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

Device Problems Device-Device Incompatibility (2919); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date, (b)(6) 2019, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2019.The complainant was unable to report the upn or lot number; therefore, the udi#, manufacture date, and expiration date are unknown.(b)(4).The complainant indicated that the device has been disposed of 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a hot axios stent was implanted in a transgastric position to treat acute pancreatitis and an infectious pancreatic walled-off necrosis (won) during an endoscopic ultrasound (eus) procedure performed on an unknown date.Reportedly, the patient had a main complaint of fever and previously had multidisciplinary treatment for severe alcohol acute pancreatitis at a previous hospital, but the fever continued.The patient was transferred to the treating hospital five weeks after the onset of acute pancreatitis to treat the infectious won.The hot axios stent was placed three days after the patient was transferred.According to the complainant, four days after stent placement, endoscopic necrosectomy was performed.During a fifth necrosectomy procedure performed 16 days after stent placement, a 5-leg forceps got caught on the first flange of the stent, and the stent moved into the stomach.The stent was removed from the stomach through the scope.A 10mm snare was then deployed in the lumen of the hot axios, and the flange of the stent was grasped from the outside using the snare.The stent was re-inserted into the pancreatic necrosis cavity endoscopically, the snare was deployed, and the hot axios flange was successfully repositioned.The stent remained in place and a total of 12 endoscopic necrosectomy procedures were completed.There were no patient complications reported as a result of this event.

• 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: 8741517
• MDR Text Key: 149479789
• Report Number: 3005099803-2019-03158
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/27/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2019
• Initial Date FDA Received: 06/27/2019
• 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): Required Intervention
• Patient Age: 65 YR