MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Perivalvular Leak (1457)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

Literature article: complex mitral paravalvular leak closure as reported through a literature review, complex mitral paravalvular leak closure, a 75-year-old patient with prior aortic and mitral valve replacement with a 17mm unknown abbott valve and a 27mm non-abbott valve implanted.The patient presented with refractory heart failure due to severe anterolateral mitral paravalvular leak (pvl) confirmed via transesophageal echocardiography.A decision was made to attempt to close the pvl with via transcatheter closure procedure.The article concluded transcatheter pvl closure is often challenging and may require different approaches and devices.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, complex mitral paravalvular leak closure", was reviewed.The research article presents a case study of a 75-year-old female with prior aortic and mitral valve replacement with a 17mm unknown abbott valve and a 27mm non-abbott valve implanted on an unknown date.It was reported on an unknown date, the patient presented with refractory heart failure due to severe anterolateral mitral paravalvular leak (pvl) confirmed via transesophageal echocardiography.A decision was made to attempt to close the pvl with via transcatheter closure procedure.Multiple attempts with different occluders including amplatzer vascular plug 2 and 3 and an unknown amplatzer duct occluder failed to occlude the pvl due to interference with the prosthesis discs and the procedure was aborted.It was later reported the patient presented with recurrent heart failure and a decision was made to attempt a second transcatheter closure.One 10mm and one 12mm amplatzer duct occluders were implanted successfully in the patient with favorable recovery and resolution of heart failure symptoms.The article concluded transcatheter pvl closure is often challenging and may require different approaches and devices.Virtual 3-dimensional modeling or printing from cardiac computed tomography (ct) data are valuable tools for pvl closure planning, providing anatomical information key for procedural approach and device selection.[the primary and corresponding author is (b)(6), s/n, (b)(6).

• Brand Name: UNKNOWN MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17335918
• MDR Text Key: 319374994
• Report Number: 2135147-2023-03050
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female