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

Model Number 27CAVGJ-514 00

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

Patient Problems Abdominal Pain (1685); Atrial Fibrillation (1729); Dyspnea (1816); Muscle Weakness (1967); Dizziness (2194); Cardiac Tamponade (2226)

Event Date 09/14/2021

Event Type  Injury  

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.

Event Description

It was reported on (b)(6) 2021, a 27mm sjm masters series coated aortic valved graft was implanted.On (b)(6) 2021, the patient presented to the clinical experiencing dyspnea, weakness, abdominal discomfort, atrial fibrillation (af), dizziness and anxiety.Medication was given to treat the af.An echocardiogram was performed a pericardial tamponade was noted.A procedure was performed and liquid was removed.It is thought that postoperative bleeding or postpericardiotomy syndrome caused the tamponade.The patient was reported to be in stable condition and was discharged on (b)(6) 2021.(crd_992 - valved grafts pas; pl4195-251; r628368101).

Manufacturer Narrative

An event of pericardial tamponade was reported.A more comprehensive assessment could not be performed as the device remains implanted 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
• MDR Report Key: 12625008
• MDR Text Key: 276360718
• Report Number: 3007113487-2021-00056
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006422
• UDI-Public: 05414734006422
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27CAVGJ-514 00
• Device Catalogue Number: 27CAVGJ-514 00
• Device Lot Number: 7322193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 95