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

Model Number TF-19A

Device Problems Calcified (1077); Degraded (1153); Occlusion Within Device (1423); Reflux within Device (1522)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020)

Event Date 03/17/2015

Event Type  Injury  

Event Description

On (b)(6) 2011, a 19mm trifecta valve was implanted due to aortic valve stenosis and insufficiency.A trans-esophageal echo on (b)(6) 2015 revealed grade ii aortic insufficiency.The patient presented with hypertensive and pulmonary edema requiring hospitalization from (b)(6) 2015.A diagnostic x-ray showed acute pulmonary edema with central and peripheral lung stasis.Medical management included oxygen and furosemide.The patient was stabilized.On (b)(6) 2015, the patient was diagnosed with severe aortic valve stenosis and regurgitation due to structural valve deterioration caused by calcification.The valve was explanted on (b)(6) 2015 and a 19mm non-sjm valve was implanted.At explant, the trifecta valve was noted to be heavily calcified in the commissural region and difficult to excise due to the small annulus.The patient was released (b)(6) 2015.

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.

• 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: 4755863
• MDR Text Key: 21058310
• Report Number: 3007113487-2015-00022
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/24/2013
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3312415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2011
• 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): Required Intervention
• Patient Age: 77 YR