RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
Report
- Report Number
- 2124215-2023-31692
- Event Type
- Injury
- Date Received
- June 26, 2023
- Date of Event
- October 15, 2022
- Report Date
- February 2, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- ONU
- UDI-DI
- 08714729976028
- PMA / PMN Number
- P190019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A1: PATIENT IDENTIFIER: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6).
A1: PATIENT IDENTIFIER: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). B5: DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION.
A1: PATIENT IDENTIFIER: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6).
A1: PATIENT IDENTIFIER: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). B5: DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION.
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THROMBOSIS AND AN AMPUTATION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 330 MM AND 100% STENOSIS WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS STUDY DEVICES. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY OF THE INDEX PROCEDURE, DURING TREATMENT OF THE TARGET LESION #001, DISSECTION OF GRADE C WAS NOTED DUE TO RANGER DRUG COATED BALLOONS. DURING THE INDEX PROCEDURE, TWO RANGER DRUG COATED BALLOONS OF SIZES 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS WERE USED TO TREAT THE TARGET LESION #001. AS A RESPONSE TO THE COMPLICATION, A BAILOUT STENT WAS PLACED. FOLLOWING THE TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE COMPLICATION WAS RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, ACUTE LIMB ISCHEMIA OF THE RIGHT LOWER EXTREMITY (RLE) OCCURRED. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2022, 156 DAYS POST INDEX PROCEDURE, 100% STENOSIS WAS NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY WERE TREATED WITH THROMBOLYSIS, CUTTING BALLOON FOLLOWED BY BARE METAL STENT PLACEMENT AND STENT GRAFT PLACEMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON (B)(6) 2022, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON 06-JAN-2023, OCCLUDED RIGHT SFA AND POPLITEAL ARTERY OCCURRED. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH RIGHT SFA THROMBOSIS. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2023, 293 DAYS POST INDEX PROCEDURE, OCCLUSION WAS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY, PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY AND DISTAL POPLITEAL ARTERY WERE TREATED WITH CUTTING BALLOON FOLLOWED BY THROMBOLYSIS. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) -2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO LIMB ISCHEMIA OF RIGHT LOWER EXTREMITY AND WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION ON THE SAME DAY. ON (B)(6) 2023, 305 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT ABOVE THE KNEE AMPUTATION IN THE RIGHT LIMB. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH COLD RIGHT LOWER EXTREMITY AND CALF CLAUDICATION. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH PROGRESSION OF SYMPTOMS AND PHYSICAL EXAMINATION REVEALED BILATERAL GROIN SEROMAS WITHOUT ABSCESS, RIGHT CALF AND FOOT WERE COOL TO TOUCH AND PURPLISH DISCOLORATION WITH NO PALPABLE DISTAL PULSES IN THE RIGHT FOOT. THE SUBJECT WAS ADMITTED TO THE HOSPITAL TO UNDERGO INTERVENTION FOR RECURRENT CRITICAL RIGHT LOWER EXTREMITY ISCHEMIA. ON THE SAME DAY COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM OF ABDOMINAL AORTA AND BILATERAL ILIOFEMORAL RUNOFF PERFORMED REVEALED THE STENTED RIGHT EXTERNAL ILIAC ARTERY, COMMON FEMORAL ARTERY AND PROFUNDA FEMORIS