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

Model Number M00553550

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Discomfort (2330)

Event Date 01/20/2023

Event Type  Death  

Event Description

It was reported to boston scientific (bsc) that the referenced axios stent and electrocautery enhanced delivery system was implanted to treat acute pancreatitis complicated by necrotic pancreatic cyst during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.This patient has a complex medical history with metastatic prostate adenocarcinoma also being treated for a deep vein thrombosis (left primary iliac vein and right femoral vein) with anticoagulants.On (b)(6) 2023, the patient presented to the emergency department with discomfort, tachycardia, and hypotension.The patient was admitted to the hospital and received two units of red blood cells, the anticoagulants were discontinued, and the patient was given protamine sulfate and pantoprazole.After several episodes of melena associated with hypotension and tachycardia, vasopressors were started.The patient was then transferred to the continuous monitoring unit.On (b)(6) 2023, an endoscopy was performed and revealed a 1 cm duodenal bulb ulcer (forrest 2b classification) treated with epinephrine injection.It was noted there was no bleeding at the site of the axios stent.After the procedure the patient improved, and vasopressors were discontinued.On (b)(6) 2023, recurrence of gastrointestinal hemorrhage occurred, an endoscopy was performed.The site of the previously treated ulcer did not show evidence of recent bleeding; however, a large clot was noted surrounding the axios stent.A ct angiography was performed and did not reveal any intra-abdominal active bleeding or false aneurysm.Additionally, it showed stable pancreatic collections, and possible ischemia of the upper pole of the spleen.On (b)(6) 2023, the patient experienced three (3) episodes of rectal bleeding and transfusion of two (2) red blood cell concentrates was given.An endoscopy on the same day showed clots in the axios stent, the clots were aspirated, and necrosis was visible intraluminally.The mucosa around the mesh was eroded and slightly hemorrhagic.The axios stent was removed with forceps, and no additional hemostasis was required.The duodenal ulcer was now a forrest iii classification, and no therapy was done.On (b)(6) 2023, recurrence of gastrointestinal hemorrhage, with hematemesis and massive rectal bleeding complicated with hemorrhagic shock requiring fluids, transfusions, and vasopressors.An emergency endoscopy was performed showing significant active bleeding with clots at the location of the removed axios stent.Ct angiography showed a large blood clot in the gastric body where the axios stent had been removed.This scan also revealed a caliber irregularity of the splenic artery in its portion initially in contact with the stent removed, without clear, arterial active bleeding.An arterio-embolization in interventional radiology was attempted and was not successful due to lack of visualization of active bleeding.As the patient was undergoing palliative chemotherapy for multi-metastatic prostate cancer and a multidisciplinary decision was made not to perform a surgery and to discontinue transfusions.The patient passed away on (b)(6) 2023.In the physician's assessment, the axios stent, along with the hemorrhage, in this patient with underlying multi-metastatic prostate cancer on palliative chemotherapy possibly was a factor in the patient's death.

Manufacturer Narrative

Initial reporter's address: (b)(6).Imdrf patient code e2321 captures the reportable patient complication of hypotension.Imdrf patient code e2006 captures the reportable patient complication of erosion.Imdrf patient code ee2111 captures the reportable patient complication of discomfort.Imdrf patient code e0506 captures the reportable patient complication of hemorrhage, major.Imdrf patient code e060109 captures the reportable patient complication of tachycardia.Impact code of f02 is being used to capture the death of the patient.Impact code f08 is being used to capture prolonged hospitalization.Impact code f0801 is being used to capture patient sent to intensive care unit.Impact code f2302 is being used to capture blood transfusion.Impact code f2303 is being used to capture patient medication.Impact code f23 is being used to capture orotracheal intubation.Impact cod f2202 is being used to capture additional endoscopic procedure (duodenal fibroscopy and oeso-gastroduodenal endoscopy) impact code f2301 is being used to capture the used of forceps to remove the stent from the patient.

• 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: 16426425
• MDR Text Key: 310049444
• Report Number: 3005099803-2023-00938
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0030506698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male