MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN TISSUE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK TISSUE HEART VALVE

Device Problems Material Split, Cut or Torn (4008); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2010, a 29mm biocor mitral valve was implanted.In (b)(6) 2023, during follow up imaging post recurrent endocarditis, the valve was observed to be extremely stenosed with valve insufficiency and torn leaflet.On (b)(6) 2024, the patient underwent an additional procedure to explant the 29mm mitral valve.A 27mm epic mitral valve was implanted as a replacement.The patient was reported to be recovering.There was no adverse patient effect.

• Brand Name: UNKNOWN TISSUE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18952484
• MDR Text Key: 338269393
• Report Number: 2135147-2024-01294
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040021
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male