DIVISIONS ENHANCED APPROPRIATELY, STENTED RIGHT SUPERFICIAL FEMORAL ARTERY WITH NO VISIBLE INTRA-ARTERIAL ENHANCEMENT BEYOND THE ORIGIN OF THE STENT, FAINT ENHANCEMENT OF THE DIMINUTIVE ANTERIOR TIBIAL ARTERY, POSTERIOR TIBIAL AND PERONEAL ARTERIES TO THE LEVEL OF THE ANKLE. THE STENTED LEFT ILIAC ARTERY ENHANCED APPROPRIATELY, LEFT COMMON FEMORAL ARTERY AND PROFUNDA FEMORIS DIVISIONS ENHANCED WITHOUT SIGNIFICANT STENOSIS, NO VISIBLE ENHANCEMENT OF THE PROXIMAL OR MID LEFT SUPERFICIAL FEMORAL ARTERY, THE LEFT POPLITEAL ARTERY AND VESSEL OF THE TRIFURCATION ENHANCED TO THE LEVEL OF ANKLE AND MIDFOOT. BASED ON THE FINDINGS, SUBJECT RIGHT LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE THROMBOLYSIS. ON (B)(6) 2023, ELECTIVE ANGIOGRAM OF RIGHT LOWER EXTREMITY REVEALED COMPLETE OCCLUSION OF RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY STENTS. ON (B)(6) 2023, 292 DAYS POST INDEX PROCEDURE, THROMBOTIC OCCLUSION NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY STENTS WERE TREATED WITH THROMBOLYSIS. EKOS LYTIC CATHETER WAS ADVANCED INTO THE TIBIOPERONEAL TRUNK AND 0.5 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INITIATED AND 500 UNITS OF HEPARIN PER HOUR WAS INFUSED THROUGH SHEATH. POST PROCEDURE, SUBJECT WAS TRANSFERRED TO ICU FOR OVERNIGHT MONITORING. ON (B)(6) 2023, REPEAT RIGHT LOWER EXTREMITY ANGIOGRAM PERFORMED REVEALED, GREATER THAN 90% STENOSIS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, DISTAL POPLITEAL ARTERY, TIBIAL PERONEAL TRUNK AND ORIGIN OF ANTERIOR TIBIAL ARTERY. ON (B)(6) 2023, 293 DAYS POST INDEX PROCEDURE, STENOSIS WAS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY WAS TREATED WITH BALLOON ANGIOPLASTY USING 4.0 MM X 80 MM AND 5.0 MM X 80 MM MUSTANG BALLOON. FOLLOW-UP ANGIOGRAM PERFORMED REVEALED PATENT RIGHT SFA AND POPLITEAL ARTERY STENT AND 90% STENOSIS AT THE DISTAL PORTION OF STENT. SUBSEQUENTLY, BALLOON DILATION WAS PERFORMED USING A 2.5 MM X 120 MM NON-BOSTON SCIENTIFIC BALLOON AND 3 MM X 100 MM NON-BOSTON SCIENTIFIC BALLOON IN TIBIAL PERONEAL TRUNK LEADING INTO THE POPLITEAL ARTERY. COMPLETION ARTERIOGRAM PERFORMED REVEALED LESS THAN 10% STENOSIS OF PROXIMAL SFA AND LESS THAN 30% STENOSIS OF DISTAL POPLITEAL ARTERY, TIBIAL PERONEAL TRUNK AND ANTERIOR TIBIAL ARTERY. ON 07-MAR-2023, PHYSICAL EXAMINATION REVEALED RIGHT POSTERIOR TIBIAL ARTERY SIGNALS HOWEVER, RIGHT FOOT REMAINED COOL TO TOUCH WITH INTACT MOTOR/SENSORY FUNCTION. ON (B)(6) 2023, SUBJECT HAD VISITED THE OUTPATIENT SETTING FOR WORSENING RIGHT LOWER EXTREMITY PAIN. ON (B)(6) 2023, THE SUBJECT VISITED THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF WORSENING RIGHT LOWER EXTREMITY PAIN. PHYSICAL EXAMINATIONS REVEALED RIGHT DORSALIS PEDIS (DP) AND POSTERIOR TIBIAL (PT) PULSES WERE ABSENT, RIGHT LOWER EXTREMITIES WAS COOL TO TOUCH WITH DEPENDENT RUBOR TO FOOT AND ANTERIOR LEG AND NONPITTING EDEMA. RUTHERFORD CLASSIFICATION ASSESSED REVEALED, CATEGORY 5 CRITICAL LIMB ISCHEMIA. ON (B)(6) 2023, ARTERIAL DUPLEX OF RIGHT LOWER EXTREMITIES PERFORMED REVEALED TOTAL IN-STENT OCCLUSION OF THE RIGHT MID SFA, DISTAL SFA AND POPLITEAL ARTERY CONSISTENT WITH NO BLOOD FLOW AND 50-75% STENOSIS OF RIGHT PROFUNDA FEMORIS ARTERY. ON (B)(6) 2023, 309 DAYS POST INDEX PROCEDURE, RIGHT ABOVE THE KNEE AMPUTATION WAS PERFORMED AS BELOW THE KNEE TISSUE EXPLORATION IDENTIFIED NECROTIC MUSCLE WITH NO VIABILITY. POST PROCEDURE, WOUND WAS DRESSED USING XEROFORM, GAUZE AND A LIGHT ACE WRAP. SUBJECT WAS TRANSFERRED TO INTERMEDIATE FLOOR FOR THE POST-OPERATIVE CARE AND WAS RECOMMENDED TO APPLY SHRINK SOCK AND STUMP PROTECTOR DAILY.
ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT THROMBOSIS AND AN AMPUTATION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 330 MM AND 100% STENOSIS WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS STUDY DEVICES. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY OF THE INDEX PROCEDURE, DURING TREATMENT OF THE TARGET LESION #001, DISSECTION OF GRADE C WAS NOTED DUE TO RANGER DRUG COATED BALLOONS. DURING THE INDEX PROCEDURE, TWO RANGER DRUG COATED BALLOONS OF SIZES 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS WERE USED TO TREAT THE TARGET LESION #001. AS A RESPONSE TO THE COMPLICATION, A BAILOUT STENT WAS PLACED. FOLLOWING THE TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE COMPLICATION WAS RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, ACUTE LIMB ISCHEMIA OF THE RIGHT LOWER EXTREMITY (RLE) OCCURRED. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2022, 156 DAYS POST INDEX PROCEDURE, 100% STENOSIS WAS NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY WERE TREATED WITH THROMBOLYSIS, CUTTING BALLOON FOLLOWED BY BARE METAL STENT PLACEMENT AND STENT GRAFT PLACEMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON (B)(6) 2022, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, OCCLUDED RIGHT SFA AND POPLITEAL ARTERY OCCURRED. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH RIGHT SFA THROMBOSIS. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2023, 293 DAYS POST INDEX PROCEDURE, OCCLUSION WAS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY, PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY AND DISTAL POPLITEAL ARTERY WERE TREATED WITH CUTTING BALLOON FOLLOWED BY THROMBOLYSIS. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO LIMB ISCHEMIA OF RIGHT LOWER EXTREMITY AND WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION ON THE SAME DAY. ON (B)(6) 2023, 305 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT ABOVE THE KNEE AMPUTATION IN THE RIGHT LIMB. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH COLD RIGHT LOWER EXTREMITY AND CALF CLAUDICATION. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH PROGRESSION OF SYMPTOMS AND PHYSICAL EXAMINATION REVEALED BILATERAL GROIN SEROMAS WITHOUT ABSCESS, RIGHT CALF AND FOOT WERE COOL TO TOUCH AND PURPLISH DISCOLORATION WITH NO PALPABLE DISTAL PULSES IN THE RIGHT FOOT. THE SUBJECT WAS ADMITTED TO THE HOSPITAL TO UNDERGO INTERVENTION FOR RECURRENT CRITICAL RIGHT LOWER EXTREMITY ISCHEMIA. ON THE SAME DAY COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM OF ABDOMINAL AORTA AND BILATERAL ILIOFEMORAL RUNOFF PERFORMED REVEALED THE STENTED RIGHT EXTERNAL ILIAC ARTERY, COMMON FEMORAL ARTERY AND PROFUNDA FEMORIS DIVISIONS ENHANCED APPROPRIATELY, STENTED RIGHT SUPERFICIAL FEMORAL ARTERY WITH NO VISIBLE INTRA-ARTERIAL ENHANCEMENT BEYOND THE ORIGIN OF THE STENT, FAINT ENHANCEMENT OF THE DIMINUTIVE ANTERIOR TIBIAL ARTERY, POSTERIOR TIBIAL AND PERONEAL ARTERIES TO THE LEVEL OF THE ANKLE. THE STENTED LEFT ILIAC ARTERY ENHANCED APPROPRIATELY, LEFT COMMON FEMORAL ARTERY AND PROFUNDA FEMORIS DIVISIONS ENHANCED WITHOUT SIGNIFICANT STENOSIS, NO VISIBLE ENHANCEMENT OF THE PROXIMAL OR MID LEFT SUPERFICIAL FEMORAL ARTERY, THE LEFT POPLITEAL ARTERY AND VESSEL OF THE TRIFURCATION ENHANCED TO THE LEVEL OF ANKLE AND MIDFOOT. BASED ON THE FINDINGS, SUBJECT RIGHT LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE THROMBOLYSIS. ON (B)(6) 2023, ELECTIVE ANGIOGRAM OF RIGHT LOWER EXTREMITY REVEALED COMPLETE OCCLUSION OF RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY STENTS. ON (B)(6) 2023, 292 DAYS POST INDEX PROCEDURE, THROMBOTIC OCCLUSION NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY STENTS WERE TREATED WITH THROMBOLYSIS. EKOS LYTIC CATHETER WAS ADVANCED INTO THE TIBIOPERONEAL TRUNK AND 0.5 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INITIATED AND 500 UNITS OF HEPARIN PER HOUR WAS INFUSED THROUGH SHEATH. POST PROCEDURE, SUBJECT WAS TRANSFERRED TO ICU FOR OVERNIGHT MONITORING. ON (B)(6) 