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

Model Number TF-23A

Device Problem Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Pulmonary Edema (2020)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013, an aortic valve replacement was performed for the surgical treatment of aortic regurgitation and this 23 mm sjm trifecta valve was implanted.At a follow-up on (b)(6) 2015, the patient was diagnosed with severe aortic regurgitation, cardiac insufficiency and acute pulmonary edema.On (b)(6) 2015, the trifecta valve was explanted and replaced with a 23 mm sorin mitroflow aortic pericardial heart valve.Upon explant, a vertical tear was observed at the stent post between the non-coronary cusp and left-coronary cusp.Concomitant procedures included mitral annuloplasty and tricuspid valvuloplasty; however, the implanted devices in the mitral and tricuspid position were not identified.The user reports the mitral and tricuspid regurgitation were secondary complications to the aortic regurgitation.The patient is ambulatory and recovering with undergoing rehabilitation.

Manufacturer Narrative

(b)(4).The results of this investigation concluded a tear and calcifications were found in cusps 2 and 3.No acute inflammation was observed, and gram stains were negative for organisms.No evidence was found to suggest the cause of the cusp tears and calcification formation was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2013, a bentall procedure was performed with a non-sjm graft.This 23 mm sjm trifecta valve was implanted in the aortic position for the surgical treatment of aortic regurgitation.At a follow-up on (b)(6) 2015, the patient was diagnosed with severe aortic regurgitation, cardiac insufficiency and acute pulmonary edema.On (b)(6) 2015, the trifecta valve was explanted and replaced with a 23 mm sorin mitroflowvalve.Upon explant, a vertical tear was observed at the stent post between the non-coronary cusp and left-coronary cusp.Concomitant procedures at the time of reoperation included mitral annuloplasty and tricuspid valvuloplasty; however, the implanted devices in the mitral and tricuspid position were not identified.The user reports the mitral and tricuspid regurgitation were secondary complications to the aortic regurgitation.The patient is ambulatory and recovering with undergoing rehabilitation.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5288633
• MDR Text Key: 33261593
• Report Number: 3001883144-2015-00046
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2013
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3656690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2011
• 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: 79 YR