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

Model Number	23VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 23mm masters series mechanical heart valve was implanted.On (b)(6) 2022, anemia was noted; the patient's hemoglobin was 6.4.Therefore, the patient was transfused 1 unit of packed red blood cell (prbc).No active bleeding was noted.No patient consequences were reported.
Additional Manufacturer Narrative
The investigation is not yet complete.A follow up report will be provided with all additional relevant information.
Event or Problem Description
Clinical information: crd_992 - valved grafts pas, patient site id: (b)(4), r685413201, r685401201.It was reported that on (b)(6) 2022, a 23mm masters series mechanical heart valve was implanted.On (b)(6) 2022, anemia was noted; the patient's hemoglobin was 6.4.Therefore, the patient was transfused 1 unit of packed red blood cell (prbc).No active bleeding was noted.No patient consequences were reported.Subsequent to the previously filed report, additional information was received that the patient had been taking the blood thinners aspirin (81 mg) and warfarin.There was no allegation that the anemia was caused by a device defect or malfunction.The device remains implanted and is reported to be performing as intended.The cause of the anemia was unknown.On (b)(6) 2022, the patient's hemoglobin was 6.4 g/dl.On (b)(6) 2022, after one unit of prbc was transfused, the patient's hemoglobin was 8.2 g/dl.On 27 may 2022, the patient's international normalized ratio (inr) was 2.5, and on (b)(6) 2022, the patient's inr was 2.8.The most recent inr on (b)(6) 2022 was 1.7.The patient has since been discharged home.
Additional Manufacturer Narrative
An event of anemia one week after the implant procedure was reported.The device was noted to be functioning as intended and the physician did not allege that the bleeding was related to a device defect.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• 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: 14778664
• Report Number: 2135147-2022-00419
• Device Sequence Number: 5936369
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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 Expiration Date: 09/30/2022
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 6650977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2018
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: Black Or African American