XACT CAROTID 82092-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-20 for XACT CAROTID 82092-01 manufactured by Abbott Vascular.

Event Text Entries

[175704185] The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10


[175704186] It was reported that the procedure performed was a carotid endarterectomy surgery. An 8x30mm xact self-expanding stent system (sess) was advanced to the left common carotid artery, and deployment was initiated. After one or two rotations of the deployment actuator, the stent jumped forward into the aortic arch but remained on an unspecified guide wire. The stent was retrieved with a snare, and an unspecified, off-label balloon-expandable stent was used to successfully complete the procedure. There were no adverse patient sequelae, but there was a clinically significant delay of 15-20 minutes in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-00774
MDR Report Key9606892
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-20
Date of Report2020-03-10
Date of Event2020-01-03
Date Mfgr Received2020-02-18
Device Manufacturer Date2018-11-08
Date Added to Maude2020-01-20
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 ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXACT CAROTID
Generic NameSELF EXPANDING PERIPHERAL STENT SYSTEM
Product CodeNIM
Date Received2020-01-20
Returned To Mfg2020-01-10
Model Number82092-01
Catalog Number82092-01
Lot Number8110861
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-20

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