SYNERGY™ H7493926008400Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729840015), received between Apr 6, 2017 and Feb 18, 2021 — classified as 1 death, 5 injuries, 7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2021Obstruction of Flow; Obstruction of Flow

  S2357 EVOLVE 4.5-5.0 CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA AND IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2020, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CAUTERIZATION. THE INDEX PROCEDURE WAS PERFORMED THAT SAME DAY. THE FIRST TARGET LESION WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 4.50 MM X 32 MM SYNERGY DRUG ELUTING STENT (DES) WITH NO RESIDUAL STENOSIS. A NON-TARGET LESION LOCATED IN OBTUSE MARGINAL (OM1) AND WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 20 MM SYNERGY DES AND WITH CUTTING BALLOON. THE SECOND NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX EXTENDING TO 1ST OB MARG AND WAS TREATED WITH THE PLACEMENT OF 3.50 MM X 32 MM OF SYNERGY DES. THE THIRD NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 32 MM SYNERGY DES. THE FOURTH NON-TARGET LESION WAS LOCATED IN DISTAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 8.00 MM SYNERGY DES. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2021, SUBJECT WA

  Patient problems: Angina; Myocardial Infarction; Restenosis

  MAUDE report 11343799 ↗
• InjuryNov 9, 2020Obstruction of Flow; Obstruction of Flow

  S2357 EVOLVE 4.5-5.0 CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED CHEST PAIN, MYOCARDIAL INFARCTION, CARDIAC ENZYME ELEVATION AND STENT THROMBOSIS OCCURRED. IN NOVEMBER 2019, THE PATIENT PRESENTED WITH AN EJECTION FRACTION OF 55%. FORTY ONE DAYS AFTER, INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENT WITH ANGINA AND WAS REFERRED FOR CARDIAC CATHERIZATION TARGET LESION #1 WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF 4.5 MM X 32 MM STUDY STENT FOLLOWING WHICH RESIDUAL STENOSIS WAS NOTED TO BE 0%. NON-TARGET LESION #1 WAS LOCATED IN OBTUSE MARGINAL (OM1) AND WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 20MM SYNERGY DRUG-ELUTING STENT (DES). NON-TARGET LESION #2 WAS LOCATED IN PROXIMAL LCX EXTENDING TO OM1 AND WAS TREATED WITH THE PLACEMENT OF 3.50 MM X 32 MM OF SYNERGY DES. NON-TARGET LESION #3 WAS LOCATED IN PROXIMAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 32MM SYNERGY DES. NON-TARGET LESION #4 WAS LOCATED IN DISTAL LCX (SAME AS THAT OF TARGET LESION) AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 8.00MM SYNERGY DES. TH

  Patient problems: Atrial Flutter; Cardiac Enzyme Elevation; Chest Pain; Myocardial Infarction; Thrombosis

  MAUDE report 10809867 ↗
• MalfunctionNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 8 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THE STENT CAME OFF THE DELIVERY SYSTEM AND WAS NOT FOUND UNDER FLUOROSCOPY. WHEN THE GUIDE CATHETER AND SHEATH WAS PULLED OUT, THE STENT WAS FOUND AND RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9355602 ↗
• MalfunctionJun 4, 2019Activation Failure; Migration; Activation Failure; Migration

  IT WAS REPORTED THAT STENT INADEQUATE APPOSITION AND STENT MIGRATION OCCURRED. THE 69% STENOSED TARGET LESION WITH A 5.5-5.6MM VESSEL DIAMETER WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA). FOLLOWING INTRAVASCULAR ULTRASOUND (IVUS), A 4.00MM X 8MM SYNERGY DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. POST-DILATATION WAS PERFORMED WITH A 5.5X8.0 NC EMERGE BALLOON CATHETER. TO CHECK STENT EXPANSION, IVUS WAS PERFORMED WHICH REVEALED THAT THE STENT NEEDED ADDITIONAL POST-DILATATION. AFTER IVUS REMOVAL, THE STENT DISLODGED AND WAS LAST SEEN IN THE ASCENDING AORTA. THE STENT WAS NOT FOUND UNDER FLUOROSCOPY AND WAS NOT RETRIEVED. IT WAS CONFIRMED THE STENT WAS NOT IN THE CAROTIDS OR LEFT VENTRICLE. A SECOND STENT WAS SUCCESSFULLY DEPLOYED IN THE LMCA AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668024 ↗
• DeathOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. CORONARY ANGIOGRAPHY WAS PERFORMED OF THE LEFT CORONARY ARTERY AND RIGHT CORONARY ARTERY. LEFT VENTRICULOGRAPHY WAS PERFORMED OF THE LEFT VENTRICLE. AT THIS POINT, THE PATIENT WAS MADE READY FOR PERCUTANEOUS CORONARY INTERVENTION TO THE OSTIAL LEFT CIRCUMFLEX (LCX) AND POSSIBLE TO THE LESION MORE DISTAL IN THE 1ST OBTUSE MARGINAL (OM1). THESE LESIONS WERE HEAVILY CALCIFIED. BALLOON ANGIOPLASTY OF THE SECOND OM AND IMPROVED THE CHANNEL TO THE OM1. BALLOON ANGIOPLASTY WAS THEN PERFORMED OF THE OM1. ANGIOGRAPHY DEMONSTRATED 70-80% RESIDUAL STENOSIS WITH NO DISSECTION AND COMPLETE TIMI-3 FLOW DISTALLY. ADDITIONAL BALLOON ANGIOPLASTY WAS THEN PERFORMED OF THE OM1, RESULTING IN 60-70% RESIDUAL STENOSIS WITH NO DISSECTION AND COMPLETE TIMI-3 FLOW DISTALLY. ADDITIONAL DILATION PERFORMED ON THE DISTAL OM STENOSIS. THE BALLOON CATHETER WAS DEFLATED AND REMOVED. A 2.50X8MM SYNERGY STENT WAS THEN ADVANCED TO THE OSTIAL CIRCUMFLEX LESION AND COULD NOT BE ADVANCED FURTHER. THE STENT WAS DEPLOYED IN THE OSTIAL CIRCUMFLEX. FINAL ANGIOGRAPHY OF THE OSTIAL CIRCUMFLEX SHOWED EXCELLENT APPEARANCE OF

  Patient problems: Death

  MAUDE report 8006123 ↗
• InjuryMar 27, 2018Migration or Expulsion of Device; Device Or Device Fragments Location Unknown; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Migration or Expulsion of Device; Device Or Device Fragments Location Unknown; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  IT WAS REPORTED THAT DEPLOYMENT ISSUES AND STENT MIGRATION OCCURRED. THE CHRONIC TOTALLY OCCLUDED (CTO) TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). AN 8F GUIDE CATHETER WAS USED IN THE RCA VIA A RIGHT FEMORAL SHEATH, A 7F GUIDE CATHETER WAS USED FOR THE LEFT CORONARY SYSTEM VIA A LEFT RADIAL SHEATH, AND A 185 CM GUIDE WIRE WAS ADVANCED INTO THE RCA TO THE PROXIMAL CAP OF THE CTO. IT WAS DECIDED TO STENT THE OSTIAL/PROXIMAL RCA WITH A 4.00 X 8 MM SYNERGY II DRUG-ELUTING STENT PRIOR TO ATTEMPTING THE DISTAL RCA CTO. THE STENT WAS DEPLOYED AT 16 ATMOSPHERES FOR 18 SECONDS AND THE GUIDE WAS DISENGAGED FOR THE DEPLOYMENT OF THE STENT. WHILE ATTEMPTING TO ENGAGE THE GUIDE BACK IN THE RCA, IT WAS NOTED THAT THE STENT WAS ENTANGLED WITH THE 8F GUIDE CATHETER. THE GUIDE CATHETER WAS THROUGH A STENT STRUT AND THE STENT WAS HUGGING THE GUIDE. THE PHYSICIAN THOUGHT THE STENT HAD WATERMELON SEEDED BACK INTO THE AORTA DURING DEPLOYMENT AND GOT CAUGHT UP IN THE GUIDE CATHETER DURING THE ATTEMPT TO RE-ENGAGE THE RCA. THE 7F GUIDE CATHETER WAS EXCHANGED FOR ANOTHER AND A 30 MM SNARE WAS INSERTED VIA THE NEW 7F GUIDE CATHETER. AFTER MULTIPLE SNARING ATTEMPTS OF THE 8F GUIDE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7373515 ↗
• MalfunctionMar 22, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT STRUTS WERE COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362412 ↗
• MalfunctionFeb 12, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS INTRODUCED ABOUT THREE-FOURTH INTO THE GUIDE, THE SHAFT OF THE CATHETER BROKE. THE BROKEN DEVICE TOGETHER WITH THE WIRE AND GUIDE WAS THEN PULLED OUT AT ONCE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7263204 ↗
• MalfunctionNov 30, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED DISTAL LEFT MAIN ARTERY. AFTER PREDILATION, A 4.00X8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTICED THAT THE STENT STRUTS WERE BENT UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070846 ↗
• MalfunctionSep 25, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATE TO SEVERELY CALCIFIED LEFT MAIN ARTERY. A 4.00 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON INFLATING THE STENT BALLOON, THE STENT SLID BACK OFF THE BALLOON ONTO THE BALLOON SHAFT. THE PHYSICIAN DID NOT NOTICE UNTIL THE DEVICE WAS REMOVED OUT OF THE PATIENT'S BODY THAT THE STENT WAS ON THE BALLOON SHAFT. A 4.0 X 8 PROMUS PREMIER DRUG-ELUTING STENT WAS THEN ADVANCED AND WAS SUCCESSFULLY DEPLOYED IN THE LEFT MAIN AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6890750 ↗
• InjurySep 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION IS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 4.00 X16 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN THE DISTAL RCA TO TREAT THE LESION. THE LESION REQUIRED A SHORTER STENT TO BE PLACED MORE PROXIMAL, SO A 4.00 X 8 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED JUST PROXIMAL TO THE 4.00 X 16MM STENT. UPON INFLATION, EVERYTHING SEEMED TO BE IN APPROPRIATE POSITION AND AGAIN A CINE SHOT WAS TAKEN; HOWEVER, IT WAS RECOGNIZED THAT THE 4.00 X 8 STENT HAD MIGRATED PROXIMALLY BY ABOUT 15MM. SO ANOTHER 4.00 X16 SYNERGY DRUG-ELUTING STENT WAS DELIVERED TO COVER THE DISTANCE BETWEEN THE FIRST STENT AND THE SECOND STENT; HOWEVER, UPON DELIVERY THROUGH THE 4.00 X 8MM SYNERGY STENT, IT CAUGHT THAT STENT AND PUSHED IT DOWN ADJACENT TO THE ORIGINAL 4.00 X 16 SYNERGY STENT. THE PHYSICIAN THEN CHOSE TO TAKE A HIGH PRESSURE BALLOON, A 4.5 X 20 APEX NON-COMPLIANT AND POST DILATED BOTH THE 4.00 X 16MM AND THE 4.00 X 8MM SYNERGY STENTS IN THOSE EXACT POSITIONS AND THAT COMPLETED THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS SAFE AND SOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6878239 ↗
• InjuryAug 18, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THERE WERE TWO TARGET LESION. THEY WERE LOCATED IN AN ANOMALOUS CIRCUMFLEX ARTERY AND IN THE OSTIAL RIGHT CORONARY ARTERY (RCA). ANGIOPLASTY WAS PERFORMED AND A STENT WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX ARTERY. HOWEVER, A DISSECTION WAS NOTICED THAT PROPAGATED BACK TO THE OSTIAL RCA. TO TREAT THE DISSECTION, A 4.00 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED, HOWEVER, THE STENT WAS DISLODGED AND BECAME LODGED IN THE INTERNAL ILIAC ARTERY. THE PHYSICIAN DETERMINED THAT THE DISLODGED STENT COULD NOT BE REMOVED AND IT WAS LEFT IMPLANTED. THE OSTIAL RCA WAS THEN IMPLANTED WITH A 3.5X8 SYNERGY STENT. IN THE CIRCUMFLEX ARTERY, SEVERAL SYNERGY STENTS (3.0X12MM, 3.0X8MM AND A 4.0X15MM) WERE SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS THEN COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL DURING AND AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806219 ↗
• MalfunctionApr 6, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER A GUIDEWIRE CROSSED THE LESION, A ROTABLATOR BURR WAS ADVANCED TO ABLATE THE LESION BUT FAILED TO CROSS THE THROMBUS. PRE-DILATATION WAS THEN PERFORMED WITH A BALLOON CATHETER AND A 4.00 X 8 SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS LESION AND IT WAS NOTED THAT A STRUT IN THE MIDDLE PART OF THE STENT WAS LIFTED UP. NO FURTHER ACTION WAS TAKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6469762 ↗