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

Model Number 21AGFN-756

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hypovolemic Shock (1917)

Event Date 04/14/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Please refer to mdr-2016-31102 for a related report for the 19mm trifecta valve.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 information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2011, a 19mm trifecta valve was implanted (b)(4).On (b)(6) 2016, the patient underwent a redo aortic valve replacement secondary to stenosis and patient-prosthesis mismatch.The trifecta valve was explanted and a 21mm regent valve was implanted (sn unknown).On (b)(6) 2016, the patient died secondary to acute respiratory failure, hemorrhagic shock, and multi-visceral failure.(clinical study patient id: (b)(4).

Manufacturer Narrative

(b)(4).Please refer to mdr-(b)(4) for a related report for the trifecta valve.

Event Description

On (b)(6) 2016, the patient required emergent redo avr secondary to stenosis and patient-prosthesis mismatch.The emergent surgery was not performed by the study investigator and what was reported to postmarket surveillance was: the trifecta valve was explanted and the aortic annulus was enlarged by nicks technique.As the patient had a fragile aorta, a bovine pericardial patch was placed and extended from the mitral leaflet to the aortic non-coronary sinus and a 21mm regent valve (sn unknown) was implanted in the aortic position.Concomitantly, due to worsening mitral regurgitation, the patient underwent a mitral valvuloplasty using a medtronic future band, and per report this was unsuccessful due to the presence of the aortic reconstruction.The surgeon then elected to implant a 27mm sjm mechanical valve in the mitral annulus.Per report, the total cardiopulmonary bypass (cpb) time was 308 minutes; the total aortic cross-clamp time was 232 minutes.The patient was weaned from cpb using low dose inotropes and transferred to the icu.After extubation, the patient required reintubation due to worsening respiratory condition with pleural effusion and slow neurological awakening.On 26 april 2016, the patient developed acute respiratory distress secondary to a right hemothorax and worsening pleural effusion post-surgery.On 28 april 2016, the patient died secondary to acute respiratory failure, hemorrhagic shock, and multi-visceral organ failure.(clinical study patient id: frlim01-1016).

• Brand Name: REGENT 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6128440
• MDR Text Key: 60915019
• Report Number: 2648612-2016-00119
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• 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): Death
• Patient Age: 61 YR