Skip to content

SYNERGY™ H7493926028500Recalls & reported problems

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

All models of SYNERGY (74)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729973461), received between Jun 26, 2019 and Feb 24, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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

  • Material Deformation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 24, 2021Material Deformation; Material Deformation

    IT WAS REPORTED STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A 3.5X20 NC EMERGE BALLOON CATHETER, A 5.00 X 28MM SYNERGY DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVAL FROM THE HOOP, IT WAS NOTED THAT THE DISTAL STENT EDGE AND STRUTS APPEARED TO BE DAMAGED. THE TECHNICIAN NOTED THAT THE STRUTS WERE STICKING UP AND NOT SMOOTH ON THE DELIVERY SYSTEM. THE STENT WAS NOT ADVANCED INTO THE GUIDE CATHETER OR LOADED INTO WIRE AND WAS REPLACED ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11372986 ↗
  • MalfunctionJun 26, 2019Material Deformation; Material Deformation

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 5.00 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED THROUGH A 6F GUIDEZILLA II GUIDE EXTENSION CATHETER. HOWEVER, THE STENT STRUTS WERE DAMAGED BY THE GUIDEZILLA. THE PHYSICIAN HAS BEEN ADVISED THAT A 4.5/5.0 WILL NOT ADVANCED THROUGH A 6F GUIDEZILLA II. THE DEVICE WAS REMOVED AND ANOTHER 5.0 STENT WAS ADVANCED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8734215 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page