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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC
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MEDTRONIC HEART VALVES DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC Back to Search Results
Model Number 200H12
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 01/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.
 
Event or Problem Description
Medtronic received information that 1 year and 6 months post implant of this 12mm pulmonary valved conduit in a (b)(6) old pediatric patient, the conduit was explanted and replaced with a 20mm valved conduit of the same model.The reason for replacement was not reported.No additional adverse patient effects were reported. .
 
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Brand Name
CONTEGRA
Common Device Name
CONDUIT,VALVED,PULMONIC
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key8400673
Report Number2025587-2019-00854
Device Sequence Number19326841
Product Code MWH
UDI-Device Identifier00643169616899
UDI-Public00643169616899
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
H020003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/01/2019
Device Model Number200H12
Device Catalogue Number200H12
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/14/2019
Initial Report FDA Received Date03/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age27 MO
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