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

Catalog Number 31M-101

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported that on an unknown date in 2004, a 31mm st.Jude mechanical mitral valve was implanted.On 09 january 2024, two leaks were noted on transesophageal echocardiogram (tee).A 14 mm x 5 mm amplatzer valvular plug iii was chosen for the paravalvular leak closure procedure.The first leak (lateral position) appeared to be bigger than expected and the device was only closing it partially.The device was recaptured and repositioned twice, but the result was unsatisfactory.The device was still attached to the cable and was retrieved.The leak closed surgically.The patient remained hemodynamically stable throughout the procedure.The patient was reported recovering.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of paravalular leak about twenty years after implant was reported.A more comprehensive assessment could not be performed as the device remains implanted and was not returned for the 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 respect to labeling design or manufacturing of the device.

Event Description

It was reported that on an unknown date in 2004, a 31mm st.Jude mechanical mitral valve was implanted.On (b)(6) 2024, two leaks were noted on transesophageal echocardiogram (tee).A 14 mm x 5 mm amplatzer valvular plug iii was chosen for the paravalvular leak closure procedure.The first leak (lateral position) appeared to be bigger than expected and the device was only closing it partially.The device was recaptured and repositioned twice, but the result was unsatisfactory.The device was still attached to the cable and was retrieved.The leak closed surgically.The patient remained hemodynamically stable throughout the procedure.The patient was reported recovering.

• Brand Name: STANDARD 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: 18636144
• MDR Text Key: 334490436
• Report Number: 2135147-2024-00474
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 02/21/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 31M-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/21/2024
• 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: 72 YR
• Patient Sex: Female