CONTEGRA 200H12

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 2020-03-18 for CONTEGRA 200H12 manufactured by Medtronic Heart Valve Division.

Event Text Entries

[183947572] 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


[183947573] Medtronic received information that 5 months and 9 days post implant of this 12mm pulmonary valved conduit in a (b)(6) old pediatric patient, it was explanted and replaced with a 16mm pulmonary valved conduit of the same model. The reason for replacement was not reported. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-00831
MDR Report Key9848689
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-12
Date Mfgr Received2020-02-24
Device Manufacturer Date2018-04-19
Date Added to Maude2020-03-18
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 VALVE 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 NameCONTEGRA
Generic NameCONDUIT,VALVED,PULMONIC
Product CodeMWH
Date Received2020-03-18
Model Number200H12
Catalog Number200H12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC HEART VALVE DIVISION
Manufacturer Address1851 E DEERE AVE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-18

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