MAUDE Adverse Event Report: SORIN GROUP / LIVANOVA USA, INC. PERCEVAL VALVE MEDIUM 23MM; HEART - VALVE, PROSTHESIS

Model Number ICV 1209

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Component Missing (2306)

Patient Problems Congestive Heart Failure (1783); Dyspnea (1816); Endocarditis (1834); Infiltration into Tissue (1931)

Event Date 02/05/2020

Event Type  Injury  

Event Description

Heart valve explanted due to defect."indication for procedure: this (b)(6) y/o gentleman first underwent an aortic valve replacement with a trifecta valve in early 2017.In (b)(6) 2019, he presented here with endocarditis of his trifecta valve and underwent a redo aortic valve replacement by this surgeon.A medium sized perceval valve was inserted.The pt did well after this and intraoperative echo showed the valve to be well seated with no perivalvular leak and a pre-discharge echo also showed that the valve was functioning well with no perivalvular leak.The pt did well for several months and around 3 weeks ago developed shortness of breath and was found to have bilateral pulmonary infiltrates.He was worked up by a pulmonologist and an echo was done showing a significant perivalvular leak around the perceval valve.He was admitted to our hosp and he was worked up including a transesophageal echo and a cta, which demonstrated that there was a large posterior perivalvular leak.The cta indicated that a portion of the valve was missing and appeared to be located in the right common iliac artery, where i was not causing any flow obstruction.The pt was in moderate congestive heart failure, being controlled with lasix.He has had previous coronary angiography demonstrating that he has mid-to-moderate coronary artery disease with no significant lesions.The valve was removed and a new valve placed.Fda safety report id# (b)(4).

• Brand Name: PERCEVAL VALVE MEDIUM 23MM
• Type of Device: HEART - VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN GROUP / LIVANOVA USA, INC. ; IT
• MDR Report Key: 9763741
• MDR Text Key: 181631937
• Report Number: MW5093328
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2020

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: Health Professional
• Device Model Number: ICV 1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 85