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

Model Number M00553660

Device Problems Premature Activation (1484); Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 Description

It was reported to boston scientific corporation that a hot axios stent was to be implanted in the pylorus to treat a pyloric stricture during a gastroduodenostomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, while the axios delivery system was being advanced over a guidewire, the coating stripped off the guidewire, and the first flange of the stent prematurely deployed inside the scope.The guidewire was cut to allow for removal of the axios delivery system from the scope.The device was removed from the scope with the stent still partially deployed on the delivery system.Another hot axios stent and another guidewire were 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.Note: the hot axios stent was being implanted in the pylorus to treat a pyloric stricture; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.

Manufacturer Narrative

Block h6: device code 1484 captures the reportable event of stent first flange premature deployment.Block h10: a hot axios stent and delivery system was returned for analysis.A visual examination of the device noted that the outer sheath was pulled back slightly from the nosecone, exposing the distal end of the stent.The stent deployment hub was in its original position, the catheter hub was moved proximally, and the catheter lock was in the locked position.The yellow safety clip was not returned.A functional evaluation was performed, and the catheter hub advanced and retracted without resistance.The stent deployment hub was also able to be moved without resistance.The stent was able to be fully deployed without any resistance or issue.The stent was measured to be within specifications.There were no other issues noted.A labeling review was performed, and there is evidence that the device was used in a manner inconsistent with the labeling.The hot axios stent was being implanted in the pylorus to treat a pyloric stricture; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.The reported deployment issues indicate operational difficulties experienced during the procedure and are likely due to anatomical or procedural factors.Some echoendoscope and elevator positions result in excess friction between the catheter and the working channel.Friction can impact the performance of the device.Procedural factors, such as the handling of the device and normal procedural difficulties encountered during the procedure, could have possibly affected the device performance and its integrity contributing to the reported event.Therefore, a review and analysis of all available information indicated that the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.

Event Description

It was reported to boston scientific corporation that a hot axios stent was to be implanted in the pylorus to treat a pyloric stricture during a gastroduodenostomy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, while the axios delivery system was being advanced over a guidewire, the coating stripped off the guidewire, and the first flange of the stent prematurely deployed inside the scope.The guidewire was cut to allow for removal of the axios delivery system from the scope.The device was removed from the scope with the stent still partially deployed on the delivery system.Another hot axios stent and another guidewire were 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.Note: the hot axios stent was being implanted in the pylorus to treat a pyloric stricture; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.

• Brand Name: AXIOS
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9226888
• MDR Text Key: 178742815
• Report Number: 3005099803-2019-05064
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0024276570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1