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

Model Number M00553550

Device Problems 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 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on february 08, 2022 that a hot axios stent was to be implanted transgastric to the pancreas to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2022.The physician was using the eus method of deployment where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1:1 fashion.During the procedure, the first flange was deployed; however, when the physician attempted to deploy the second flange inside the scope, the second flange could not be deployed.The stent was removed partially deployed from the patient and the procedure was completed using another axios stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of stent partially deployed.Block h10: an axios stent and electrocautery-enhanced delivery system were returned for analysis.The stent was received fully covered by the outer sheath and undeployed.The delivery system was returned in its original position.Visual examination of the returned device found the outer sheath kinked.The tip did not show evidence of electrocautery.Functional inspection was performed; the catheter passed through the luer without resistance and the hub was able to move as expected and without issue.No other problems with the stent and delivery system were noted.Based on the available information, the investigation concluded that the observed failure of outer sheath kinked was likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, and/or the technique used by the physician, could have contributed to the outer sheath kinked.The reported event of stent partially deployed could not be confirmed.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.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 (b)(6) 2022 that a hot axios stent was to be implanted transgastric to the pancreas to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2022.The physician was using the eus method of deployment where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1:1 fashion.During the procedure, the first flange was deployed; however, when the physician attempted to deploy the second flange inside the scope, the second flange could not be deployed.The stent was removed partially deployed from the patient and the procedure was completed using another axios stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 13624857
• MDR Text Key: 288103744
• Report Number: 3005099803-2022-01047
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K150692
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0027627999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 88 KG