SYNERGY™ H7493926028270Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729840282), received between Jan 26, 2017 and Nov 24, 2021 — classified as 3 deaths, 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Bent” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.75 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WENT IN TO THE BODY AND UP THROUGH THE GUIDE CATHETER. HOWEVER, DURING INTRODUCTION, THE PHYSICIAN REALIZED THAT SOMETHING WAS WRONG WITH IT. UPON REMOVAL, THE PHYSICIAN NOTICED THE FRAYED STENT STRUTS. IT WAS NOTED THAT THE STENT NEVER MADE IT TO THE LESION AND WAS NEVER DEPLOYED. THE PROCEDURE WAS COMPLETED USING ALTERNATE METHOD OR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867495 ↗
• MalfunctionMay 1, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT FAILED TO CROSS THE LESION AND THE RAILING BROKE. THE PHYSICIAN ATTEMPTED TO CROSS THE SECOND STENT, A 2.50 X 12 SYNERGY DRUG-ELUTING STENT; HOWEVER, THE PHYSICIAN STOPPED THE PROCEDURE WHEN HE NOTICED THAT THE RAILING WAS GOING TO BREAK AGAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10017488 ↗
• MalfunctionDec 4, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-NOV-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410378 ↗
• MalfunctionJul 9, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JUN2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION AS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75X28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773381 ↗
• MalfunctionMar 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX ARTERY. A 2.75 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS UNABLE TO GET THROUGH THE WATCHDOG HEMOSTASIS VALVE AND WHEN THE DEVICE WAS REMOVED, THE STENT WAS NOT MOUNTED ON THE BALLOON. THE DEPLOYMENT SYSTEM WAS REMOVED THROUGH WATCHDOG WITH THE STENT STILL ON DEPLOYMENT SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429460 ↗
• DeathMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT CARDIOGENIC SHOCK AND DEATH OCCURRED. IN (B)(6) 2016, DUE TO A CLINICAL STATUS ASSESSMENT INDICATING THE QUALIFYING CONDITION OF UNSTABLE ANGINA, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS 95% STENOSED, 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS TREATED WITH PRE DILATATION AND PLACEMENT OF A 2.75 X 28 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT WAS DIAGNOSED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION CONSIDERED NOT RELATED TO THE DEVICE. AS THERE WERE NO ACUTE WALL MOTION ABNORMALITIES IN THE DISTRIBUTION OF THE PREVIOUSLY PLACED BYPASS GRAFTS, THE PHYSICIAN DEEMED THAT NO CORONARY ANGIOGRAPHY WAS REQUIRED. TWO DAYS LATER, THE EJECTION FRACTION WAS IMPROVED FROM 30% TO 50% AND WALL MOTION ABNORMALITY WAS CONSISTENT WITH OBSTRUCTION OF THE POSTERIOR CIRCUMFLEX ARTERY PER ANALYSIS. THE PATIENT HAD A CHANGE IN MEDICATION DOSE OF ISOSORBIDE MONONITRATE ALONG WITH REDUCTION OF DOSE IN AMLODIPINE DURING THE HOSPITAL COURSE. THE PATIENT WAS DISCHARG

  Patient problems: Cardiogenic Shock; Death

  MAUDE report 8417572 ↗
• MalfunctionDec 19, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN NEGATIVE PRESSURE WAS APPLIED WITH THE INDEFLATOR, IT WAS NOTED IN THE HUB OF THE DELIVERY CATHETER AS WELL AS IN THE INDEFLATOR TUBING, THAT THE BALLOON RUPTURED. THE PHYSICIAN WAS UNABLE TO PULL THE STENT BACK INTO THE GUIDE, SO THE WIRE, STENT DELIVERY CATHETER, AND GUIDE WERE REMOVED. ANOTHER 2.75X28MM SYNERGY STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179042 ↗
• MalfunctionDec 13, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 2.75 X 28MM SYNERGY II DRUG ELUTING STENT, IT WAS NOTED THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8163240 ↗
• InjuryJul 27, 2018Obstruction of Flow; Obstruction of Flow

  (B)(6). IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2016, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. TARGET LESION #1WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 28 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2017, THE PATIENT WAS ADMITTED DUE TO WORSENING CONGESTIVE HEART FAILURE, CONSIDERED NOT RELATED TO THE STUDY DEVICE, AND TREATED WITH MEDICATIONS. STRESS TEST SHOWED NO ISCHEMIA. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT AGAIN PRESENTED TO EMERGENCY ROOM DUE TO ACCELERATING ANGINA PECTORIS FOR THE LAST FEW WEEKS ON A DAILY BASIS AND WITH ANY ACTIVITY. THE PATIENT WAS NOTED TO HAVE ELEVATED TROPONIN WITH WORSENING CHEST PAIN, AND ATRIAL FIBRILLATION WITH FAST VENTRICULAR RESPONSE. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. ON ADMISSION, CARDIAC EXAMINATIONS REVEALED SHORTNESS O

