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

Model Number 23AGN-751

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Obstruction/Occlusion (2422); Fibrosis (3167)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturing reference number: 3001883144-2021-00051.On (b)(6) 2000, the patient was implanted with a 23mm regent aortic mechanical prosthesis.18 years later, the prosthesis had to be changed due to a high gradient that was measured on it(41-44mmhg) that was likely due to fibrous pannus located on the ventricular face or the aortic prosthetic annulus, partially impairing leaflet mobility.On (b)(6) 2018, the patient underwent an aortic valve replacement and received a 21mm trifecta valve.On (b)(6) 2021, the patient underwent another aortic valve replacement due to early degeneration of the trifecta valve with clear calcification of the cusp corresponding to the antero-right aortic sigmoid that is totally immobile and restrictive responsible for an aortic disease with a predominant intra-prosthetic aortic regurgitation grade iv/v and a slightly tight aortic stenosis (aortic trans-valvular median gradient measured again at 34 mmhg).It is associated to a small peri-prosthetic leak grade i/iv at the expense of the septal side of the aortic annulus.The trifecta valve was then explanted and replaced by a 23mm carpentier bioprosthesis valve.During the procedure the physician noticed a larger tear on the cusp placed on the right coronary leaflet side.

Manufacturer Narrative

An event of high gradient likely due to pannus formation was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM REGENT 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
• MDR Report Key: 11691021
• MDR Text Key: 246227534
• Report Number: 2648612-2021-00039
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR