CRYOVALVE SG SGPV00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-09 for CRYOVALVE SG SGPV00 manufactured by Cryolife, Inc..

Event Text Entries

[20236660] The allograft was noted to be cracked at implant. However, they implanted it anyway and it "fell apart".
Patient Sequence No: 1, Text Type: D, B5

[20400309] The investigation is ongoing. The device will be returned, but has not been received yet. Any additional info will be reported in a follow up report.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1063481-2008-00015
• MDR Report Key: 1044567
• Report Source: 05,06
• Date Received: 2008-05-09
• Date of Report: 2008-05-07
• Date of Event: 2008-05-07
• Date Mfgr Received: 2008-05-07
• Device Manufacturer Date: 2008-03-02
• Date Added to Maude: 2009-05-05
• 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: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: BRYAN BROSSEAU
• Manufacturer Street: 1655 ROBERTS BLVD.
• Manufacturer City: KENNESAW GA 30144
• Manufacturer Country: US
• Manufacturer Postal: 30144
• Manufacturer Phone: 7704193355
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRYOVALVE SG
• Generic Name: PULMONARY VALVE
• Product Code: OHA
• Date Received: 2008-05-09
• Catalog Number: SGPV00
• Device Expiration Date: 2009-03-29
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CRYOLIFE, INC.
• Manufacturer Address: KENNESAW GA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2008-05-09