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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Perivalvular Leak (1457)

Patient Problem Hemolytic Anemia (2279)

Event Date 07/07/2023

Event Type  Injury  

Event Description

The article, ¿case which underwent the replacement of the atrioventricular valves by chimney techniques¿, was reviewed.The article presents a case study of a 7 years old male patient that had a prior 25mm non-abbott valve.It was reported on an unknown date, the 25mm non-abbott valve was explanted and a 27mm sjm unknown mechanical valve was implanted.On a later unknown date when the patient was approximately 40 years old, the patient presented with hemolytic paravalvular leak associated with the 27mm sjm valve.A decision was made to explant the sjm valve and replaced with a 23mm non-abbott valve.The patient status was reported as stable.[the primary author was kentaro yamashita, keio university hospital, 35 shinanomachi, shinjuku city, tokyo 160-0016, japan].

Manufacturer Narrative

Summarized patient outcomes/complications of mechanical heart valve were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were surgical intervention, hospitalization, paravalvular leak and hemolytic anemia.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 17789363
• MDR Text Key: 323937422
• Report Number: 2135147-2023-04111
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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?: Yes
• Date Manufacturer Received: 08/29/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Male