MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A

Device Problems Backflow (1064); Material Split, Cut or Torn (4008)

Patient Problems Fatigue (1849); Muscle Weakness (1967); Low Cardiac Output (2501); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a patient that had received a 23mm sjm trifecta valve on (b)(6) 2017 now presented to the emergency room (b)(6) 2021 with congestive heart failure, low cardiac output, fatigue and weakness.The patients physical examination revealed a heart murmur.An echocardiogram was performed revealing severe aortic regurgitation (ar) and a central jet which occupied a tear area.Using the new york heart association (nyha) functional classification standards, class ill heart failure was confirmed.The patient underwent surgical explant of the 23 trifecta valve and a new, non-abbott device was placed.Upon explant, structural valve deterioration (svd) was suspected (photo attached).The patient was reported to have been stable throughout the procedure.The procedure was successful and no patient consequences or procedural delays were reported.The patient is currently stable and is being monitored in the intensive care unit (icu).The faulty device will not be returning as the device has reported to be discarded by the hospital.No additional information has been provided.

Manufacturer Narrative

An event of heart failure and structural valve deterioration was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, three photos were received for analysis.Based solely on the aforementioned photos, the valve appeared to have a leaflet tear.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• MDR Report Key: 12277896
• MDR Text Key: 265085280
• Report Number: 3007113487-2021-00014
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: BR00005888
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 67