SYNERGY™ H7493926032270Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729840343), received between Dec 16, 2016 and Oct 28, 2020 — classified as 1 death, 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CHEST PAIN AND STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION AND A 2.75 X 32 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING INTERVENTION, THE PATIENT WAS SENT TO THEIR ROOM. HOWEVER, THE FOLLOWING DAY, PATIENT HAD CHEST PAIN AND STENT THROMBOSIS WAS OBSERVED IN THE MID LAD. THE VESSEL WAS DILATED USING A 3.0 X 12MM NON-COMPLIANT BALLOON CATHETER AND INTRAVENOUS ULTRASOUND WAS PERFORMED WITH NO DISSECTION NOTCED AND WITH TIMI 3 FLOW. A BALLOON PUMP WAS INSERTED AND THE PATIENT WAS SENT TO BYPASS SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 10750606 ↗
• MalfunctionAug 3, 2020Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-JUL-2020. IT WAS REPORTED THAT FAILURE TO CROSS LESION OCCURRED. A 2.75 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE THE STENT DID NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10357036 ↗
• InjuryDec 17, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS, MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, AND CARDIAC ARREST OCCURRED. THE MULTIVESSEL PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH MULTIPLE STENOSIS TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, FIRST DIAGONAL BRANCH (D1) AND SECOND OBTUSE MARGINAL BRANCH (OM2). A PCI WAS PERFORMED ON THE 80% STENOSED, 20MM LONG, TARGET LESION BETWEEN THE PROXIMAL LAD TO MID LAD. A NON-BSC WIRE PASSED THROUGH THE LESION, ANGIOPLASTY WAS PERFORMED USING A 2.25MM X 15MM NC EMERGE BALLOON CATHETER AT 14 ATMOSPHERES FOR 15 SECONDS. HOWEVER, THE BALLOON RUPTURED AND GOT SEPARATED. THE PHYSICIAN DEPLOYED THE 2.75MM X 32MM SYNERGY DRUG-ELUTING STENT TO THE AFFECTED AREA. POST-STENT ANGIOPLASTY WAS PERFORMED USING A 3.00MM X 15MM NC EMERGE AT 18 ATMOSPHERES FOR 10 SECONDS, BUT THE BALLOON GOT STUCK ON THE WIRE. ANOTHER NON-BSC BALLOON WAS USED FOR ANGIOPLASTY. THE STENT BECAME THROMBOSED AND WAS TREATED WITH ANGIOPLASTY AND A 2.5MM X 28MM SYNERGY DRUG-ELUTING STENT DEPLOYED TO OVERLAP THE FIRST PLACED STENT. ANGIOPLASTY WAS PERFORMED USING A NON-BSC BALLOON. THERE WAS A 0% RESIDUAL STENOSIS POST INTERVENTION. A PCI WAS PERFORMED ON THE 90% STENOSED TAR

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Myocardial Infarction; Thrombosis

  MAUDE report 9484211 ↗
• InjuryDec 11, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE POST DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.75 X 32 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, THE STENT BALLOON DID NOT COME DOWN ALL THE WAY AND WHEN TRIED TO REMOVE THE BALLOON, IT SUCKED THE GUIDE CATHETER DAMAGING THE FRESHLY DEPLOYED SYNERGY STENT. THE STENT ACCORDIONED AND SHORTENED IN THE OSTIUM. ANOTHER STENT WAS PLACED ON THE PROXIMAL AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451414 ↗
• DeathJun 4, 2019Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2018, THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION # 1 WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00 X 38 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE TARGET LESION # 2 WAS A LONG LESION EXTENDING FROM PROXIMAL RIGHT CORONARY ARTERY (RCA) TO MID RCA WITH 80% STENOSIS AND WAS 56 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF 2.75 X 38 MM AND 2.75 X 32 MM STUDY STENTS. FOLLOWING POST DILATATION, RESIDUA STENOSIS WAS 0% WITH TIMI 3 FLOW. POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2019, THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM VIA EMERGENCY MEDICAL SERVICES. THE PATIENT WAS FOUND TO BE UNRESPONSIVE, PULSELESS AND APNEIC. THE PATIENT WAS ALSO NOTED TO HAVE SHORTNESS OF BREATH. ON ARRIVAL TO EMERGENCY DEPARTMENT, ELECTROCARDIOGRAM

  Patient problems: Cardiopulmonary Arrest; Death; Thrombosis

  MAUDE report 8668990 ↗
• InjuryMay 21, 2019Obstruction of Flow; Activation Failure; Obstruction of Flow; Activation Failure

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT INSUFFICIENT STENT APPOSITION AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2018, THE PATIENT PRESENTED WITH STABLE ANGINA. THE INDEX PROCEDURE WAS PERFORMED THE SAME DAY. TARGET LESION WAS IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO DISTAL RCA WITH 95% STENOSIS AND WAS 70 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 38 MM AND 2.75 X 32 MM SYNERGY STENTS FOLLOWED BY POST-DILATATION WITH 0% RESIDUAL STENOSIS. ON THE SAME DAY, OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND REVEALED STENT MALPOSITION IN FOCAL AREAS THROUGHOUT THE STENT WHICH WAS ADDITIONALLY POST DILATED WITH A 3.25 NC BALLOON DISTALLY AND WITH A 3.5 MM NC BALLOON PROXIMALLY. FINAL OCT ANGIOGRAM REVEALED WELL OPPOSED STENT AND NO RESIDUAL STENOSIS WITH TIMI 3 FLOW. IN (B)(6) 2018, THE PATIENT PRESENTED WITH COMPLAINTS OF RECURRENT EXERTIONAL CHEST PAIN WHICH RESOLVED WITH REST BUT REQUIRED NITROGLYCERIN OCCASIONALLY. THE SYMPTOMS INCREASED IN THE PAST THREE MONTHS. THE PATIENT ALSO COMPLAINED OF CHEST PRESSURE AND SHORTNESS OF BREATH WITH EXERCISE. TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWE

  Patient problems: Chest Pain; Dyspnea; Heart Failure; Reocclusion

  MAUDE report 8628722 ↗
• MalfunctionAug 22, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811409 ↗
• MalfunctionMar 3, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 32 SYNERGY II DRUG ELUTING STENT (DES) WAS SELECTED TO TREAT THE LESION. HOWEVER, UPON REMOVAL OF THE STENT PROTECTOR, THE STENT WAS STRETCHED OFF THE BALLOON. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6377871 ↗
• InjuryJan 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A.2.75X32MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE GUIDE EXTENSION CATHETER, THE STENT SHEARED OFF FROM THE DELIVERY BALLOON AND WAS DISLODGED IN THE LAD. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A BALLOON CATHETER AND BALLOONED THE DISLODGED STENT FLOATING ON THE EXISTING WIRE THEN DEPLOYED THE STENT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DOING FINE AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6225175 ↗
• MalfunctionDec 16, 2016Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 32 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE STENT STRUT WAS NOTED TO BE MALFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6182491 ↗