MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number M00553660

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Septic Shock (2068); Hematemesis (4478)

Event Date 03/01/2021

Event Type  Death  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2021 as the event occurred before (b)(6) 2021 when the article was published.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Literature source: patel, r.H., everett, b.T., akselrod, d., frasca, j.D., & gordon, s.R.(2021).Fatal aortoesophageal fistula complicating placement of a 20-mm lumen-apposing metal stent for refractory esophagojejunal anastomotic stricture.Acg case reports journal, 8(3).Doi:10.14309/crj.0000000000000548.(b)(4).The patient expired, the stent remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Boston scientific became aware of an event involving a hot axios stent through the article "fatal aortoesophageal fistula complicating placement of a 20-mm lumen-apposing metal stent for refractory esophagojejunal anastomotic stricture" by dr.Rupal h.Patel, et al.It was reported to boston scientific corporation on april 05, 2021 that a hot axios stent was implanted to treat a benign refractory esophagojejunal anastomotic stricture in the esophagus during a procedure performed on an unknown date.It was reported that the plan was to leave the axios implanted for 12 weeks.During the procedure, the axios stent was successfully deployed.However, 6 weeks after the stent placement procedure the patient experienced hematemesis and hemodynamic instability.An upper endoscopy was performed and rapid arterial hemorrhage from the distal edge of the stent was noted.Computerized tomography angiogram and arteriogram were also performed and an aortoenteric fistula was noted, as well as, erosion of the distal flange into the aorta.The aortoenteric fistula was treated with an endovascular stent graft; however, the patient subsequently developed septic shock from escherichia coli bacteremia and passed away the next day.In the physician's assessment, there was a relationship between the patient's death and the axios stent.It is unknown if an autopsy was performed.The physician reported it might be best to avoid using the 20-mm lams for benign refractory esophageal strictures and instead use the smaller 15-mm lams.The physician suspects that the size of axios and the radial force exerted by the flange width may have resulted in the development of the aortoesophageal fistula.Note: it was reported that the axios stent was intended to be placed to treat a benign refractory esophagojejunal anastomotic stricture in the esophagus.However, per the hot axios stent and electrocautery- enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.The hot axios stent is not indicated to be implanted in the esophagus.

• Brand Name: AXIOS
• 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: 11745134
• MDR Text Key: 247945179
• Report Number: 3005099803-2021-01915
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2021

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: M00553660
• Device Catalogue Number: 5366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/29/2021
• 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): Death; Other
• Patient Age: 66 YR