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 HANCOCK 11 PORCINE HEART VALVE, SIZE TI
  • 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 HANCOCK 11 PORCINE HEART VALVE, SIZE TI Back to Search Results
Model Number 33M12J5378
Device Problems Fitting Problem (2183); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014, a (b)(6) year old female patient was taken to the operating room for mitral and tricuspid valve surgery.During surgery, upon the surgeon seating the 33-hancock ii mitral prosthesis, the surgeon could see disruption of leaflets from the sewn ring.Because of this, the prosthesis was not seated and it was removed.The prosthesis was replaced with a 231 bovine pericardial valve and this prosthesis was successfully seated with good apposition on the annulus.The procedure was completed and the patient was transferred to the cardiac surgery icu for routine postoperative care.Site was subsequently discharged on (b)(6) 2014.There was no adverse event to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HANCOCK 11 PORCINE HEART VALVE, SIZE TI
Type of Device
HANCOCK 11 PORCINE HEART VALVE, SIZE TI
Manufacturer (Section D)
MEDTRONIC
MDR Report Key3840199
MDR Text Key4411437
Report NumberMW5036325
Device Sequence Number1
Product Code DTI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number33M12J5378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/22/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight93
-
-