MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM® MASTERS SERIES VALVED GRAFT; HEART-VALVE, MECHANICAL

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

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 11/23/2021

Event Type  Injury  

Event Description

It was reported on (b)(6) 2021, a sjm® masters series valved graft was implanted.Post procedure, increased drainage and features of a tamponade were noted.A resternotomy was performed and the patient was transfused red blood cells and plasma.On (b)(6) 2021, bloody discharge was noted from the wound of the sternum.A tamponade evacuation and sternum re-fixation was performed.The patient status is unknown however is still in the intensive care unit (icu).Additional information was requested but cannot be obtained.Crd_992 - valved grafts pas; pl5012-156; (b)(4).

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

An event of tamponade and increased drainage were reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM® MASTERS SERIES VALVED GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13043076
• MDR Text Key: 282607153
• Report Number: 3007113487-2021-00114
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 138 KG