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

Model Number TF-19A

Device Problem Crack (1135)

Patient Problems Dyspnea (1816); Palpitations (2467)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Analysis of the valve is in progress.

Event Description

In (b)(6) 2009, the patient underwent aortic valve replacement secondary to aortic stenosis and a 21mm non-sjm tissue valve was implanted.On (b)(6) 2013, the non-sjm valve was explanted due to an increased gradient and a 19mm trifecta tissue valve was implanted without issue.In (b)(6) 2015, an increasing gradient (> 60mmhg) was noted.As of (b)(6) 2015, the gradient increased to 70mmhg and the patient reported palpitations and dyspnea upon exertion; however the plan was to monitor the patient and consider surgical intervention if the gradient persisted.On (b)(6) 2016, a re-do avr was performed and the trifecta valve was explanted.All three cusps had been mobile on echo.At explant, pannus was observed on the inflow surface of each cusp and was the suspected cause of the elevated gradient.At explant, a tear or crack was reported in the base of the right coronary cusp and it is unknown when and how it occurred.A non-sjm was implanted.

Manufacturer Narrative

Updated to include model of original non-sjm valve.The results of this investigation concluded all three cusps contained a tear.There was pannus ingrowth on the inflow basilar aspect of all three cusps.Special stains were negative for organisms and no acute inflammation or significant calcifications were present.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest the cause of the tears and pannus were 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

In (b)(6) 2009, the patient underwent aortic valve replacement secondary to aortic stenosis and a 21mm medtronic mosaic tissue valve was implanted.

• 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: 5500903
• MDR Text Key: 40342697
• Report Number: 3001883144-2016-00026
• 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: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/20/2014
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3810911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2012
• 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): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 46