SYNERGY™ XD H7493941808250Recalls & reported problems
Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3 · Implant
All models of SYNERGY XD (65)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729980780), received between Jun 17, 2021 and Apr 21, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break2
- Failure to Advance1
Patient problems
- Anxiety1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2023Break; Failure to Advance; Break; Failure to Advance
IT WAS REPORTED THAT SHAFT BREAK AND VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE IN HALF. THE PHYSICIAN REMOVED THE PIECES FROM CATHETER, AND DISSECTION WAS ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. DURING ADVANCEMENT OF THE STENT THROUGH A 6F GUIDE CATHETER, THE SHAFT BROKE AT THE HEMOSTASIS VALVE. THE PROCEDURE WAS COMPLETED WITH NON-BOSTON SCIENTIFIC DEVICE AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: Vascular Dissection
MAUDE report 16786859 ↗InjuryJun 17, 2021Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND THE PATIENT EXPERIENCED ANXIETY. A 2.50 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER CRACKED/FRACTURED. THE DEVICE WAS REMOVED BY PULLING OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED ANXIETY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT HAS FULLY RECOVERED.
Patient problems: Anxiety
MAUDE report 12021600 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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