AXIOS STENT AND DELIVERY SYSTEM M00553530 5353

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-08 for AXIOS STENT AND DELIVERY SYSTEM M00553530 5353 manufactured by Boston Scientific Corporation.

Event Text Entries

[174310208] (b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[174310209] It was reported to boston scientific corporation that a hot axios stent was to be implanted transduodenal to the bile duct to treat cholestasis caused by pancreatic cancer during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the second flange of the stent failed to deploy. The device was removed from the patient with the stent partially deployed on the delivery system, and a second hot axios stent was placed to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable and okay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-06444
MDR Report Key9565825
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-08
Date of Report2020-02-14
Date of Event2019-12-09
Date Mfgr Received2020-01-25
Device Manufacturer Date2019-10-24
Date Added to Maude2020-01-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAXIOS STENT AND DELIVERY SYSTEM
Generic NamePANCREATIC STENT, COVERED, METALLIC, REMOVABLE
Product CodePCU
Date Received2020-01-08
Returned To Mfg2020-01-06
Model NumberM00553530
Catalog Number5353
Lot Number0024653589
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-08

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