Model Number 23VAVGJ-515 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Anemia (1706); Unspecified Infection (1930); Pericardial Effusion (3271)
|
Event Date 03/03/2023 |
Event Type
Injury
|
Event Description
|
Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6) (r749173601).It was reported that on (b)(6) 2023, a 23mm sjm masters series valsalva aortic valved graft was successfully implanted.On (b)(6) 2023, a slight leak was seen from the sternotomy wound and it was confirmed the patient had an infection.On (b)(6) 2023, antibiotic was administered.On (b)(6) 2023, slight leakage of serious turbid content was observed.On (b)(6) 2023, a surgical chest sheathing was performed to revise the wound site.Two units of red blood cells were administered.On (b)(6) 2023, a transthoracic echocardiogram (tte) was performed, and a trace of fluid was seen in the pericardial sac.Warfarin was restarted.On (b)(6) 2023, tte showed fluid in the pericardial sac up to 10mm at the rv/lv lateral and posterior walls; in the left pleural cavity, up to 25mm of fluid was also observed.The pericardial effusion did not lead to tamponade.The fluid in the pericardial sac was believed to be procedure related.The patient continued to be monitored in the study.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event of pericardial effusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.
|
|
Manufacturer Narrative
|
Additional information: b5, h6, h10 an event of pericardial effusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.
|
|
Event Description
|
Clinical information: crd_992 - valved grafts pas, patient site id: pl5012 - 199 (r749173601, r754286001) subsequent to the initially filed report, the following information was received that the patient had a low hemoglobin of 7.6 g/dl on (b)(6)2023.The patient's hemoglobin improved on 12 march 2023 to 9.6g/dl and increased to 10.3 g/dl on 16 march 2023.No additional information was provided.
|
|
Search Alerts/Recalls
|