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

Model Number M00553560

Device Problems Positioning Problem (3009); Activation Failure (3270)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas for pseudocyst drainage during an endoscopic ultrasound (eus) procedure performed on november 21, 2023.During the procedure, the stent first flange was deployed; however, it did not expand.The physician attempted to retract the stent near the wall of the pseudocyst, but the stent moved out of its position.The stent was removed from the patient partially deployed.The patient experienced bleeding at the puncture site and an open surgery was performed to address the patient's complications and complete the procedure.In the physician's assessment, there was relationship between the stent and the bleeding.

Manufacturer Narrative

Block h6: imdrf device code a1502 captures the reportable event of stent first flange difficult to position imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf impact code f19 captures the reportable event of surgical intervention performed.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas for pseudocyst drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2023.During the procedure, the stent first flange was deployed; however, it did not expand.The physician attempted to retract the stent near the wall of the pseudocyst, but the stent moved out of its position.The stent was removed from the patient partially deployed.The patient experienced bleeding at the puncture site and an open surgery was performed to address the patient's complications and complete the procedure.In the physician's assessment, there was relationship between the stent and the bleeding.

Manufacturer Narrative

Block h6: imdrf device code a1502 captures the reportable event of stent first flange difficult to position.Imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf impact code f19 captures the reportable event of surgical intervention performed.Block h10: an axios stent and electrocautery enhanced delivery system were received for analysis.Visual examination of the returned device found the stent partially deployed.Functional inspection was performed, by sliding the catheter lock to the right to unlock the catheter, then the catheter control hub was moved up and down.The catheter passed through the luer without resistance.Also, the stent hub was move down to the second and fourth position without any problem.The stent was deployed without problems.No other problems were noted with the stent and delivery system.The reported events of stent first flange failure to expand and stent first flange difficult to position cannot be confirmed as these events occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.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: 18312708
• MDR Text Key: 330299083
• Report Number: 3005099803-2023-06567
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K220112
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0032234594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• 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 Outcome(s): Required Intervention