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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM RIGID SADDLE RING RING, ANNULOPLASTY

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ST. JUDE MEDICAL PUERTO RICO, INC. SJM RIGID SADDLE RING RING, ANNULOPLASTY Back to Search Results
Model Number RSAR-28
Device Problems Material Rupture; Biocompatibility
Event Type  Injury  
Manufacturer Narrative

Events of a rupture, leakage and infection were 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. Mdr report for heartmate ii device was submitted under (b)(4).

 
Event Description

The following article information was obtained from "omental flap for the device infection of the heartmate¿" (id#(b)(4)). On an unknown date, a mitral annuloplasty was performed for the surgical treatment of severe mitral regurgitation. A 28mm abbott rigid saddle (rsar-28) was used to perform a papillary muscle lift. After the procedure, the patient was reported with a fever of 39 degrees and methicillin-sensitive s. Aureus was detected. At an unknown point in time, the rsar-28 ruptured, resulting in the recurrence of severe mitral regurgitation. Surgery was performed and a lvad (heartmateii) was implanted as well as a mitral valve replacement with a 31mm magna mitral ease valve was performed. Infection continued after the procedure, requiring antibiotic therapy with multiple drugs and the administration of g globulin. An ormental flap was used to prevent device infection of the heartmate ii which could have been induced by the infected malgranulation around the drive line cannulas. The condition of the patient gradually improved, and the patient was discharged 2 and a half months post-procedure.

 
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Brand NameSJM RIGID SADDLE RING
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer (Section G)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth , MN 55442
6517565400
MDR Report Key8067334
Report Number2648612-2018-00087
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberRSAR-28
Device Catalogue NumberRSAR-28
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/13/2018 Patient Sequence Number: 1
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