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 E100-29M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Pseudoaneurysm (2605)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 29mm epic valve was implanted.On (b)(6) 2019, a left ventricle rupture (mild) and pseudoaneurysm occurred.The valve was explanted and replaced on (b)(6) 2019 with 27mm epic valve.There was no known issue with the 29mm epic valve but do to damage of annulus the valve was explanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to left ventricle rupture, pseudoaneurysm and annulus damage.The investigation found that there was organizing hemorrhage on the sewing cuff.A gram stain was negative for organisms.There was a thin layer of fibrin on the cusps.No acute inflammation or significant calcifications were present.The valve met dimensional specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that there was no "particular problem" with the epic valve, but that the rupture and pseudoaneurysm required the valve to be replaced.

Event Description

Correction: on (b)(6) 2019, a 29mm epic valve was implanted.On (b)(6) 2019, a left ventricle rupture (mild) and pseudoaneurysm occurred.The valve was explanted and replaced on (b)(6) 2019 with 27mm epic valve.There was no known issue with the 29mm epic valve but do to damage of annulus the valve was noted.The patient was reported to be in stable condition.

• 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: 9745991
• MDR Text Key: 183010059
• Report Number: 3008452825-2020-00120
• 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: 03/05/2020

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: 03/12/2023
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 6927363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention