CRYOVEIN V060 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-07 for CRYOVEIN V060 * manufactured by Cryolife, Inc..

Event Text Entries

[357465] Received urgent tissue notification from cryolife for a femoral vein that had been implanted into a patient. This prompted a retrospective review of the case, revealing that the patient did have post-op infections requiring surgical intervention and long-term antibiotics. The patient underwent a right superficial femoral vein to suprarenal inferior vena cava with cryopreserved femoral vein, left to right superficial femoral vein to cryopreserved graft, and bilateral superficial femoral artery to cryopreserved vein arteriovenous fistula for venous obstruction (inferior vena cava, iliac, and bilateral common femoral) with venous claudication. The patient developed an infected left groin hematoma and femoral venous bypass graft disruption requiring wide, sharp debridement and jet lavage of bilateral groins, interposition vein graft to fem-fem venous bypass and bilateral sartorius flap coverage of femoral vessels several weeks later. Operative closure of both groin wounds was done several weeks later.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 542129
• MDR Report Key: 542129
• Date Received: 2004-07-07
• Date of Report: 2004-07-06
• Date of Event: 2003-06-26
• Report Date: 2004-07-06
• Date Reported to FDA: 2004-07-07
• Date Added to Maude: 2004-09-08
• Event Key: 0
• Report Source Code: User Facility 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: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CRYOVEIN
• Generic Name: FEMORAL VEIN ALLOGRAFT
• Product Code: LMO
• Date Received: 2004-07-07
• Model Number: V060
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 531497
• Manufacturer: CRYOLIFE, INC.
• Manufacturer Address: 1655 ROBERTS BOULEVARD, NW KENNESAW GA 30144 US

Device Sequence Number: 2

• Brand Name: CRYOVEIN
• Generic Name: FEMORAL VEIN ALLOGRAFT
• Product Code: LMO
• Date Received: 2004-07-07
• Model Number: V060
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 531498
• Manufacturer: CRYOLIFE, INC
• Manufacturer Address: 1655 ROBERTS BOULEVARD, NW KENNESAW GA 30144 US

Device Sequence Number: 3

• Brand Name: CRYOVEIN
• Generic Name: FEMORAL VEIN ALLOGRAFT
• Product Code: LMO
• Date Received: 2004-07-07
• Model Number: V060
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 531499
• Manufacturer: CRYOLIFE, INC
• Manufacturer Address: 1655 ROBERTS BOULEVARD, NW KENNESAW GA 30144 US

Device Sequence Number: 4

• Brand Name: CRYOVEIN
• Generic Name: FEMORAL VEIN ALLOGRAFT
• Product Code: LMO
• Date Received: 2004-07-07
• Model Number: V060
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 531500
• Manufacturer: CRYOLIFE, INC
• Manufacturer Address: 1655 ROBERTS BOULEVARD, NW KENNESAW GA 30144 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2004-07-07