NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT A FEMORAL SURGICAL GRAFT WAS SUCCESSFULLY SUTURED IN A PERPENDICULAR PLACEMENT TO AN EXISTING FEMORAL SURGICAL GRAFT. WHILE MOVING THE PATIENT OFF THE SURGICAL TABLE A HEMATOMA WAS IDENTIFIED AT THE ANASTOMOSIS OF THE SURGICAL GRAFT PLACEMENT. A REVISION OF THE LEAKING SURGICAL GRAFT WAS PERFORMED AT THE ANASTOMOSIS OF THE GRAFT TO GRAFT PLACEMENT. THE PATIENT WAS ADMITTED TO HOSPITAL EIGHT DAYS POST SURGICAL GRAFT PLACEMENT FOR BLEEDING AT THE ANASTOMOSIS OF THE GRAFT TO GRAFT PLACEMENT. A REVISION OF THE SURGICAL GRAFT WAS PERFORMED. THE CURRENT PATIENT STATUS IS UNKNOWN.
N
Patient 1
MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE SUBASSEMBLIES, MATERIAL REVIEW REPORTS, RAW MATERIAL TESTING, MANUFACTURING PROCESS, AND QUALITY CONTROL INSPECTION. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT THAT HAS BEEN REPORTED FOR THIS CORPORATE LOT NUMBER TO DATE. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, A VISUAL INSPECTION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. PHOTO REVIEW: FIVE DIGITAL PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST IMAGES SHOWED THE LABEL OF THE GRAFT IDENTIFYING THE CATALOG NUMBER AS F8008TWSC AND LOT NUMBER IS VTAT0739. THIS MATCHED THE REPORTED CATALOG AND LOT NUMBER PROVIDED. THE SECOND PHOTO SHOWED ONE EPTFE GRAFT COVERED IN FLUID. ONE END OF THE GRAFT APPEARED TO BE SUTURED INTO THE PATIENT SOMEWHERE WITHIN THE BODY HOWEVER THE LOCATION WAS NOT VISIBLE. ONE END OF THE GRAFT WAS VISIBLE HOWEVER THE END APPEARED CLEAN, NO RIP OR TEARS WERE IDENTIFIED IN THE PHOTO. THE THIRD PHOTO SHOWED THE SAME ANATOMICAL SCENE AS THE SECOND PHOTO; HOWEVER, THE SIDE OF THE GRAFT WAS VISIBLE. NO RIP OR TEARS WERE IDENTIFIED IN THE PHOTO. IN EITHER PHOTO PROVIDED NO BLUE LINES COULD BE SEEN IDENTIFYING THE GRAFT AS A BARD GRAFT. THE FOURTH PHOTO SHOWED AN OPEN PROCEDURE WITH WHAT APPEARED TO BE THE ORIGINAL GRAFT IN PLACE. NO NEW GRAFT WAS IDENTIFIED, NOR ANY TEARS OR RIPS WERE IDENTIFIED. THE FIFTH PHOTO SHOWED TWO GRAFTS ADJOINED IN PERPENDICULAR CONFIGURATION. BLUE LINES COULD BE IDENTIFIED IN EACH GRAFT, THEREFORE IDENTIFYING THEM AS BARD GRAFTS. NO TEARS OR RIPS WERE IDENTIFIED ON EITHER GRAFT IN THE PHOTO. BASED ON THE PROVIDED PHOTOS, THE INVESTIGATION WAS INCONCLUSIVE FOR TORN MATERIAL. CONCLUSION: THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS WERE NOT PROVIDED. PHOTOS WERE PROVIDED AND REVIEWED. BASED ON THE PROVIDED PHOTOS, THE INVESTIGATION WAS INCONCLUSIVE FOR TORN MATERIAL. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT WAS UNKNOWN WHETHER PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT INSTRUCTION FOR USE (IFU) STATES: EPTFE GRAFTS DO NOT STRETCH (ARE NON-ELASTIC) IN THE LONGITUDINAL DIRECTION. THE CORRECT GRAFT LENGTH FOR EACH PROCEDURE MUST BE DETERMINED BY CONSIDERING THE PATIENT'S BODY WEIGHT, POSTURE, AND THE RANGE OF MOTIONS ACROSS THE ANATOMICAL AREA OF GRAFT IMPLANTATION. FAILURE TO CUT THE GRAFT TO AN APPROPRIATE LENGTH MAY RESULT IN ANASTOMOTIC OR GRAFT DISRUPTION, LEADING TO EXCESSIVE BLEEDING, AND LOSS OF LIMB OR LIMB FUNCTION, AND/OR DEATH. AGGRESSIVE AND/OR EXCESSIVE GRAFT MANIPULATION WHEN TUNNELING, OR PLACEMENT WITHIN A TOO TIGHT OR TOO SMALL TUNNEL, MAY LEAD TO SEPARATION OF THE SPIRAL BEADING AND/OR GRAFT BREAKAGE. WHEN SUTURING, AVOID EXCESSIVE TENSION ON THE SUTURE LINE, INAPPROPRIATE SUTURE SPACING AND BITES, AND GAPS BETWEEN THE GRAFT AND HOST VESSEL. FAILURE TO FOLLOW CORRECT SUTURING TECHNIQUES MAY RESULT IN SUTURE HOLE ELONGATION, SUTURE PULL-OUT, ANASTOMOTIC BLEEDING AND/OR DISRUPTION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
IT WAS REPORTED THAT A FEMORAL SURGICAL GRAFT WAS SUCCESSFULLY SUTURED IN A PERPENDICULAR PLACEMENT TO AN EXISTING FEMORAL SURGICAL GRAFT. WHILE MOVING THE PATIENT OFF THE SURGICAL TABLE A HEMATOMA WAS IDENTIFIED AT THE ANASTOMOSIS OF THE SURGICAL GRAFT PLACEMENT. A REVISION OF THE LEAKING SURGICAL GRAFT WAS PERFORMED AT THE ANASTOMOSIS OF THE GRAFT TO GRAFT PLACEMENT. THE PATIENT WAS ADMITTED TO HOSPITAL EIGHT DAYS POST SURGICAL GRAFT PLACEMENT FOR BLEEDING AT THE ANASTOMOSIS OF THE GRAFT TO GRAFT PLACEMENT. A REVISION OF THE SURGICAL GRAFT WAS PERFORMED. THE CURRENT PATIENT STATUS IS UNKNOWN.