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

Model Number AXS-10-10

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

The complainant was unable to confirm the lot number; therefore, the device manufacture and expiration dates cannot be determined.(b)(4).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 june 02, 2017, that a cold axios stent was implanted in a transgastric position for gallbladder drainage during a procedure in (b)(6) 2012.Reportedly, the patient was considered a high surgical risk patient.The stent was properly placed in a satisfactory location, draining into the gastric posterior antrum.According to the complainant, within hours of the axios placement procedure, the patient developed peritoneal signs, which raised suspicion of a leak.The physician decided to operate on the patient.The patient underwent a cholecystectomy and intra-peritoneal bleeding was reported.The physician reported that the bleeding was not related to the axios stenting procedure as no bleeding was observed during the endoscopic procedure; the bleeding was considered related to surgery.The patient remained hospitalized and died approximately 1 month after surgery.Attempts to obtain additional information regarding the circumstances surrounding this event 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 - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6666480
• MDR Text Key: 78375051
• Report Number: 3005099803-2017-01847
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: SIMILAR
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AXS-10-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 89 YR