MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL

Model Number 19AGFN-756

Device Problem Obstruction of Flow (2423)

Patient Problems Death (1802); Thrombus (2101)

Event Date 05/23/2019

Event Type  Death  

Event Description

On (b)(6) 2019, the patient underwent an aortic and mitral valve replacement.Per the patient's husband, after the valves were implanted the leaflets of a device became obstructed, potentially due to a blood clot, and wouldn't open.On (b)(6) 2019, the patient died.Additional information has been requested.

Manufacturer Narrative

An event of the leaflets of the valve not opening, and patient death due to multisystem organ failure was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2019, the patient underwent an aortic and mitral valve replacement.Implanting a 19mm regent valve in the aortic position and a 27mm masters valve in the mitral position.The procedure was successful and the patient was transferred to the icu in stable condition.On (b)(6) 2019, mediastinal washouts with clot evacuation was performed.On (b)(6) 2019, the patient was taken to the cath lab for a chest exploration to evaluate the grafts, which were observed to be patent, but the leaflets of the aortic regent valve were not opening.On (b)(6) 2019, a tee was performed revealed a normal function mitral masters valve, but confirmed the leaflets of the regent valve not moving.On (b)(6) 2019, the patient died due to multisystem organ failure.The user believes the chest exploration and mediastinal washouts caused the obstruction of the leaflets.The patient's act levels ranged from 150-200 second.No additional information is available.

• Brand Name: SJM HEART VALVE (UNKNOWN)
• 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
• MDR Report Key: 8733034
• MDR Text Key: 149143765
• Report Number: 2648612-2019-00048
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR