Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number HC150-14
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 two years and ten months post implant of this 14mm pulmonary valved conduit in an infant, the conduit was explanted and replaced with an 18mm conduit of the same model.The reason for replacement wasn't reported.No additional adverse patient effects were reported. .
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HANCOCK
Common Device Name
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key8334179
Report Number2025587-2019-00582
Device Sequence Number11343395
Product Code LWR
UDI-Device Identifier00681490908740
UDI-Public00681490908740
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P790007
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/12/2019
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 Date07/06/2016
Device Model NumberHC150-14
Device Catalogue NumberHC150-14
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/17/2019
Initial Report FDA Received Date02/12/2019
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 Age46 MO
-
-