DIALYSIS GRAFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for DIALYSIS GRAFT manufactured by W. L. Gore And Assoc..

Event Text Entries

[9458] Frequent clotting inside of plastic grafts. Rptr's son was born in 1959. At the age of 16, he received a bovine graft through which he received his dialysis treatments. The graft remained implanted for approx five yrs without problems. Rptr stated that the graft did not clot once in those five yrs. Approx four yrs after receiving the bovine graft, rptr's son received a kidney transplant. The transplanted kidneys functioned properly for approx 12 yrs and three months. At that time a "plastic" graft was implanted. During the next 22 months, rptr's son was hospitalized 11 times because of "clotting in the graft. " he was recently hospitalized on 8/6/93, 8/26/93 and 9/9/93. He is still hospitalized as of 9/14/93. He is in icu as a result of complications which occurred in the or during treatment of the last episode of clotting. Rptr's son now receives dialysis treatments. He is in a unit of approx 20 pts. Rptr stated that at one time, 8 of the 20 or so pts in the unit were hospitalized for clotting in their plastic grafts. The treatment for this problem is to either declot the graft or replace it if declotting is not possible. The area around the graft becomes infected much more frequently than with the bovine graft. Rptr stated that when she inquired about the possibility of her son receiving another bovine graft rather than a plastic graft, she was told that a) bovine grafts are too expensive and b) bovine grafts have been banned by fda.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000224
MDR Report Key11552
Date Received1994-02-07
Date of Report1993-09-14
Date Added to Maude1994-02-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDIALYSIS GRAFT
Product CodeFIQ
Date Received1994-02-07
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11552
ManufacturerW. L. GORE AND ASSOC.
Manufacturer AddressFLAGSTAFF AZ 86001 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-02-07

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