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

Model Number RSAR-32

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); Hemolytic Anemia (2279)

Event Date 03/25/2014

Event Type  Injury  

Event Description

The info provided to sjm indicated the pt underwent a mitral valve annuloplasty on (b)(6) 2013, due to an anterior leaflet chordal rupture.This 32 mm sjm rigid saddle ring was implanted.Slight bulging of the p2 and p3 segments was noted, but no prolapse was observed.Two artificial chordae were placed to the anterior mitral leaflet and four were placed to the posterior mitral leaflet.Around (b)(6) 2013, the pt developed hemolytic anemia.Antihypertensive therapy was not effective and a transfusion was required.A transesophageal echocardiogram revealed regurgitation from the a2 segment to the posterior mitral leaflet.On (b)(6) 2014, a re-do mitral valve annuloplasty was performed.This ring was explanted and replaced by a 32 mm ring from another mfr.Two artificial chordae were placed to the anterior mitral leaflet.The pt underwent plication for moderate leakage noted at the p3/a3 commissure.Postoperatively, the pt was reported to be stable w/o mitral regurgitation.

• Brand Name: SJM RIGID SADDLE RING
• Type of Device: RIGID SADDLE RING
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO; caguas PR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55542 ; 6517565400
• MDR Report Key: 3868381
• MDR Text Key: 21729596
• Report Number: 2648612-2014-00021
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2014
• Device Model Number: RSAR-32
• Device Catalogue Number: RSAR-32
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 53