CRYOARTERY FEMORAL POPLITEAL ARTERY HUMAN ALLOGRAFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-29 for CRYOARTERY FEMORAL POPLITEAL ARTERY HUMAN ALLOGRAFT manufactured by Cryolife Inc..

Event Text Entries

[79287554] On (b)(6)2017, the pt had a left right femoral - femoral bypass using cryopreserved artery. On (b)(6)2017, the pt came to the ed for eval with reports of drainage from the right femoral incision site. She was taken to the operating room for exploration of the right and left groin, evacuation of hematoma right groin, evacuation of seroma left groin, exploration graft, repair of fem-fem bypass graft with interposition autograft washout and drainage. The fem-fem graft had a defect (a hole) in it. The mfr was called intraoperatively and specifically asked "do defects in cryo-artery occur post-implantation," they said yes. I asked "is this a sign of infection. " it did not look infected. There was no pus or purulence in the wound. I want to make sure there was no infected graft that needed to be removed. They said no. Sometimes it can happen where there is a defect in the mid portion of the graft. Per the surgeon, "again, this is a defective graft. " the attempted repair was not successful, so they did an interposition autograft repair. The pt developed a positive blood culture which grew pseudomonas aeruginosa. On (b)(6)2017, the pt returned to the operating room for a bilateral groin exploration, removal of infected fem-fem graft washout, debridement of artery repair superficial femoral artery bilaterally with patch angioplasty bovine pericardium, repair femoral vein, washout and drainage with irrigation of wounds and placement of jp drain and closure. Pt was discharged home with a piv ine for long term iv antibiotics.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6689791
• MDR Report Key: 6689791
• Date Received: 2017-06-29
• Date of Report: 2017-06-27
• Date of Event: 2017-05-08
• Date Facility Aware: 2017-06-08
• Report Date: 2017-06-27
• Date Reported to FDA: 2017-06-27
• Date Reported to Mfgr: 2017-06-27
• Date Added to Maude: 2017-07-06
• 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
• Reporter Occupation: RISK MANAGER
• 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: 0

Device Details

• Brand Name: CRYOARTERY FEMORAL POPLITEAL ARTERY HUMAN ALLOGRAFT
• Generic Name: NONE
• Product Code: DYF
• Date Received: 2017-06-29
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CRYOLIFE INC.
• Manufacturer Address: KENNESAW GA 30144 US 30144

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2017-06-29