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); Activation Failure (3270)

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

Event Date 04/14/2022

Event Type  malfunction  

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)- cystogastrostomy procedure performed on (b)(6).2022.During the procedure, the second flange did not deploy.The physician also noted that the first flange did not fully expand.The stent was removed partially deployed and a different device was used to complete the procedure.There were no patient complications due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Initial reporter address:(b)(6).(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

Block b5 has been updated with the additional information received on november 09, 2022.Block e1: initial reporter address: chandigarh rd, near civil hospital, phase 6, sec-56, sas nagar.Block h6: medical device problem code a150101 captures the reportable event of stent first flange failed to expand.Medical device problem code a15 captures the reportable event of stent partially deployed.Block h10 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 a hot axios stent was to be implanted transgastric to the pancreas to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus)- cystogastrostomy procedure performed on (b)(6) 2022.During the procedure, the second flange did not deploy.The physician also noted that the first flange did not fully expand.The stent was removed partially deployed and a different device was used to complete the procedure.There were no patient complications due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on november 09, 2022: it was reported that the physician did not attempt to re-constrain the stent.

Manufacturer Narrative

Block b5 :has been updated with the additional information received on november 09, 2022.Block e1: initial reporter address: chandigarh rd, near civil hospital, phase 6, sec-56, sas nagar.Block h6: medical device problem code a150101 captures the reportable event of stent first flange failed to expand.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 returned partially deployed.Visual examination of the returned device found one wire of the stent broken and holes were noted on the stent cover.The inner tube was also kinked.Functional inspection was performed, the stent was able to be deployed; however, resistance was felt and the proximal flange did not expand.No other problems were noted to the stent and delivery system.The investigation concluded that the observed failure of stent partially deployed and inner tube kinked were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, the technique used by the physician and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the stent partial deployment and inner tube kinked.The reported event of stent first flange failure to expand cannot be confirmed; the stent first flange was received fully expanded.Taking all available information into consideration, investigation findings do not lead to a clear conclusion about the cause of the reported events.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation on april 14, 2022, that a hot axios stent was to be implanted transgastric to the pancreas to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus)- cystogastrostomy procedure performed on (b)(6) 2022.During the procedure, the second flange did not deploy.The physician also noted that the first flange did not fully expand.The stent was removed partially deployed and a different device was used to complete the procedure.There were no patient complications due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on november 09, 2022.It was reported that the physician did not attempt to re-constrain the stent.

• 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: 14291431
• MDR Text Key: 293485334
• Report Number: 3005099803-2022-02335
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2023

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: 01/18/2024
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0028698862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 11/09/2022; 12/13/2022
• Supplement Dates FDA Received: 12/01/2022; 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 78 KG