The stent was scheduled to be removed on an unknown date.Additional information received on december 13, 2022: it was reported that the axios stent was placed transgastric to the pancreas.The stent successfully drained the fluid and resolved the issue; however, the stent caused severe pain at the location of the stent and irritation whenever the patient eat fried foods or excessive amount of food.The patient underwent limited diet for 5 weeks.On an unknown date, the stent was removed, and the patient was able to eat without experiencing pain.

Manufacturer Narrative

Blocks b5 and h6 (patient codes) have been updated with the additional information received on december 13, 2022.Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block g2: report source: medwatch# mw5113327.Block h6: imdrf patient code e1002 captures the reportable event of abdominal pain.Impact code f23 captures the reportable event of unexpected medical intervention.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED 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: 15971314
• MDR Text Key: 305413552
• Report Number: 3005099803-2022-07447
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female