MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. EPIC STENTED TISSUE VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Obstruction of Flow (2423)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

Related manufacturing reference number 3014918977-2021-00013.The article, "transcatheter aortic valve implantation for degenerated aortic valves: experience with a new supra-annular device.The spanish allegra valve-in-valve (saviv) registry", was reviewed.This research article is a retrospective single center experience to evaluate the results of valve-in-valve procedures performed with the allegra device.4 trifecta (st.Jude medical), 1 epic supra, 1 biocor/epic, and 23 non-abbott devices that were associated with the study.The article concluded that the allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.The primary and correspondence author of the article is raúl moreno, md, phd, interventional cardiology, university hospital la paz, paseo la castellana, 261 madrid 28046 spain, email: raulmorenog@hotmail.Com.

Manufacturer Narrative

As reported in a research article, one epic valve had early degeneration and were replaced with a transcatheter valve.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.

• Brand Name: EPIC STENTED TISSUE VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 11968374
• MDR Text Key: 265835181
• Report Number: 3001883144-2021-00086
• 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
• Report Date: 07/23/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR