RANGER
Report
- Report Number
- 2124215-2023-60942
- Event Type
- Injury
- Date Received
- November 13, 2023
- Date of Event
- June 15, 2023
- Report Date
- December 5, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- ONU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A1: PATIENT IDENTIFIER- (B)(6). A2: AGE AT THE TIME OF ENROLLMENT- 65 YEARS OLD. E1: INITIAL REPORTER PHONE- (B)(6).
B5 4.0 MM X 6 MM STERLING PTA BALLOON CORRECTED TO 4.0 MM X 60 MM STERLING PTA BALLOON. A1: PATIENT IDENTIFIER- (B)(6). A2: AGE AT THE TIME OF ENROLLMENT- 65 YEARS OLD. E1: INITIAL REPORTER PHONE- +(B)(6).
A1: PATIENT IDENTIFIER- (B)(6). A2: AGE AT THE TIME OF ENROLLMENT- 65 YEARS OLD. E1: INITIAL REPORTER PHONE- +(B)(6).
H6 ARTERIOSCLEROSIS/ATHEROSCLEROSIS CODE ADDED. A1: PATIENT IDENTIFIER- (B)(6). A2: AGE AT THE TIME OF ENROLLMENT- 65 YEARS OLD. E1: INITIAL REPORTER PHONE- (B)(6).
B5 UPDATED: A2: AGE AT THE TIME OF ENROLLMENT- 65 YEARS OLD. E1: INITIAL REPORTER PHONE- (B)(6).
ELEGANCE STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH 5.1 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.1 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 51 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4.0 MM X 6 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5.0 MM X 60 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS PRESENTED WITH THE SYMPTOMS RELATED TO STENOSIS IN RIGHT MID POPLITEAL ARTERY. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT MID POPLITEAL ARTERY WAS REVASCULARIZED USING DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ADDITIONALLY, RIGHT PROXIMAL POPLITEAL ARTERY WAS ALSO TREATED. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED.
ELEGANCE STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON 06-DEC-2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH 5.1 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.1 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 51 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4.0 MM X 60 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5.0 MM X 60 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS PRESENTED WITH THE SYMPTOMS RELATED TO STENOSIS IN RIGHT MID POPLITEAL ARTERY. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT MID POPLITEAL ARTERY WAS REVASCULARIZED USING DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ADDITIONALLY, RIGHT PROXIMAL POPLITEAL ARTERY WAS ALSO TREATED. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR 6 MONTH FOLLOW UP VISIT AND WAS EXPERIENCING CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIAL DOPPLER ULTRASOUND WAS PERFORMED WHICH REVEALED: -RIGHT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH CORRECT AMPLITUDE PROXIMALLY RELATED TO A STENOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY WITH VELOCITY AT 378 CM/S, THE WAVEFORMS IN POPLITEAL AND DISTAL REGIONS ARE NOTED TO BE MONOPHASIC, THE POPLITEAL ARTERY WAS NOTED TO BE PATENT. RIGHT ABI IS MEASURED AT 0.69 WHICH WAS NOTED TO HAVE SLIGHT IMPROVEMENT FROM THE BASELINE INDEX. -LEFT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH GOOD AMPLITUDE DISTALLY, LEFT ABI MEASURED AT 0.81, WHICH WAS NOTED TO HAVE GREATER IMPROVEMENT FROM THE BASELINE INDEX. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMBS FOR LAST 2 MONTHS AND WAS PLANNED FOR ASSESSMENT OF RIGHT POPLITEAL ARTERY. ON (B)(6) 2023, SUBJECT WAS PRESENTED TO THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIOGRAPHY WAS PERFORMED WHICH REVEALED: -RIGHT LEG: MORE THAN 70% STENOSIS WAS NOTED IN THE PROXIMAL PORTION OF THE RIGHT EXTERNAL ILIAC ARTERY, A TRIANGLE SHAPED (60%) STENOSIS WAS NOTED IN THE PROXIMAL POPLITEAL ARTERY AT THE SITE OF ANGIOPLASTY PERFORMED DURING INDEX PROCEDURE AND THERE WAS AN ULCER OR MINOR DISSECTION NOTED IN DISTAL SUPERFICIAL FEMORAL ARTERY WHICH WAS CONSIDERED INSIGNIFICANT, AND THE REST ARTERIES WERE FOUND TO BE PATENT. -LEFT LEG: THE LEFT ILIAC AXIS INCLUDING THE STENTS AT COMMON ILIAC ARTERY WAS FOUND TO BE PATENT. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT PROXIMAL POPLITEAL ARTERY WAS REVASCULARIZED USING 5.6 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. OF NOTE, THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY WAS ALSO TREATED.
