CG FUTURE BAND 638RL30

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 2020-03-12 for CG FUTURE BAND 638RL30 manufactured by Medtronic Heart Valves Division.

Event Text Entries

[188623968] Product analysis: no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188623969] Medtronic received information that this patient presented to the hospital following non-st segment myocardial infarction (nstemi). Upon admission the patient required an intra-aortic balloon pump (iabp). The patient was then taken for emergent mitral valve surgery and coronary artery bypass grafting (cabg). The patient's native mitral valve had a torn papillary muscle resulting in a flail anterior and posterior leaflet and severe regurgitation. A medtronic mitral annuloplasty ring was used in conjunction with neochords in an attempt to repair the native mitral valve. It was reported that initially the repair appeared to be successful, but after removing the cross-clamp, moderate to severe residual mitral regurgitation was noted. As a result, the annuloplasty ring was explanted and replaced with a non-medtronic bioprosthetic valve. The patient was supported via venous-arterial extracorporeal membrane oxygenation (ecmo) and the pre-existing iabp at the conclusion of the operation. No additional adverse patient effects related to a medtronic device were reported.?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-00766
MDR Report Key9827582
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-01-30
Date Mfgr Received2020-02-13
Device Manufacturer Date2019-01-28
Date Added to Maude2020-03-12
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC HEART VALVES DIVISION
Manufacturer Street1851 E DEERE AVE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal Code92705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCG FUTURE BAND
Generic NameRING, ANNULOPLASTY
Product CodeKRH
Date Received2020-03-12
Model Number638RL30
Catalog Number638RL30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC HEART VALVES DIVISION
Manufacturer Address1851 E DEERE AVE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-12

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