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

Device Problem Obstruction of Flow (2423)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reference manufacturer report numbers: 2648612-2020-00127; 2648612-2020-00128.The article, 'which is the best prosthesis in an isolated or combined tricuspid valve replacement?' was reviewed.This research article is a retrospective multi center experience to compare the long-term results of mechanical and biological prostheses in patients who underwent isolated, or combined tricuspid valve replacement.Edwards lifesciences pericardial tissue heart valve; medtronic hancock ii porcine heart valve, mosaic porcine bioprosthesis and mechanical heart valves; abbott epic serial model tissue heart valve and masters series mechanical heart valve were associated to the study.The article concluded that biological prostheses may be an optimal choice for patients, especially for patients without ebsteins anomaly, in isolated tricuspid valve replacement.The primary author of the article is peng liu, md of department of cardiovascular surgery, fuwai central china cardiovascular hospital, henan province peoples hospital, henan cardiovascular hospital and zhengzhou university, zhengzhou, henan, china.(b)(6).

Manufacturer Narrative

As reported in a research article, complications from valve implant included structural valve deterioration, reoperation, thrombosis and a bleeding event.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
• 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: 10912584
• MDR Text Key: 218910213
• Report Number: 3001883144-2020-00114
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR