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

Model Number TF-23A

Device Problem Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

The reported event of a torn leaflet could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2015, a 23 mm trifecta valve was implanted.On (b)(6) 2017, the patient came as an emergency case from another hospital.During an echocardiogram, severe aortic insufficiency.At the time of tavr procedure on fluoroscopy there was confirmation of a tear of the left coronal leaflet.A transcatheter valve-in-surgical valve procedure was performed.A 23 mm edwards sapien 3 valve was implanted with no relevant insufficiency on tee and angiography.The patient is reported to be stable.

Event Description

On (b)(6) 2015, a 23 mm trifecta valve was implanted.On (b)(6) 2017, the patient came as an emergency case from another hospital.During an echocardiogram, severe aortic insufficiency was noted with a suspected rupture of the left coronal leaflet.At the time of tavr procedure on fluoroscopy there was confirmation of a tear of the left coronal leaflet.Because the patient had an increased surgical risk profile (euroscore: i: 37.7%) the indication for catheter-guided aortic valve implantation (tavi) was provided and performed on (b)(6) 2017.A 23 mm edwards sapien valve was implanted with no relevant insufficiency on tee and angiography.On (b)(6) 2017, the patient was initially successfully extubated after adequate weaning.Due to respiratory fatigue despite niv therapy, the patient was again intubated on (b)(6) 2017.On (b)(6) 2017 the patient was extubated after stabilization and respiratory improvement.Subsequently, niv and high-flow therapy resulted in a significant improvement and stabilization of the patient¿s respiratory situation.No pathogens were detected in the blood cultures.Standard mrsa screening provided a negative result.Increasing infection parameters led to the initiation of antibiotic therapy with tazobac, supplemented by rifampicin and vancomycin.The patient¿s infection parameters dropped significantly under this treatment and the antibiotic therapy was discontinued on (b)(6) 2018.Under continued cardiopulmonary monitoring in conjunction with respiratory training and stepwise systematic return to a normal diet, the patient was able to mobilize to the level of ambulation in the hallway.The standard 24-hr holter recorded after a thv procedure to exclude high-grade arrhythmias, showed a sinus rhythm of 52-76 bpm on average, without any relevant pauses.The post-procedural echocardiographic follow-up confirmed the proper position, expansion and function of the valve stent.At the time of discharge on 04 jan 2018, the patient was in stable cardiopulmonary condition.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 7263170
• MDR Text Key: 99790612
• Report Number: 3008452825-2018-00030
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2017
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 5158051
• Other Device ID Number: 05414734052030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR