MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, LLC SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number	29VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Arrhythmia (1721); Hypoxia (1918); Cardiac Tamponade (2226); Respiratory Failure (2484)
Date of Event	02/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported on (b)(6) 2022, a 29mm sjm masters series valsalva aortic valved graft was implanted.On (b)(6) 2022, the patient had post-op respiratory failure and was continued on full vent support.On (b)(6) 2022, the patient extubated.On (b)(6) 2022, the patient was reintubated due to hypoxia and on (b)(6) 2022, it was attempted to wean the patient off of oxygen (o2) and conduction disturbances were noted on an electrocardiogram (ecg).The patient remained on ac with sedation and iv norepinephrine.On (b)(6) 2022, the patient extubated again.On (b)(6) 2022, an echocardiogram was performed and a pericardial tamponade was noted.No intervention was for the arrhythmia.A subxiphoid pericardial window was performed and the patient re intubated again.On (b)(6) 2022, the patient received a tracheostomy.The patient remains in the hospital and is not doing well.((b)(4) - valved grafts pas; (b)(4)).
Additional Manufacturer Narrative
An event of leukocytosis, blood loss anemia, hypoxia, conduction disturbances, respiratory failure and a pericardial tamponade was reported.A more comprehensive 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13607419
• Report Number: 3005334138-2022-00159
• Device Sequence Number: 13945363
• Product Code: LWQ
• UDI-Device Identifier: 05414734009508
• UDI-Public: 05414734009508
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 06/30/2023
• Device Model Number: 29VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 7049837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American