MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) SJM TISSUE HEART VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Backflow (1064); Perivalvular Leak (1457)

Patient Problem Heart Failure (2206)

Event Type  Injury  

Event Description

It was reported through a research article identifying amplatzer vascular plugs that may be related to a surgical intervention and abbott bioprosthetic valve that may be explanted.Specific patient information is documented as an (b)(6) female.Details are listed in the attached article, titled "an additional concept in predicting percutaneous paravalvular leak closure failure".In 2006, the patient underwent a mitral valve replacement with an abbott bioprosthetic valve.It was reported that the patient was evaluated for heart failure and found to have severe mitral regurgitation and paravalvular leak at the prosthetic valve.Due to the high surgical risk, four amplatzer vascular plug was used to close the paravalvular leak.During the procedure, with each plug deployment, the leak expanded.Four devices were deployed and the regurgitation remained severe.The procedure was aborted due to the possibility of causing complete prosthetic valve detachment.A surgical prosthetic replacement was performed.

Manufacturer Narrative

As reported in a research article, a implanted mitral bioprosthetic valve was replaced surgically due to regurgitation and paravalular leak.The results of the investigation are inconclusive since 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 TISSUE HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9579534
• MDR Text Key: 174657450
• Report Number: 3008452825-2020-00012
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/12/2020
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR