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

Model Number	27MJ-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemolytic Anemia (2279); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, "delayed hemolytic transfusion reaction after mitra! valve replacement : report of a case", was reviewed.The research article presents a case study of delayed hemolytic transfusion reaction (dhtr) after mitral valve replacement (mvr).A (b)(6) woman with a history of blood transfusion was admitted for mvr.Preoperative laboratory test were negative for irregular antibodies except anti-dia.She underwent mvr using a mechanical prosthesis with a 27mm sjm mechanical heart valve.Compatible blood products were transfused perioperatively.On post-operative day 13.She developed hemoglobinuria mid anemia with elevated serum total bilirubin and lactic dehydrogenase levels.Transesophageal echocardiography showed trivial transvalvular leakage.Laboratory test successfully identified another irregular antibody, anti-jkb antibody.The patient had a jkb negative blood transfusion.And did not need re-operation.Later.She recovered with no signs of hemolysis.The article concluded that since anti­-jk1'antibody gets undetectable within a few months, it is difficult to find out before surgery.As hemoly­sis following cardiac surgery is more commonly associated with prostheses and extracorporeal circulation than dhtr.Physicians should however be aware of this unusual complication especially in patients who undergo blood transfusions.The primary author of the article is shogo isomura, department of cardiovascular surgery, nagano chuo hospital, japan, 380-0814 nagano, 1570.
Additional Manufacturer Narrative
As reported in a research article, a patient had hemoglobinuria mid anemia 13 days after replacement of their mitral valve with a mechanical heart valve.The valve was found to have trivial transvalvular leakage, and the patient recovered.Further laboratory testing revealed that the patient had anti-jkb antibody, which can lead to delayed hemolytic transfusion reaction.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.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: 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: 14164553
• Report Number: 2135147-2022-00183
• Device Sequence Number: 20300744
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 51 KG