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

Model Number M00553650

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion code is being used in lieu of an adequate conclusion code for "device not returned".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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a hot axios stent was to be implanted in a transgastric position to treat a 9-cm pancreatic pseudocyst during an endoscopic ultrasound (eus) pseudocyst drainage procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician successfully deployed the first flange of the stent.The first flange of the stent was then pulled back against the inner wall of the pseudocyst and deployment of the second flange was performed.Reportedly, the physician was using the alternative method of deployment where the second flange of the stent is fully-deployed in the scope, and the stent is then released from the scope by advancing the catheter and retracting the scope in a 1-to-1 fashion.After deployment of the second flange, it was noted that the entire stent was positioned inside of the pseudocyst.Eus was performed, and the stent was noted to be located at the bottom of the pseudocyst.A second hot axios stent was then implanted to complete the procedure.A second attempt was made to visualize the first axios stent under eus, but it could not be found.The patient was scheduled to return to the hospital two weeks after the procedure to have both stents removed.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: AXIOS STENT AND DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7705321
• MDR Text Key: 114537959
• Report Number: 3005099803-2018-02311
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150692
• 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: 06/26/2018

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 Expiration Date: 05/10/2020
• Device Model Number: M00553650
• Device Lot Number: 0022105692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• 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