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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE Back to Search Results
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.
 
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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 Key16358553
MDR Text Key309374495
Report Number3005099803-2023-00683
Device Sequence Number1
Product Code PCU
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K150692
Number of Events Reported1
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 NumberM00553550
Device Catalogue Number5355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2023
Initial Date FDA Received02/10/2023
Supplement Dates Manufacturer Received02/16/2023
04/12/2023
Supplement Dates FDA Received03/07/2023
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 Number1
Patient Outcome(s) Required Intervention; Other;
Patient Age83 YR
Patient SexMale
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