RANGER
Report
- Report Number
- 2124215-2022-52066
- Event Type
- Injury
- Date Received
- December 21, 2022
- Date of Event
- June 13, 2022
- Report Date
- July 18, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- ONU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PATIENT IDENTIFIER- (B)(6). AGE AT TIME OF ENROLLMENT: 77 YEARS.
(B)(6).
A1: PATIENT IDENTIFIER- (B)(6). A2: AGE AT TIME OF ENROLLMENT: 77 YEARS.
B5 UPDATED A1: PATIENT IDENTIFIER- (B)(6). A2: AGE AT TIME OF ENROLLMENT: (B)(6) YEARS.
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING REVASCULARIZATION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 100 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATATION WAS PERFORMED USING 6 MM X 60 MM NON-BOSTON SCIENTIFIC LITHOTRIPSY DEVICE AND 5 MM X 20 MM CUTTING BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICE, 6 MM X 120 MM RANGER DRUG-COATED BALLOON. FOLLOWING POST DILATATION WITH 6.5 MM X 100 MM NON-BOSTON SCIENTIFIC STENT AND 6 MM X 120 MM NON-BOSTON SCIENTIFIC DRUG COATED BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF CLAUDICATION IN THE RIGHT CALF WITH ACTIVITY AND OCCASIONALLY AT REST AND OUTPATIENT DUPLEX REVEALED RIGHT ABI OF 0.62. SUBSEQUENTLY, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAPHY PERFORMED REVEALED PATENT COMMON FEMORAL ARTERY, NON-OBSTRUCTIVE RIGHT PROFUNDA FEMORAL ARTERY AND PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY WITH OCCLUSION OF PREVIOUSLY IMPLANTED FEMORAL TO POPLITEAL ARTERY STENT, OCCLUSION OF POSTERIOR TIBIAL ARTERY WITH DIFFUSE MODERATE TO SEVERE CALCIFIC DISEASE OF THE ANTERIOR TIBIAL ARTERY, TIBIAL PERONEAL TRUNK, AND PERONEAL ARTERY. ON (B)(6) 2022, 214 DAYS POST INDEX PROCEDURE, 85% STENOSIS NOTED IN THE RIGHT POPLITEAL ARTERY AT THE LEVEL OF KNEE WAS TREATED WITH ATHERECTOMY USING NON-BOSTON SCIENTIFIC ROTATIONAL ATHERECTOMY DEVICE AND RESIDUAL STENOSIS NOTED IN THE POPLITEAL ARTERY WAS TREATED WITH 5 MM X 40 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. SUBSEQUENTLY, REPEAT ANGIOGRAPHY REVEALED GREATER THAN 50% RESIDUAL IN-STENT STENOSIS IN THE DISTAL SFA WHICH WAS TREATED WITH ROTATIONAL ATHERECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 6 MM X 120 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE LESS THAN 20%. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY.
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING REVASCULARIZATION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 100 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATATION WAS PERFORMED USING 6 MM X 60 MM NON-BOSTON SCIENTIFIC LITHOTRIPSY DEVICE AND 5 MM X 20 MM CUTTING BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICE, 6 MM X 120 MM RANGER DRUG-COATED BALLOON. FOLLOWING POST DILATATION WITH 6.5 MM X 100 MM NON-BOSTON SCIENTIFIC STENT AND 6 MM X 120 MM NON-BOSTON SCIENTIFIC DRUG COATED BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON (B)(6) 2021 THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022 SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF CLAUDICATION IN THE RIGHT CALF WITH ACTIVITY AND OCCASIONALLY AT REST AND OUTPATIENT DUPLEX REVEALED RIGHT ABI OF 0.62. SUBSEQUENTLY, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAPHY PERFORMED REVEALED PATENT COMMON FEMORAL ARTERY, NON-OBSTRUCTIVE RIGHT PROFUNDA FEMORAL ARTERY AND PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY WITH OCCLUSION OF PREVIOUSLY IMPLANTED FEMORAL TO POPLITEAL ARTERY STENT, OCCLUSION OF POSTERIOR TIBIAL ARTERY WITH DIFFUSE MODERATE TO SEVERE CALCIFIC DISEASE OF THE ANTERIOR TIBIAL ARTERY, TIBIAL PERONEAL TRUNK, AND PERONEAL ARTERY. ON (B)(6) 2022, 214 DAYS POST INDEX PROCEDURE, 85% STENOSIS NOTED IN THE RIGHT POPLITEAL ARTERY AT THE LEVEL OF KNEE WAS TREATED WITH ATHERECTOMY USING NON-BOSTON SCIENTIFIC ROTATIONAL ATHERECTOMY DEVICE AND RESIDUAL STENOSIS NOTED IN THE POPLITEAL ARTERY WAS TREATED WITH 5 MM X 40 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. SUBSEQUENTLY, REPEAT ANGIOGRAPHY REVEALED GREATER THAN 50% RESIDUAL IN-STENT STENOSIS IN THE DISTAL SFA WHICH WAS TREATED WITH ROTATIONAL ATHERECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 6 MM X 120 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE LESS THAN 20%. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. IT WAS FURTHER REPORTED THAT ON THE ONSET DATE WAS (B)(6) 2022 WHEN SUBJECT NOTED WITH SEVERE CLAUDICATION SYMPTOMS IN THE RIGHT CALF WITH ACTIVITY AND OCCASIONALLY AT REST AND OUTPATIENT DUPLEX REVEALED RIGHT ABI OF 0.62.
ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING REVASCULARIZATION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 100 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATATION WAS PERFORMED USING 6 MM X 60 MM NON-BOSTON SCIENTIFIC LITHOTRIPSY DEVICE AND 5 MM X 20 MM CUTTING BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICE, 6 MM X 120 MM RANGER DRUG-COATED BALLOON. FOLLOWING POST DILATATION WITH 6.5 MM X 100 MM NON-BOSTON SCIENTIFIC STENT AND 6 MM X 120 MM NON-BOSTON SCIENTIFIC DRUG COATED BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF CLAUDICATION IN THE RIGHT CALF WITH ACTIVITY AND OCCASIONALLY AT REST AND OUTPATIENT DUPLEX REVEALED RIGHT ABI OF 0.62. SUBSEQUENTLY, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAPHY PERFORMED REVEALED PATENT COMMON FEMORAL ARTERY, NON-OBSTRUCTIVE RIGHT PROFUNDA FEMORAL ARTERY AND PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY WITH OCCLUSION OF PREVIOUSLY IMPLANTED FEMORAL TO POPLITEAL ARTERY STENT, OCCLUSION OF POSTERIOR TIBIAL ARTERY WITH DIFFUSE MODERATE TO SEVERE CALCIFIC DISEASE OF THE ANTERIOR TIBIAL ARTERY, TIBIAL PERONEAL TRUNK, AND PERONEAL ARTERY. ON (B)(6) 2022, 214 DAYS POST INDEX PROCEDURE, 85% STENOSIS NOTED IN THE RIGHT POPLITEAL ARTERY AT THE LEVEL OF KNEE WAS TREATED WITH ATHERECTOMY USING NON-BOSTON SCIENTIFIC ROTATIONAL ATHERECTOMY DEVICE AND RESIDUAL STENOSIS NOTED IN THE POPLITEAL ARTERY WAS TREATED WITH 5 MM X 40 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. SUBSEQUENTLY, REPEAT ANGIOGRAPHY REVEALED GREATER THAN 50% RESIDUAL IN-STENT STENOSIS IN THE DISTAL SFA WHICH WAS TREATED WITH ROTATIONAL ATHERECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 6 MM X 120 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE LESS THAN 20%. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. IT WAS FURTHER REPORTED THAT ON THE ONSET DATE WAS (B)(6) 2022, WHEN SUBJECT NOTED WITH SEVERE CLAUDICATION SYMPTOMS IN THE RIGHT CALF WITH ACTIVITY AND OCCASIONALLY AT REST AND OUTPATIENT DUPLEX REVEALED RIGHT ABI OF 0.62. IT WAS AGAIN FURTHER REPORTED THAT THE TARGET LESION WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT PROXIMAL POPLITEAL ARTERY EXTENDING INTO RIGHT MID POPLITEAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 100 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. DURING THE INITIAL TREATMENT ON (B)(6) 2021, PRE-DILATATION WAS PERFORMED USING 6 MM X 60 MM NON-BOSTON SCIENTIFIC LITHOTRIPSY DEVICE, 4 MM X 40 MM COYOTE BALLOON AND 5 MM X 20 MM CUTTING BALLOON. TREATMENT OF THE RIGHT SFA WAS PERFORMED BY STUDY DEVICE, 6 MM X 120 MM RANGER DRUG-COATED BALLOON. FOLLOWED BY PLACEMENT OF 6.5MM X 100MM NON-BOSTON SCIENTIFIC STENT AND BALLOON DILATION WITH 6 MM X 120 MM NON-BOSTON SCIENTIFIC DRUG-COATED BALLOON. FURTHERMORE, ON (B)(6) 2022, 214 DAYS POST INDEX PROCEDURE, 100% STENOSIS WAS NOTED IN THE RIGHT POPLITEAL ARTERY AT THE LEVEL OF KNEE.
ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING REVASCULARIZATION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 100 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATATION WAS PERFORMED USING 6 MM X 60 MM NON-BOSTON SCIENTIFIC LITHOTRIPSY DEVICE AND 5 MM X 20 MM CUTTING BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICE, 6 MM X 120 MM RANGER DRUG-COATED BALLOON. FOLLOWING POST DILATATION WITH 6.5 MM X 100 MM NON-BOSTON SCIENTIFIC STENT AND 6 MM X 120 MM NON-BOSTON SCIENTIFIC DRUG COATED BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF CLAUDICATION IN THE RIGHT CALF WITH ACTIVITY AND OCCASIONALLY AT REST AND OUTPATIENT DUPLEX REVEALED RIGHT ABI OF 0.62. SUBSEQUENTLY, SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAPHY PERFORMED REVEALED PATENT COMMON FEMORAL ARTERY, NON-OBSTRUCTIVE RIGHT PROFUNDA FEMORAL ARTERY AND PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY WITH OCCLUSION OF PREVIOUSLY IMPLANTED FEMORAL TO POPLITEAL ARTERY STENT, OCCLUSION OF POSTERIOR TIBIAL ARTERY WITH DIFFUSE MODERATE TO SEVERE CALCIFIC DISEASE OF THE ANTERIOR TIBIAL ARTERY, TIBIAL PERONEAL TRUNK, AND PERONEAL ARTERY. ON (B)(6) 2022, 214 DAYS POST INDEX PROCEDURE, 85% STENOSIS NOTED IN THE RIGHT POPLITEAL ARTERY AT THE LEVEL OF KNEE WAS TREATED WITH ATHERECTOMY USING NON-BOSTON SCIENTIFIC ROTATIONAL ATHERECTOMY DEVICE AND RESIDUAL STENOSIS NOTED IN THE POPLITEAL ARTERY WAS TREATED WITH 5 MM X 40 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. SUBSEQUENTLY, REPEAT ANGIOGRAPHY REVEALED GREATER THAN 50% RESIDUAL IN-STENT STENOSIS IN THE DISTAL SFA WHICH WAS TREATED WITH ROTATIONAL ATHERECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 6 MM X 120 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE LESS THAN 20%. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. IT WAS FURTHER REPORTED THAT ON THE ONSET DATE WAS (B)(6) 2022, WHEN SUBJECT NOTED WITH SEVERE CLAUDICATION SYMPTOMS IN THE RIGHT CALF WITH ACTIVITY AND OCCASIONALLY AT REST AND OUTPATIENT DUPLEX REVEALED RIGHT ABI OF 0.62. IT WAS AGAIN FURTHER REPORTED THAT DURING THE INITIAL TREATMENT ON (B)(6) 2021, PRE-DILATATION WAS PERFORMED USING 6 MM X 60 MM NON-BOSTON SCIENTIFIC LITHOTRIPSY DEVICE, 4 MM X 40 MM COYOTE BALLOON AND 5 MM X 20 MM CUTTING BALLOON. TREATMENT OF THE RIGHT SFA WAS PERFORMED BY STUDY DEVICE, 6 MM X 120 MM RANGER DRUG-COATED BALLOON. IT WAS AGAIN FURTHER REPORTED THAT ON (B)(6) 2022, SUBJECT VISITED FOR THE FOR 6-MONTH FOLLOW UP WITH THE COMPLAINTS OF RECURRENT CLAUDICATION AND RIGHT DUPLEX ULTRASOUND PERFORMED REVEALED EVIDENCE OF 50-75% STENOSIS IN THE PROFUNDA FEMORAL ARTERY, OCCLUDED DISTAL SFA AND POPLITEAL ARTERY STENTS WITH RECONSTITUTION IN THE MID POPLITEAL ARTERY. IN ADDITION, RIGHT ABI WAS MODERATELY REDUCED TO 0.62. OF NOTE, ON (B)(6) 2021, ABI WAS NOTED TO BE 0.75.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2839901 | RANGER | CATHETER, PERCUTANEOUS | ONU | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |