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

Model Number 25CAVGJ-514 00

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

Patient Problem Pericardial Effusion (3271)

Event Date 11/29/2021

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) 2021, a 25mm sjm masters series coated aortic valved graft was implanted.On (b)(6) 2021, substantial post-operative drainage was noted.An echocardiogram was performed multiple times pericardial fluid levels and there was no need for re-exploration or pericardiocentesis.The patient was administrated colchicum and ibuprofen.The patient did not experience any symptoms.It is thought that postpericardiotomy syndrome was the cause of the pericardial effusion.The patient was reported to in stable condition and since has been discharged.(b)(4).

Manufacturer Narrative

An event of pericardial effusion and "post-operative drainage" 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 COATED AORTIC 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: 13337890
• MDR Text Key: 289088094
• Report Number: 3007113487-2022-00026
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006316
• UDI-Public: 05414734006316
• 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: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25CAVGJ-514 00
• Device Catalogue Number: 25CAVGJ-514 00
• Device Lot Number: 7974042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 92 KG