2023, REPEAT RIGHT LOWER EXTREMITY ANGIOGRAM PERFORMED REVEALED, GREATER THAN 90% STENOSIS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, DISTAL POPLITEAL ARTERY, TIBIAL PERONEAL TRUNK AND ORIGIN OF ANTERIOR TIBIAL ARTERY. ON (B)(6) 2023, 293 DAYS POST INDEX PROCEDURE, STENOSIS WAS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY WAS TREATED WITH BALLOON ANGIOPLASTY USING 4.0 MM X 80 MM AND 5.0 MM X 80 MM MUSTANG BALLOON. FOLLOW-UP ANGIOGRAM PERFORMED REVEALED PATENT RIGHT SFA AND POPLITEAL ARTERY STENT AND 90% STENOSIS AT THE DISTAL PORTION OF STENT. SUBSEQUENTLY, BALLOON DILATION WAS PERFORMED USING A 2.5 MM X 120 MM NON-BOSTON SCIENTIFIC BALLOON AND 3 MM X 100 MM NON-BOSTON SCIENTIFIC BALLOON IN TIBIAL PERONEAL TRUNK LEADING INTO THE POPLITEAL ARTERY. COMPLETION ARTERIOGRAM PERFORMED REVEALED LESS THAN 10% STENOSIS OF PROXIMAL SFA AND LESS THAN 30% STENOSIS OF DISTAL POPLITEAL ARTERY, TIBIAL PERONEAL TRUNK AND ANTERIOR TIBIAL ARTERY. ON (B)(6) 2023, PHYSICAL EXAMINATION REVEALED RIGHT POSTERIOR TIBIAL ARTERY SIGNALS HOWEVER, RIGHT FOOT REMAINED COOL TO TOUCH WITH INTACT MOTOR/SENSORY FUNCTION. ON (B)(6) 2023, SUBJECT HAD VISITED THE OUTPATIENT SETTING FOR WORSENING RIGHT LOWER EXTREMITY PAIN. ON (B)(6) 2023, THE SUBJECT VISITED THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF WORSENING RIGHT LOWER EXTREMITY PAIN. PHYSICAL EXAMINATIONS REVEALED RIGHT DORSALIS PEDIS (DP) AND POSTERIOR TIBIAL (PT) PULSES WERE ABSENT, RIGHT LOWER EXTREMITIES WAS COOL TO TOUCH WITH DEPENDENT RUBOR TO FOOT AND ANTERIOR LEG AND NONPITTING EDEMA. RUTHERFORD CLASSIFICATION ASSESSED REVEALED, CATEGORY 5 CRITICAL LIMB ISCHEMIA. ON (B)(6) 2023, ARTERIAL DUPLEX OF RIGHT LOWER EXTREMITIES PERFORMED REVEALED TOTAL IN-STENT OCCLUSION OF THE RIGHT MID SFA, DISTAL SFA AND POPLITEAL ARTERY CONSISTENT WITH NO BLOOD FLOW AND 50-75% STENOSIS OF RIGHT PROFUNDA FEMORIS ARTERY. ON (B)(6) 2023, 309 DAYS POST INDEX PROCEDURE, RIGHT ABOVE THE KNEE AMPUTATION WAS PERFORMED AS BELOW THE KNEE TISSUE EXPLORATION IDENTIFIED NECROTIC MUSCLE WITH NO VIABILITY. POST PROCEDURE, WOUND WAS DRESSED USING XEROFORM, GAUZE AND A LIGHT ACE WRAP. SUBJECT WAS TRANSFERRED TO INTERMEDIATE FLOOR FOR THE POST-OPERATIVE CARE AND WAS RECOMMENDED TO APPLY SHRINK SOCK AND STUMP PROTECTOR DAILY. IT WAS FURTHER REPORTED THAT THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA, DISTAL SFA, RIGHT PROXIMAL POPLITEAL ARTERY AND RIGHT DISTAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 330 MM AND 100% STENOSIS AND TASC II D LESION. ON (B)(6) 2022, THE SUBJECT EXPERIENCED SUDDEN ONSET OF RIGHT FOOT COLDNESS, HEAVINESS, AND MILD NUMBNESS. ON (B)(6) 2022, THE SUBJECT VISITED THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF LEFT FOOT DISCOMFORT AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON EXAMINATION, SUBJECT WAS NOTED TO HAVE COLD, PULSELESS RIGHT FOOT WITH RUTHERFORD CLASSIFICATION OF 4. ON (B)(6) 2022, RIGHT LOWER EXTREMITY ARTERIAL DUPLEX REVEALED THROMBOTIC OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY STENT AND SCATTERED CALCIFIED WITH MULTIPHASIC WAVEFORMS IN THE COMMON FEMORAL ARTERY. ON THE SAME DAY, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAM PERFORMED REVEALED MODERATE DISEASE IN COMMON FEMORAL ARTERY AND PROFUNDA FEMORAL ARTERY, OCCLUDED SUPERFICIAL FEMORAL ARTERY, OCCLUDED P1 AND P2 SEGMENTS, 70% STENOSIS IN THE MID ANTERIOR TIBIAL ARTERY, DIMINUTIVE BUT PATENT TIBIALPERONEAL TRUNK, PERONEAL ARTERY, AND POSTERIOR TIBIAL ARTERY. ON (B)(6) 2022, 155 DAYS POST INDEX PROCEDURE, THROMBOTIC OCCLUSION NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND RIGHT POPLITEAL ARTERY WERE TREATED BY THROMBOLYSIS USING 0.5 MG PER HOUR TPA VIA NON-BOSTON SCIENTIFIC CATHETER PLACED IN RIGHT POPLITEAL ARTERY BACK TO THE COMMON FEMORAL ARTERY. ADDITIONALLY, 0.25 MG OF TPA PER HOUR WAS INITIATED THROUGH THE SHEATH TO TREAT SEVERE STENOSIS NOTED IN THE RIGHT EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY. ON (B)(6) 2022, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAM