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

Model Number M00553660

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

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(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 implanted in a transgastric position to treat an encapsulated walled-off necrosis (won) in the pancreas during a hot axios stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's won contained 10% necrosis, and the patient underwent 6 necrosectomy procedures.According to the complainant, on (b)(6) 2020, the patient experienced a severe pancreatic cyst hemorrhage.Interventional radiology (ir) and endoscopic hemostasis were performed.The patient also received a blood transfusion.There is no information available if there was a was relationship between the stent and the bleeding.Reportedly, on (b)(6) 2020, the bleeding was resolved and the patient had recovered.On (b)(6) 2020, the stent removal procedure was performed and the stent was successfully removed.

Event Description

It was reported to boston scientific corporation on july 30, 2020 that a hot axios stent was implanted in a transgastric position to treat an encapsulated walled-off necrosis (won) in the pancreas during a hot axios stent placement procedure performed on (b)(6)2020.Reportedly, the patient's won contained 10% necrosis, and the patient underwent 6 necrosectomy procedures.According to the complainant, on (b)(6) 2020, the patient experienced a severe pancreatic cyst hemorrhage.Interventional radiology (ir) and endoscopic hemostasis were performed.The patient also received a blood transfusion.There is no information available if there was a was relationship between the stent and the bleeding.Reportedly, on (b)(6) 2020, the bleeding was resolved and the patient had recovered.On (b)(6) 2020, the stent removal procedure was performed and the stent was successfully removed.Additional information received on august 20, 2020.The complainant reported that the patient experienced a severe pancreatic cyst hemorrhage.Further information from the complainant confirmed that the bleeding occurred from the same pancreatic cysts that hot axios stent was placed, but the bleeding point was not close to axios stent.According to the physician, the bleeding was not related to the axios stent.

Manufacturer Narrative

Blocks b5, e1 (initial reporter title, initial reporter first name and initial reporter last name), e3 and h6 (patient codes) have been updated with additional information received on august 20, 2020.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: conclusion code 4316 is being used in lieu of an appropriate code to capture the conclusion of device not returned.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.

• 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: 10430636
• MDR Text Key: 203653011
• Report Number: 3005099803-2020-03474
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• PMA/PMN Number: K163272
• 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: 09/10/2020

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: M00553660
• Device Catalogue Number: 5366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 63