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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2023

Event Type  Injury  

Event Description

User facility medwatch report mw5148612 received that states "it was learned that a 19 mm st.Jude mechanical valve was implanted on (b)(6) 2017 and explanted on (b)(6) 2023.This report reflects information received by fda in the form of a notification per 803.22 (b)(2)." it was reported that in an unknown date in 2017, a 19mm mechanical heart valve was successfully implanted.On (b)(6) 2023, the valve was explanted.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Medwatch report # mw5148612.

Manufacturer Narrative

An event of explant due to unknown reason was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, could not be performed as the device was not returned for analysis.The device serial number was not provided, and therefore the device history record could not be reviewed.Factors that may cause or contribute to structural valve deterioration of heart valves include implant-related factors, biological factors, and patient-related factors.No implant-related or biological factors could be confirmed as information related to the implant procedure was not provided from the account.The patient¿s medical history included was not known.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.

• 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: 18487261
• MDR Text Key: 332579145
• Report Number: 2135147-2024-00179
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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?: No
• Date Manufacturer Received: 02/02/2024
• 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; Hospitalization