RX HERCULINK ELITE STENT SYSTEM 1011502-15

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 2020-03-19 for RX HERCULINK ELITE STENT SYSTEM 1011502-15 manufactured by Abbott Vascular.

Event Text Entries

[184442093] The product was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot. The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure. It is likely that manipulation during advancement or back and forth movement during advancement likely caused the stent dislodgement against the guiding catheter or other devices used in the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10


[184442094] It was reported that the procedure was performed to treat a lesion in the heavily calcified renal artery. The herculink elite stent system was advanced through the unspecified guide catheter and it was noted that the stent dislodged, remaining in the guide catheter. There was no resistance noted during advancement. As the stent remained in the guide catheter, the devices were removed as a single unit, without difficulty, and the stent remained in the guide catheter. There was no adverse patient effect and no clinically significant delay. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-02690
MDR Report Key9857937
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-07-31
Date Added to Maude2020-03-19
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 NameRX HERCULINK ELITE STENT SYSTEM
Generic NameSTENT, RENAL
Product CodeNIN
Date Received2020-03-19
Model Number1011502-15
Catalog Number1011502-15
Lot Number9073161
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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