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: ST. JUDE MEDICAL CATD SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL
  • 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
 

ST. JUDE MEDICAL CATD SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 27MECJ-502
Device Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
On (b)(6) 2017, a 27mm masters valve was implanted.On (b)(6) 2019, restricted movement of a leaflet was reported and the device was explanted.A new 27mm masters valve (serial #: (b)(4) was successfully implanted.
 
Event Description
On (b)(6) 2017, a 27mm masters valve was implanted.On (b)(6) 2019, restricted movement of a leaflet was reported and the device was explanted.A new 27mm masters valve (serial #: (b)(6)) was successfully implanted.
 
Manufacturer Narrative
An event of restricted leaflet movement and valve explant was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SJM MASTERS SERIES VALVE EXPANDED CUFF
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL CATD
4 robbins drive
westford MA 01886
MDR Report Key9110932
MDR Text Key162696002
Report Number2648612-2019-00069
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P810002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number27MECJ-502
Device Catalogue Number27MECJ-502
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age21 YR
-
-