SYMMETRY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-08 for SYMMETRY * manufactured by *.

Event Text Entries

[16288823] Multiple pts in the reporter's and surrounding institutions have had coronary bypass surgery with a symmetry device used to attach the vein graft to the aorta. Several have had post operative myocardial infarction and re-catheterization reveals device closure resulting in graft loss. Reporter know's personally of two pt deaths related to this. There are other pts with mi and others who have required reoperation within months to correct this graft loss. On re-cath, reporter has seen only one of probably 30 symmetry devices that have patency. This included pts operated on at four different institutions by different surgeons. Reporter can't imagine this is a unique experience.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028949
• MDR Report Key: 471395
• Date Received: 2003-07-08
• Date of Report: 2003-07-08
• Date Added to Maude: 2003-07-15
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SYMMETRY
• Generic Name: *
• Product Code: NCA
• Date Received: 2003-07-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 460237
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2003-07-08