ABSOLUTE PRO BILIARY 1011915-080

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 2020-03-31 for ABSOLUTE PRO BILIARY 1011915-080 manufactured by Abbott Vascular.

Event Text Entries

[185725748] 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


[185725749] It was reported that the procedure was to treat a distal superficial femoral artery. A 6. 0x80mm absolute pro stent was advanced to the lesion and deployed without issue. However, it was noted that there was resistance with the anatomy when advancing. When the absolute pro delivery system was being retrieved, resistance was met with the 6fr sheath and the outer sheath of the absolute pro tore off (remaining within the sheath). The absolute pro and introducer sheath were then removed all together. There were no adverse patient effects and no clinically significant delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03134
MDR Report Key9903652
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-06-05
Date Added to Maude2020-03-31
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 NameABSOLUTE PRO BILIARY
Generic NameSELF EXPANDING PERIPHERAL STENT SYSTEM
Product CodeFGE
Date Received2020-03-31
Returned To Mfg2020-03-31
Catalog Number1011915-080
Lot Number9060561
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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