PERCEVAL VALVE MEDIUM 23MM ICV 1209

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for PERCEVAL VALVE MEDIUM 23MM ICV 1209 manufactured by Sorin Group / Livanova Usa, Inc..

Event Text Entries

[181631937] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093328
• MDR Report Key: 9763741
• Date Received: 2020-02-26
• Date of Report: 2020-02-24
• Date of Event: 2020-02-05
• Date Added to Maude: 2020-02-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERCEVAL VALVE MEDIUM 23MM
• Generic Name: HEART - VALVE, PROSTHESIS
• Product Code: DTI
• Date Received: 2020-02-26
• Model Number: ICV 1209
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SORIN GROUP / LIVANOVA USA, INC.
• Manufacturer Address: IT

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-02-26