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

Model Number TF-21A

Device Problem Leak/Splash (1354)

Patient Problem Pulmonary Edema (2020)

Event Date 10/18/2015

Event Type  Injury  

Manufacturer Narrative

Gtin number: (b)(4).

Event Description

Two days after implantation of this 21 mm sjm trifecta valve the patient developed pulmonary edema and a central leak in the valve was seen on echocardiogram.The valve was explanted on (b)(6) 2015 and replaced with a 21 mm edwards magna ease valve.The patient is doing well.

Manufacturer Narrative

(b)(4).The results of this investigation confirmed a prolapse in cusp 1, resulting in incomplete coaptation of the cusps.Two puncture marks were identified near one another located on the post 2 side of the prolapsed leaflet.It is unknown how or when this damage occurred.The device history record and functional inspection test videos for this valve were reviewed, with the results indicating the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by review of the valve's device history record, the analysis performed.The cause of the reported prolapse remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5233562
• MDR Text Key: 31525956
• Report Number: 3008452825-2015-00106
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2017
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 5045469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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