PERFORMED REVEALED DIFFUSE DISEASE OF APPROXIMATELY 80% STENOSIS IN SFA HOWEVER WITH NO SIGNIFICANT THROMBUS, 80% STENOSIS IN POPLITEAL ARTERY WITH NO TOTAL OCCLUSION AND 80% STENOSIS IN MID ANTERIOR TIBIAL ARTERY. ON (B)(6) 2022, 156 DAYS POST INDEX PROCEDURE, STENOSIS NOTED IN RIGHT SFA, AND RIGHT POPLITEAL ARTERY WAS TREATED USING 5 MM X 220 MM STERLING BALLOON ANGIOPLASTY FOLLOWED BY THE PLACEMENT OF 5 MM X 25 MM NON-BOSTON SCIENTIFIC STENT EXTENDING FROM THE RIGHT POPLITEAL ARTERY TO THE RIGHT PROXIMAL SFA AND POST DILATED USING 5 MM X 220 MM STERLING BALLOON. SUBSEQUENTLY, PROXIMAL SFA AND DISTAL COMMON FEMORAL ARTERY STENOSIS WERE TREATED BY THE PLACEMENT OF A 5 MM X 100 MM LNNOVA STENT AND WAS POST DILATED WITH 5 MM X 220 MM STERLING BALLOON. ADDITIONALLY, STENOSIS NOTED IN THE EXTERNAL ILIAC ARTERY TREATED BY BALLOON ANGIOPLASTY USING A 5 MM X 220 MM STERLING BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. SUBSEQUENTLY, RESIDUAL THROMBUS NOTED IN THE BRANCHES OF THE PROFUNDA AND THE TIBIOPERONEAL TRUNK WERE TREATED WITH THROMBOLYSIS USING 0.5 MG OF TPA VIA SHEATH PLACED IN RIGHT EXTERNAL ILIAC ARTERY. ON (B)(6) 2022, FOLLOW UP ANGIOGRAM SHOWED THROMBOTIC OCCLUSION WAS 100 % CLEARED THROUGH THE RIGHT FEMORAL, POPLITEAL ARTERY, TIBIOPERONEAL TRUNK, PERONEAL ARTERY, AND POSTERIOR TIBIAL ARTERIES. THE RIGHT ANTERIOR TIBIAL ARTERY WAS NOTED TO HAVE SIGNIFICANT STENOSIS WHICH WAS FLOW-LIMITING AND WAS TREATED USING 3 MM X 200 MM MUSTANG BALLOON. ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY WAS PERFORMED WHICH SHOWED SPASM IN THE ARTERY AND WAS RESOLVED AFTER INJECTION OF 300 MG OF NITROGLYCERIN. ON THE SAME DAY, THE POST-PROCEDURE ANGIOGRAM SHOWED THREE-VESSEL RUNOFF AND THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT THE EVENT DATE OF THE CRITICAL LIMB ISCHEMIA OF THE RIGHT LOWER EXTREMITIES WAS CHANGED FROM (B)(6) 2023 TO (B)(6) 2023.
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THROMBOSIS AND AN AMPUTATION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 330 MM AND 100% STENOSIS WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS STUDY DEVICES. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY OF THE INDEX PROCEDURE, DURING TREATMENT OF THE TARGET LESION #001, DISSECTION OF GRADE C WAS NOTED DUE TO RANGER DRUG COATED BALLOONS. DURING THE INDEX PROCEDURE, TWO RANGER DRUG COATED BALLOONS OF SIZES 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS WERE USED TO TREAT THE TARGET LESION #001. AS A RESPONSE TO THE COMPLICATION, A BAILOUT STENT WAS PLACED. FOLLOWING THE TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE COMPLICATION WAS RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, ACUTE LIMB ISCHEMIA OF THE RIGHT LOWER EXTREMITY (RLE) OCCURRED. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2022, 156 DAYS POST INDEX PROCEDURE, 100% STENOSIS WAS NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY WERE TREATED WITH THROMBOLYSIS, CUTTING BALLOON FOLLOWED BY BARE METAL STENT PLACEMENT AND STENT GRAFT PLACEMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON (B)(6) 2022, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, OCCLUDED RIGHT SFA AND POPLITEAL ARTERY OCCURRED. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH RIGHT SFA THROMBOSIS. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2023, 293 DAYS POST INDEX PROCEDURE, OCCLUSION WAS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY, PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY AND DISTAL POPLITEAL ARTERY WERE TREATED WITH CUTTING BALLOON FOLLOWED BY THROMBOLYSIS. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO LIMB ISCHEMIA OF RIGHT LOWER EXTREMITY AND WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION ON THE SAME DAY. ON (B)(6) 2023, 305 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT ABOVE THE KNEE AMPUTATION IN THE RIGHT LIMB. ON (B)(6)2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6)2023, THE EVENT WAS CONSIDERED TO BE RESOLVED.
