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

Catalog Number UNK TISSUE HEART VALVE

Device Problem Device Stenosis (4066)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment medwatch report # mw5151734.

Event Description

Medwatch form mw5151734 received 06 march 2024: it was reported to medtronic that approximately 5 years after the implant of this st.Jude medical valve, severe aortic stenosis was identified in a transthoracic echocardiogram (tte).A surgical intervention was noted to have been done.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).It was reported that on an unknown date approximately five years ago an unknown abbott valve was implanted.On an unknown recent date, the patient returned for intervention due to severe aortic stenosis noted on transthoracic echocardiogram (tte).A valve replacement was performed.

Event Description

Medwatch form mw5151734 received 06 march 2024: it was reported to medtronic that approximately 5 years after the implant of this st.Jude medical valve, severe aortic stenosis was identified in a transthoracic echocardiogram (tte).A surgical intervention was noted to have been done.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).It was reported that on an unknown date approximately five years ago an unknown abbott valve was implanted.On an unknown recent date, the patient returned for intervention due to severe aortic stenosis noted on transthoracic echocardiogram (tte).A valve replacement was performed.

Manufacturer Narrative

Medwatch form mw5151734 attached.An event of intervention due to severe aortic stenosis after five years of implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, could not be performed as the device was not returned for analysis.No implant-related factors could be confirmed as information related to the implant procedure was not provided from the account.The device serial number was not provided, and therefore the device history record could not be reviewed.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: 19015499
• MDR Text Key: 339060387
• Report Number: 2135147-2024-01462
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• 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
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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