SYNERGY™ XD H7493941828450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729981220), received between May 11, 2021 and Oct 2, 2023 — classified as 1 injury, 2 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. FOLLOWING PRE-DILATATION USING A 4.50 X 20 NC QUANTUM APEX AND A 3.50 X 12 EMERGE BALLOON CATHETERS, A 4.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE LESION AND THE SHAFT SNAPPED NEAR THE PROXIMAL HUB. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857829 ↗
• MalfunctionNov 28, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED THROUGH A NON-BOSTON SCIENTIFIC GUIDE CATHETER. HOWEVER, DURING INTRODUCTION, ADVANCING DIFFICULTY WAS ENCOUNTERED AND THE DEVICE BROKE MID-SHAFT. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY XD DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869211 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. THE GREATER THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING DEPLOYMENT OF A 28MM X 4.50MM SYNERGY XD DRUG-ELUTING STENT AND POST DILATION WITH A 20MM X 5.00MM NC QUANTUM APEX BALLOON CATHETER, A VESSEL PERFORATION WAS NOTED IN THE LAD. THE PERFORATION WAS COVERED WITH A STENT AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Perforation

  MAUDE report 11810297 ↗