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

Catalog Number UNK TISSUE HEART VALVE

Device Problems Off-Label Use (1494); Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Aneurysm (1708); Erosion (1750); Dyspnea (1816); Hemolysis (1886); Unspecified Infection (1930); Sepsis (2067); Pseudoaneurysm (2605); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/19/2023

Event Type  Injury  

Event Description

The article, "repeat aortic valve replacement (avr) for pseudoaneurysm of mitral aortic intervalvular fibrosa (p maivf) repair due to hemolytic anemia 6 years after avr: a case report", was reviewed.The article presented a case study of a 55-year-old male patient with congenital aortic bicuspid valve and severe aortic stenosis.It was reported that on an unknown date, a 25mm unknown sjm/abbott aortic valve was implanted for off label use in a bicuspid aortic valve.Six years post-procedure on an unknown date, the patient presented with sepsis due to methicillin-sensitive staphylococcus aureus and infected abdominal aortic aneurysm (iaaa).The patient was discharged on the 25th hospitalization day under oral antibiotic medication following intravenous antibiotic therapy.It was then reported four months later the patient presented for shortness of breath, jaundice due to hemolytic anemia, and transesophageal echocardiography (tee) revealed pseudoaneurysm behind aortic valve.Transthoracic echocardiography (tte) showed mild aortic regurgitation from the dorsal circumference of the prosthetic valve.A decision was made to perform repeat aortic valve replacement with pseudoaneurysm of the mitral-aortic intervalvular fibrosa (p-maivf) repair.After removal of the 25mm valve, a 20mm x 15mm defect was confirmed for the first time in the left ventricular outflow tract just below the non-coronary cusp of the native aortic valve.There were no macroscopic findings of active infection around the defect and bacterial culture results during surgery were negative.The defect was closed with a 28mm x 23mm bovine pericardial patch and a 23mm carpentier edwards inspiris valve was implanted.The patient was discharged 12 days after surgery.The article concluded the present case was considered to be a very rare case in which surgery was performed because the blood flow entering and leaving the p-maivf contacted the prosthetic valve ring, resulting in hemolysis, severe anemia, and heart failure.[the primary and corresponding author was masanobu yamauchi, shimane prefectural central hospital, 4 chome 1-1, himebara, izumo city, shimane 693-8555, japan, with corresponding email: yamauchi@spch.Izumo.Shimane.Jp].

Manufacturer Narrative

Literature article: repeat aortic valve replacement (avr) for pseudoaneurysm of mitral aortic intervalvular fibrosa (p maivf) repair due to hemolytic anemia 6 years after avr: a case report d4 - the udi number is not known as the part and lot numbers were not provided investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

As reported in a research article, repeat aortic valve replacement (avr) for pseudoaneurysm of mitral aortic intervalvular fibrosa (p maivf) repair due to hemolytic anemia 6 years after avr.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.

• 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: 18668588
• MDR Text Key: 334906608
• Report Number: 2135147-2024-00573
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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: 02/27/2024
• 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: 55 YR
• Patient Sex: Male