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

Model Number M00553560

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978); Poor Visibility (4072)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on september 29, 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas to treat a 60% necrosis collection during a pancreatic drainage procedure performed on (b)(6) 2022.During the procedure, the endoscopic marker found on the delivery system could not be seen when the second flange of the axios stent was attempted to be deployed.At the end of the procedure, after the physician completed the step #4 of deployment, the second flange of the axios stent was not deployed and remained inside the delivery system.The axios stent was removed from the patient partially deployed.The procedure was completed with another axios stent.There were no patient complications as a result of this event.Note: it was reported that the axios stent was intended to be placed to treat a necrosis collection with 60% necrotic material.However, per the axios stent and electrocautery-enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery and bile duct after failed ercp in patients with biliary obstruction due to a malignant stricture.The hot axios stent is not indicated to be implanted in a necrosis collection with >30% necrotic material.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6) 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas to treat a 60% necrosis collection during a pancreatic drainage procedure performed on (b)(6) 2022.During the procedure, the endoscopic marker found on the delivery system could not be seen when the second flange of the axios stent was attempted to be deployed.At the end of the procedure, after the physician completed the step #4 of deployment, the second flange of the axios stent was not deployed and remained inside the delivery system.The axios stent was removed from the patient partially deployed.The procedure was completed with another axios stent.There were no patient complications as a result of this event.Note: it was reported that the axios stent was intended to be placed to treat a necrosis collection with 60% necrotic material.However, per the axios stent and electrocautery-enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery and bile duct after failed ercp in patients with biliary obstruction due to a malignant stricture.The hot axios stent is not indicated to be implanted in a necrosis collection with >30% necrotic material.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of axios stent partially deployed.An axios stent and electrocautery enhanced delivery system was received for analysis.The stent was returned fully deployed and expanded.Visual examination of the returned device found the inner sheath kinked in different sections.The stent cover was also found damaged (holes).No other problems were noted to the stent and delivery system.The investigation concluded that the observed failure of inner sheath kinked was likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, the technique used by the physician and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the inner sheath kinked.A labeling review was performed and, from the information available, this device was used in a manner inconsistent per the instructions for use (ifu) / product label.It was reported that the axios stent was intended to be placed to treat a necrosis collection with 60% necrotic material.The ifu states, "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery and bile duct after failed ercp in patients with biliary obstruction due to a malignant stricture." the hot axios stent is not indicated to be implanted in a necrosis collection with >30% necrotic material.The reported event of delivery system not visible under eus or fluoroscopy cannot be confirmed, because it occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.The reported event of stent partially deployed cannot be confirmed; the stent was returned fully deployed and expanded.Taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported event.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15624599
• MDR Text Key: 301919948
• Report Number: 3005099803-2022-06135
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0029675154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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 Sex: Male
• Patient Weight: 70 KG