MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Valvular Stenosis (2697)

Event Date 07/30/2014

Event Type  Injury  

Event Description

A 21mm trifecta valve was implanted in the aortic position on (b)(6) 2011.The patient was hospitalized (b)(6) 2014 for the management of complete heart block complicated by an infective endocarditis on an aortic bioprosthesis.The patient was placed on a dual course of antibiotics.The initial echo performed (b)(6) 2014 showed a degenerated, calcified valve with a mean gradient of 70mm hg with no signs of visible vegetation.Following an episode of torsade de pointe and repeated episodes of nsvt, the patient received an implantable defibrillator on (b)(6) 2014.The patient was transferred to a skilled facility for further rehabilitation.On (b)(6), the patient was readmitted to the cardiac unit for consideration of a replacement avr.A repeat tte revealed a compromised valve associated with severe stenosis and mild paravalvular leak (pvl) suspected to have been the result of a small rupture of a suture.On a subsequent ct scan the valve was considered normal without evidence of pvl.The final decision was due to multiple co-morbidities (alcoholic dilated cardiomyopathy, ulcerated oesophageal variaces, chronic alcoholism, cirrahosis child b9) a redo valve procedure is contraindicated.

Manufacturer Narrative

(b)(4).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, 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 incident could not be conclusively determined.

Manufacturer Narrative

(b)(4).

Event Description

Per report, the patient was diagnosed with recurrent endocarditis on (b)(6) 2015.On (b)(6) 2015, the 21mm trifecta valve was explanted and replaced with a second trifecta valve (size unknown).(clinical study patient id: (b)(6)).

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4838638
• MDR Text Key: 5945650
• Report Number: 3007113487-2015-00026
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

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: Other
• Device Expiration Date: 03/28/2013
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3368840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2011
• 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: 53 YR
• Patient Weight: 80