MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; REGENT ROTATABLE VALVE

Model Number 19AGFN-756

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Pannus (1447); Thrombosis (2100)

Event Date 01/23/2014

Event Type  Injury  

Event Description

The info provided to sjm indicated the pt underwent an aortic valve replacement with this valve on an unk date.A tricuspid valve repair was also performed at that time.The aortic valve was explanted and was found to be thrombosed in the open position.It was reported the surgeon believed the valve thrombosed because pledgets were used on the inflow aspect, which he indicated was an implant technique error.The pt was reported to be fine postoperatively.Additional info received indicated the valve was examined by the hospital's pathology dept.The pathologist reported there was pannus formation on the valve.The pannus formation was reported to be due to the suture knot ends being left too long which caused the pannus to attach to the knots.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the info received, the cause of the reported pannus and thrombus formation resulting in the valve to be explanted remains unk.However, additional info indicated there was user error while implanting the valve resulting in the tissue formation.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: REGENT ROTATABLE VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; caguas PR
• Manufacturer Contact: denise johnson, rn ; 177 e. county rd. b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3645110
• MDR Text Key: 4181145
• Report Number: 2648612-2014-00007
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 29 YR