ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Report
- Report Number
- 2124215-2023-28430
- Event Type
- Injury
- Date Received
- June 7, 2023
- Date of Event
- May 3, 2023
- Report Date
- April 3, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIU
- UDI-DI
- 08714729876618
- PMA / PMN Number
- P180011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A1: PATIENT IDENTIFIER: (B)(6).
A1: PATIENT IDENTIFIER - (B)(6).
A1: PATIENT IDENTIFIER - (B)(6).
ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT RE-OCCLUSION OF TARGET LESION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (PPA) WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.8 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 132 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED WITH SHOCKWAVE LITHOTRIPSY DEVICE AND PRE-DILATION WAS PERFORMED USING 2.5 MM X 150 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM RANGER DRUG-COATED BALLOON STUDY DEVICE FOLLOWED BY THE PLACEMENT OF SIZE 6.0 MM X 120 MM ELUVIA DRUG ELUTING STENT. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. DURING INDEX PROCEDURE, DISSECTION OF GRADE E COMPLICATION WAS NOTED DUE TO 5 MM X 200 MM RANGER DRUG-COATED BALLOON AND RESIDUAL STENOSIS WAS ALSO NOTED. IN RESPONSE TO THE COMPLICATIONS, 6 MM X 120 MM ELUVIA DRUG ELUTING STENT WAS IMPLANTED TO RESOLVE THE COMPLICATION. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2023, THE SUBJECT WAS NOTED SYMPTOMS RELATED TO CRITICAL LIMB ISCHEMIA. ON (B)(6) 2023, 56 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT EXTERNAL ILIAC ARTERY, LEFT INTERNAL ILIAC ARTERY AND LEFT DISTAL SFA WERE TREATED USING DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ANOTHER 6MM X 80MM RANGER DRUG-COATED BALLOON WAS USED FOR DILATION DURING THE INDEX PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF OCCASIONAL THROBBING PAIN AT THE SITE OF NONHEALING WOUND OF LEFT HALLUX. SUBSEQUENTLY, ON THE SAME DAY, DUPLEX ULTRASOUND AND NON-INVASIVE VASCULAR TESTING WAS PERFORMED WHICH REVEALED ABI OF 0.79 IN THE LEFT LOWER EXTREMITY AND OCCLUDED STENT IN LEFT DISTAL SFA. BASED ON THESE FINDINGS, REVASCULARIZATION WAS RECOMMENDED TO OPTIMIZE THE HEALING OF THE LEFT FOOT WOUND. ON (B)(6) 2023, ARTERIOGRAPHY PERFORMED REVEALED SIGNIFICANT STENOSIS OF 50% IN LEFT EXTERNAL ILIAC ARTERY, CALCIFIC OCCLUSION IN THE LEFT SFA, PATENT POPLITEAL ARTERY WITH STABLE TWO VESSEL RUNOFF TO THE FOOT VIA POSTERIOR TIBIAL ARTERY AND PERONEAL ARTERY. ON (B)(6) 2023, 56 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT SFA STENT WAS TREATED WITH ATHERECTOMY AND THROMBECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 5MM RANGER DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED.
