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

Model Number M00553640

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

Patient Problems Diarrhea (1811); Fistula (1862)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the article was received.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: initial reporter facility name: institute of clinical andexperimental medicine (ikem),prague block g2: literature source: rishi p.Et al.Cholecystocolonic fistula following endoscopic ultrasound-guided gallbladder drainage for stump cholecystitis.Clinical journal of gastroenterology (2023) 16:116-120.Block h6: imdrf patient code e1008 captures the reportable event of diarrhea.Imdrf patient code e2314 captures the reportable event of fistula.Imdrf impact code f23 captures the reportable event of additional intervention performed to remove the stent and close the puncture site.

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "cholecystocolonic fistula following endoscopic ultrasound-guided gallbladder drainage for stump cholecystitis." according to the literature, an axios stent and electrocautery enhanced delivery system was implanted transgastric to gallbladder to treat a stump cholecystitis during an endoscopic ultrasound-guided gallbladder drainage procedure performed on an unknown date.Correct positioning of the stent was confirmed via fluoroscopy and computed tomography (ct) scan.It was reported that 2 weeks post stent placement, the patient experienced diarrhea which was managed with cholestyramine.An upper endoscopy with cholecystoscopy procedure 4 weeks post stent placement was performed and a cholecystocolonic fistula was noted at the distal end of the double pigtail stent located in the colon at the hepatic flexure.The axios and double pigtail stent were removed and a through the scope clips were used to close the cholecystogastric tract.

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "cholecystocolonic fistula following endoscopic ultrasound-guided gallbladder drainage for stump cholecystitis." according to the literature, an axios stent and electrocautery enhanced delivery system was implanted transgastric to gallbladder to treat a stump cholecystitis during an endoscopic ultrasound-guided gallbladder drainage procedure performed on an unknown date.Correct positioning of the stent was confirmed via fluoroscopy and computed tomography (ct) scan.It was reported that 2 weeks post stent placement, the patient experienced diarrhea which was managed with cholestyramine.An upper endoscopy with cholecystoscopy procedure 4 weeks post stent placement was performed and a cholecystocolonic fistula was noted at the distal end of the double pigtail stent located in the colon at the hepatic flexure.The axios and double pigtail stent were removed and a through the scope clips were used to close the cholecystogastric tract.

Manufacturer Narrative

Block b3: approximated based on the date the article was received.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: initial reporter facility name: institute of clinical and experimental medicine (ikem), prague block g2: literature source: rishi p.Et al.Cholecystocolonic fistula following endoscopic ultrasound-guided gallbladder drainage for stump cholecystitis.Clinical journal of gastroenterology (2023) 16:116-120.Block h6: imdrf patient code e1008 captures the reportable event of diarrhea.Imdrf patient code e2314 captures the reportable event of fistula.Imdrf impact code f23 captures the reportable event of additional intervention performed to remove the stent and close the puncture site.

• 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: 16776973
• MDR Text Key: 313655935
• Report Number: 3005099803-2023-02066
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: 08714729904588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153088
• 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,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00553640
• Device Catalogue Number: 5364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• 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: 50 YR
• Patient Sex: Male