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

Catalog Number UNK TISSUE HEART VALVE

Device Problems Off-Label Use (1494); Central Regurgitation (4068)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Literature article attached: transcatheter aortic valve replacement in congenital heart disease.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "transcatheter aortic valve replacement in congenital heart disease", was reviewed.The article presented a case study of a 43-year-old male tetralogy of fallot who underwent 5 total surgeries, 4 of which were sternotomies, and 2 percutaneous interventions.It was reported that on an unknown date, a 33mm unknown biocor valve was implanted for off label tricuspid valve replacement and a 27mm unknown biocor valve was implanted for aortic valve (av) replacement.On an unknown date, the patient presented with triscuspid valve and av prosthetic valve dysfunction and biventricular failure.Transthoracic echocardiography (tte) and transesophageal echocardiography (tee) revealed severe prosthetic aortic regurgitation (ar) and aortic stenosis (as) (peak gradient of 74 mm hg, mean gradient of 34 mm hg, dimensionless index of 0.24), as well as severe tricuspid regurgitation.A decision was made to perform a transcatheter aortic valve-in-valve (viv) procedure with a 26mm edwards sapien s3 valve.The patient also underwent concomitant transcatheter tricuspid valve replacement (ttvr) with an unknown device.The patient's clinical status improved significantly and was accepted for heart and liver transplantation.The article concluded that transcatheter aortic valve replacement (tavr) can be an effective intervention in congenital heart disease (chd) in select clinical scenarios, proving both feasible and safe with good short-term outcomes in this small case series.In high surgical risk, it can be used as a bridge to recovery, future surgery, transplantation, or palliation.There is an important need for large prospective clinical trials of tavr in chd.[the primary and corresponding author was joanna ghobrial, department of cardiovascular medicine, cleveland clinic, 9500 euclid avenue, cleveland ohio 99175, usa, with corresponding e-mail: ghobrij@ccf.Org].

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.As reported in a research article, transcatheter aortic valve replacement in congenital heart disease.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 18624553
• MDR Text Key: 334337991
• Report Number: 2135147-2024-00455
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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: 02/14/2024
• 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: 43 YR
• Patient Sex: Male