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

Model Number M00553560

Device Problems Difficult or Delayed Positioning (1157); Use of Device Problem (1670); Activation Failure (3270)

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

Event Date 04/26/2022

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 pancreas to treat a pancreatic pseudocyst during a cystogastrostomy procedure performed on (b)(6) 2022.During the procedure, resistance was felt when deploying the first flange of the stent.Eventually, the first flange was deployed but did not fully expand.The stent was removed from the patient partially deployed on the delivery system and another axios stent was implanted 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.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Blocks b5 and h6 (device codes) have been corrected with the additional information received on july 25, 2022.Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: medical device problem code a150101 captures the reportable event of stent first flange failed to expand.Block h10: an axios stent and electrocautery enhanced delivery system were returned for analysis.Visual examination of the returned device found the stent fully deployed and expanded.The deployment hub was received in position "2".The stent cover was inspected and was found with coating voids that exceeded the normal amount specified.No other problems were noted to the stent and delivery system.The reported event of stent first flange failure to expand was not confirmed; the stent was received fully deployed and expanded.The reported event of stent difficult to deploy could not be confirmed because this failure occurred during the procedure and could not be functionally/visually verified.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 pancreatic pseudocyst with more than 75% necrotic material.The ifu states, "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; however, this device is not indicated to be implanted in pancreatic pseudocyst with >30% necrotic material.Additionally, the stent cover was found with coating voids which may caused by the necrotic material resistance.Therefore, a review and analysis of all available information indicated the most probable cause is cause traced to intentional off-label, unapproved, or contraindicated use.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation on april 26, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to pancreas to treat a pancreatic pseudocyst during a cystogastrostomy procedure performed on (b)(6) 2022.During the procedure, resistance was felt when deploying the first flange of the stent.Eventually, the first flange was deployed but did not fully expand.The stent was removed from the patient partially deployed on the delivery system and another axios stent was implanted 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.It was reported that the axios stent was intended to be placed to treat a pancreatic pseudocyst with more than 75% 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 axios stent is not indicated to be implanted in pancreatic pseudocyst with >30% necrotic material.

• 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: 14455330
• MDR Text Key: 292371573
• Report Number: 3005099803-2022-02693
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0027239285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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