• 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 PUERTO RICO, INC. (CS) SJM MECHANICAL HEART VALVE; 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 PUERTO RICO, INC. (CS) SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 29M-101
Device Problem Gradient Increase (1270)
Patient Problems Dyspnea (1816); Thrombosis (2100)
Event Date 08/12/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
A (b)(6) male patient was implanted with this 29 mm sjm mechanical heart valve on (b)(6) 2015.The patient complained of a dry cough with breathlessness for five days and on (b)(6) 2015, a 2-d echocardiogram showed peak/mean gradient across the mitral valve prosthesis at 44/32 mmhg.Also present was valve thrombosis with severe pah (rvsp~86mmhg).The patient was admitted and thrombolyzed with inj streptokinase (15 lac units) in infusion.On (b)(6) 2015 a second 2-d echocardiogram was performed and showed the peak/mean gradient across the mitral valve prosthesis at 22/11 mmhg, mva: 2.3q.Coms by pht, epasp: 31 mmhg.The patient was reported to be stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SJM MECHANICAL HEART VALVE
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer (Section G)
ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key5202327
MDR Text Key30441180
Report Number2648612-2015-00032
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P810002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/28/2015
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
Device Operator Health Professional
Device Expiration Date06/17/2018
Device Model Number29M-101
Device Catalogue Number29M-101
Device Lot Number4121901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2015
Initial Date FDA Received11/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age32 YR
Patient Weight55
-
-