CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS 3000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS 3000 manufactured by Edwards Lifesciences.

MAUDE Entry Details

• Report Number: 2015691-2020-11196
• MDR Report Key: 9889750
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-27
• Date of Report: 2020-03-04
• Date of Event: 2013-05-31
• Date Mfgr Received: 2020-03-04
• Device Manufacturer Date: 2007-07-17
• Date Added to Maude: 2020-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. AMRITHA SRINIVASAN
• Manufacturer Street: ONE EDWARDS WAY MLE-2
• Manufacturer City: IRVINE CA 92614
• Manufacturer Country: US
• Manufacturer Postal: 92614
• Manufacturer Phone: 9492504062
• Manufacturer G1: EDWARDS LIFESCIENCES LLC
• Manufacturer Street: ONE EDWARDS WAY
• Manufacturer City: IRVINE CA 92614
• Manufacturer Country: US
• Manufacturer Postal Code: 92614
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
• Generic Name: HEART-VALVE, REPLACEMENT
• Product Code: DYE
• Date Received: 2020-03-27
• Model Number: 3000
• Lot Number: R-07G1428
• Device Expiration Date: 2011-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EDWARDS LIFESCIENCES
• Manufacturer Address: ONE EDWARDS WAY IRVINE CA 92614 US 92614

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2020-03-27