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

Model Number 17AGFN-756

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

Patient Problems Death (1802); Necrosis (1971); Respiratory Failure (2484)

Event Type  Death  

Manufacturer Narrative

As reported in a research article, two patients died while in the hospital, one due to respiratory failure and the other due to necrosis after implantation with a mechanical heart valve.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturing reference number: 2648612-2020-00136 the article," long-term outcomes and echocardiographic data after aortic valve replacement with a 17-mm mechanical valve" was reviewed.This research article is a retrospective single center study to investigate the long-term clinical and hemodynamic outcomes after aortic valve replacement (avr) with a 17-mm mechanical valve.St.Jude medical regent prosthetic valve is associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that avr with the 17-mm mechanical prosthesis had acceptable long-term clinical and hemodynamic outcomes.The primary and correspondence author of this article is homare okamura, md, phd, department of cardiovascular surgery, saitama medical center, jichi medical university, 1-847 amanuma-cho, omiya-ku, saitama 330-8503, japan with the email homareokamura@omiya.Jichi.Ac.Jp.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10963480
• MDR Text Key: 220105812
• Report Number: 2648612-2020-00135
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• 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: 73 YR