SYNERGY™ H7493926028450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729973386), received between Apr 21, 2020 and Oct 26, 2021 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  EVOLVE_LV_XLV CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2019, THE SUBJECT INDEX PROCEDURE WAS PERFORMED AND QUALIFYING CONDITION WAS UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE SUBJECT WAS ENROLLED IN THE 4.5/5.0 COHORT OF THE EVOLVE LV XLV STUDY. TARGET LESION 1 WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 24 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 28 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ADDITIONALLY, NON-TARGET LESION WAS ALSO TREATED. THE NON-TARGET LESION 1 WAS LOCATED IN RIGHT-POSTERIOR DESCENDING ARTERY (R-PDA) WAS TREATED WITH PLACEMENT OF 3.00 MM X 28 MM AND 2.25 MM X 32 MM SYNERGY STENTS. ON THE SAME DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, POST INDEX PROCEDURE, SUBJECT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN, AND NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT. IT IS UNKNOWN WHETHER AUTOPSY WAS PERFORMED OR NOT. IT WAS FURTHER REPORTED THAT PRIMARY CAUSED OF DEATH WAS ANOXIC BRAIN INJURY. FURTHERMORE, IT WAS REPORTED THAT THE PHYSICIAN CONSIDERED

  Patient problems: Anemia; Cardiac Arrest; Chest Pain; Fever; Ischemia; Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Respiratory Failure; Restenosis; Thrombosis/Thrombus

  MAUDE report 12699323 ↗
• 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 B

  Patient problems: Cardiac Arrest

  MAUDE report 11328637 ↗
• MalfunctionJan 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. 4.50 X 28MM AND 4.50 X 24MM SYNERGY II DRUG-ELUTING STENTS WERE UNABLE TO PASS THROUGH A 6F GUIDEZILLA GUIDE CATHETER AND WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11235546 ↗
• InjuryApr 21, 2020Adverse 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 MYOCARDIAL INFARCTION AND UNSTABLE ANGINA OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED THE TARGET LESION #1 WAS LOCATED IN SAPHENOUS VEIN GRAFT (SVG) EXTENDING FROM SVG TO 2ND MARGINAL WITH 95% STENOSIS AND WAS 50 MM LONG WITH A DISTAL VESSEL DIAMETER OF 4.5 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF 4.5 MM X 32 MM AND 4.5 MM X 28 MM SYNERGY DRUG-ELUTING STENTS. POST PROCEDURE, RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2020, SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH COMPLAINTS OF LEFT SIDED CHEST PAIN RADIATING TO LEFT ARM THAT BEGAN AT 4AM IN THE MORNING AND WOKE HIM UP FROM SLEEP. SUBJECT HAD SOME SHORTNESS OF BREATH, HOWEVER DENIED NAUSEA, VOMITING, DIAPHORESIS, ORTHOPNEA, EDEMA AND DIFFICULTY BREATHING. SUBJECT TOOK 2 BABY ASPIRINS THAT BROUGHT RELIEF PRIOR TO ARRIVAL TO ED. SUBJECT ALSO ENDORSED SEVERAL MONTHS OF DRY COUGH, HOWEVER NO NEW COUGH OR FEVERS. HE RECEIVED NITROGLYCERINE IN THE ED THAT HELPED WITH

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 9982726 ↗