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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC
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MEDTRONIC HEART VALVE DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC Back to Search Results
Model Number 200H16
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.
 
Event or Problem Description
Medtronic received information that this 16mm pulmonary valved conduit was implanted and explanted during the same procedure in this pediatric patient, and replaced with an 18mm pulmonary valved conduit for unknown reasons.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 VALVE DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key8821987
Report Number2025587-2019-02320
Device Sequence Number18918210
Product Code MWH
UDI-Device Identifier00643169616912
UDI-Public00643169616912
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
H020003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/24/2019
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 Date07/30/2021
Device Model Number200H16
Device Catalogue Number200H16
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2019
Initial Report FDA Received Date07/24/2019
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 Age18 MO
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