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

Catalog Number 29VAVGJ-515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted.On (b)(6) 2023, the patient experienced hypoxia.The patient was placed on a heated high flow cannula.Symptoms resolved on 26 may 2023 and the patient was discharged the following day on (b)(6) 2023.

Manufacturer Narrative

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

Manufacturer Narrative

An event of hypoxia was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Field indicated that the graft was functioning as intended when the patient experienced hypoxia.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted.On (b)(6) 2023, the patient experienced hypoxia.The graft was functioning as intended when the patient experienced hypoxia.The patient was placed on a heated high flow cannula.Symptoms resolved on (b)(6) 2023 and the patient no longer required the nasal cannula.The patient was discharged the following day on (b)(6) 2023.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES 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: 17148612
• MDR Text Key: 317446672
• Report Number: 2135147-2023-02633
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 8802644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White