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 THV 1000-21 3F AORTIC BIO 21MM; 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 THV 1000-21 3F AORTIC BIO 21MM; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number 1000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Aortic Valve Stenosis (1717)
Date of Event 06/27/2017
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.
 
Event or Problem Description
Medtronic received information that 6 years 5 months post implant of this aortic bioprosthetic valve, the device was replaced valve-in-valve with a medtronic transcatheter valve due to aortic stenosis.No other adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
THV 1000-21 3F AORTIC BIO 21MM
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 Key6739618
Report Number3008592544-2017-00040
Device Sequence Number10955457
Product Code LWR
UDI-Device Identifier00613994868220
UDI-Public00613994868220
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P060025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/27/2017
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 Date05/26/2015
Device Model Number1000
Device Catalogue Number1000-21
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/27/2017
Initial Report FDA Received Date07/25/2017
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 Age69 YR
-
-