FDA Adverse Event Other Summary report: N

DISTAFLO EPTFE BYPASS GRAFT

MDR report key: 256608 · Received October 28, 1999

Report

Report Number
MW4002654
Event Type
Other
Date Received
October 28, 1999
Date of Event
August 3, 1999
Report Date
October 18, 1999
Manufacturer
IMPRA, INC.
Product Code
DSY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IN 1998 PT UNDERWENT A RIGHT FEMORAL TO ANTERIOR TIBIAL BYPASS WITH A GORE-TEX GRAFT WITH A MODIFIED MILLER CUFF TO PRESERVE LIMB FUNCTION. HE PRESENTED IN 3/99 WITH INCREASING REST PAIN AND WAS TREATED WITH HEPARIN AND ATTEMPTS WERE MADE TO USE UROKINASE; THE GRAFT APPEARED TO BE OCCLUDED FOR AT LEAST TWO MONTHS AND ATTEMPTS TO ESTABLISH PATENCY WERE UNSUCCESSFUL. AN ANGIOGRAM INDICATED THAT A NEW AREA OF STENOSIS HAD OCCURRED IN THE DORSALIS PEDIS AND MAY HAVE CONTRIBUTED TO THE GRAFT OCCLUSION. THE PT WAS OFFERED A LAST ATTEMPT FOR LIMB SALVAGE BY PERFORMING A FEMORAL ANTERIOR TIBIAL BYPASS AND ANGIOPLASTY OF THE DORSALIS PEDIS. HE CONSENTED TO ENROLLMENT IN THE ABOVE NAMED PROTOCOL AND WAS RANDOMIZED TO THE STANDARD IMPRA GRAFT WITH MODIFIED MILLER CUFF. HIS ONE MONTH FOLLOW-UP SHOWED AN IMPROVED ANKLE-BRACHIAL INDEX. HE NEXT PRESENTED AT 4.5 MONTHS WITH NEW ONSET LEG PAIN; DUPLEX STUDIES VERIFIED GRAFT OCCLUSION. HE RETURNED TO THE VASCULAR CLINIC. HE DID NOT KEEP THE NEXT APPOINTMENT. IT WAS LEARNED THAT THE PT WAS A RESIDENT AT A REHABILITATION FACILITY. THE PT WAS CONTACTED DIRECTLY AND HE RELATED HE UNDERWENT A RIGHT ABOVE THE KNEE AMPUTATION AT HOSP BUT DID NOT KNOW THE DATE. IN RPTR'S JUDGEMENT, CAUSALITY IS RELATED TO THE GRAFT OCCLUSION. HOWEVER, AT THE PRESENT TIME RPTR DOES NOT HAVE CAUSE TO BELIEVE THESE EVENTS OCCURRED AS A RESULT OF THE TYPE OF PROSTHETIC GRAFT USED VERSUS THE CHOICE OF ANOTHER TYPE OF PROSTHETIC GRAFT. ACCORDING TO RPTR, PROSTHETIC GRAFTS HAVE A HIGHER INCIDENCE OF OCCLUSION AND ARE USUALLY ONLY OFFERED IF AN AUTOLOGOUS GRAFT IS NOT AN OPTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DISTAFLO EPTFE BYPASS GRAFT Implant BYPASS GRAFT DSY IMPRA, INC. NI NI

Patients

Seq Age Sex Outcome Treatment
1 66 YR Other