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THROMBOSIS AND AN AMPUTATION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 330 MM AND 100% STENOSIS WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS STUDY DEVICES. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY OF THE INDEX PROCEDURE, DURING TREATMENT OF THE TARGET LESION #001, DISSECTION OF GRADE C WAS NOTED DUE TO RANGER DRUG COATED BALLOONS. DURING THE INDEX PROCEDURE, TWO RANGER DRUG COATED BALLOONS OF SIZES 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS WERE USED TO TREAT THE TARGET LESION #001. AS A RESPONSE TO THE COMPLICATION, A BAILOUT STENT WAS PLACED. FOLLOWING THE TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE COMPLICATION WAS RESOLVED. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, ACUTE LIMB ISCHEMIA OF THE RIGHT LOWER EXTREMITY (RLE) OCCURRED. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2022, 156 DAYS POST INDEX PROCEDURE, 100% STENOSIS WAS NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY WERE TREATED WITH THROMBOLYSIS, CUTTING BALLOON FOLLOWED BY BARE METAL STENT PLACEMENT AND STENT GRAFT PLACEMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON 21-OCT-2022, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 20022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, OCCLUDED RIGHT SFA AND POPLITEAL ARTERY OCCURRED. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH RIGHT SFA THROMBOSIS. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2023, 293 DAYS POST INDEX PROCEDURE, OCCLUSION WAS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY, PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY AND DISTAL POPLITEAL ARTERY WERE TREATED WITH CUTTING BALLOON FOLLOWED BY THROMBOLYSIS. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO LIMB ISCHEMIA OF RIGHT LOWER EXTREMITY AND WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION ON THE SAME DAY. ON (B)(6) 2023, 305 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT ABOVE THE KNEE AMPUTATION IN THE RIGHT LIMB. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH COLD RIGHT LOWER EXTREMITY AND CALF CLAUDICATION. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH PROGRESSION OF SYMPTOMS AND PHYSICAL EXAMINATION REVEALED BILATERAL GROIN SEROMAS WITHOUT ABSCESS, RIGHT CALF AND FOOT WERE COOL TO TOUCH AND PURPLISH DISCOLORATION WITH NO PALPABLE DISTAL PULSES IN THE RIGHT FOOT. THE SUBJECT WAS ADMITTED TO THE HOSPITAL TO UNDERGO INTERVENTION FOR RECURRENT CRITICAL RIGHT LOWER EXTREMITY ISCHEMIA. ON THE SAME DAY COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM OF ABDOMINAL AORTA AND BILATERAL ILIOFEMORAL RUNOFF PERFORMED REVEALED THE STENTED RIGHT EXTERNAL ILIAC ARTERY, COMMON FEMORAL ARTERY AND PROFUNDA FEMORIS DIVISIONS ENHANCED APPROPRIATELY, STENTED RIGHT SUPERFICIAL FEMORAL ARTERY WITH NO VISIBLE INTRA-ARTERIAL ENHANCEMENT BEYOND THE ORIGIN OF THE STENT, FAINT ENHANCEMENT OF THE DIMINUTIVE ANTERIOR TIBIAL ARTERY, POSTERIOR TIBIAL AND PERONEAL ARTERIES TO THE LEVEL OF THE ANKLE. THE STENTED LEFT ILIAC ARTERY ENHANCED APPROPRIATELY, LEFT COMMON FEMORAL ARTERY AND PROFUNDA FEMORIS DIVISIONS ENHANCED WITHOUT SIGNIFICANT STENOSIS, NO VISIBLE ENHANCEMENT OF THE PROXIMAL OR MID LEFT SUPERFICIAL FEMORAL ARTERY, THE LEFT POPLITEAL ARTERY AND VESSEL OF THE TRIFURCATION ENHANCED TO THE LEVEL OF ANKLE AND MIDFOOT. BASED ON THE FINDINGS, SUBJECT RIGHT LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE THROMBOLYSIS. ON (B)(6) 2023, ELECTIVE ANGIOGRAM OF RIGHT LOWER EXTREMITY REVEALED COMPLETE OCCLUSION OF RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY STENTS. ON (B)(6) 2023, 292 DAYS POST INDEX PROCEDURE, THROMBOTIC OCCLUSION NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY STENTS WERE TREATED WITH THROMBOLYSIS. EKOS LYTIC CATHETER WAS ADVANCED INTO THE TIBIOPERONEAL TRUNK AND 0.5 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INITIATED AND (B)(4) UNITS OF HEPARIN PER HOUR WAS INFUSED THROUGH SHEATH. POST PROCEDURE, SUBJECT WAS TRANSFERRED TO ICU FOR OVERNIGHT MONITORING. ON (B)(6) 2023, REPEAT RIGHT LOWER EXTREMITY ANGIOGRAM PERFORMED REVEALED, GREATER THAN 90% STENOSIS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, DISTAL POPLITEAL ARTERY, TIBIAL PERONEAL TRUNK AND ORIGIN OF ANTERIOR TIBIAL ARTERY. ON (B)(6) 2023, 293 DAYS POST INDEX PROCEDURE, STENOSIS WAS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY WAS TREATED WITH BALLOON ANGIOPLASTY USING 4.0 MM X 80 MM AND 5.0 MM X 80 MM MUSTANG BALLOON. FOLLOW-UP ANGIOGRAM PERFORMED REVEALED PATENT RIGHT SFA AND POPLITEAL ARTERY STENT AND 90% STENOSIS AT THE DISTAL PORTION OF STENT. SUBSEQUENTLY, BALLOON DILATION WAS PERFORMED USING A 2.5 MM X 120 MM NON-BOSTON SCIENTIFIC BALLOON AND 3 MM X 100 MM NON-BOSTON SCIENTIFIC BALLOON IN TIBIAL PERONEAL TRUNK LEADING INTO THE POPLITEAL ARTERY. COMPLETION ARTERIOGRAM PERFORMED REVEALED LESS THAN 10% STENOSIS OF PROXIMAL SFA AND LESS THAN 30% STENOSIS OF DISTAL POPLITEAL ARTERY, TIBIAL PERONEAL TRUNK AND ANTERIOR TIBIAL ARTERY. ON (B)(6) 2023, PHYSICAL EXAMINATION REVEALED RIGHT POSTERIOR TIBIAL ARTERY SIGNALS HOWEVER, RIGHT FOOT REMAINED COOL TO TOUCH WITH INTACT MOTOR/SENSORY FUNCTION. ON (B)(6) 2023, SUBJECT HAD VISITED THE OUTPATIENT SETTING FOR WORSENING RIGHT LOWER EXTREMITY PAIN. ON (B)(6) 2023, THE SUBJECT VISITED THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF WORSENING RIGHT LOWER EXTREMITY PAIN. PHYSICAL EXAMINATIONS REVEALED RIGHT DORSALIS PEDIS (DP) AND POSTERIOR TIBIAL (PT) PULSES WERE ABSENT, RIGHT LOWER EXTREMITIES WAS COOL TO TOUCH WITH DEPENDENT RUBOR TO FOOT AND ANTERIOR LEG AND NONPITTING EDEMA. RUTHERFORD CLASSIFICATION ASSESSED REVEALED, CATEGORY 5 CRITICAL LIMB ISCHEMIA. ON (B)(6) 2023, ARTERIAL DUPLEX OF RIGHT LOWER EXTREMITIES PERFORMED REVEALED TOTAL IN-STENT OCCLUSION OF THE RIGHT MID SFA, DISTAL SFA AND POPLITEAL ARTERY CONSISTENT WITH NO BLOOD FLOW AND 50-75% STENOSIS OF RIGHT PROFUNDA FEMORIS ARTERY. ON (B)(6) 2023, 309 DAYS POST INDEX PROCEDURE, RIGHT ABOVE THE KNEE AMPUTATION WAS PERFORMED AS BELOW THE KNEE TISSUE EXPLORATION IDENTIFIED NECROTIC MUSCLE WITH NO VIABILITY. POST PROCEDURE, WOUND WAS DRESSED USING XEROFORM, GAUZE AND A LIGHT ACE WRAP. SUBJECT WAS TRANSFERRED TO INTERMEDIATE FLOOR FOR THE POST-OPERATIVE CARE AND WAS RECOMMENDED TO APPLY SHRINK SOCK AND STUMP PROTECTOR DAILY. IT WAS FURTHER REPORTED THAT THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA, DISTAL SFA, RIGHT PROXIMAL POPLITEAL ARTERY AND RIGHT DISTAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 330 MM AND 100% STENOSIS AND TASC II D LESION. ON (B)(6) 2022, THE SUBJECT EXPERIENCED SUDDEN ONSET OF RIGHT FOOT COLDNESS, HEAVINESS, AND MILD NUMBNESS. ON (B)(6) 2022, THE SUBJECT VISITED THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF