MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-31M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Renal Failure (2041)

Event Type  Injury  

Manufacturer Narrative

In an research article events of acute kidney injury and hemodynamic instability were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "emergency surgical retrieval of a migrated lambre device through the mitral valve" was reviewed.This research article presents a case study on a (b)(6) male with several cardiovascular risk factors, coronary artery disease with multiple stents and permanent atrial fibrillation who underwent left atrial appendage occlusion (laao) using a non-abbott device.Four days post-procedure the device embolized into the left ventricle, causing severe mitral valve regurgitation, severe mitral valve stenosis and hemodynamic instability that required emergency surgery.There was severe damage in the anterior leaflet and chords of the mitral valve and a 31mm epic tissue heart valve was implanted in the patient's mitral position and the left atrial appendage was closed with direct sutures.The patient was successfully weaned from cardiopulmonary bypass and transferred to the intensive care unit, where they had episodes of paroxysmal atrial fibrillation; from postoperative day 4, atrial fibrillation persisted until the patient was discharged.Acute kidney injury delayed the recovery because the patient was moved to the normal ward on the postoperative day10 and discharged home on postoperative day 17.No additional information was provided.The article concluded that despite being a relatively new device, the lambre occluder has proven its safety and equivalence with the 2 most frequently implanted laao devices.The primary and correspondence author of the article is daniel martinez-lopez, hospital universitario puerta de hierro majadahonda, manuel de falla 1, 28222 majadahonda, spain with the corresponding email: dani.Martinezlop@gmail.Com.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12488666
• MDR Text Key: 271929570
• Report Number: 3001883144-2021-00126
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-31M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR