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

Model Number M00553550

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 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the evaluation has not yet been completed.Upon receipt and 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 transgastric to the duodenum to treat gastric obstruction to the duodenum during a gastrointestinal connection procedure performed on (b)(6), 2019.According to the complainant, as the physician was withdrawing the guidewire through the axios delivery system, the guidewire got stuck and could not be moved.The device was removed from the patient with the stent fully covered by the outer sheath.After the device was removed from the patient, the physician attempted to remove the guidewire from the axios delivery system, and the stent prematurely deployed off the delivery system.The procedure was not completed because another hot axios stent was not available.On (b)(6) 2019, another hot axios was successfully implanted.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 transgastric to the duodenum to treat gastric obstruction to the duodenum; however the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or the biliary tract.

Manufacturer Narrative

Device code 1484 captures the reportable event of stent premature deployment.A hot axios stent and delivery system was returned for analysis.A visual examination of the device noted that the stent was received fully deployed and expanded.A guidewire was stuck inside the axios delivery system and could not be removed.The guidewire was peeled, and the corewire was exposed.The axios 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 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 measured to be within specifications.There were no other issues noted.The reported deployment issues indicate operational difficulties experienced during the procedure and are likely due to anatomical or procedural factors.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.A labeling review was performed, and there was evidence that the device was used in a manner inconsistent with the labeling.The hot axios stent was being implanted transgastric to the duodenum to treat gastric obstruction to the duodenum; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or the biliary tract.

Event Description

It was reported to boston scientific corporation that a hot axios stent was to be implanted transgastric to the duodenum to treat gastric obstruction to the duodenum during a gastrointestinal connection procedure performed on (b)(6) 2019.According to the complainant, as the physician was withdrawing the guidewire through the axios delivery system, the guidewire got stuck and could not be moved.The device was removed from the patient with the stent fully covered by the outer sheath.After the device was removed from the patient, the physician attempted to remove the guidewire from the axios delivery system, and the stent prematurely deployed off the delivery system.The procedure was not completed because another hot axios stent was not available.On (b)(6) 2019, another hot axios was successfully implanted.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 transgastric to the duodenum to treat gastric obstruction to the duodenum; however the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or the biliary tract.

• 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
• MDR Report Key: 9269066
• MDR Text Key: 182374265
• Report Number: 3005099803-2019-05259
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0023651046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR