MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-21

Device Problems Calcified (1077); Gradient Increase (1270); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816)

Event Date 08/20/2021

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

It was reported on (b)(6) 2020, a 21mm epic supra valve w/flexfit was implanted.The patient presented with shortness of breath, aortic stenosis and increased gradient.On (b)(6) 2021, the valve was explanted and upon explant calcification was noted on the leaflets as well as pannus which was causing the narrowing of the lumen.A non-abbott valve was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to "shortness of breath, aortic stenosis and increased gradient".The investigation found that all three cusps had thrombus on the outflow side.Cusp 1 and cusp 3 had folds/retractions with incomplete coaptation.There was no inflammation or significant calcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The immobilizing thrombus on the outflow of the cusps would have contributed to the reported stenosis.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12527189
• MDR Text Key: 273156675
• Report Number: 3007113487-2021-00047
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P040021
• 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,Followup
• Report Date: 12/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: ESP100-21
• Device Lot Number: BR00021033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 103 KG