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

Model Number M00553570

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/01/2019

Event Type  Injury  

Event Description

Note: this report pertains to one of three devices indicated in the literature used between december 01, 2019 through december 31, 2020.Refer to manufacturer report # 3005099803-2022-07389, and 3005099803-2022-07394 for the associated device information.Boston scientific became aware of events through the article "novel 15-mm long lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections located > 10mm from the luminal wall" by dr.Mouen a.Khashab, et al.A 15mm hot axios stents were used during the study and were implanted for pancreatic fluid collection located > 10mm from the gastric or duodenal wall during an endoscopic ultrasound (eus) with axios drainage procedures performed between december 2019 and december 2020.35 patients successfully underwent the stent placement procedure for the management of pfcs; 26 patients had walled-off necrosis and 9 patients had pancreatic pseudocyst.According to the literature, one patient with an 80mm pfc which is located 13mm from the luminal wall encountered stent misdeployment (the subject of mfr.Report # 3005099803-2022-07394).Consequently, a fully covered self-expanding metal stent was placed through the axios stent.Both stents were successfully removed following complete resolution of the pfc at 46 days.Two patients encountered bleeding of moderate severity which were related to the axios stents.One patient had melena requiring blood transfusion post stent placement (the subject of this report).An upper endoscopy was performed and no active bleeding was found.When the pfc had collapsed with no residual solid debris, the axios stent was removed and two double-pigtail plastic stents were placed across the tract.The other patient had encountered bleeding during the axios stent dilation and was the bleeding was address intraprocedurally with adrenaline injection and hemostatic gel application (the subject of mfr.Report # 3005099803-2022-07389).Furthermore, no further bleeding occurred on both cases and resolution of the pfc was seen on progress imaging.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Dat e 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.Report source: literature source: (b)(6) novel 15-mm long lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections located > 10mm from the luminal wall.Endoscopy 2022; 54: 706-711.(b)(4).

• 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: 15983342
• MDR Text Key: 305491896
• Report Number: 3005099803-2022-07376
• 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: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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: 11/21/2022
• 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