XIENCE PRIME 1011734-38Recalls & reported problems
Abbott Vascular Inc. · XIENCE PRIME LL Everolimus Eluting Coronary Stent System 3.50 mm x 38 mm / Rapid-Exchange · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648177279), received between Jan 10, 2018 and Jan 15, 2018 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Angina2
- Dyspnea1
- Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR DESCENDING ARTERY. ON (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. THREE XIENCE PRIME STENTS (3.5 X 38 MM, 3.5 X 18 MM, AND 2.5 X 28 MM) WERE IMPLANTED WITHOUT ISSUES. THE PATIENT WAS DISCHARGED AND GIVEN MEDICATION. ON (B)(6) 2014, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN WORSE THAN FOUR YEARS AND THREE MONTHS AGO. MEDICATIONS WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina
MAUDE report 7191627 ↗InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2013 FOUR XIENCE STENTS WERE IMPLANTED IN THE PROXIMAL, MID, AND DISTAL RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2016 THE PATIENT HAD STABLE ANGINA WITH DYSPNEA/SHORTNESS OF BREATH. DIAGNOSTIC CORONARY ANGIOGRAPHY WAS PERFORMED AND THE CONDITION RESOLVED. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED FOR RESTENOSIS IN THE PROXIMAL AND DISTAL RCA STUDY LESIONS. THE PATIENT EXPIRED ON (B)(6) 2017 OF UNKNOWN CAUSE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Angina; Dyspnea; Stenosis
MAUDE report 7180929 ↗
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
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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