MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTES SERIES VALVE EXPANDED CUFF

Model Number 23AECJ-502

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 02/24/2014

Event Type  Injury  

Event Description

This valve was implanted to replace an sjm 23mm masters series valve that was explanted due to endocarditis.The valve was implanted using pledgeted sutures.The pt was taken off bypass and a trans-esophageal echocardiogram (tee) reveled central leakage.Both leaflets appeared to be moving and the pt was put back on bypass to visually assess the valve, which revealed no obstructions.The valve was rotated 90 degrees and the pt was taken off bypass.Tee revealed continued central leakage.The valve was removed and another 23mm sjm master series valve (model: 23aecj-502, serial: (b)(4)) was implanted.No leakage was observed on tee.The pt experienced a tear in the aorta from cross-clamping that required surgical repair.The pt had an uneventful recovery.

• Brand Name: SJM MASTES SERIES VALVE EXPANDED CUFF
• Manufacturer (Section D): ST. JUDE MEDICAL; caguas PR
• Manufacturer Contact: denise johnson, rn ; lot 20 b st; p.o. box 998; caguas, PR 00725 ; 6517564470
• MDR Report Key: 3738641
• MDR Text Key: 4277810
• Report Number: 2648612-2014-00016
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2014

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 Date: 11/18/2018
• Device Model Number: 23AECJ-502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2013
• 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: 57 YR