ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL
|
Back to Search Results |
|
Model Number 29VAVGJ-515 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Atrial Flutter (1730); Pleural Effusion (2010); Tachycardia (2095); Pericardial Effusion (3271); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446)
|
Event Date 01/30/2023 |
Event Type
Injury
|
Event Description
|
Clinical information: (b)(4).Patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was implanted.On (b)(6) 2023, the patient presented to the emergency department complaining of syncope, shortness of breath, and palpitations.A newly onset atrial flutter with tachycardia was observed on ekg.Patient was admitted to the hospital.Patient's bnp was elevated.On ct scan, patient had new small left-sided pleural effusion and mild pericardial effusion seen.Mild cardiomegaly, trace right, and mild interstitial edema was also observed.Patient's symptoms were clinically consistent with newly onset heart failure.Patient was administered iv amiodarone and diltiazem.Patient was transferred to study site for further observation.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event of syncope, shortness of breath, tachycardia palpitations, small left-sided pleural effusion, mild pericardial effusion, cardiomegaly, trace right, and mild interstitial edema 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 all specifications.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
|
Event Description
|
Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on 10 january 2023, a 29mm sjm masters series valsalva aortic valved graft was implanted.On 30 january 2023, the patient presented to the emergency department complaining of syncope, shortness of breath, and palpitations.A newly onset atrial flutter with tachycardia was observed on ekg.Patient was admitted to the hospital.Patient's bnp was elevated.On ct scan, patient had new small left-sided pleural effusion and mild pericardial effusion seen.Mild cardiomegaly, trace right, and mild interstitial edema was also observed.Patient's symptoms were clinically consistent with newly onset heart failure.Patient was administered iv amiodarone and diltiazem.Patient was transferred to study site for further observation.On 01 february 2023, on transthoracic echocardiogram (tte), the device had a normal appearance and function.There were no device issues or malfunction noted on the implanted 29mm sjm masters series valsalva aortic valved graft.
|
|
Search Alerts/Recalls
|
|
|