MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number 15AHPJ-505

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

Patient Problems Dyspnea (1816); Hematoma (1884); Hypoxia (1918)

Event Date 01/28/2021

Event Type  Injury  

Event Description

It was reported that a 15mm sjm masters series hemodynamic plus valve was implanted (b)(6) 2021.Immediately post operatively, the patient had increased chest tube output and the decision was made to re-explore at bedside.A moderate mediastinal hematoma was removed.It was noted that there were several oozing sites but there was no surgical bleeding sites.The patient received factor vii and thrombin.It was noted that the event was related to the procedure.It was noted that the patient had a very complex medical history and their hospital stay was prolonged secondary to their chronic conditions.No additional information was provided.This event is being conservatively reported.(b)(4), 15mm surgical aortic valve pas, (b)(4).

Manufacturer Narrative

An event of hemorrhage and immediate postoperative increase in chest tube output was reported.A more comprehensive assessment could not be performed as the device 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 HEMODYNAMIC PLUS VALVE
• 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: 13553286
• MDR Text Key: 286741474
• Report Number: 3005334138-2022-00136
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05415067016515
• UDI-Public: 05415067016515
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2023
• Device Model Number: 15AHPJ-505
• Device Catalogue Number: 15AHPJ-505
• Device Lot Number: 6427108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 3 KG