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SYNERGY™ H7493926112220Recalls & 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
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 08714729840503), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryJan 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT UPON TRACKING THE VERY SHARP ANGLED LESION, THE STENT CAME OFF THE BALLOON AND HAD TO BE DEPLOYED PROXIMAL TO THE TARGET LESION. DIFFICULTY TREATING THE TARGET LESION WAS THEN ENCOUNTERED BECAUSE THEY WERE TRYING TO GET AN ADDITIONAL STENT THROUGH THE STENT DEPLOYED IN THE WRONG LOCATION. THEY HAD TO BALLOON REPEATEDLY WITH A NON-COMPLIANT BALLOON CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Code Available

    MAUDE report 9654388 ↗

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Sources and updates

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