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

Model Number 29VAVGJ-515

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

Patient Problems Anemia (1706); Arrhythmia (1721); Hypoxia (1918); Cardiac Tamponade (2226); Respiratory Failure (2484)

Event Date 02/19/2022

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event 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)).

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
• Type of Device: 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
• MDR Text Key: 286936535
• Report Number: 3005334138-2022-00159
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009508
• UDI-Public: 05414734009508
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2019
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American