MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN TISSUE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK TISSUE HEART VALVE

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis/Thrombus (4440)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "sinus of valsalva and leaflet thrombosis after surgical aortic valve replacement"na.

Event Description

The article, "sinus of valsalva and leaflet thrombosis after surgical aortic valve replacement", was reviewed.The article presented a case study of a 78-year-old female patient with aortic valve stenosis.It was reported that on an unknown date, a 23mm epic valve was chosen for implant.The valve was implanted in the supra-annular position.Prior to discharge, the patient's transthoracic echocardiography (tte) showed ejection fraction 70.1% and the mean pressure gradient (mpg) was 14.7mmhg.The patient was discharged on the sixth day uneventfully and prescribed aspirin and warfarin for three months.It was later reported 14 months post-operatively, the patient presented with dyspnea on exertion.Tte revealed the patient's mpg increased to 50mmhg and noted thickening of the leaflets.Four-dimensional volume rendering computed tomography (4dct) with contrast demonstrated hypoattenuated leaflet thickening (halt) in all three leaflets and thrombus formation in the sinus of valsalva.The patient was restarted on oral anticoagulant (oac) therapy with warfarin.After four months of oac, repeat computed tomography demonstrated halt was resolved and tte showed mpg improved to 14mmhg.The article concluded that when increasing in gradient at relatively early postoperative period has been observed after surgical aortic valve replacement (savr), halt should be considered.[the primary and corresponding author was (b)(6), (b)(6) hospital, (b)(6), with corresponding email: (b)(6).

Manufacturer Narrative

Summarized patient outcomes/complications of epic valve were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were dyspnea, unexpected medical intervention, hospitalization, aortic valve stenosis, thrombus and fibrotic thickening of leaflet.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• Brand Name: UNKNOWN TISSUE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18447259
• MDR Text Key: 332149117
• Report Number: 2135147-2024-00077
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female