SYNERGY™ H7493926020450Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729973362), received between May 21, 2019 and Nov 26, 2024 — classified as 2 deaths, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.50MM X 20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE STENT SYSTEM BROKE IN HALF. THE PHYSICIAN TOOK THE STENT OUT AND GOT A DIFFERENT ONE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785325 ↗
• DeathFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2020, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. TARGET LESION 1 WAS LOCATED IN LEFT MAIN CORONARY ARTERY (LMCA) WITH 85 % STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.50 MM X 20 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0 % WITH TIMI FLOW 3. ON THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, POST INDEX PROCEDURE, SUBJECT EXPIRED DUE TO SUDDEN CARDIAC DEATH AND IN RESPONSE TO THE EVENT NO ACTION WAS TAKEN AND AUTOPSY WAS NOT PERFORMED.

  Patient problems: Cardiac Arrest

  MAUDE report 13471886 ↗
• DeathFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE 4.5-5.0 CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT DIED. IN (B)(6) 2020, CLINICAL STATUS ASSESSMENT INDICATED THAT THE SUBJECT QUALIFYING CONDITION WAS MULTIVESSEL DISEASE. PRIOR TO THE PROCEDURE, THE SUBJECT WAS FOUND TO HAVE INDICATION OF MYOCARDIAL INFARCTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT WITH 95% STENOSIS AND WAS 48 MM LONG WITH REFERENCE VESSEL DIAMETER OF 4.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 4.50 MM X 28 MM AND 4.50 MM X 20 MM STUDY STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ON THE NEXT DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, THE SUBJECT EXPERIENCED CARDIAC ARREST AND WAS HOSPITALIZED ON THE SAME DAY. THE FOLLOWING DAY, THE SUBJECT WAS PRONOUNCED DEAD. IT WAS FURTHER REPORTED THAT PER THE PARAMEDICS, THE SUBJECT WAS BREATHING WITH A PALPABLE PULSE ON THEIR ARRIVAL. HOWEVER, SUDDENLY THE SUBJECT BECAME UNRESPONSIVE WITH LOSS OF PULSE AND APNEA. THE SUBJECT WAS GIVEN WITH 5 ADMINISTRATIONS OF INTRAVENOUS EPINEPHRINE PRIOR TO ARRIVAL AT THE EMERGENCY DEPARTMENT. ON ARRIVAL, THERE WAS A PALPABLE PULSE

  Patient problems: Cardiac Arrest

  MAUDE report 11328641 ↗
• MalfunctionFeb 20, 2020Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JAN2020. IT WAS REPORTED THAT THE SHAFT BROKE IN A PORTION THAT COULD NOT ENTER THE PATIENT'S BODY. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER PLACING A 6FR EBU 3.5 NON-BSC GUIDE CATHETER AND A NON-BSC WIRE IN THE PROXIMAL LAD, A 4.50X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT A MODERATE THROMBUS BUT THE SHAFT SNAPPED AT THE HUB. THE DEVICE WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-BSC WIRE AND ANOTHER 4.5X20MM SYNERGY STENT OF SAME. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING GREAT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732964 ↗
• MalfunctionSep 18, 2019Break; Break

  IT WAS REPORTED THAT STENT BROKE INSIDE THE GUIDELINER. A 5.00 X 24 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS DEFORMED INSIDE THE GUIDELINER AND WOULD NOT EXIT. A 4.50 X 20 SYNERGY DES WAS THEN ADVANCED, BUT IT ALSO FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT BROKE INSIDE THE GUIDELINER. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9083541 ↗
• MalfunctionMay 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. DURING UNPACKING OF A 4.50 X 20 SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT HAD SHIFTED ON THE DELIVERY CATHETER. THE CATHETER NEVER ENTERED THE PATIENT'S BODY AND THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8629678 ↗
• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. A 4.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. UPON INSERTION, IT WAS NOTED THAT THE PHYSICIAN KINKED THE CATHETER SHAFT SLIGHTLY BUT PROCEEDED TO INSERT THE DEVICE. HOWEVER, THE HYPOTUBE FRACTURED AND SEPARATED ITSELF FROM THE PROXIMAL PORTION OF THE CATHETER. THE DEVICE WAS COMPLETELY REMOVED VIA THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627313 ↗