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

Model Number M00553550

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

Patient Problem Death (1802)

Event Date 08/05/2018

Event Type  Death  

Manufacturer Narrative

The complainant indicated that the device remains implanted 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 august 20, 2018 that a hot axios stent was successfully implanted to treat a pancreatic fluid collection during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2018.Reportedly, prior to stent placement, the patient had presented with discomfort due to chronic pancreatitis that was ongoing for approximately 18 months.The patient's pancreatic fluid collection had necrotic tissue visible within and was approximately 20 cm in size.The stent placement was completed without any complications during and immediately post procedure, and there was no alleged deficiency of the axios device.According to the complainant, following the procedure, the patient was kept in the hospital overnight for routine observation, as part of the physician's normal post-procedure protocol.The patient left the hospital the next day with no observed complications and returned home.On (b)(6) 2018, the patient was found at home deceased.Attempts by boston scientific obtain additional information regarding the patient's cause of death and the relationship between the axios stent and the patient's death have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: AXIOS STENT AND 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7881357
• MDR Text Key: 120428228
• Report Number: 3005099803-2018-60276
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2020
• Device Model Number: M00553550
• Device Catalogue Number: 50270
• Device Lot Number: 0021850192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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): Death
• Patient Age: 68 YR