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

Model Number	M00553670
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a hot axios stent was to be implanted to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) guided drainage procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent completely came off the delivery system when the first flange was attempted to be deployed.The fully deployed stent was removed and another axios stent was used to complete the procedure.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 stable.
Additional Manufacturer Narrative
Block h6: problem code 1484 captures the reportable event of stent prematurely deployed.Block h10: a hot axios stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received completely deployed and the delivery system was received in position 4.The outer sheath was kinked near the luer section.A destructive inspection was necessary to destroy the delivery system; the outer sheath was found detached.The outer diameter of the stent was measured and was found to be within specifications.No other issues with the stent and delivery system were noted.The reported event of stent premature deployment could not be confirmed; this failure occurred during the procedure and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, and/or the anatomy of the patient, limited the performance of the device and contributed to stent premature deployment.It may be that the physician felt some resistance during removal which caused the physician to use excessive force trying to remove the device causing the outer sheath to kinked and detached.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a hot axios stent was to be implanted to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) guided drainage procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent completely came off the delivery system when the first flange was attempted to be deployed.The fully deployed stent was removed and another axios stent was used to complete the procedure.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 stable.

• Brand Name: AXIOS
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10472387
• Report Number: 3005099803-2020-03632
• Device Sequence Number: 2828560
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: 08714729979333
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2021
• Device Model Number: M00553670
• Device Catalogue Number: 5367
• Device Lot Number: 0024896255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention