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Promus PREMIER™ H7493952816270Recalls & reported problems

Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3 · Implant

All models of Promus PREMIER (56)

Data updated Oct 18, 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 08714729844723), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 20, 2018Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75X16MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE INSERTING THE DEVICE INTO THE GUIDE, THE SHAFT BROKE MIDWAY FROM THE HUB. THE DEVICE WAS REMOVED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7706385 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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