ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

WE HAVE RECEIVED A PIECE OF THE GRAFT THAT WAS EXPLANTED BY THE SURGEON. THE PIECE WAS MEASURED TO BE 5 CM IN LENGTH. WE OBSERVED A SEMI-CIRCULAR WEAR ON THE GRAFT MATERIAL AT ONE END OF THE GRAFT WHILE THE OTHER END APPEARED TO BE NORMAL. THE END WHERE WE OBSERVED THE WEAR WAS LIKELY THE SECTION THAT PRESENTED THE COMPLICATIONS TO THE PATIENT. HOWEVER, IT COULD NOT BE DETERMINED IF THE WEAR WAS DUE TO THE GRAFT MATERIAL DETERIORATION OR IF IT OCCURRED WHEN SURGEON EXPLANTED THE GRAFT. THE GRAFT WAS IMPLANTED IN THE PATIENT FOR MORE THAN 4 YEARS. THE GRAFT DID NOT SHOW ANY SIGNS OF INCORPORATION TO ITS SURROUNDING TISSUE. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. DURING MANUFACTURING PROCESS, THE EXACT GRAFT WAS INSPECTED BY A QUALITY CONTROL INSPECTOR AS WELL AS BY A MANUFACTURING STAFF FOR HOLES, BROKEN THREADS AND ANY LOOSE FIBERS IN THE GRAFT. NO DEFECT WAS NOTED DURING THE INSPECTION PROCESS. A SAMPLE OF GRAFTS FROM THIS LOT NUMBER WERE ALSO TESTED FOR WATER PERMEABILITY AND PUNCTURE TEST. ALL OF THE SAMPLES MET ITS SPECIFICATION. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FROM THIS LOT. THEREFORE, WE BELIEVE THAT IT WAS AN ISOLATED INCIDENT. DURING OUR FOLLOW-UP INVESTIGATION, WE LEARNED: ON (B)(6) 2020, THE PATIENT WAS PRESENTED WITH REST AND STRESS PAINS IN THE RIGHT THIGH THAT HAVE BEEN PRESENT FOR ABOUT 10 DAYS. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL BY HER GENERAL PRACTITIONER WITH LEG VEIN THROMBOSIS. PATIENT PRE-EXISTING CONDITIONS INCLUDE TYPE II DIABETES MELLITUS, HYPERTENSION, STRESS INCONTINENCE. CLINICAL FINDINGS ON ADMISSION: EXTERNALLY NO HEMATOMA DISCOLORATION ON THE THIGH, PRESSURE PAIN ON THE RIGHT GROIN, PERIPHERAL PULSES WEAK BUT PALPABLE ON BOTH SIDES, POLYNEUROPATHY KNOWN, MOTOR SKILLS UNREMARKABLE. HEART SOUNDS PURELY RHYTHMIC, VESICULAR BREATHING SOUND ON BOTH SIDES, ABDOMINAL WALL SOFT NO PRESSURE PAIN, NO DEFENSE TENSION. SONOGRAPHY: ARTERIAL FALSE ANEURYSM RIGHT GROIN RESTING ECG: SINUS RHYTHM, LEFT TYPE, HEART RATE 83 / MIN, RS ENVELOPE V3 / 4, NO SIGNIFICANT REGRESSION DISORDERS. CT PELVIC LEG ANGIOGRAPHY WITH CONTRAST WAS PERFORMED ON (B)(6) 2020. THE VISCERAL ARTERIES WERE FILLING WITH CONTRACT. MODERATE TO HIGH GRADE STENOSIS ON THE CELIAC TRUNK WITH POST-STENOTIC DILATION, POSSIBLY FUNCTIONAL. AMS AND RENAL ARTERIES WERE PROPERLY DISPLAYED DURING ANGIOGRAPHY. ON THE RIGHT THIGH WHICH PRESENTED THE COMPLICATION, SURGEON DIAGNOSED AN OCCLUSION OF THE FEM-POP BYPASS, A LONG-STRETCHED LIQUID CAVITY IS SHOWN WITH DIFFERENT DENSITY VALUES AND CONTRAST MEDIUM ABSORPTION AT THE EDGE. MULTIPLE AIR POCKETS IN THE AREA AFTER SURGERY. IN THE DISTAL PORTION FLUID COLLECTION IN THE SARTORIUS MUSCLE, STARTING FROM THE BYPASS HEIGHT, REPEATEDLY SEPTATED. HERE ALSO CONTRAST AGENT UPTAKE ON THE MARGIN. THE DISTAL ANASTOMOSIS IS PRESUMABLY REFILLED RETROGRADE. CONTRAST INFUSION OF THE ARTERY PROFUNDA