MULTI-LINK CORONARY STENT SYSTEM 1012165-33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-27 for MULTI-LINK CORONARY STENT SYSTEM 1012165-33 manufactured by Abbott Vascular.

Event Text Entries

[181342689] The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10


[181342690] It was reported that the procedure was to treat a moderately tortuous, moderately calcified de novo proximal left circumflex (cx) artery that was 75 percent stenosed. A whisper guide wire was advanced to the lesion and a trek balloon was used to pre-dilate the lesion. A 2. 5x33mm multi-link8 was attempted to advance but failed to cross the lesion because of the tortuous anatomy. Resistance was noted with anatomy during removal and the multi-link 8 was noted to be separated in two pieces at the proximal shaft. The device was simply removed. Another same size multi-link 8 was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-01851
MDR Report Key9765642
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-27
Date of Report2020-02-27
Date of Event2020-02-05
Date Mfgr Received2020-02-07
Device Manufacturer Date2018-06-18
Date Added to Maude2020-02-27
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 # 3005718570 (P099)
Manufacturer StreetCASHEL ROAD
Manufacturer CityCLONMEL TIPPERARY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMULTI-LINK CORONARY STENT SYSTEM
Generic NameCORONARY STENT DELIVERY SYSTEM
Product CodeMAF
Date Received2020-02-27
Catalog Number1012165-33
Lot Number8061841
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2020-02-27

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