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

Model Number CVD0027

Device Problem Leak/Splash (1354)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Edema (1820)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

Event Description

In 2013, a 23mm trifecta valve was implanted.On (b)(6) 2019, a 25mm portico (serial #: (b)(4)) was implanted as part of a valve-in-valve procedure due to severe insufficiency and aortic regurgitation.In addition, the patient reportedly had symptoms of dyspnea and edema.The patient is stable.

Event Description

In 2013, a 23mm trifecta valve was implanted.On (b)(6) 2019, a 25mm portico (serial #: (b)(6) was implanted as part of a valve-in-valve procedure due to severe insufficiency and aortic regurgitation.In addition, the patient reportedly had symptoms of dyspnea and edema.The patient is stable.

Manufacturer Narrative

An event of a valve-in-valve performed due to dyspnea, edema and insufficiency was reported.The results of the investigation are inconclusive since the device remains implanted and was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.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 CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9142475
• MDR Text Key: 162467367
• Report Number: 3008452825-2019-00451
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention