MAUDE MDR 6689791

MDR report key
6689791
Report number
6689791
Event key
0
Event type
3
Date of event
2017-05-08
Date received
2017-06-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CRYOARTERY FEMORAL POPLITEAL ARTERY HUMAN ALLOGRAFTNONECRYOLIFE INC.DYFI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-2901. H; 2. O

Event Narratives#

D

Patient 1

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.