MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-21A

Device Problems Perivalvular Leak (1457); Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Syncope (1610); Aortic Regurgitation (1716); Dyspnea (1816); Dizziness (2194)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2018, a 21mm epic stented porcine heart valve was implanted.On (b)(6) 2019, the patient returned with symptoms of shortness of breath, fainting, and dizziness.Structural valve deterioration was noted during further investigation.The patient is reported to be stable and discharged from the hospital, and scheduled to return in the future for a redo surgery.

Manufacturer Narrative

An event of shortness of breath, fainting, dizziness, and structural valve deterioration seen on echo was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, a 21mm epic stented porcine heart valve was implanted.On (b)(6) 2019, the patient returned with symptoms of shortness of breath, fainting, and dizziness.An echo was performed and structural valve deterioration was noted.It was found that there is a mild paravalvular leak, severe valvular aortic stenosis and an increase in the pressure gradient.The patient is reported to be stable and discharged from the hospital, and scheduled to return in the future for a redo surgery.Additional information had been requested.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• 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: 8897406
• MDR Text Key: 154431567
• Report Number: 3008452825-2019-00408
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• 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: 10/08/2019

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: 03/06/2022
• Device Model Number: E100-21A
• Device Catalogue Number: E100-21A
• Device Lot Number: 6377229
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR