RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
Report
- Report Number
- 2124215-2023-69455
- Event Type
- Injury
- Date Received
- December 22, 2023
- Date of Event
- March 2, 2023
- Report Date
- July 9, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- ONU
- UDI-DI
- 08714729976042
- PMA / PMN Number
- P190019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A1 - PATIENT IDENTIFIER: (B)(6). H6 - PATIENT CODES: REMOVED RESTENOSIS, ADDED NECROSIS.
A1 - PATIENT IDENTIFIER: (B)(6) A2: PATIENT AGE: 81 YEARS AT TIME OF ENROLLMENT CORRECTION ON H6 - PATIENT CODES: ADDED BACK RESTENOSIS AS PART OF CORRECTION WHICH WAS INCORRECTLY REMOVED.
A1 - PATIENT IDENTIFIER: (B)(6). H6 - PATIENT CODES: REMOVED RESTENOSIS, ADDED NECROSIS.
A1 - PATIENT IDENTIFIER: (B)(6).
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. 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 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 380 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) EXCHANGEABLE SYSTEM 1.50 SOLID ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BSC 014 PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, 287 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. OCCLUSION NOTED IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, AND LEFT DISTAL SUPERFICIAL FEMORAL WAS TREATED BY PLACEMENT OF DRUG ELUTING STENT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT THE ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO GANGRENE ON THE 1ST AND 2ND TOES OF LEFT LEG, AND NOT RELATED TO STENOSIS IN THE LEFT SFA AS PREVIOUSLY REPORTED, AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH GANGRENE ON THE FIRST AND SECOND LEFT TOES AND WAS RECOMMENDED FOR EMERGENT ANGIOGRAM ALONG WITH ENDOVASCULAR INTERVENTION. ON THE SAME DAY, PERIPHERAL ANGIOGRAPHY WAS PERFORMED WHICH REVEALED: THE DISTAL AORTA, BILATERAL COMMON ILIAC, AND EXTERNAL ILIAC WERE WITHIN NORMAL LIMITS, CLINICALLY NON-SIGNIFICANT CALCIUM AT LEFT COMMON FEMORAL ARTERY, PATENT, NON-DISEASED PROFUNDA, OCCLUDED PROXIMAL SUPERFICIAL FEMORAL ARTERY AND RECONSTITUTION OF ABOVE-KNEE POPLITEAL ARTERY VIA THE PROFUNDA WITH PATENT BELOW-KNEE POPLITEAL ARTERY, OCCLUDED DISTAL ANTERIOR TIBIAL ARTERY AND CHRONICALLY OCCLUDED TIBIOPERONEAL TRUNK AND THE PERONEAL ARTERY. ON THE SAME DAY, 287 DAYS POST INDEX PROCEDURE, OCCLUSION WAS NOTED IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL AND POPLITEAL ARTERY WERE TREATED BY BALLOON ANGIOPLASTY USING 3 MM AND 5 MM BALLOON. REPEAT ANGIOGRAM DEMONSTRATED SEGMENTAL RESIDUAL STENOSIS ALONG THE ENTIRE LENGTH OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. HENCE, 5 MM X 10 MM NON-BOSTON SCIENTIFIC (BSC) STENT WAS DEPLOYED FROM THE DISTAL ABOVE LEFT KNEE POPLITEAL TO THE ADDUCTOR CANAL WHICH WAS POST DILATED USING 5MM BALLOON. SUBSEQUENTLY, 6 MM X 150 MM DRUG-COATED STENT WAS DEPLOYED PROXIMALLY WHICH WAS POST DILATED USING 5 MM BALLOON FOLLOWING WHICH 6 MM X 100 MM DRUG-COATED STENT WAS DEPLOYED IN OVERLAPPING MANNER AND WAS POST DILATATED USING 6 MM BALLOON. BASED ON FINAL ANGIOGRAM, 7 MM X 150 MM DRUG COATED STENT WAS PLACED AT LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY FOLLOWED BY POST DILATATION WITH A 6 MM BALLOON. POST PROCEDURAL ANGIOGRAM OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL DEMONSTRATED NO RESIDUAL STENOSIS. IN ADDITION, ON THE SAME DAY, DURING REVASCULARIZATION PROCEDURE, OCCLUSION NOTED IN THE LEFT ANTERIOR TIBIAL ARTERY WAS TREATED USING 2.5 MM BALLOON AND DORSALIS PEDIS WAS TREATED BY BALLOON ANGIOPLASTY USING 1.5 MM BALLOON. COMPLETION ANGIOGRAM DEMONSTRATED INLINE FLOW. DURING THE END OF THE PROCEDURE, THE SUBJECT HAD A SUDDEN ONSET OF HEMOPTYSIS AND WAS HOSPITALIZED. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED.
ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. 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 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 380 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) EXCHANGEABLE SYSTEM 1.50 SOLID ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BSC 014 PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, 287 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. OCCLUSION NOTED IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, AND LEFT DISTAL SUPERFICIAL FEMORAL WAS TREATED BY PLACEMENT OF DRUG ELUTING STENT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT THE ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO GANGRENE ON THE 1ST AND 2ND TOES OF LEFT LEG, AND NOT RELATED TO STENOSIS IN THE LEFT SFA AS PREVIOUSLY REPORTED AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH GANGRENE ON THE FIRST AND SECOND LEFT TOES AND WAS RECOMMENDED FOR EMERGENT ANGIOGRAM ALONG WITH ENDOVASCULAR INTERVENTION. ON THE SAME DAY, PERIPHERAL ANGIOGRAPHY WAS PERFORMED WHICH REVEALED: THE DISTAL AORTA, BILATERAL COMMON ILIAC, AND EXTERNAL ILIAC WERE WITHIN NORMAL LIMITS, CLINICALLY NON-SIGNIFICANT CALCIUM AT LEFT COMMON FEMORAL ARTERY, PATENT, NON-DISEASED PROFUNDA, OCCLUDED PROXIMAL SUPERFICIAL FEMORAL ARTERY AND RECONSTITUTION OF ABOVE-KNEE POPLITEAL ARTERY VIA THE PROFUNDA WITH PATENT BELOW-KNEE POPLITEAL ARTERY, OCCLUDED DISTAL ANTERIOR TIBIAL ARTERY AND CHRONICALLY OCCLUDED TIBIOPERONEAL TRUNK AND THE PERONEAL ARTERY. ON THE SAME DAY, 287 DAYS POST INDEX PROCEDURE, OCCLUSION WAS NOTED IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL AND POPLITEAL ARTERY WERE TREATED BY BALLOON ANGIOPLASTY USING 3 MM AND 5 MM BALLOON. REPEAT ANGIOGRAM DEMONSTRATED SEGMENTAL RESIDUAL STENOSIS ALONG THE ENTIRE LENGTH OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. HENCE, 5 MM X 10 MM NON-BOSTON SCIENTIFIC (BSC) STENT WAS DEPLOYED FROM THE DISTAL ABOVE LEFT KNEE POPLITEAL TO THE ADDUCTOR CANAL WHICH WAS POST DILATED USING 5MM BALLOON. SUBSEQUENTLY, 6 MM X 150 MM DRUG-COATED STENT WAS DEPLOYED PROXIMALLY WHICH WAS POST DILATED USING 5 MM BALLOON FOLLOWING WHICH 6 MM X 100 MM DRUG-COATED STENT WAS DEPLOYED IN OVERLAPPING MANNER AND WAS POST DILATATED USING 6 MM BALLOON. BASED ON FINAL ANGIOGRAM, 7 MM X 150 MM DRUG COATED STENT WAS PLACED AT LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY FOLLOWED BY POST DILATATION WITH A 6 MM BALLOON. POST PROCEDURAL ANGIOGRAM OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL DEMONSTRATED NO RESIDUAL STENOSIS. IN ADDITION, ON THE SAME DAY, DURING REVASCULARIZATION PROCEDURE, OCCLUSION NOTED IN THE LEFT ANTERIOR TIBIAL ARTERY WAS TREATED USING 2.5 MM BALLOON AND DORSALIS PEDIS WAS TREATED BY BALLOON ANGIOPLASTY USING 1.5 MM BALLOON. COMPLETION ANGIOGRAM DEMONSTRATED INLINE FLOW. DURING THE END OF THE PROCEDURE, THE SUBJECT HAD A SUDDEN ONSET OF HEMOPTYSIS AND WAS HOSPITALIZED. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, SUBJECT WAS SEEN BY PODIATRY DUE TO GANGRENE IN LEFT FOOT. ON (B)(6) 2023, SUBJECT WAS PRESENTED TO EMERGENCY DEPARTMENT (ED) WITH THE COMPLAINTS OF GANGRENE OF 1ST AND 2ND DIGITS OF LEFT FOOT AND END STAGE RENAL DISEASE (ESRD). THE SUBJECT WAS CONSULTED WITH PODIATRY AND INFECTIOUS DISEASE DEPARTMENT AND WAS DECIDED TO PERFORM AMPUTATION OF 2 TOES OF LEFT FOOT. ON (B)(6) 2023, ARTERIAL DUPLEX ULTRASOUND OF LEFT LOWER EXTREMITY SHOWED NO DETECTABLE FLOW WITHIN THE LEFT STENTED FEMORAL AND POPLITEAL, POSTERIOR TIBIAL, ANTERIOR TIBIAL AND PERONEAL ARTERIES. PLAQUE WAS VISUALIZED WITHIN THE PROXIMAL DEEP FEMORAL