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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

(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.

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 in the pancreas for pseudocyst drainage during an endoscopic ultrasound (eus) procedure performed on june 01, 2022.During the procedure, post puncture, the first flange of the axios stent was deployed with some resistance; however, it was unable to fully expand.Consequently, when the catheter was retracted, the stent came out of the cyst completely.The stent was removed from the patient and the procedure was not completed due to device availability.The puncture site was closed with an ovesco clip and there were no patient complications due to this event.

Event Description

It was reported to boston scientific corporation on june 01, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted in the pancreas for pseudocyst drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6), 2022.During the procedure, post puncture, the first flange of the axios stent was deployed with some resistance; however, it was unable to fully expand.Consequently, when the catheter was retracted, the stent came out of the cyst completely.The stent was removed from the patient and the procedure was not completed due to device availability.The puncture site was closed with an ovesco clip and there were no patient complications due to this event.

Manufacturer Narrative

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.An axios stent and electrocautery enhanced delivery system were received for analysis.The stent was received partially deployed and the delivery system was returned in the original position.Visual inspection found two wires of the stent broken (distal-proximal).The stent cover was damaged.The outer sheath was kinked in two sections and in the luer.The tip did not show evidence of electrocautery.During functional inspection, the stent was able to deploy without problems.No other issues were noted to the stent and delivery system.The reported events of stent first flange difficult to position and stent first flange failure to expand could not be confirmed as these occurred during the procedure and are not possible to replicate in the laboratory of analysis.The damages observed to the device were most likely due to procedural factors encountered during the procedure.It may be that the lesion characteristics and the technique used by the user, limited the performance of the device and contributed to stent wire broken, stent cover damaged, and stent partially deployed.Also, the handling of the device and the interaction with the scope could have contributed to the observed event of outer sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Block h11: block h6 (impact codes) has been corrected.

• 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: 14780555
• MDR Text Key: 294952960
• Report Number: 3005099803-2022-03372
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0028720116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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 Outcome(s): Required Intervention