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

Model Number TF-25A

Device Problem Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Congestive Heart Failure (1783); Dyspnea (1816); Mitral Regurgitation (1964); Tricuspid Regurgitation (2112); Cusp Tear (2656)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013 a 25mm trifecta valve was implanted.Recently, the patient presented with dyspnea and congestive heart failure and was referred to his cardiologist.An echo was performed and documented severe aortic regurgitation, mitral regurgitation and moderate tricuspid regurgitation.The valve was explanted (b)(6) 2015.Upon direct visual inspection ex vivo, the non-coronary cusp was found torn away from the top of the strut.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Two photographs of the sjm trifecta bioprosthesis were provided from the field; one prior to explant and one post-explant.Both photos showed portions of the outflow side of the valve.What appeared to be blood and body fluids were observed covering what was visible of the sewing cuff, stent post, and cusps.What appeared to be a tear was observed along the base of one of the cusps.The tear appeared to run from the top of one of the stent posts, to approximately the mid-portion of the cusp base.Do to the limited view of the device, no additional observations were able to be made.The device history record was reviewed, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported event 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: 5034818
• MDR Text Key: 24251914
• Report Number: 3008452825-2015-00067
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/13/2015
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3933192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2013
• 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: 60 YR