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

Model Number M00553650

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

Patient Problem Sepsis (2067)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6) clinical trial.(b)(4).The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a hot axios stent was implanted in a transgastric position to treat a pancreatic walled-off necrosis during an inpatient stent placement procedure performed on (b)(6) 2019.The stent was placed as part of the (b)(6) clinical trial.The patient was enrolled into the clinical trial on (b)(6) 2019.According to the complainant, on (b)(6) 2019, the patient developed sepsis, and an abdominal computer tomography (ct) was performed.The ct showed signs of a new systemic infection, including fever, leukocytosis, and visualization of gas bubbles within the necrotic tissue.A necrosectomy procedure was performed on (b)(6) 2019 for insufficient won size reduction and to treat the patient's sepsis.The patient's won was measured to be greater than 3cm.The hot axios stent was confirmed to be patent and draining pus, necroses, and debris.Another necrosectomy procedure was performed on (b)(6) 2019 for insufficient won size reduction.The patient's won was again measured to be greater than 3cm.The hot axios stent was confirmed to be patent and draining pus, necroses, and debris.On (b)(6) 2019, under ct fluoroscopy guidance, serial dilation was performed, and a 12 french pigtail stent was placed due to the patient's illness.Insufficient won size reduction was noted.On (b)(6) 2019, two double pigtail stents were placed and balloon dilation of the tract was performed.The patient's won was measured to be less than 3cm.Drainage and patency of the hot axios stent were confirmed.According to the complainant, the sepsis was unlikely to be related to the axios stent and stent placement, and probably related to the complex necrotic debris.Reportedly, the patient's hospitalization was prolonged as a result of this event.As of (b)(6) 2019, the patient's condition was reported to be recovered.

• Brand Name: AXIOS
• 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: 9312831
• MDR Text Key: 168081369
• Report Number: 3005099803-2019-05506
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2021
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0024248637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR