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	Vascular Dissection (3160)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a 23mm sjm masters series valsalva aortic valved graft was successfully implanted due to severe aortic insufficiency.Concomitant procedures included aortic root and ascending aorta dilation.During surgery, after going off the pump, a right coronary artery button tear occurred.A coronary bypass was performed.The cause of the button tear was thought to be involuntary traction of the button.It was noted that there were minor complications in intensive care but it was not related to the bypass procedure.There was no device deficiency noted.The device remains implanted.
Event or Problem Description
Clinical study patient id: crd_992, (b)(4).It was reported that on 23 march 2022, a 23mm sjm masters series valsalva aortic valved graft was successfully implanted due to severe aortic insufficiency.Concomitant procedures included aortic root and ascending aorta dilation.During surgery, after going off the pump, a right coronary artery button tear occurred.A coronary bypass was performed.The cause of the button tear was thought to be involuntary traction of the button.It was noted that there were minor complications in intensive care but it was not related to the bypass procedure.There was no device deficiency noted.The device remains implanted.No additional information was reported.
Additional Manufacturer Narrative
An event of right coronary artery button tear 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.Information from the field indicated that the tear was thought to be due to an involuntary traction of the button, which caused the tear.

• 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: 14304439
• Report Number: 2135147-2022-00237
• Device Sequence Number: 20162097
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 05/01/2023
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 7795275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2021
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White