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Promus PREMIER™ H7493925212220Recalls & 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 08714729828792), received between Oct 3, 2017 and Oct 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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

  • Bent1
  • Device Damaged Prior to Use1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 3, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 12 X 2.25 PROMUS PREMIER¿ DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WAS BENT. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 12 X 2.25 PROMUS PREMIER¿ DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 6912302 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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