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

Model Number AJ-501

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  malfunction  

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) 2023, a 21mm master's standard a ortic was selected for an implant.During the procedure, when lowering the device, one of the metallic leaflets broke.Quickly, the broken device was recovered from the patient and was replaced with a new 21mm master's standard a ortic that completed the procedure.There was no harm to the patient.

Manufacturer Narrative

An event of one of the valve leaflets breaking while it was being lowered into the patient was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A returned device assessment could not be performed as the device was not returned for analysis.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2023, a 21mm sjm masters series mechanical heart valve was selected for an implant.During the procedure, when lowering the device, one of the metallic leaflets broke.Quickly, the broken device was recovered from the patient and was replaced with a new 21mm masters series mechanical heart valve that completed the procedure.There was no harm to the patient.

Event Description

N/a.

Manufacturer Narrative

An event of one of the valve leaflets breaking while it was being lowered into the patient was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The device was received for examination, and it was confirmed that a leaflet was fractured.The cause of the reported event could not be conclusively determined, however as it was reported that the device was being lowered into the patient when it broke, it is possible that too much pressure was put on the valve during the process, causing a leaflet to fracture.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES 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: 16975962
• MDR Text Key: 316213311
• Report Number: 2135147-2023-02240
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AJ-501
• Device Catalogue Number: 21AJ-501
• Device Lot Number: 31101430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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 Age: 25 YR
• Patient Sex: Male
• Patient Weight: 67 KG