GRAFTMASTER 1012580-19

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 2020-03-30 for GRAFTMASTER 1012580-19 manufactured by Abbott Vascular.

Event Text Entries

[188560428] The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. The reported patient effect of perforation is listed in the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use (ifu) as a known patient effect of coronary stenting procedures. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The investigation determined the reported failure to seal appears to be related to circumstances of the procedure. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The additional graftmaster device is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10


[188560429] It was reported that the patient presented with a free perforation with extravasation in the mid left anterior descending artery. The patients health was declining toward death prior to use of the rx graftmaster stents. A 2. 8x16mm rx graftmaster covered stent was deployed first at 12 atmospheres (atm), but the perforation was exacerbated and did not seal. Patient developed cardiac tamponade. Then another 2. 80x19mm rx graftmaster covered stent was deployed at 16 atm, but the perforation was exacerbated and did not seal. Cardiac tamponade was still present. The patient died of coronary perforation. An autopsy was not performed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03074
MDR Report Key9897573
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-02
Date Mfgr Received2020-03-06
Device Manufacturer Date2018-05-11
Date Added to Maude2020-03-30
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 NameGRAFTMASTER
Generic NameCORONARY STENT DELIVERY SYSTEM
Product CodeMAF
Date Received2020-03-30
Model Number1012580-19
Catalog Number1012580-19
Lot Number8051141
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
101. Required No Informationntervention 2020-03-30

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