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

Model Number	M00553750
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
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 that a cold axios stent was to be implanted in a transgastric position to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2016.According to the complainant, during deployment of the second flange of the axios stent, the physician accidentally pulled on the handle of the delivery system too quickly, which pulled the first flange of the stent out of the target site and deployed the second flange in the patient's stomach.The stent remained attached to the delivery system and the physician was able to "recapture" the stent into the catheter.The stent was then removed from the patient on the delivery system.However, as the device was removed from the scope, the stent detached from the delivery system and became stuck inside the scope, just distal to the biopsy cap.The physician was unable to remove the stent from the scope by hand.The scope was then removed from the patient and the delivery system was reinserted into the scope.The stent was successfully pushed out of the scope with the delivery system.The procedure was then completed with another cold axios stent and delivery system.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
A fully-deployed cold axios delivery system was received for analysis.The axios stent was not returned.A visual examination of the device noted that the catheter was kinked just distal to the luer and the distal end of the catheter was slightly flattened.The polyimide inner shaft was kinked at multiple points.A functional evaluation of the device revealed no issues.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a cold axios stent was to be implanted in a transgastric position to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2016.According to the complainant, during deployment of the second flange of the axios stent, the physician accidentally pulled on the handle of the delivery system too quickly, which pulled the first flange of the stent out of the target site and deployed the second flange in the patient's stomach.The stent remained attached to the delivery system and the physician was able to "recapture" the stent into the catheter.The stent was then removed from the patient on the delivery system.However, as the device was removed from the scope, the stent detached from the delivery system and became stuck inside the scope, just distal to the biopsy cap.The physician was unable to remove the stent from the scope by hand.The scope was then removed from the patient and the delivery system was reinserted into the scope.The stent was successfully pushed out of the scope with the delivery system.The procedure was then completed with another cold axios stent and delivery system.There were no patient complications 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
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6206595
• Report Number: 3005099803-2016-04051
• Device Sequence Number: 10991548
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: (01)08714729904632(17)20170428(10)FGS00443
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K140561
• 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): 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: M00553750
• Device Lot Number: FGS00443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1