ARTERY WITH THE ELEVATED PEAK SYSTOLIC VELOCITY AND THE RATIO BEING LESS THAN 2:1 ACROSS THE LESION. NORMAL WAVEFORMS WERE NOTED AT THE PROXIMAL AND DISTAL TO THE LESION. BASED ON THE ABOVE FINDINGS, ON THE SAME DAY THE SUBJECT WAS ADMITTED TO HOSPITAL FOR FURTHER TREATMENT AND CARE. ON (B)(6) 2023, SUBJECT COMPLAINED OF GENERALIZED WEAKNESS. SUBSEQUENTLY, THE SUBJECT CONDITION WAS DISCUSSED WITH PODIATRY AND VASCULAR SURGERY. AND DUE TO THE CONTINUOUS ISCHEMIC CONDITION IN THE LEFT LIMB EVEN AFTER MULTIPLE REVASCULARIZATION PROCEDURES, THE SUBJECT WAS RECOMMENDED FOR LEFT BELOW KNEE AMPUTATION. ADDITIONALLY, DUE TO THE SUBJECT RECENT HEMODIALYSIS THROUGH RIGHT INTERNAL JUGULAR PERMCATH, LOW FLOW WAS NOTED. HENCE, THE SUBJECT WAS OFFERED REPLACEMENT OF RIGHT INTERNAL JUGULAR PERMCATH. ON (B)(6) 2023, 390 DAYS POST INDEX PROCEDURE, LEFT BELOW KNEE AMPUTATION WAS PERFORMED (TLA/003). POST SURGERY, HEMOSTASIS WAS ACHIEVED. THE STUMP WAS THEN WRAPPED IN KERLIX, AND AN ACE BANDAGE AND A KNEE IMMOBILIZER WAS APPLIED. SUBSEQUENTLY, ON THE SAME DAY, THE RIGHT INTERNAL JUGULAR PERMCATH WAS REPLACED WITH A NEW 24 CM PERMCATH. THE SUBJECT TOLERATED THE PROCEDURE WELL AND TRANSFERRED TO POST-ANESTHESIA CARE UNIT (PACU). ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED WITH SEQUELAE. ON (B)(6) 2023, POST-SURGERY SUBJECTS CONDITION WAS NOTED TO BE STABLE HOWEVER STILL EXPERIENCED GENERALIZED WEAKNESS. ON (B)(6) 2023, SUBJECTS CONDITION IMPROVED HOWEVER REMAINED ON IV ANTIBIOTICS (500 MG CEFEPIME) EVERY 24 HOURS AND WAS AWAITING SUBACUTE REHABILITATION PLACEMENT. ON (B)(6) 2023, SUBJECT UNDERWENT HEMODIALYSIS AND HAD PERMANENT PACEMAKER (PPM) UPGRADED TO AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD). ON (B)(6) 2023, POST DISCUSSION WITH CARDIOLOGY AND NEPHROLOGY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL AND TRANSFERRED TO SUBACUTE REHAB CARE ON IV CEFEPIME 500 MG EVERY 24 HOURS AND HEMODIALYSIS.
ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS ON 19-MAY-2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 380 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) EXCHANGEABLE SYSTEM 1.50 SOLID ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BSC 014 PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, 287 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. OCCLUSION NOTED IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, AND LEFT DISTAL SUPERFICIAL FEMORAL WAS TREATED BY PLACEMENT OF DRUG ELUTING STENT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT THE ON 02-MAR-2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO GANGRENE ON THE 1ST AND 2ND TOES OF LEFT LEG, AND NOT RELATED TO STENOSIS IN THE LEFT SFA AS PREVIOUSLY REPORTED, AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. 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 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 380 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) EXCHANGEABLE SYSTEM 1.50 SOLID ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BSC 014 PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, 287 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. OCCLUSION NOTED IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, AND LEFT DISTAL SUPERFICIAL FEMORAL WAS TREATED BY PLACEMENT OF DRUG ELUTING STENT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1609529 | RANGER PACLITAXEL-COATED PTA BALLOON CATHETER | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER | ONU | BOSTON SCIENTIFIC CORPORATION | 1973-03 | 01296H22 | 08714729976042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Other |