SYNERGY™ H7493926020250Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 08714729840152), received between Dec 6, 2016 and Apr 29, 2025 — classified as 3 deaths, 12 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNSTABLE ANGINA OCCURRED. ON (B)(6) 2019, A 2.50 MM X 20 MM SYNERGY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). ADDITIONALLY, A 3 X 20 MM SYNERGY STENT WAS IMPLANTED IN PROXIMAL LAD. ON (B)(6) 2021, THE PATENT PRESENTED WITH UNSTABLE ANGINA. THE TARGET LESION WAS LOCATED AT THE MID LAD AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER WAS 3.0 MM. THE TARGET LESION WAS PREDILATED WITH A 2.5 MM X 20 MM BALLOON ANGIOPLASTY CATHETER AND LASER CATHETER, RESULTING INTO 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH A 3.00 MM X 20 MM AGENT DCB STUDY DEVICE SUCCESSFULLY WITH 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR.

  Patient problems: Angina; Restenosis

  MAUDE report 21930148 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE STENT WAS BROKEN BEFORE ENTERING INTO PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942356 ↗
• InjuryNov 12, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, STENT THROMBOSIS OCCURRED WITHIN THE HOUR AFTER LEAVING THE PROCEDURE ROOM. THE PATIENT HAD THE THERAPEUTIC RANGE FOR ACTIVATED CLOTTING TIME DURING THE CASE AS WELL AS PLAVIX OR BRILLANTA AND ASPIRIN MEDICATIONS ON BOARD. THE PATIENT WAS BROUGHT INTO THE LAB AND THE STENT THROMBOSIS WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Thrombosis

  MAUDE report 10831597 ↗
• MalfunctionSep 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. 2.50 X 20 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, AFTER BEING PREPARED AND LOADED ON THE WIRE, IT WAS NOTICED THAT SOME OF THE DISTAL STRUTS WERE STICKING OUT. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT'S COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10510756 ↗
• MalfunctionJun 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE MALFORMED. 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 10186607 ↗
• InjuryJun 2, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT CONDITION DETERIORATED. A 2.50 X 20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND CAUSED A SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE NEEDED TO BE PERFORMED QUICKLY AS THE PATIENT CONDITION WAS DETERIORATING.

  Patient problems: Injury

  MAUDE report 10112054 ↗
• MalfunctionMar 17, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. WHILE A 2.50X20MM SYNERGY II DRUG ELUTING STENT WAS BEING ADVANCED FOR TREATMENT, THE HYPOTUBE BROKE IN HALF. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842825 ↗
• MalfunctionFeb 13, 2020Break; Entrapment of Device; Difficult to Remove; Break; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50X20MM SYNERGY DRUG-ELUTING STENT WAS USED IN A PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, DURING PLACEMENT, THE DEVICE BECAME STUCK WITH THE WIRE AND UPON PULLING THE DEVICE OUT, THE HYPOTUBE BROKE INTO PIECES. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED BY DEPLOYING A NEW STENT WITH THE SAME SIZE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706928 ↗
• MalfunctionDec 3, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON LOADING THE STENT ONTO THE WIRE, RESISTANCE WAS FELT AND WAS NOTED THAT THE STENT DELIVERY SYTEM BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE STENT WAS PULLED OFF THE DELIVERY CATHETER WHILE THE PHYSICIAN WAS TRYING TO TAKE THE CATHETER OFF THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404215 ↗
• MalfunctionOct 17, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50X20MM SYNERGY DRUG ELUTING STENT WAS ADVANCED THROUGH A 6F LONG GUIDEZILLA II EXTENSION CATHETER TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND UPON REMOVING THE DEVICE FROM THE GUIDEZILLA II, THE STENT WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS ABORTED AND THE PHYSICIAN DECIDED TO TREAT THE PATIENT WITH ORAL MEDICATION FOR A MONTH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED AND LOCATED IN A MILDLY TORTUOUS AND MILDLY TO MODERATELY CALCIFIED PROXIMAL DIAGONAL. THERE WAS A SIGNIFICANT BEND OF APPROXIMATELY 40 DEGREES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203094 ↗
• InjurySep 10, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. IN (B)(6) 2019, THE PATIENT UNDERWENT LEFT HEART CATHETERIZATION TO TREAT AN OCCLUDED STENT IN THE DIAGONAL ARTERY. FOLLOWING PRE-DILATATION WITH A 2.5MM BALLOON, A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED. THE STENT WAS UNABLE TO BE DEPLOYED AND DURING REMOVAL, THE DEVICE BROKE. FOURTEEN DAYS LATER, A DIAGNOSTIC HEART CATHETERIZATION WAS PERFORMED AND A SYNERGY DRUG-ELUTING STENT WAS OBSERVED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN OCCLUSION WAS NOTED DISTAL TO THE STENT. THE OCCLUSION LOOKED TO BE A BALLOON (2 MARKERS) THAT WAS LEFT IN THE PROXIMAL LAD. IT WAS FURTHER REPORTED THAT THE SYNERGY STENT BECAME ENTANGLED ON THE PREVIOUS STENT AND AFTER PULLING ON THE STENT SYSTEM TO REMOVE IT, THE STENT CATHETER BROKE. SNARING WAS ATTEMPTED BUT FAILED. THE PATIENT WAS THEN REFERRED TO A CARDIAC SURGEON IN ANOTHER FACILITY.

