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

Model Number M00553540

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the month and year the first procedures were performed.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Literature source: pawa, r., dorrell, r., russell, g., nguyen, m., clark, c., mishra, g., pawa, s.Endoscopic management of hemorrhagic pancreatic fluid collections: a propensity-matched analysis.Den open.2022 dec 8; 3(1):e195.Patient code 2187 captures the reportable event of hemorrhage, major.Impact code f2301 is being used to capture the reportable intervention of removal of the original stent and placement of a double pigtail plastic stent.

Event Description

Note: this report pertains to one of three devices indicated in the literature used between november 2015 and november 2021.Refer to manufacturer report # 3005099803-2023-00408, 3005099803-2023-00409, and 3005099803-2023-00410 for the associated device information.Boston scientific became aware of events through the article "endoscopic management of hemorrhagic pancreatic fluid collections: a propensity-matched analysis" by dr.Rishi pawa, et al.A 15mm x 10mm axios stent and electrocautery- enhanced delivery system was placed to treat a walled-off pancreatic necrosis while a 10mm x 10mm axios stent and electrocautery- enhanced delivery system was placed to treat a pseudocyst during stent placement procedures performed between november 2015 and november 2021.There were 15 patients for the hemorrhagic pancreatic fluid collections (hpfc) group and 30 patients for the non-hemorrhagic pancreatic fluid collections (nhpfc) group.According to the literature, two adverse events occurred in the hpfc group.One patient (the subject of this report) encountered a self-limiting upper gastrointestinal bleeding at the site of the stent placement.The second patient (the subject of mfr.Report #3005099803-2023-00409) encountered an upper gastrointestinal bleeding post stent placement secondary to impingement of the stent on the apposing cyst wall which resulted in bleeding and treated with epinephrine injection.The axios stents were removed in both patients and replaced with double pigtail plastic stents.In the nhpfc group, 3 adverse events occurred (the subject of mfr.Report #3005099803-2023-00410); 3 patients had persistent fever post stent placement.A repeat endoscopy was performed and a necrotic material occluding the stent was noted.All three patients were treated with iv antibiotics and an endoscopic necrosectomy was performed to address the symptoms.Note: no further information has been obtained despite good faith efforts.

• 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: 16305304
• MDR Text Key: 308866834
• Report Number: 3005099803-2023-00408
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2023

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
• Device Model Number: M00553540
• Device Catalogue Number: 5354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/06/2023
• 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 Age: 43 YR
• Patient Sex: Male