MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 27AJ-501

Device Problem Insufficient Information (3190)

Patient Problem Aneurysm (1708)

Event Type  Injury  

Manufacturer Narrative

An event of an aortic root aneurysm was 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.

Event Description

The following information was obtained from the (b)(6).On post-natal day 4, the patient underwent a blalock park platsy and pulmonary artery (pa) banding.At (b)(6) of age, the patient underwent an arterial switch procedure with lecompte maneuver and closure of a vsd.Gradually, the patient developed aortic regurgitation that progressed to a moderate grade.At the age of (b)(6), the patient underwent an avr with a 27mm masters valve implanted and a concomitant enlargement of the main pulmonary artery.The patient received the valve well, however, after ten years post implant, the patient developed a large aortic root aneurysm, measuring 73mm.At the age of (b)(6), the masters valve was explanted and patient underwent a bentall procedure with a 25mm carbomedic valve with 28mm carbo-seal valsalva graft.During this third sternotomy incision, the aortic root was exposed through a right pulmonary artery approach and the left and right coronary bottoms were re-excised.As the aortic root aneurysm was replaced with the graft, the right pa was reconstructed by direct re-anastomosis.Post-operatively, the patient was reported to be stable.No additional information is expected.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• 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 Key: 8559633
• MDR Text Key: 143383290
• Report Number: 2648612-2019-00028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27AJ-501
• Device Catalogue Number: 27AJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• 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: 31 YR