ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM

Report

Report Number: 2124215-2026-09893
Event Type: Injury
Date Received: February 24, 2026
Date of Event: January 1, 2021
Report Date: March 26, 2026
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: NIU
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A2: THE SUBJECTS MEAN AGE WAS 72 YEARS. A3A/A3B: 82.4% OF STUDY PARTICIPANTS WERE MALE. B3: THE EVENT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE DATASET. D6A: THE IMPLANT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE DATASET. E1: THE FIRST AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY. E1: +011(086)57187236114. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. XU, Y., WANG, B., QIU, C., LI, Q., YE, M., SHI, Z., FANG, X., HE, C., FENG, Z., SANG, H., GUO, L., & WU, Z. (2025). ELUVIA STENT IN ENDOVASCULAR TREATMENT OF FEMOROPOPLITEAL OCCLUSIVE DISEASE: EARLY RESULTS OF THE CHALLENGE STUDY. VASCULAR, 0(0), 1-10. HTTPS://DOI.ORG/10.1177/17085381251342326

Additional Manufacturer Narrative · 0

A2: THE SUBJECTS MEAN AGE WAS 72 YEARS. A3A/A3B: 82.4% OF STUDY PARTICIPANTS WERE MALE. B3: THE EVENT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE DATASET. D6A: THE IMPLANT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE DATASET. E1: (B)(6) HOSPITAL. E1: (B)(6). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. XU, Y., WANG, B., QIU, C., LI, Q., YE, M., SHI, Z., FANG, X., HE, C., FENG, Z., SANG, H., GUO, L., & WU, Z. (2025). ELUVIA STENT IN ENDOVASCULAR TREATMENT OF FEMOROPOPLITEAL OCCLUSIVE DISEASE: EARLY RESULTS OF THE CHALLENGE STUDY. VASCULAR, 0(0), 1-10. HTTPS://DOI.ORG/10.1177/17085381251342326. INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE REMAINED IMPLANTED; THEREFORE, A TECHNICAL ANALYSIS WAS UNABLE TO BE PERFORMED. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE ELUVIA DEVICE CONFIRMED THAT THE REPORTED EVENTS ARE KNOWN EVENTS DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

Description of Event or Problem · 0

IT WAS REPORTED VIA ATTACHED LITERATURE THAT PATIENTS TREATED WITH ELUVIA EXPERIENCED AN ARRAY OF ADVERSE EVENTS POST PROCEDURE. FROM JANUARY 2021 TO NOVEMBER 2023, 159 PATIENTS WHO WERE TREATED WITH THE ELUVIA STENT FOR PERIPHERAL ARTERIAL DISEASE (PAD) CHARACTERIZED BY FEMOROPOPLITEAL OCCLUSIVE DISEASE (FPOD) WERE ENROLLED IN A PROSPECTIVE OBSERVATIONAL STUDY. ALL PATIENTS UNDERWENT ELUVIA STENT DEPLOYMENT; OTHER STENTS WERE USED AS RESCUE STENTS. BASELINE CHARACTERISTICS, PROCEDURE DETAILS, AND FOLLOW-UP OUTCOMES WERE COLLECTED IN THE VASCBASE DATABASE, WHICH IS ESTABLISHED ACROSS 10 VASCULAR CENTERS IN CHINA. FOUR ADVERSE EVENT COMPLICATIONS OCCURRED DURING THE PERIOPERATIVE PERIOD: ONE PATIENT DEVELOPED A PSEUDOANEURYSM AT THE PUNCTURE SITE, ONE PATIENT SUFFERED MINOR AMPUTATION, AND TWO DEVELOPED TRANSIENT RENAL DYSFUNCTION. DURING THE 12-MONTH FOLLOW-UP PERIOD, EIGHT PATIENTS DEVELOPED RESTENOSIS AND ONE DEVELOPED ACUTE STENT THROMBOSIS. TWO PATIENTS UNDERWENT MAJOR AMPUTATION ABOVE THE ANKLE. APPROXIMATELY ONE-THIRD OF PATIENTS WITH SYMPTOMATIC PAD EXPERIENCED AT LEAST ONE VASCULAR-RELATED HOSPITALIZATION OVER THE TWO-YEAR OBSERVATION PERIOD.

Description of Event or Problem · 0

IT WAS REPORTED VIA ATTACHED LITERATURE THAT PATIENTS TREATED WITH ELUVIA EXPERIENCED AN ARRAY OF ADVERSE EVENTS POST PROCEDURE. FROM (B)(6) 2021 TO (B)(6) 2023, 159 PATIENTS WHO WERE TREATED WITH THE ELUVIA STENT FOR PERIPHERAL ARTERIAL DISEASE (PAD) CHARACTERIZED BY FEMOROPOPLITEAL OCCLUSIVE DISEASE (FPOD) WERE ENROLLED IN A PROSPECTIVE OBSERVATIONAL STUDY. ALL PATIENTS UNDERWENT ELUVIA STENT DEPLOYMENT; OTHER STENTS WERE USED AS RESCUE STENTS. BASELINE CHARACTERISTICS, PROCEDURE DETAILS, AND FOLLOW-UP OUTCOMES WERE COLLECTED IN THE VASCBASE@ DATABASE, WHICH IS ESTABLISHED ACROSS 10 VASCULAR CENTERS IN CHINA. FOUR ADVERSE EVENT COMPLICATIONS OCCURRED DURING THE PERIOPERATIVE PERIOD: ONE PATIENT DEVELOPED A PSEUDOANEURYSM AT THE PUNCTURE SITE, ONE PATIENT SUFFERED MINOR AMPUTATION, AND TWO DEVELOPED TRANSIENT RENAL DYSFUNCTION. DURING THE 12-MONTH FOLLOW-UP PERIOD, EIGHT PATIENTS DEVELOPED RESTENOSIS AND ONE DEVELOPED ACUTE STENT THROMBOSIS. TWO PATIENTS UNDERWENT MAJOR AMPUTATION ABOVE THE ANKLE. APPROXIMATELY ONE-THIRD OF PATIENTS WITH SYMPTOMATIC PAD EXPERIENCED AT LEAST ONE VASCULAR-RELATED HOSPITALIZATION OVER THE TWO-YEAR OBSERVATION PERIOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
229914	ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM	STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING	NIU	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR	Male	Required Intervention\| O\| S\| H