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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/16/2022

Event Type  malfunction  

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 walled-of-necrosis (won) with 40-45% necrotic material during an endoscopic ultrasound (eus) pseudocyst drainage procedure performed on (b)(6) 2022.During the procedure, the stent could not fully deploy.The stent was removed from the patient partially deployed and a plastic stent was used to complete the procedure.There were no patient complications as a result of this event.The patient was under observation to check the puncture site and procedure completion and the patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the axios stent was intended to be placed to treat a walled-of-necrosis with 40-45% 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 walled-of-necrosis with 30% necrotic material.It was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery enhanced delivery system directions for use state, rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of axios stent partially deployed.Block h10: an axios stent and electrocautery enhanced delivery system were returned for analysis.Visual examination of the returned device found the stent completely deployed.The delivery system was returned in position "2".Functional inspection was performed; the catheter was able to pass through the luer without resistance.Also, the stent hub was able to be moved down to the second and fourth position.No other problems were noted to the stent and delivery system.The reported event of stent partially deployed could not be confirmed as the stent was received completely deployed.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the device was intended to be placed to treat a walled-of-necrosis with >30% necrotic material.The ifu states, "the hot 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 placed to treat a walled-of-necrosis with >30% necrotic material.Furthermore, it was reported that the handle was rotated as the device was luer locked to the scope.The ifu states "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported event as the stent was returned completely deployed.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

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 walled-of-necrosis (won) with 40-45% necrotic material during an endoscopic ultrasound (eus) pseudocyst drainage procedure performed on (b)(6) 2022.During the procedure, the stent could not fully deploy.The stent was removed from the patient partially deployed and a plastic stent was used to complete the procedure.There were no patient complications as a result of this event.The patient was under observation to check the puncture site and procedure completion and the patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the axios stent was intended to be placed to treat a walled-of-necrosis with 40-45% 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 walled-of-necrosis with >30% necrotic material.It was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery enhanced delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

• 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: 15375385
• MDR Text Key: 306329905
• Report Number: 3005099803-2022-05045
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0028949940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 50 KG