Esprit™ 1203300-18Recalls & reported problems
Abbott Vascular Inc. · Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.00mm x 18mm Rapid-Exchange · Class 3 · Implant
All models of Esprit (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648356971), received between Sep 2, 2025 and Sep 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS TREAT THE OSTIUM OF THE ANTERIOR TIBIAL ARTERY. A 3.0X18MM ESPRIT BELOW THE KNEE (BTK) WAS IMPLANTED WITHOUT ISSUE; HOWEVER, THE 3.0X18MM WAS A SMALLER STENT THAN WHAT THE PHYSICIAN WANTED TO USE BUT WAS ONLY SIZE AVAILABLE AND PLANNED FOR RE-INTERVENTION ON A LATER DATE. ON (B)(6) 2025, WHEN ADVANCING A 4FR X 90CM ANGLED GUIDE CATHETER ATTEMPTING TO CROSS THE PREVIOUSLY IMPLANTED ESPRIT RESISTANCE WAS MET AND THE SCAFFOLD ACCORDIONED AND FOLDED UP ON ITSELF. IT WAS OBSERVED ANGIOGRAPHICALLY AS THE PLATINUM MARKERS WENT FROM 18MM APART TO ABOUT 2MM APART. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932729 ↗
Other Scaffold, Infrapopliteal, Absorbable devices
- Esprit™ 1203300-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable1 death47 reports
- Esprit™ 1203250-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable37 reports
- Esprit™ 1203350-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable1 death30 reports
- Esprit™ 1203375-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable16 reports
- Esprit™ 1203300-28Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable10 reports
- Esprit™Abbott Vascular Inc. · Scaffold, infrapopliteal, absorbable4 reports
- Esprit™Abbott Vascular Inc. · Scaffold, infrapopliteal, absorbable3 reports
- Esprit™ 1203250-28Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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