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

Model Number ESP100-19

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Abscess (1690); Bacterial Infection (1735); Endocarditis (1834); Fever (1858)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer report number: 3001883144-2021-00133.It was reported that on (b)(6) 2021, a double valve replacement procedure was performed.A 19 mm epic supra valve w/flexfit was implanted in the aortic position and a 27 mm epic stented porcine heart valve w/flexfit system in the mitral position.On (b)(6) 2021, the patient presented with persistent high grade fever.Echo was performed and it was noted that they had developed early aortic prosthetic valve endocarditis, increased gradient across the aortic valve, and vegetative growth over the mitral valve.Vancomycin was given to the patient as treatment.On (b)(6) 2021, it was discovered that the vegetation on the mitral valve had resolved, while the aortic prosthetic valve endocarditis had progressed with development of annular abscess and with gradients increased across the valve.On (b)(6) 2021, the 19 mm epic supra valve w/flexfit was explanted and replaced with a 19 mm non-abbott device and placed on iv antibiotics to resolve the event.The patient is stable.No additional information as provided.

Manufacturer Narrative

Explant due to endocarditis and high gradient was reported.The investigation found that cusp 3 was perforated consistent with possible incision.There was mild thinning at the base of cusp 1.Biological foreign material was adhered to cusps 1 and 3.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.The cause of the reported event could not be conclusively determined.

• 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: 12547596
• MDR Text Key: 273807403
• Report Number: 3007113487-2021-00051
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/06/2022

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: 01/22/2024
• Device Model Number: ESP100-19
• Device Lot Number: BR00023528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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