ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Report
- Report Number
- 2124215-2025-63212
- Event Type
- Injury
- Date Received
- September 18, 2025
- Date of Event
- August 21, 2025
- Report Date
- December 8, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIU
- UDI-DI
- 08714729876854
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A2 - AGE AT TIME OF EVENT: 68 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.
A2 - AGE AT TIME OF EVENT: 68 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION. ADDITIONAL INFORMATION PROVIDED STATED THAT THE RESTENOSIS WAS ATTRIBUTED TO ONLY ONE ELUVIA STENT. THIS HAS BEEN REPORTED UNDER REPORT NUMBER 2124215-2025-62928.
H6 - EVALUATION METHOD CODES: UPDATED. A2 - AGE AT TIME OF EVENT: 68 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION. ADDITIONAL INFORMATION PROVIDED STATED THAT THE RESTENOSIS WAS ATTRIBUTED TO ONLY ONE ELUVIA STENT. THIS HAS BEEN REPORTED UNDER REPORT NUMBER 2124215-2025-62928.
IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING MEDICATION OR ADJUSTED REGIMEN. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENTS AS PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA AND LEFT DISTAL SFA WITH 4.86 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.78 MM DISTAL REFERENCE VESSEL DIAMETER WITH 260 MM LESION LENGTH WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC (TRANS-ATLANTIC INTER-SOCIETY CONSENSUS) II CLASS C LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 120 MM STERLING PTA BALLOON AND 5 MM X 120 MM NON-BOSTON SCIENTIFIC (BSC) PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF TWO 6 MM X 120 MM AND ONE 6 MM X 60 MM ELUVIA DRUG ELUTING STENTS, STUDY DEVICES. FOLLOWING TREATMENT, POST DILATION WAS PERFORMED USING 5 MM X 80 MM STERLING PTA BALLOON AND, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. OF NOTE, DURING THE TREATMENT OF TARGET LESION, A COMPLICATION OF DISSECTION GRADE B WAS NOTED DUE TO THE 5 MM X 120 MM NON-BSC BALLOON, WHICH WAS TREATED BY PLACEMENT OF BAILOUT STENT AND THE COMPLICATION WAS CONSIDERED TO BE RESOLVED. TWO DAYS LATER, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2025, 1162 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH RESTENOSIS OF THE LEFT PROXIMAL SFA. IN RESPONSE TO THE EVENT, MEDICATION WAS GIVEN OR REGIMEN ADJUSTED.
IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING MEDICATION OR ADJUSTED REGIMEN. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENTS AS PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA AND LEFT DISTAL SFA WITH 4.86 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.78 MM DISTAL REFERENCE VESSEL DIAMETER WITH 260 MM LESION LENGTH WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC (TRANS-ATLANTIC INTER-SOCIETY CONSENSUS) II CLASS C LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 120 MM STERLING PTA BALLOON AND 5 MM X 120 MM NON-BOSTON SCIENTIFIC (BSC) PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF TWO 6 MM X 120 MM AND ONE 6 MM X 60 MM ELUVIA DRUG ELUTING STENTS, STUDY DEVICES. FOLLOWING TREATMENT, POST DILATION WAS PERFORMED USING 5 MM X 80 MM STERLING PTA BALLOON AND, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. OF NOTE, DURING THE TREATMENT OF TARGET LESION, A COMPLICATION OF DISSECTION GRADE B WAS NOTED DUE TO THE 5 MM X 120 MM NON-BSC BALLOON, WHICH WAS TREATED BY PLACEMENT OF BAILOUT STENT AND THE COMPLICATION WAS CONSIDERED TO BE RESOLVED. TWO DAYS LATER, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2025, 1162 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH RESTENOSIS OF THE LEFT PROXIMAL SFA. IN RESPONSE TO THE EVENT, MEDICATION WAS GIVEN OR REGIMEN ADJUSTED. IT WAS FURTHER REPORTED THAT ONLY ONE 6 MM X 120 MM ELUVIA DES (STUDY DEVICE) WAS NOTED TO BE STENOSED, AND THIS ELUVIA DES WAS NOT STENOSED.
IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING MEDICATION OR ADJUSTED REGIMEN. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENTS AS PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA AND LEFT DISTAL SFA WITH 4.86 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.78 MM DISTAL REFERENCE VESSEL DIAMETER WITH 260 MM LESION LENGTH WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC (TRANS-ATLANTIC INTER-SOCIETY CONSENSUS) II CLASS C LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 120 MM STERLING PTA BALLOON AND 5 MM X 120 MM NON-BOSTON SCIENTIFIC (BSC) PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF TWO 6 MM X 120 MM AND ONE 6 MM X 60 MM ELUVIA DRUG ELUTING STENTS, STUDY DEVICES. FOLLOWING TREATMENT, POST DILATION WAS PERFORMED USING 5 MM X 80 MM STERLING PTA BALLOON AND, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. OF NOTE, DURING THE TREATMENT OF TARGET LESION, A COMPLICATION OF DISSECTION GRADE B WAS NOTED DUE TO THE 5 MM X 120 MM NON-BSC BALLOON, WHICH WAS TREATED BY PLACEMENT OF BAILOUT STENT AND THE COMPLICATION WAS CONSIDERED TO BE RESOLVED. TWO DAYS LATER, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2025, 1162 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH RESTENOSIS OF THE LEFT PROXIMAL SFA. IN RESPONSE TO THE EVENT, MEDICATION WAS GIVEN OR REGIMEN ADJUSTED. IT WAS FURTHER REPORTED THAT ONLY ONE 6 MM X 120 MM ELUVIA DES (STUDY DEVICE) WAS NOTED TO BE STENOSED, AND THIS ELUVIA DES WAS NOT STENOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2839594 | ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | BOSTON SCIENTIFIC CORPORATION | 24653 | 0026989975 | 08714729876854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |