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 Dyspnea (1816); Fever (1858); Unspecified Infection (1930); Perforation (2001); Septic Shock (2068)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Event date: approximated based on the year the literature was published.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: sene, pape-mamadou, esmail, eslam, vandenbroucke-menu, franck, diakite, aly-thieman, liu chen kiow, jeremy, sahai, anand.Diaphragmatic perforation after electrocautery-assisted lumen-apposing metal stent placement for refractory perisplenic abscess.Endoscopic ultrasound 11(6): p 522-524, nov-dec 2022.| doi: 10.4103/eus-d-22-00001.Imdrf patient code e1906 captures the reportable patient complication of empyema.Imdrf patient code e0717 captures the reportable patient complication of dyspnea.Imdrf patient code e230101 captures the reportable patient complication of fever.Imdrf patient code e233605 captures the reportable patient complication of septic shock.Imdrf patient code e2114 captures the reportable patient complication of perforation.Impact code f19 is being used to capture the surgical intervention.Impact code f23 is being used to capture the additional intervention of pleural chest tube.Impact code f0801 is being used to capture the patient outcome of being admitted to the intensive care unit.

Event Description

Boston scientific became aware of an event involving an axios stent and electrocautery enhanced delivery system through the article "diaphragmatic perforation after electrocautery-assisted lumen-apposing metal stent placement for refractory perisplenic abscess" by dr.Pape-mamadou sene, et al.According to the literature, a 15mm x10mm axios stent and electrocautery enhanced delivery system was implanted to treat a persistent pancreatic fluid collection (pfc) during an endoscopic ultrasound (eus)-guided cyst-gastrostomy procedure.The axios stent was deployed with no fluoroscopy and with no wire guidance.There was instantaneous drainage of pus and no evidence of immediate complications.Approximately 24 hours after discharge, the patient developed shortness of breath and fever, and was readmitted with septic shock and empyema.Computed tomography (ct) scan showed communication between the extra gastric flange of the axios stent, the pfc, and possibly the left pleural space.The proximal end of the axios can be seen inside the stomach, while air can be seen exiting its distal end in the left subphrenic region, appearing to be in communication with the left costophrenic recess.A pleural chest tube was inserted, and the patient was stabilized and sent for surgical exploration.After opening the abdominal wall, the axios stent was in direct contact with the abdominal surface of the diaphragm.An orifice was identified in the diaphragm, compatible with a perforation induced by the stent delivery system.The stent was removed, the abscesses were drained, and the diaphragmatic and gastric orifices were closed.Lung decortication was performed 2 days later, and the patient was admitted to the intensive care unit for postoperative surveillance and stabilization.

• 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: 16379264
• MDR Text Key: 309578590
• Report Number: 3005099803-2023-00772
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/15/2023

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: M00553550
• Device Catalogue Number: 5355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/15/2023
• 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; Other
• Patient Age: 71 YR
• Patient Sex: Male