XIENCE V 1009540-15Recalls & reported problems
Abbott Vascular Inc. · XIENCE V Everolimus Eluting Coronary Stent System 2.75 mm x 15 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 08717648063930), received between Jul 11, 2017 and Jul 11, 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
- Angina1
- Stenosis1
- Test Result1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2013, 3.5X12MM AND 2.75X15MM XIENCE V STENTS WERE IMPLANTED IN THE LEFT MAIN (LM) CORONARY ARTERY AND PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY LESIONS. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED FOR UNSTABLE ANGINA. TROPONIN WAS NEGATIVE. STRESS TEST WAS POSITIVE. PER IMAGING, THERE WAS RESTENOSIS IN BOTH XIENCE V STENTS IN THE LEFT MAIN (LM) AND CIRCUMFLEX (CX) ARTERIES. DUAL ANTIPLATELET THERAPY (DAPT) MEDICATIONS WERE CHANGED AND ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) DE NOVO LESION. THE EVENT RESOLVED WITHOUT SEQUELA. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED FOR ANGINA. DAPT MEDICATION WAS PROVIDED. NON-ABBOTT STENTS WERE PLACED IN THE RCA. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED FOR ANGINA. CARDIOVASCULAR MEDICATION WAS PROVIDED AND PERCUTANEOUS INTERVENTION WAS PERFORMED IN THE PROXIMAL CX, PLACING A XIENCE STENT IN THE RESTENOSED 3.5X12MM AND 2.75X15MM XIENCE V STENTS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.
Patient problems: Angina; Stenosis; Test Result
MAUDE report 6703157 ↗
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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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