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

Device Problem Migration (4003)

Patient Problems Death (1802); Sepsis (2067)

Event Date 03/29/2019

Event Type  Death  

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device 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

It was reported to boston scientific corporation that a hot axios stent was implanted in a transduodenal position to facilitate biliary drainage during an endoscopic ultrasound (eus) guided biliary drainage procedure performed on (b)(6) 2019.Reportedly, the patient had locally advanced inoperable pancreatic cancer and severe chronic obstructive airway disease (coad).The patient had previously undergone a failed endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the bile duct was punctured using a 19 gauge eus needle and a guide wire was passed into the bile duct.A cholangiogram was performed to confirm access to the bile duct.The hot axios stent was placed using eus visualization, and following the stent placement, bile was observed to be draining into the duodenum through the stent.The guide wire was removed, and the physician checked the stent position using eus.The physician felt that the stent was appropriately positioned.Reportedly, the patient did not do well overnight, and a computed tomography (ct) scan showed that the distal flange of the stent was located between the bile duct and the duodenum.The patient refused further treatment and died later that night.The clinical cause of the patient's death was sepsis related to a leak from the gastrointestinal (gi) and biliary tract.According to the physician, upon reflection, the imaging was complex, and although he felt it was appropriately positioned during the procedure the physician could not absolutely confirm the first flange was inside the bile duct.He stated that "in retrospect i may have pushed the bile duct wall away from the duodenum and deployed the distal flange in a false space between the duodenum and bile duct".

• Brand Name: AXIOS STENT AND 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8555105
• MDR Text Key: 143243483
• Report Number: 3005099803-2019-02183
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• 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