FEMORIS. NARROW-CALIBER POPLITEAL ARTERY WITH SEMICIRCULAR CALCIFICATIONS AND MODERATE STENOSIS. EXIT OF A FILIFORM ANTERIOR TIBIAL ARTERY, WHICH ONLY APPEARS TO BE FILLED WITH CONTRAST PROXIMALLY. SIGNIFICANT CALCIFICATIONS OF THE TIBIOFIBULAR TRUNK. DIVISION INTO A NARROW POSTERIOR TIBIAL ARTERY AND FIBULAR ARTERY. RESTRICTED TWO-VESSEL SUPPLY. INGUINAL DRAINAGE OVER THE RIGHT, WHICH ENDS LATERALLY OF THE FLUID CAVITY. ON THE LEFT THIGH, THE SURGEON ALSO NOTICED A SEMI-CIRCULAR CALCIFICATION AND INSTALLATION OF A FEM-POP BYPASS. CIRCULAR COMPRESSION SEAM AROUND THE ENTIRE BYPASS. THE BYPASS DISPLAYED WELL IN ITSELF. THE DISTAL PORTION SHOWS FLUID COLLECTION FROM THE BYPASS, HOLDING CONTRAST ON THE EDGE TOWARDS MEDIODORSAL (DENSITY VALUES OVER 20 HE). MAXIMUM AXIAL EXPANSION 2.7 CM. CONTRAST INTO THE ARTERY PROFUNDA FEMORIS. POPLITEAL ARTERY NARROW-CALIBER WITH MODERATE CALCIFICATIONS. BRANCH OF THE ANTERIOR TIBIAL ARTERY, ALSO ONLY FILIFORM. TRUNCUS TIBIO-FIBULARIS WITH MULTIPLE CALCIFICATIONS. NARROW POSTERIOR TIBIAL ARTERY AND FIBULAR ARTERY. SEVERELY RESTRICTED TWO-VESSEL SUPPLY. EVALUATION: THE CAUSE WAS DETERMINED TO BE OCCLUSION OF THE FEM-POP BYPASS GRAFT (ALBOGRAFT VASCULAR GRAFT) ON THE RIGHT THIGH. PERIPROSTHETIC, LONG-DISTANCE FLUID COLLECTION (IMAGE-MORPHOLOGICAL SUSPECTED ABSCESS), AFTER CONSULTATION WITH THE COLLEAGUE OF THE VASCULAR SURGERY DEPARTMENT, THERE WERE MULTIPLE TIMES OCCURRED HEMATOMAS / SEROMAS, ALSO IN THE SARTORIUS MUSCLE. SEVERELY RESTRICTED TWO-VESSEL SUPPLY TO THE RIGHT LOWER LEG. PERFUSED FEM.-POP. BYPASS ON THE LEFT. PERIPROSTHETIC COMPRESSION LIGATURE. AT THE LEVEL OF THE DISTAL ANASTOMOSIS, FLUID COLLECTION IS EVIDENT, AS WELL AS ON THE OPPOSITE SIDE. RESTRICTED TWO-VESSEL SUPPLY TO THE LEFT LOWER LEG. THE SECTION OF THE RUPTURED ALBOGRAFT WAS THEN EXPLANTED ON (B)(6) 2020. THE OPERATION WAS CARRIED UNDER GENERAL ANESTHESIA. INTRAOPERATIVELY, THE DAMAGED PIECE OF THE FEMORO-POPLITEAL BYPASS GRAFT WAS REMOVED AND THE ENDS WERE THEN LIGATED. THE PATIENT'S SYMPTOMS IMPROVED SIGNIFICANTLY IMMEDIATELY AFTER THE SURGERY. THE WOUND WAS ALWAYS IRRITABLE AND SHOWED A PRIMARY TENDENCY TO HEAL. THE PERIPHERAL MOTOR SKILLS AND SENSITIVITY WERE INTACT AT ALL TIMES. AN ANGIO-CT SHOWED THE FINDING OF A PERIPROSTHETIC LONG-DISTANCE FLUID RETENTION ON THE RIGHT CORRESPONDING TO THE INTRAOPERATIVE FINDING OF A PARTLY OLD, PARTLY FRESH HEMATOMA. AT THE TIME OF DISCHARGE, THE PATIENT WAS INDEPENDENTLY MOBILE AT THE WARD LEVEL AND ALSO FREE OF SYMPTOMS. ON (B)(6) 2020, PATIENT WAS DISCHARGED INPATIENT TREATMENT WITHOUT SYMPTOMS. PATIENT WAS RECOMMENDED: REGULAR WOUND CONTROL AND DRESSING CHANGES. SUTURE REMOVAL AFTER 14 DAYS. PAIN-ADAPTED ANALGESIA. CHECK-UP WITH THE PHYSICIAN IN 2 WEEKS FOR CLINICAL CONTROL AND PLANNING OF FURTHER THERAPY.

Description of Event or Problem

SPONTANEOUS VERTICAL RUPTURE OF THE GRAFT IN THE AREA OF THE PROXIMAL UPPER THIRD IN LENGTH, AWAY FROM THE ANASTOMOSIS.