MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-21

Device Problems Obstruction of Flow (2423); Incomplete Coaptation (2507); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article "very early and unusual aortic bioprosthetic valve deterioration 9 months after implantation" was reviewed.This article is a single case report of a patient who underwent aortic valve replacement with a 21mm epic supra valve on (b)(6) 2020.Nine months post-procedure, he experienced bioprosthesis deterioration of unknown etiology due to inward bending of the stent posts causing leaflet restriction and severe aortic stenosis.The patient refused redo surgery and continued to be symptomatic with dyspnea for the next 2 years until he expired.The primary author is madhu shukla, md, of department of cardiology, jaipur golden hospital, delhi, india.The corresponding author is jagdish c.Mohan, md, with corresponding email: a51hauzkhas@gmail.Com.

Manufacturer Narrative

Additional information: h6, h10; correction: h6.As reported in a research article, 9 months after the patient had an epic valve implanted, the stent posts were being inward due to an unknown cause, which resulted in leaflet restriction and stenosis.The patient refused reoperation and had symptoms of dyspnea.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Corrected information for: d1 and d4.Originally reported under a 21mm biocor supra valve, but the correct valve is a 21mm epic supra valve.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10185953
• MDR Text Key: 196224571
• Report Number: 3001883144-2020-00057
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESP100-21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 72 YR