  Patient problems: Myocardial Infarction; Reocclusion

  MAUDE report 7726693 ↗
• MalfunctionJun 22, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 2.75X28MM SYNERGY II STENT, IT WAS NOTICED THAT THE STENT WAS DAMAGED. IT LOOKED LIKE IT WAS BENT AND HAD SOMETHING ON IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Patient Involvement

  MAUDE report 7631901 ↗
• MalfunctionFeb 28, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  SAME CASE AS MDR ID: 2134265-2018-01404. IT WAS REPORTED THAT THE RO MARKER BAND COULD NOT BE VISUALIZED DURING DEPLOYMENT. THE 80% TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATATION, A 2.75 X 28MM SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, DURING DEPLOYMENT, THE STENT COULD NOT BE VISUALIZED. AFTER THAT A 2.75 X 38MM SYNERGY II STENT WAS ADVANCED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED DURING DEPLOYMENT. THE PHYSICIAN DOUBLE CHECKED EVERYTHING AND THE STENT STILL COULD NOT BE VISUALIZED. A THIRD STENT WAS THEN DEPLOYED WITHOUT ANY PROBLEMS WITH VISUALIZING AND THE PROCEDURE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303951 ↗
• MalfunctionDec 14, 2017Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.75X28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE BALLOON RUPTURED AND IT GOT CAUGHT ON THE STENT STRUT. THE DEVICE WAS PULLED OUT AS A WHOLE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7119319 ↗
• MalfunctionSep 21, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW BALLOON DEFLATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 28 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN WENT UP ON THE STENT DELIVERY BALLOON, THERE WAS JUST FLOW COMING DOWN. THE BALLOON WAS SLOW TO DEFLATE AND IT WAS STUCK IN THE STENT FOR A MINUTE. THE STENT DELIVERY BALLOON EVENTUALLY DEFLATED IN LESS THAN A MINUTE AND WAS REMOVED INTACT FROM THE PATIENT'S BODY IN A DEFLATED STATE. THE PATIENT DID NOT HAVE ANY SYMPTOMS WHILE THE STENT DELIVERY BALLOON REMAINED INFLATED. POST-DILATATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. THE PRECEPTOR FELT THE CONTRAST RATIO MAY HAVE BEEN TOO HIGH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6883924 ↗
• DeathJul 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITIONS AS UNSTABLE ANGINA AND SILENT ISCHEMIA AND WAS FURTHER REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% STENOSIS AND WAS 20.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM.. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 28 MM SYNERGYII STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. SIX DAYS AFTER, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN JUNE 2017, THE PATIENT EXPIRED IN HOSPICE CARE WITH UNKNOWN CAUSE.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Death; Dyspnea; Fatigue

  MAUDE report 6735239 ↗
• MalfunctionMay 23, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.75 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE PHYSICIAN NOTICED THAT THE STENT LOOKED FUNNY UNDER FLUOROSCOPY. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE STENT STRUTS WERE NOTED TO BE FRAYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6585822 ↗
• MalfunctionJan 31, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX). AFTER PRE-DILATATION WAS PERFORMED, A 2.75 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE STENT STRUTS WERE NOTED TO BE DAMAGED AND CRUMPLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75 X 28 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6291746 ↗
• DeathJan 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR IDS: 2134265-2017-00288, 2134265-2017-00290, 2134265-2017-00291. IT WAS REPORTED THAT VESSEL PERFORATION, VENTRICULAR FIBRILLATION, SLOW FLOW AND PATIENT'S DEATH OCCURRED. THIS WAS A VERY HIGH RISK PROCEDURE ON A VERY COMPROMISED PATIENT. THE TARGET LESION WAS LOCATED IN THE CALCIFIED PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOUR SYNERGY II DRUG-ELUTING STENTS OF SIZE 3.00X16MM, 2.75X28MM, 2.5X24MM, AND 2.25X20MM WERE IMPLANTED FROM PROXIMAL TO DISTAL LESION IN ORDER. AFTER THE DEPLOYMENT OF THE LAST 2.25X20MM STENT, THE PHYSICIAN PULLED THE BALLOON BACK APPROXIMATELY 10-15MM AND RE-INFLATED THE BALLOON APPROXIMATELY AT 26 ATMOSPHERES. HOWEVER, ON THE NEXT INJECTION, A LARGE PERFORATION WAS NOTED IN LAD. THE PATIENT'S CONDITION WAS CONTINUOUSLY GETTING WORSE AS THE PHYSICIAN ATTEMPTED TO SEAL THE PERFORATION AND DO A SIMULTANEOUS PERICARDIAL TAP. EVENTUALLY, THE PHYSICIAN WAS ABLE TO PERFORM THE TAP AND DEPLOYED A 2.80X26MM NON-BSC STENT. SUBSEQUENTLY, THE PATIENT'S CONDITION CONTINUED TO WORSEN. THE PATIENT HAD MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION ARREST AND HAD LIMITED FLOW IN THE CORONARY ARTERIES. MULTIPLE EFFORTS WERE MADE TO RESCUE T

  Patient problems: Death; Obstruction/Occlusion; Perforation of Vessels; Ventricular Fibrillation

  MAUDE report 6278666 ↗