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

Model Number 21AGFN-756

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

Patient Problems Endocarditis (1834); Fever (1858); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient was implanted with a 21mm regent mechanical valve.An event of fever, pseudoaneurysm, infection, and valve explant was reported.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 manufacturer reference number: 2648612-2022-00005.The article, "the case report which twice redo aortic valve replacement (avr) was required due to a vasculo-behcet's disease", was reviewed.This research article reported a case study of a patient who developed aneurysm of the sinus of valsalva and annuloaortic abscess at (b)(6) years old.Severe aortic regurgitation was also confirmed at the same time.A 21mm regent mechanical valve was consequently implanted after discussion within the medical team.It was noted that in order to sew the valve into the annulus, the annulus was reconstructed.The bacteria that originated in the annuloaortic abscess was unknown.Six months after the initial aortic valve replacement (avr), the patient developed a high fever.Pseudoaneurysm at aortic root was confirmed and prosthetic valve infection was suspected.A redo avr was determined to be required.Annulus was reconstructed again by pericardium.At the time, the bacteria that originated the infection was unknown.The 21mm regent valve was explanted and a 23mm regent valve was implanted by bentall procedure.After the redo avr, c-reactive protein (crp) value did not decrease and reoccurrence of annuloaortic pseudoaneurysm was observed.Infectious endocarditis was ruled out and behcet's disease was suspected.Steroid medication was administered and crp value gradually declined.One month later, a 3rd avr was performed.The 23mm regent valve was explanted and a 21mm regent valve was implanted by bentall procedure again.Steroid medication was prescribed after the final surgery.The patient was reported to have turned (b)(6) years old presently and attended university with energy.

• 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 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13287234
• MDR Text Key: 289061908
• Report Number: 2648612-2022-00004
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/18/2022
• 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): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male