SYNERGY™ XD H7493941832220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729980766), received between Apr 16, 2021 and Feb 7, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON OCCURRED. A 2.25 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO PROCEDURE, IT WAS NOTICED THAT THE STENT ITSELF APPEARED TO BE DAMAGED AND NOT SEATED ON THE BALLOON. THE STENT DELIVERY SHAFT WAS NOTED TO BE BENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE STENT OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315821 ↗
• InjuryDec 1, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A 2.25X32 SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT BROKE NEAR THE HUB THAT RESULTED IN DISSECTION OF VESSEL WITHOUT SYMPTOMS OR LOSS OF FLOW. THE PATIENT WAS THEN ADMITTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 15896479 ↗
• InjuryJan 6, 2022Leak/Splash; Difficult to Remove; Material Deformation; Activation Failure; Leak/Splash; Difficult to Remove; Material Deformation; Activation Failure

  IT WAS REPORTED THAT INSUFFICIENT APPOSITION, REMOVAL DIFFICULTY, VESSEL PERFORATION, ACUTE THROMBOSIS, AND MYOCARDIAL INFARCTION WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED DISTAL CIRCUMFLEX ARTERY. A 2.25 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON INFLATION, THE STENT BALLOON WAS ONLY ABLE TO INFLATE TO 3 ATMOSPHERES BEFORE LOSING PRESSURE WHICH RESULTED IN A PARTIALLY DEPLOYED STENT. THE PHYSICIAN TRIED TO REMOVE THE BALLOON BUT IT WAS STUCK. HE PULLED BACK THE BALLOON HARDER WHICH FREED THE BALLOON BUT IT CAUSED THE WIRE TO JUMP FORWARD RESULTING IN A PERFORATION OF THE ARTERY. THE DEVICE WAS REMOVED INTACT AND A HYPOTUBE KINK WAS NOTED. ATRIAL FIBRILLATION AND SUBSEQUENT THROMBOSIS WERE ENCOUNTERED AND THE PATIENT EXPERIENCED ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE PATIENT'S ARTERY WAS COILED OFF TO TREAT THE PERFORATION. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS POST-PROCEDURE WAS STABLE.

  Patient problems: Myocardial Infarction; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 13180339 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING. THE 2.25 X 32 MM SYNERGY XD DRUG-ELUTING STENT WAS USED FOR TREATMENT. HOWEVER, DURING INSERTION, THE PROXIMAL EDGE OF THE STENT WAS KINKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 2.25 X 32 MM SYNERGY XD DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682436 ↗