BIOGRAFT

Report

Report Number: 2183620-1998-00006
Event Type: Injury
Date Received: March 11, 1998
Date of Event: December 4, 1997
Report Date: March 11, 1998
Manufacturer: BIO-VASCULAR, INC.
Product Code: LXA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AN EVALUATION OF THE EXPLANT SAMPLE WAS PERFORMED BY THE QUALITY DEPARTMENT AT BIO-VASCULAR, INC. THE GROSS EXAMINATION OF THE GRAFT SAMPLE DEMONSTRATED THAT THE ELASTICA LAMINA DID APPEAR TO BE BROKEN UP. HOWEVER, CO WAS UNABLE TO DETERMINE IF THIS CONDITION WAS PRESENT PRIOR TO IMPLANTATION. CO DISCUSSED THIS CASE WITH ANOTHER EXPERIENCED BIOGRAFT SURGEON AND HE INDICATED THAT THE BREAKDOWN OF THE BIOGRAFT MAY HAVE BEEN DUE TO THE THROMBECTOMY PROCEDURE THAT WAS PERFORMED. HE SAID THAT THIS TECHNIQUE CAN INFLICT INJURY ON THE GRAFT MATERIAL. HE COMMENTED THAT HE HAS NOT EXPERIENCED A BIOGRAFT MALFUNCTION THAT WAS DUE TO THIS TYPE OF FAILURE OF THE GRAFT. AGAIN, THIS GRAFT MET WITH ALL TESTING AND INSPECTION REQUIREMENTS BEFORE IT WAS APPROVED. THIS INFO WAS COMMUNICATED TO THE SURGEON WHO EXPERIENCED THE COMPLICATION.

Description of Event or Problem · 1

THE SURGEON REPORTED THAT ON DECEMBER 4, 1997, A PT HAD TWO BIOGRAFT DEVICES IMPLANTED. THE NEXT DAY FOLLOWING THE SURGERY, THE PROXIMAL PART OF THE BYPASS, WHICH WAS THE ABOVE MENTIONED SHORT GRAFT, HAD OCCLUDED & A THROMBECTOMY OF THAT SMALLER GRAFT WAS PERFORMED. THE THROMBECTOMY REVEALED THAT ALTHOUGH THE PROXIMAL & DISTAL ANASTOMOSIS WERE INTACT, THE INTIMA SEEMED TO BE SEPARATING. THE OTHER DISTAL BIOGRAFT WAS COMPLETELY PATENT & FUNCTIONING WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BIOGRAFT Implant	UMBILICAL VEIN GRAFT	LXA	BIO-VASCULAR, INC.	403505	1-6K04-1275

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Required Intervention