ELEGANCE STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH 5.1 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.1 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 51 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4.0 MM X 60 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5.0 MM X 60 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS PRESENTED WITH THE SYMPTOMS RELATED TO STENOSIS IN RIGHT MID POPLITEAL ARTERY. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT MID POPLITEAL ARTERY WAS REVASCULARIZED USING DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ADDITIONALLY, RIGHT PROXIMAL POPLITEAL ARTERY WAS ALSO TREATED. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR 6 MONTH FOLLOW UP VISIT AND WAS EXPERIENCING CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIAL DOPPLER ULTRASOUND WAS PERFORMED WHICH REVEALED: -RIGHT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH CORRECT AMPLITUDE PROXIMALLY RELATED TO A STENOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY WITH VELOCITY AT 378 CM/S, THE WAVEFORMS IN POPLITEAL AND DISTAL REGIONS ARE NOTED TO BE MONOPHASIC, THE POPLITEAL ARTERY WAS NOTED TO BE PATENT. RIGHT ABI IS MEASURED AT 0.69 WHICH WAS NOTED TO HAVE SLIGHT IMPROVEMENT FROM THE BASELINE INDEX. -LEFT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH GOOD AMPLITUDE DISTALLY, LEFT ABI MEASURED AT 0.81, WHICH WAS NOTED TO HAVE GREATER IMPROVEMENT FROM THE BASELINE INDEX. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMBS FOR LAST 2 MONTHS AND WAS PLANNED FOR ASSESSMENT OF RIGHT POPLITEAL ARTERY. ON (B)(6) 2023, SUBJECT WAS PRESENTED TO THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIOGRAPHY WAS PERFORMED WHICH REVEALED: -RIGHT LEG: MORE THAN 70% STENOSIS WAS NOTED IN THE PROXIMAL PORTION OF THE RIGHT EXTERNAL ILIAC ARTERY, A TRIANGLE SHAPED (60%) STENOSIS WAS NOTED IN THE PROXIMAL POPLITEAL ARTERY AT THE SITE OF ANGIOPLASTY PERFORMED DURING INDEX PROCEDURE AND THERE WAS AN ULCER OR MINOR DISSECTION NOTED IN DISTAL SUPERFICIAL FEMORAL ARTERY WHICH WAS CONSIDERED INSIGNIFICANT, AND THE REST ARTERIES WERE FOUND TO BE PATENT. -LEFT LEG: THE LEFT ILIAC AXIS INCLUDING THE STENTS AT COMMON ILIAC ARTERY WAS FOUND TO BE PATENT. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT PROXIMAL POPLITEAL ARTERY WAS REVASCULARIZED USING 5.6 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. OF NOTE, THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY WAS ALSO TREATED. IT WAS AGAIN FURTHER REPORTED THAT ON (B)(6) 2023. ADDITIONALLY, MORE THAN 70% STENOSIS NOTED IN THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY WAS TREATED BY PLACEMENT OF 9 MM X 40 MM EPIC STENT FOLLOWED BY DILATION USING 8.2 MM BALLOON.
ELEGANCE STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH 5.1 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.1 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 51 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4.0 MM X 6 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5.0 MM X 60 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS PRESENTED WITH THE SYMPTOMS RELATED TO STENOSIS IN RIGHT MID POPLITEAL ARTERY. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT MID POPLITEAL ARTERY WAS REVASCULARIZED USING DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ADDITIONALLY, RIGHT PROXIMAL POPLITEAL ARTERY WAS ALSO TREATED. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR 6 MONTH FOLLOW UP VISIT AND WAS EXPERIENCING CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIAL DOPPLER ULTRASOUND WAS PERFORMED WHICH REVEALED: -RIGHT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH CORRECT AMPLITUDE PROXIMALLY RELATED TO A STENOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY WITH VELOCITY AT 378 CM/S, THE WAVEFORMS IN POPLITEAL AND DISTAL REGIONS ARE NOTED TO BE MONOPHASIC, THE POPLITEAL ARTERY WAS NOTED TO BE PATENT. RIGHT ABI IS MEASURED AT 0.69 WHICH WAS NOTED TO HAVE SLIGHT IMPROVEMENT FROM THE BASELINE INDEX. -LEFT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH GOOD AMPLITUDE DISTALLY, LEFT ABI MEASURED AT 0.81, WHICH WAS NOTED TO HAVE GREATER IMPROVEMENT FROM THE BASELINE INDEX. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMBS FOR LAST 2 MONTHS AND WAS PLANNED FOR ASSESSMENT OF RIGHT POPLITEAL ARTERY. ON (B)(6) 2023, SUBJECT WAS PRESENTED TO THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIOGRAPHY WAS PERFORMED WHICH REVEALED: -RIGHT LEG: MORE THAN 70% STENOSIS WAS NOTED IN THE PROXIMAL PORTION OF THE RIGHT EXTERNAL ILIAC ARTERY, A TRIANGLE SHAPED (60%) STENOSIS WAS NOTED IN THE PROXIMAL POPLITEAL ARTERY AT THE SITE OF ANGIOPLASTY PERFORMED DURING INDEX PROCEDURE AND THERE WAS AN ULCER OR MINOR DISSECTION NOTED IN DISTAL SUPERFICIAL FEMORAL ARTERY WHICH WAS CONSIDERED INSIGNIFICANT, AND THE REST ARTERIES WERE FOUND TO BE PATENT. -LEFT LEG: THE LEFT ILIAC AXIS INCLUDING THE STENTS AT COMMON ILIAC ARTERY WAS FOUND TO BE PATENT. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT PROXIMAL POPLITEAL ARTERY WAS REVASCULARIZED USING 5.6 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. OF NOTE, THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY WAS ALSO TREATED.
IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2022 AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID POPLITEAL ARTERY WITH 5.1 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.1 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 51 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4.0 MM X 60 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5.0 MM X 60 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS PRESENTED WITH THE SYMPTOMS RELATED TO STENOSIS IN RIGHT MID POPLITEAL ARTERY. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT MID POPLITEAL ARTERY WAS REVASCULARIZED USING DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ADDITIONALLY, RIGHT PROXIMAL POPLITEAL ARTERY WAS ALSO TREATED. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR 6 MONTH FOLLOW UP VISIT AND WAS EXPERIENCING CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIAL DOPPLER ULTRASOUND WAS PERFORMED WHICH REVEALED: -RIGHT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH CORRECT AMPLITUDE PROXIMALLY RELATED TO A STENOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY WITH VELOCITY AT 378 CM/S, THE WAVEFORMS IN POPLITEAL AND DISTAL REGIONS ARE NOTED TO BE MONOPHASIC, THE POPLITEAL ARTERY WAS NOTED TO BE PATENT. RIGHT ABI IS MEASURED AT 0.69 WHICH WAS NOTED TO HAVE SLIGHT IMPROVEMENT FROM THE BASELINE INDEX. -LEFT LEG; THE WAVEFORMS ARE NOTED TO BE MONOPHASIC WITH GOOD AMPLITUDE DISTALLY, LEFT ABI MEASURED AT 0.81, WHICH WAS NOTED TO HAVE GREATER IMPROVEMENT FROM THE BASELINE INDEX. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMBS FOR LAST 2 MONTHS AND WAS PLANNED FOR ASSESSMENT OF RIGHT POPLITEAL ARTERY. ON (B)(6) 2023, SUBJECT WAS PRESENTED TO THE HOSPITAL FOR RECURRENCE OF CLAUDICATION IN THE RIGHT LOWER LIMB. ON THE SAME DAY, LOWER LIMB ARTERIOGRAPHY WAS PERFORMED WHICH REVEALED: -RIGHT LEG: MORE THAN 70% STENOSIS WAS NOTED IN THE PROXIMAL PORTION OF THE RIGHT EXTERNAL ILIAC ARTERY, A TRIANGLE SHAPED (60%) STENOSIS WAS NOTED IN THE PROXIMAL POPLITEAL ARTERY AT THE SITE OF ANGIOPLASTY PERFORMED DURING INDEX PROCEDURE AND THERE WAS AN ULCER OR MINOR DISSECTION NOTED IN DISTAL SUPERFICIAL FEMORAL ARTERY WHICH WAS CONSIDERED INSIGNIFICANT, AND THE REST ARTERIES WERE FOUND TO BE PATENT. -LEFT LEG: THE LEFT ILIAC AXIS INCLUDING THE STENTS AT COMMON ILIAC ARTERY WAS FOUND TO BE PATENT. ON (B)(6) 2023, 314 DAYS POST INDEX PROCEDURE, 60% STENOSIS NOTED IN RIGHT PROXIMAL POPLITEAL ARTERY WAS REVASCULARIZED USING 5.6 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. OF NOTE, THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY WAS ALSO TREATED. IT WAS AGAIN FURTHER REPORTED THAT ON (B)(6) 2023. ADDITIONALLY, MORE THAN 70% STENOSIS NOTED IN THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY WAS TREATED BY PLACEMENT OF 9 MM X 40 MM EPIC STENT FOLLOWED BY DILATION USING 8.2 MM BALLOON. IT WAS FURTHER REPORTED THAT OCCLUSION NOTED IN THE RIGHT PROXIMAL POPLITEAL ARTERY WAS TREATED BY 5 X 60 MM RANGER DCB. HENCE, ONLY RIGHT MID POPLITEAL ARTERY WAS TREATED BY STUDY DEVICE. ADDITIONALLY, ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL FOR THE STUDY SPECIFIC 6 MONTH FOLLOW UP VISIT AND RUTHERFORD ASSESSMENT PERFORMED REVEALED CATEGORY 3 SEVERE CLAUDICATION. ON THE SAME DAY, THE SUBJECT REPORTED TO HAVE SYMPTOMS RELATED TO THE EVENT SINCE MID-JUNE AND HAD BEEN LIMPING SINCE THEN. (B)(6) 2023 IS CONSIDERED AS THE ONSET DATE OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2239760 | RANGER | CATHETER, PERCUTANEOUS | ONU | BOSTON SCIENTIFIC CORPORATION | 1177-01 | 07690H21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |