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 2020-01-17 for AXIOS STENT AND DELIVERY SYSTEM M00553530 5353 manufactured by Boston Scientific Corporation.

Event Text Entries

[176834912] Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. The exact date of the event is unknown. The provided event date, (b)(6) 2019, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 12/23/2019. (b)(4). Although expected, the device has not been received for analysis. Upon receipt and 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


[176834913] It was reported to boston scientific corporation that a hot axios stent was to be implanted transduodenal to the bile duct during an ultrasound-guided biliary drainage procedure performed on an unknown date. According to the complainant, during the procedure, the first flange of the stent began deploying further from the tip of the delivery system than the physician had experienced in previous stent placement procedures, and the first flange was deployed outside of the bile duct. The device was removed from the patient with the stent still partially deployed on the delivery system. The procedure was completed by placing another stent through the existing puncture site created during the attempted axios stent placement. There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-00076
MDR Report Key9604317
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-17
Date of Report2020-01-17
Date of Event2019-12-01
Date Mfgr Received2019-12-23
Device Manufacturer Date2019-07-31
Date Added to Maude2020-01-17
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 Received2020-01-17
Model NumberM00553530
Catalog Number5353
Lot Number0024194209
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2020-01-17

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