LEFT FOOT DISCOMFORT AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON EXAMINATION, SUBJECT WAS NOTED TO HAVE COLD, PULSELESS RIGHT FOOT WITH RUTHERFORD CLASSIFICATION OF 4. ON (B)(6) 2022, RIGHT LOWER EXTREMITY ARTERIAL DUPLEX REVEALED THROMBOTIC OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY STENT AND SCATTERED CALCIFIED WITH MULTIPHASIC WAVEFORMS IN THE COMMON FEMORAL ARTERY. ON THE SAME DAY, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAM PERFORMED REVEALED MODERATE DISEASE IN COMMON FEMORAL ARTERY AND PROFUNDA FEMORAL ARTERY, OCCLUDED SUPERFICIAL FEMORAL ARTERY, OCCLUDED P1 AND P2 SEGMENTS, 70% STENOSIS IN THE MID ANTERIOR TIBIAL ARTERY, DIMINUTIVE BUT PATENT TIBIALPERONEAL TRUNK, PERONEAL ARTERY, AND POSTERIOR TIBIAL ARTERY. ON (B)(6) 2022, 155 DAYS POST INDEX PROCEDURE, THROMBOTIC OCCLUSION NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND RIGHT POPLITEAL ARTERY WERE TREATED BY THROMBOLYSIS USING 0.5 MG PER HOUR TPA VIA NON-BOSTON SCIENTIFIC CATHETER PLACED IN RIGHT POPLITEAL ARTERY BACK TO THE COMMON FEMORAL ARTERY. ADDITIONALLY, 0.25 MG OF TPA PER HOUR WAS INITIATED THROUGH THE SHEATH TO TREAT SEVERE STENOSIS NOTED IN THE RIGHT EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY. ON (B)(6) 2022, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAM PERFORMED REVEALED DIFFUSE DISEASE OF APPROXIMATELY 80% STENOSIS IN SFA HOWEVER WITH NO SIGNIFICANT THROMBUS, 80% STENOSIS IN POPLITEAL ARTERY WITH NO TOTAL OCCLUSION AND 80% STENOSIS IN MID ANTERIOR TIBIAL ARTERY. ON (B)(6) 2022, 156 DAYS POST INDEX PROCEDURE, STENOSIS NOTED IN RIGHT SFA, AND RIGHT POPLITEAL ARTERY WAS TREATED USING 5 MM X 220 MM STERLING BALLOON ANGIOPLASTY FOLLOWED BY THE PLACEMENT OF 5 MM X 25 MM NON-BOSTON SCIENTIFIC STENT EXTENDING FROM THE RIGHT POPLITEAL ARTERY TO THE RIGHT PROXIMAL SFA AND POST DILATED USING 5 MM X 220 MM STERLING BALLOON. SUBSEQUENTLY, PROXIMAL SFA AND DISTAL COMMON FEMORAL ARTERY STENOSIS WERE TREATED BY THE PLACEMENT OF A 5 MM X 100 MM LNNOVA STENT AND WAS POST DILATED WITH 5 MM X 220 MM STERLING BALLOON. ADDITIONALLY, STENOSIS NOTED IN THE EXTERNAL ILIAC ARTERY TREATED BY BALLOON ANGIOPLASTY USING A 5 MM X 220 MM STERLING BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. SUBSEQUENTLY, RESIDUAL THROMBUS NOTED IN THE BRANCHES OF THE PROFUNDA AND THE TIBIOPERONEAL TRUNK WERE TREATED WITH THROMBOLYSIS USING 0.5 MG OF TPA VIA SHEATH PLACED IN RIGHT EXTERNAL ILIAC ARTERY. ON (B)(6) 2022, FOLLOW UP ANGIOGRAM SHOWED THROMBOTIC OCCLUSION WAS 100 % CLEARED THROUGH THE RIGHT FEMORAL, POPLITEAL ARTERY, TIBIOPERONEAL TRUNK, PERONEAL ARTERY, AND POSTERIOR TIBIAL ARTERIES. THE RIGHT ANTERIOR TIBIAL ARTERY WAS NOTED TO HAVE SIGNIFICANT STENOSIS WHICH WAS FLOW-LIMITING AND WAS TREATED USING 3 MM X 200 MM MUSTANG BALLOON. ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY WAS PERFORMED WHICH SHOWED SPASM IN THE ARTERY AND WAS RESOLVED AFTER INJECTION OF 300 MG OF NITROGLYCERIN. ON THE SAME DAY, THE POST-PROCEDURE ANGIOGRAM SHOWED THREE-VESSEL RUNOFF AND THE EVENT WAS CONSIDERED TO BE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841881 | RANGER PACLITAXEL-COATED PTA BALLOON CATHETER | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER | ONU | BOSTON SCIENTIFIC CORPORATION | 1973-03 | 00861H22 | 08714729976028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention| H| O |