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

Model Number M00553560

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Event date: approximated based on the year the literature was published.It was reported that a 20mm x 10mm axios stent and electrocautery enhanced delivery system was used; however, the upn and lot number of the suspect device were not provided in the literature, therefore, the manufacture and expiration dates are unknown.Literature source: ebrahim, m., werge, m., hadi, a., lahchich, m., nagras, z., lauritsen, m., schmidt, p., hansen, e., novovic, s., karstensen, j.Clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15cm) walled -off pancreatic necrosis: retrospective, single tertiary center cohort study.Digestive endoscopy 2022; 34: 1245-1252.Https://doi.Org/10.1111/den.14295.Imdrf device code (b)(4).Impact code (b)(4).

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15 cm) walled-off pancreatic necrosis: retrospective, single tertiary center cohort study" by dr.Mohamed ebrahim, et al.It was reported to boston scientific corporation on october 19, 2022, that an axios stent and electrocautery enhanced delivery system was implanted to treat an acute pancreatitis with walled-off necrosis (won) during an endosonographic-guided drainage procedure performed on an unknown date.After initial percutaneous self-expandable metallic stent drainage.The patient developed a pancreatico-cutaneous fistula, and a surgery was performed to address the patient complication.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15 cm) walled-off pancreatic necrosis: retrospective, single tertiary center cohort study".See citation in block h10.It was reported to boston scientific corporation on october 19, 2022, that an axios stent and electrocautery enhanced delivery system was implanted to treat an acute pancreatitis with walled-off necrosis (won) during an endosonographic-guided drainage procedure performed on an unknown date.The patient experienced colonic perforation.One occurred at the transverse colon which was addressed with a surgical creation of a temporary loop ileostomy.The other one was closed with an endoscopic clip.Bleeding was also noted which was addressed intraoperatively with transfusion and a combination of endo clips, balloon tamponade, and coagulation.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block b3: approximated based on the year the literature was published.Block d4; h4: it was reported that a 20mm x 10mm axios stent and electrocautery enhanced delivery system was used; however, the upn and lot number of the suspect device were not provided in the literature, therefore, the manufacture and expiration dates are unknown.Block g2: literature source: ebrahim, m., werge, m., hadi, a., lahchich, m., nagras, z., lauritsen, m., schmidt, p., hansen, e., novovic, s., karstensen, j.Clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15cm) walled -off pancreatic necrosis: retrospective, single tertiary center cohort study.Digestive endoscopy 2022; 34: 1245-1252.Https://doi.Org/10.1111/den.14295.Block h6: imdrf device code e2114 captures the reportable patient complication of perforation.Imdrf device code e0506 captures the reportable patient complication of bleeding.Impact code f23 captures the additional intervention performed to address patient complication.Block h11: blocks b5, h6 (patient codes and impact codes) and h10 have been corrected.

• 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: 15745615
• MDR Text Key: 303184713
• Report Number: 3005099803-2022-06551
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 01/19/2023

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: M00553560
• Device Catalogue Number: 5356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/19/2023
• 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