XIENCE Skypoint™ 1804325-12Recalls & reported problems
Abbott Vascular Inc. · XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 3.25 mm x 12 mm / Rapid-Exchange · Class 3 · Implant
All models of XIENCE Skypoint (69)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648233302), received between Aug 25, 2021 and Sep 27, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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.
Most reported problems
Device problems
- Deflation Problem1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2021Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, AND THE BALLOON WAS INFLATED THREE TIMES AT 12 ATMOSPHERES. HOWEVER, THE BALLOON COULD ONLY PARTIALLY DEFLATE AFTER STENT IMPLANTATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE CONTRAST MIX WAS 100% AS OPPOSED TO A 50/50 MIX. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533014 ↗MalfunctionAug 25, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED AT 12 ATMOSPHERES. AFTER STENT DEPLOYMENT, THERE WAS DIFFICULTY REMOVING THE BALLOON FROM THE STENT IMPLANT. 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 12365049 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 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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