MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number M00553640

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Sepsis (2067)

Event Date 06/06/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant reported that the device was not expired.Initial reporter city, state and zip code: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 (b)(6) 2020 that a hot axios stent was successfully implanted in a transgastric position to treat an encapsulated walled-off necrosis (won) with 70% fluid content in the pancreas during a procedure performed on (b)(6) 2020.According to the complainant, on (b)(6) 2020, stent removal procedure was performed.During the procedure, the removal of the stent was attempted 2 to 3 times and it was successfully removed using a snare or forceps.On (b)(6) 2020, the patient experienced sepsis and was given conservative treatment.In the physician's assessment, the physician is not sure if the sepsis and the stent are related.Reportedly, hemostasis was performed once; however, the details were unknown.There is no information available if there was a relationship between the stent and the bleeding.

Manufacturer Narrative

Blocks b5 and h6 (patient code) have been updated with additional information received on (b)(6) 2020.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant reported that the device was not expired.Block e1: initial reporter city, state and zip code: (b)(6) block h6: patient code 2067 captures the reportable event of sepsis.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; 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 (b)(6), 2020 that a hot axios stent was successfully implanted in a transgastric position to treat an encapsulated walled-off necrosis (won) with 70% fluid content in the pancreas during a procedure performed on (b)(6) 2020.According to the complainant, on(b)(6), 2020, stent removal procedure was performed.During the procedure, the removal of the stent was attempted 2 to 3 times and it was successfully removed using a snare or forceps.On (b)(6) 2020, the patient experienced septic sysmptoms and was given conservative treament.In the physician's assessment, the physician is not sure if the sepsis and the stent are related.Reportedly, hemostasis was performed once; however, the details were unknown.There is no information available if there was relationship between the stent and the bleeding.***additional information received on (b)(6) 2020*** according to the complainant, on (b)(6) 2020, moderate bleeding inside the pancreatic cyst was noted.Reportedly, an endoscopic hemostatis was perfomed.In the physician's assessment the bleeding was not related to axios but was caused by a scope procedure.On (b)(6) 2020, a follow-up was performed and sepsis was noted.The patient was reported to be recovering on (b)(6), 2020.

• Brand Name: AXIOS
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10235975
• MDR Text Key: 197798208
• Report Number: 3005099803-2020-02626
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: 08714729904588
• Combination Product (y/n): N
• PMA/PMN Number: K153088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00553640
• Device Catalogue Number: 5364
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 75