XIENCE PRIME 1011733-38Recalls & reported problems
Abbott Vascular Inc. · XIENCE PRIME LL Everolimus Eluting Coronary Stent System 3.00 mm x 38 mm / Rapid-Exchange · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648177194), received between May 30, 2017 and May 30, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2013 THREE XIENCE PRIME STENTS (SIZES 2.5 X 38, 3.0 X 38, 3.5 X 18 MM) WERE IMPLANTED IN THE 75% STENOSIS IN THE LEFT MAIN TRUNK TO TREAT AN ACUTE MYOCARDIAL INFARCTION. ON (B)(6) 2016, RESTENOSIS (90%) WAS FOUND IN THE 2.5 X 38MM AND 3.0 X 38MM XIENCE PRIME STENTS. THESE WERE TREATED WITH A CUTTING BALLOON AND THE EVENT RESOLVED. ON (B)(6) 2017 RESTENOSIS (75%) WAS FOUND IN THE 2.5 X 38MM AND 3.0 X 38MM XIENCE PRIME STENTS. THESE WERE TREATED WITH A DRUG ELUTING STENT AND THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Stenosis
MAUDE report 6599631 ↗
Other Coronary drug-eluting stent devices
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- 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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