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 08/09/2023

Event Type  Injury  

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided.D6 - the date of implanted is estimated as the date of procedure for reportability purposes ((b)(6) 2013).Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

User facility medwatch report mw5148110 received that states ¿through edwards implant patient registry and investigation, it was learned a st.Jude mechanical valve (implanted in 2013) was explanted due to unknown reasons and replaced with a 23mm 11500a aortic valve.Patient post-operative status noted as in recovery.Patient: 71-year-old female."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".It was reported that on an unknown date in 2013, an unknown mechanical heart valve was implanted in a patient.On (b)(6) 2023, it was reported that the valve was explanted due to unknown reason and replaced with a non-abbott device.Patient status is unknown.

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 remains implanted and 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: 18422593
• MDR Text Key: 331665135
• Report Number: 2135147-2023-05771
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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?: No
• Date Manufacturer Received: 01/12/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female