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 Hematoma (1884); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Peritonitis (2252)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the year the literature was published.Initial reporter name and address:: the initial reporter's facility name is (b)(6) hospital.Lot #, device manufacture date: a 15mm x 10mm axios stent was used; however, the upn and lot number of the complaint device was not provided.Therefore, the lot expiration and device manufacture dates are unknown.Report source: literature source: su, j., liu, c., li, p., wu, j.Contralateral gallbladder perforation and hemoperitoneum caused by an electrocautery-enhanced lumen-apposing metal stent during endoscopic ultrasound-guided gallbladder drainage.Endoscopy.2023 dec;55(s 01): e42-e43.Doi: 10.1055/a-1929-9259.Epub 2022 sep 22.Pmid: 36138531; pmcid: pmc9812679.Imdrf patient code e1024 captures the reportable patient complication of peritonitis.Imdrf patient code e0505 captures the reportable patient complication of hematoma.Imdrf patient code e211401 captures the reportable patient complication of perforation, organ(s).Imdrf patient code e0505 captures the reportable patient complication of biliary leak.Imdrf patient code e0506 captures the reportable patient complication of hemorrhage, major.Impact code f2303 is being used to capture the medication required.Impact code f12 is being used to capture serious injury/illness/impairment.Impact code f23 is being used to capture the unexpected medical intervention of percutaneous peritoneal drainage.Impact code f2301 is being used to capture the use of snare to remove blood clots.Impact code f2302 is being used to capture blood transfusion procedure performed.

Event Description

Boston scientific became aware of an event involving an axios stent and electrocautery enhanced delivery system through the article "contralateral gallbladder perforation and hemoperitoneum caused by an electrocautery-enhanced lumen-apposing metal stent during endoscopic ultrasound-guided gallbladder drainage" by su jiayi et al.According to the literature, the patient was admitted with malignant distal biliary obstruction.The patient underwent repeated attempts of endoscopic retrograde cholangiopancreatography (ercp) but were unsuccessful.Percutaneous transhepatic gallbladder drainage (ptgd) was performed following a complication of biliary peritonitis.Endoscopic ultrasound- guided biliary drainage (eus-bd) was not feasible considering the limited diameter of the bile duct after ptgd drainage.Therefore, endoscopic ultrasound- guided gallbladder drainage (eus-gbd) procedure was performed using an axios stent and electrocautery enhanced delivery system.During the procedure, the axios electrocautery tip accidentally penetrated the contralateral gallbladder neck which resulted in the perforation of the gallbladder, bile leakage, and extra luminal bleeding.The axios stent was immediately pulled back into the gallbladder and deployed the axios stent in the correct position.A dilation balloon was used to dilate the axios stent up to 11.5 mm, which allowed a therapeutic gastroscope to pass through the stent into the gallbladder.Endoscopic inspection revealed blood clots in the gallbladder, obscuring the endoscopic view.An endoscopic snare was used to remove the blood clots, exposing the perforation of the gallbladder wall.Endoscopic closure of the perforation was performed using through-the- scope clips.After the procedure, the patient developed abdominal bleeding and peritonitis, and received percutaneous peritoneal drainage, blood transfusion (4 units, suspension of red blood cells) and antibiotics.Percutaneous peritoneal drainage decreased gradually, and abdominal pain was relieved after conservative treatment without laparotomy.The patient was discharged after removing the percutaneous transhepatic gallbladder drainage (ptgd) and abdominal drainage tube 7 days later.

Manufacturer Narrative

Blocks b5, d4 (model number, catalog number, unique identifier #), d6a, d7a, g4, and h8 have been updated with the additional information received on february 16, 2023.Block b3: approximated based on the year the literature was published.Block e1: the initial reporter's facility name is (b)(6).Block d4, h4: a 15mm x 10mm axios stent was used; however, the upn and lot number of the complaint device was not provided.Therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: su, j., liu, c., li, p., wu, j.Contralateral gallbladder perforation and hemoperitoneum caused by an electrocautery-enhanced lumen-apposing metal stent during endoscopic ultrasound-guided gallbladder drainage.Endoscopy.2023 dec;55(s 01): e42-e43.Doi: 10.1055/a-1929-9259.Epub 2022 sep 22.Pmid: 36138531; pmcid: pmc9812679.Block h6: imdrf patient code e1024 captures the reportable patient complication of peritonitis.Imdrf patient code e0505 captures the reportable patient complication of hematoma.Imdrf patient code e211401 captures the reportable patient complication of perforation, organ(s).Imdrf patient code e0505 captures the reportable patient complication of biliary leak.Imdrf patient code e0506 captures the reportable patient complication of hemorrhage, major.Impact code f2303 is being used to capture the medication required.Impact code f12 is being used to capture serious injury/illness/impairment.Impact code f23 is being used to capture the unexpected medical intervention of percutaneous peritoneal drainage.Impact code f2301 is being used to capture the use of snare to remove blood clots.Impact code f2302 is being used to capture blood transfusion procedure performed.

Event Description

Boston scientific became aware of an event involving an axios stent and electrocautery enhanced delivery system through the article "contralateral gallbladder perforation and hemoperitoneum caused by an electrocautery-enhanced lumen-apposing metal stent during endoscopic ultrasound-guided gallbladder drainage" by su jiayi et al.According to the literature, the patient was admitted with malignant distal biliary obstruction.The patient underwent repeated attempts of endoscopic retrograde cholangiopancreatography (ercp) but were unsuccessful.Percutaneous transhepatic gallbladder drainage (ptgd) was performed following a complication of biliary peritonitis.Endoscopic ultrasound- guided biliary drainage (eus-bd) was not feasible considering the limited diameter of the bile duct after ptgd drainage.Therefore, endoscopic ultrasound- guided gallbladder drainage (eus-gbd) procedure was performed using an axios stent and electrocautery enhanced delivery system.During the procedure, the axios electrocautery tip accidentally penetrated the contralateral gallbladder neck which resulted in the perforation of the gallbladder, bile leakage, and extra luminal bleeding.The axios stent was immediately pulled back into the gallbladder and deployed the axios stent in the correct position.A dilation balloon was used to dilate the axios stent up to 11.5 mm, which allowed a therapeutic gastroscope to pass through the stent into the gallbladder.Endoscopic inspection revealed blood clots in the gallbladder, obscuring the endoscopic view.An endoscopic snare was used to remove the blood clots, exposing the perforation of the gallbladder wall.Endoscopic closure of the perforation was performed using through-the- scope clips.After the procedure, the patient developed abdominal bleeding and peritonitis, and received percutaneous peritoneal drainage, blood transfusion (4 units, suspension of red blood cells) and antibiotics.Percutaneous peritoneal drainage decreased gradually, and abdominal pain was relieved after conservative treatment without laparotomy.The patient was discharged after removing the percutaneous transhepatic gallbladder drainage (ptgd) and abdominal drainage tube 7 days later.Additional information received on february 16, 2023.It was reported that the axios stent was implanted on (b)(6) 2022.

Manufacturer Narrative

Block e1 (initial reporter first name, last name, and email) has been updated with the additional information received on april 12, 2023.Blocks b5, d4 (model number, catalog number, unique identifier #), d6a, d7a, g4, and h8 have been updated with the additional information received on february 16, 2023.Block b3: approximated based on the year the literature was published.Block e1: the initial reporter's facility name is (b)(6) hospital.Block d4, h4: a 15mm x 10mm axios stent was used; however, the upn and lot number of the complaint device was not provided.Therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: su, j., liu, c., li, p., wu, j.Contralateral gallbladder perforation and hemoperitoneum caused by an electrocautery-enhanced lumen-apposing metal stent during endoscopic ultrasound-guided gallbladder drainage.Endoscopy.2023 dec;55(s 01): e42-e43.Doi: 10.1055/a-1929-9259.Epub 2022 sep 22.Pmid: 36138531; pmcid: pmc9812679.Block h6: imdrf patient code e1024 captures the reportable patient complication of peritonitis.Imdrf patient code e0505 captures the reportable patient complication of hematoma.Imdrf patient code e211401 captures the reportable patient complication of perforation, organ(s).Imdrf patient code e0505 captures the reportable patient complication of biliary leak.Imdrf patient code e0506 captures the reportable patient complication of hemorrhage, major.Impact code f2303 is being used to capture the medication required.Impact code f12 is being used to capture serious injury/illness/impairment.Impact code f23 is being used to capture the unexpected medical intervention of percutaneous peritoneal drainage.Impact code f2301 is being used to capture the use of snare to remove blood clots.Impact code f2302 is being used to capture blood transfusion procedure performed.

Event Description

Boston scientific became aware of an event involving an axios stent and electrocautery enhanced delivery system through the article "contralateral gallbladder perforation and hemoperitoneum caused by an electrocautery-enhanced lumen-apposing metal stent during endoscopic ultrasound-guided gallbladder drainage" by su jiayi et al.According to the literature, the patient was admitted with malignant distal biliary obstruction.The patient underwent repeated attempts of endoscopic retrograde cholangiopancreatography (ercp) but were unsuccessful.Percutaneous transhepatic gallbladder drainage (ptgd) was performed following a complication of biliary peritonitis.Endoscopic ultrasound- guided biliary drainage (eus-bd) was not feasible considering the limited diameter of the bile duct after ptgd drainage.Therefore, endoscopic ultrasound- guided gallbladder drainage (eus-gbd) procedure was performed using an axios stent and electrocautery enhanced delivery system.During the procedure, the axios electrocautery tip accidentally penetrated the contralateral gallbladder neck which resulted in the perforation of the gallbladder, bile leakage, and extra luminal bleeding.The axios stent was immediately pulled back into the gallbladder and deployed the axios stent in the correct position.A dilation balloon was used to dilate the axios stent up to 11.5 mm, which allowed a therapeutic gastroscope to pass through the stent into the gallbladder.Endoscopic inspection revealed blood clots in the gallbladder, obscuring the endoscopic view.An endoscopic snare was used to remove the blood clots, exposing the perforation of the gallbladder wall.Endoscopic closure of the perforation was performed using through-the- scope clips.After the procedure, the patient developed abdominal bleeding and peritonitis, and received percutaneous peritoneal drainage, blood transfusion (4 units, suspension of red blood cells) and antibiotics.Percutaneous peritoneal drainage decreased gradually, and abdominal pain was relieved after conservative treatment without laparotomy.The patient was discharged after removing the percutaneous transhepatic gallbladder drainage (ptgd) and abdominal drainage tube 7 days later.Additional information received on february 16, 2023 it was reported that the axios stent was implanted on (b)(6) 2022.

• 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: 16358553
• MDR Text Key: 309374495
• Report Number: 3005099803-2023-00683
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

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: 01/25/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/16/2023; 04/12/2023
• Supplement Dates FDA Received: 03/07/2023; 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male