ELEGANCE CLINICAL STUDY: IT WAS REPORTED THAT RE-OCCLUSION OF TARGET LESION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (PPA) WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.8 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 132 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED WITH SHOCKWAVE LITHOTRIPSY DEVICE AND PRE-DILATION WAS PERFORMED USING 2.5 MM X 150 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM RANGER DRUG-COATED BALLOON STUDY DEVICE FOLLOWED BY THE PLACEMENT OF SIZE 6.0 MM X 120 MM ELUVIA DRUG ELUTING STENT. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. DURING INDEX PROCEDURE, DISSECTION OF GRADE E COMPLICATION WAS NOTED DUE TO 5 MM X 200 MM RANGER DRUG-COATED BALLOON AND RESIDUAL STENOSIS WAS ALSO NOTED. IN RESPONSE TO THE COMPLICATIONS, 6 MM X 120 MM ELUVIA DRUG ELUTING STENT WAS IMPLANTED TO RESOLVE THE COMPLICATION. ON 17-MAR-2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON 03-MAY-2023, THE SUBJECT WAS NOTED SYMPTOMS RELATED TO CRITICAL LIMB ISCHEMIA. ON 09-MAY-2023, 56 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT EXTERNAL ILIAC ARTERY, LEFT INTERNAL ILIAC ARTERY AND LEFT DISTAL SFA WERE TREATED USING DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON 10-MAY-2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ANOTHER 6MM X 80MM RANGER DRUG-COATED BALLOON WAS USED FOR DILATION DURING THE INDEX PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF OCCASIONAL THROBBING PAIN AT THE SITE OF NONHEALING WOUND OF LEFT HALLUX. SUBSEQUENTLY, ON THE SAME DAY, DUPLEX ULTRASOUND AND NON-INVASIVE VASCULAR TESTING WAS PERFORMED WHICH REVEALED ABI OF 0.79 IN THE LEFT LOWER EXTREMITY AND OCCLUDED STENT IN LEFT DISTAL SFA. BASED ON THESE FINDINGS, REVASCULARIZATION WAS RECOMMENDED TO OPTIMIZE THE HEALING OF THE LEFT FOOT WOUND. ON (B)(6) 2023, ARTERIOGRAPHY PERFORMED REVEALED SIGNIFICANT STENOSIS OF 50% IN LEFT EXTERNAL ILIAC ARTERY, CALCIFIC OCCLUSION IN THE LEFT SFA, PATENT POPLITEAL ARTERY WITH STABLE TWO VESSEL RUNOFF TO THE FOOT VIA POSTERIOR TIBIAL ARTERY AND PERONEAL ARTERY. ON 09-MAY-2023, 56 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT SFA STENT WAS TREATED WITH ATHERECTOMY AND THROMBECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 5MM RANGER DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON 10-MAY-2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON 09-MAY-2023, THE PREVIOUSLY PLACED ELUVIA STENT WAS NOTED TO BE FRACTURED. BALLOON ANGIOPLASTY WAS PERFORMED IN THE LEFT MID SFA BETWEEN 2 STENT ENDS USING 6 MM STERLING BALLOON. SUBSEQUENTLY, THE SAME SEGMENT CONTAINING THE FRACTURED SFA STENT WAS RE-STENTED USING 6 MM X 100 MM AND 6 MM X 60 MM NON-BOSTON SCIENTIFIC STENTS. POST DILATION WAS PERFORMED USING A 6 MM BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%.
ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT RE-OCCLUSION OF TARGET LESION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6)2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (PPA) WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.8 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 132 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED WITH SHOCKWAVE LITHOTRIPSY DEVICE AND PRE-DILATION WAS PERFORMED USING 2.5 MM X 150 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM RANGER DRUG-COATED BALLOON STUDY DEVICE FOLLOWED BY THE PLACEMENT OF SIZE 6.0 MM X 120 MM ELUVIA DRUG ELUTING STENT. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. DURING INDEX PROCEDURE, DISSECTION OF GRADE E COMPLICATION WAS NOTED DUE TO 5 MM X 200 MM RANGER DRUG-COATED BALLOON AND RESIDUAL STENOSIS WAS ALSO NOTED. IN RESPONSE TO THE COMPLICATIONS, 6 MM X 120 MM ELUVIA DRUG ELUTING STENT WAS IMPLANTED TO RESOLVE THE COMPLICATION. ON (B)(6)2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6)2023, THE SUBJECT WAS NOTED SYMPTOMS RELATED TO CRITICAL LIMB ISCHEMIA. ON (B)(6)2023, 56 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT EXTERNAL ILIAC ARTERY, LEFT INTERNAL ILIAC ARTERY AND LEFT DISTAL SFA WERE TREATED USING DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6)2023, THE EVENT WAS CONSIDERED TO BE RESOLVED.
IT WAS REPORTED THAT RE-OCCLUSION OF TARGET LESION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (PPA) WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.8 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 132 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED WITH SHOCKWAVE LITHOTRIPSY DEVICE AND PRE-DILATION WAS PERFORMED USING 2.5 MM X 150 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM RANGER DRUG-COATED BALLOON STUDY DEVICE FOLLOWED BY THE PLACEMENT OF SIZE 6.0 MM X 120 MM ELUVIA DRUG ELUTING STENT. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. DURING INDEX PROCEDURE, DISSECTION OF GRADE E COMPLICATION WAS NOTED DUE TO 5 MM X 200 MM RANGER DRUG-COATED BALLOON AND RESIDUAL STENOSIS WAS ALSO NOTED. IN RESPONSE TO THE COMPLICATIONS, 6 MM X 120 MM ELUVIA DRUG ELUTING STENT WAS IMPLANTED TO RESOLVE THE COMPLICATION. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2023, THE SUBJECT WAS NOTED SYMPTOMS RELATED TO CRITICAL LIMB ISCHEMIA. ON (B)(6) 2023, 56 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT EXTERNAL ILIAC ARTERY, LEFT INTERNAL ILIAC ARTERY AND LEFT DISTAL SFA WERE TREATED USING DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ANOTHER 6MM X 80MM RANGER DRUG-COATED BALLOON WAS USED FOR DILATION DURING THE INDEX PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF OCCASIONAL THROBBING PAIN AT THE SITE OF NONHEALING WOUND OF LEFT HALLUX. SUBSEQUENTLY, ON THE SAME DAY, DUPLEX ULTRASOUND AND NON-INVASIVE VASCULAR TESTING WAS PERFORMED WHICH REVEALED ABI OF 0.79 IN THE LEFT LOWER EXTREMITY AND OCCLUDED STENT IN LEFT DISTAL SFA. BASED ON THESE FINDINGS, REVASCULARIZATION WAS RECOMMENDED TO OPTIMIZE THE HEALING OF THE LEFT FOOT WOUND. ON (B)(6) 2023, ARTERIOGRAPHY PERFORMED REVEALED SIGNIFICANT STENOSIS OF 50% IN LEFT EXTERNAL ILIAC ARTERY, CALCIFIC OCCLUSION IN THE LEFT SFA, PATENT POPLITEAL ARTERY WITH STABLE TWO VESSEL RUNOFF TO THE FOOT VIA POSTERIOR TIBIAL ARTERY AND PERONEAL ARTERY. ON (B)(6) 2023, 56 DAYS POST INDEX PROCEDURE, OCCLUSION NOTED IN THE LEFT SFA STENT WAS TREATED WITH ATHERECTOMY AND THROMBECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 5MM RANGER DRUG-COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE PREVIOUSLY PLACED ELUVIA STENT WAS NOTED TO BE FRACTURED. BALLOON ANGIOPLASTY WAS PERFORMED IN THE LEFT MID SFA BETWEEN 2 STENT ENDS USING 6 MM STERLING BALLOON. SUBSEQUENTLY, THE SAME SEGMENT CONTAINING THE FRACTURED SFA STENT WAS RE-STENTED USING 6 MM X 100 MM AND 6 MM X 60 MM NON-BOSTON SCIENTIFIC STENTS. POST DILATION WAS PERFORMED USING A 6 MM BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE TARGET LESION WAS IN THE LEFT EXTERNAL ILIAC ARTERY, LEFT COMMON FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY. THE DISSECTION WAS NOTED IN THE LEFT FEMOROPOPLITEAL JUNCTION. IT IS UNKNOWN WHICH DEVICE CAUSED THE DISSECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1367714 | ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | BOSTON SCIENTIFIC CORPORATION | 24657 | 0029503938 | 08714729876618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention |