MAUDE Adverse Event Report: SORIN MITROFLOW VALVE #27; PERICARDIAL TISSUE VALVE

Catalog Number LXA27

Device Problems Material Disintegration (1177); Occlusion Within Device (1423); Sticking (1597)

Patient Problems Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Complete Heart Block (2627)

Event Date 04/08/2015

Event Type  Death  

Event Description

Patient presented on (b)(6) 2015 with chest pain, left bundle branch block, and hypotension.Patient taken directly to the cath lab, no cardiac intervention done during the procedure due to visualization of a thrombotic occlusion of the aortic valve prosthesis, after discussion with the family it was decided the patient was not a good surgical candidate and thrombolytic therapy was given.The patient had a tee the following day which showed a heavily degenerated bioprosthesis in the aortic position with significantly decreased leaflet excursion with evidence of severe aortic stenosis.Compared to the tee done on (b)(6) 2015 there is a significant degeneration of the aortic valve bioprosthesis noted on the current study.The patient continued to deteriorate during his hospitalization and expired on (b)(6) 2015.Dates of use: (b)(6) 2013 - (b)(6)2015.Diagnosis or reason for use: heart valve.

• Brand Name: MITROFLOW VALVE #27
• Type of Device: PERICARDIAL TISSUE VALVE
• Manufacturer (Section D): SORIN
• MDR Report Key: 4739692
• MDR Text Key: 5827876
• Report Number: MW5042398
• Device Sequence Number: 1
• Product Code: LWR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: LXA27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR