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

Model Number M00553550

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fever (1858); Sepsis (2067)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the stent remains implanted; therefore, a failure 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 june 01, 2021 that a hot axios stent was implanted transgastic to the gallbladder on (b)(6) 2021 as part of the 92147168 axios for gallbladder drainage ide clinical trial.The patient was enrolled into the clinical trial on (b)(6) 2021.On (b)(6) 2021, the patient experienced positive blood cultures enterococcus faecium with fever.The patient was treated with antibiotics and hospitalization was prolonged.The event was reported to be resolved on (b)(6) 2021 and the stent remains implanted.In the physician's assessment, the positive blood cultures enterococcus faecium with fever had a relationship to the axios stent.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a hot axios stent was implanted transgastic to the gallbladder on (b)(6) 2021 as part of the 92147168 axios for gallbladder drainage ide clinical trial.The patient was enrolled into the clinical trial on (b)(6) 2021.On (b)(6) 2021, the patient experienced positive blood cultures enterococcus faecium with fever.The patient was treated with antibiotics and hospitalization was prolonged.The event was reported to be resolved on (b)(6) 2021 and the stent remains implanted.In the physician's assessment, the positive blood cultures enterococcus faecium with fever had a relationship to the axios stent.Additional information received on august 16, 2021: the patient complication of positive blood cultures enterococcus faecium with fever was updated to sepsis.The patient was treated with antibiotics and there was no prolonged hospitalization due to this event.The event was reported to be resolved on (b)(6) 2021 and the stent remains implanted.In the physician's assessment, the sepsis had a probable relationship to the axios stent.

Manufacturer Narrative

Block b5, h6 (patient codes and impact codes) and h10 have been updated with the additional information received on august 16, 2021.Block h6: patient code e0306 captures the reportable event of sepsis.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the stent remains implanted; 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.Block h11: block b1 has been corrected.

Event Description

It was reported to boston scientific corporation on june 01, 2021 that a hot axios stent was implanted transgastric to the gallbladder on (b)(6), 2021 as part of the 92147168 axios for gallbladder drainage ide clinical trial.The patient was enrolled into the clinical trial on (b)(6), 2021.On (b)(6), 2021, the patient experienced positive blood cultures enterococcus faecium with fever.The patient was treated with antibiotics and hospitalization was prolonged.The event was reported to be resolved on (b)(6), 2021 and the stent remains implanted.In the physician's assessment, the positive blood cultures enterococcus faecium with fever had a relationship to the axios stent.***additional information received on august 16, 2021*** the patient complication of positive blood cultures enterococcus faecium with fever was updated to sepsis.The patient was treated with antibiotics and there was no prolonged hospitalization due to this event.The event was reported to be resolved on (b)(6), 2021 and the stent remains implanted.In the physician's assessment, the sepsis had a probable relationship to the axios stent.***additional information received on april 13, 2022 and april 15, 2022*** it was reported that imaging was performed and it was noted that the axios lumen was in good position; however, residual debris was noted in the gallbladder lumen.The patient was scheduled for removal of the debris from the gallbladder lumen, but due to oncological disease progression, supported care was initiated.The patient recovered from sepsis and survived until (b)(6) 2021, succumbing to oncological disease progression.In the physician's assessment, it is possible that the residual debris in the gallbladder lumen caused the sepsis; therefore, the sepsis had a "possible" relationship to the axios stent and axios stent placement procedure.

Manufacturer Narrative

Block b1, b5, h6 (device codes) and h10 have been updated with the additional information received on april 13, 2022 and april 15, 2022.Block h6: medical device problem code a1409 captures the reportable event of stent obstruction.Patient code e0306 captures the reportable event of sepsis.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the stent remains implanted; 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.

• 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: 12035497
• MDR Text Key: 257749120
• Report Number: 3005099803-2021-02900
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0026529753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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
• Patient Age: 34 YR
• Patient Sex: Male