MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART COATED AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number 25CAVGJ-514 00

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 a 25mm masters series heart coated aortic valved graft was selected for an implant.During the procedure, the holder handles was fully inserted into the orifice at a 90 degree angle.The physician rotated the valve with the valve rotator, no resistance was felt.The leaflet fell off and was completely removed from the patient.Device was exchange with a new 25mm masters series heart coated aortic valved graft that was implanted.The patient remains hemodynamically stable throughout the procedure.The patient's surgery time was extended by more than an hour, and the cardiopulmonary bypass machine worked for more than an hour, however no injury was reported.The patient is currently begin observed in the intensive care unit.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

An event of the leaflet being dislodged and fractured was confirmed.The investigation found that one of the leaflets was dislodged from the orifice.The dislodged leaflet was fractured into multiple pieces and was returned back.The valve orifice was not fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There was no evidence of the material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.Based on the information received, the root cause of the reported incident could not be conclusively determined.

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED GRAFT
• 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: 15470987
• MDR Text Key: 300458248
• Report Number: 2135147-2022-01314
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006316
• UDI-Public: 05414734006316
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• 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,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25CAVGJ-514 00
• Device Catalogue Number: 25CAVGJ-514 00
• Device Lot Number: 8253968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2021
• 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