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion

  MAUDE report 8984171 ↗
• MalfunctionAug 19, 2019Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. DURING UNPACKING OF A 2.50 X 20 SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE OUTER FOIL PACKET HAD ALREADY BEEN OPENED OR SEPARATED AND THE STERILITY OF THE DEVICE WAS COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 8907949 ↗
• MalfunctionJul 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGE OCCURRED. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED AND ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE BACK OF THE STENT CAME OFF AND COULD NOT BE DEPLOYED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8847973 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL ARTERY. A SYNERGY STENT, SAMURAI GUIDEWIRE, ENCORE BALLOON, AND A COMET PRESSURE GUIDEWIRE WERE ALL USED DURING THE PROCEDURE. WHILE A 2.50 X 20 SYNERGY STENT WAS ADVANCED TO THE TARGET LESION, THE CATHETER BROKE. THIS OCCURRED DURING THE PROCEDURE AND INSIDE THE PATIENT BODY. ALL DEVICES WERE REMOVED AND THE GUIDE, WIRE, AND INFLATION DEVICE WERE ALL STILL CONNECTED. THE PROCEDURE WAS COMPLETED WITH A NON BSC STENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750235 ↗
• MalfunctionJun 26, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE DIAGONAL ARTERY. A 2.50 X 20MM SYNERGY DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT, THE BALLOON WAS NOTED TO BE STICKING TO THE STENT. AFTER APPLYING NEGATIVE PRESSURE 4 TIMES IT RELEASED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S PROGNOSIS WAS VERY GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736982 ↗
• MalfunctionJun 13, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY ISSUE OCCURRED. A 2.50 X 20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, THE INNER PACKAGE WAS NOTED TO BE OPENED. THE DEVICE WAS NOT USED IN PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8697497 ↗
• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE 30CM FROM THE HUB WHEN PUSHING THE DELIVERY STENT. THE DEVICE WAS COMPLETELY REMOVED EASILY FORM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696168 ↗
• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT CIRCUMFLEX. A 2.50X20MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT GOT BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695842 ↗
• MalfunctionMay 20, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29APR2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 20 SYNERGY 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 8624160 ↗
• MalfunctionMay 9, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50 X 20 MM SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595321 ↗
• MalfunctionApr 8, 2019Device-Device Incompatibility; Difficult to Advance; Material Deformation; Device-Device Incompatibility; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ANTERIOR DESCENDING ARTERY. A 2.50 X 20 SYNERGY DRUG ELUTING STENT WAS USED FOR TREATMENT. THE STENT WAS USED THRICE AND FAILED TO CROSS THE LESION. A NON-BSC GUIDELINER WAS PLACED INTO THE LEFT MAIN ON THE FOURTH ATTEMPT. HOWEVER, THE STENT CAUGHT UP ON THE COLLAR OF THE GUIDELINER THAT LIFTED OFF A FEW OF THE STENT STRUTS WHICH MADE IT HARD FOR THE STENT TO DEPLOY INTO THE PATIENT'S BODY. THE STENT WAS TAKEN OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492550 ↗
• MalfunctionMar 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION AS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO BE DELIVERED. WHEN IT WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTICED THAT THE PROXIMAL EDGE OF THE STENT STRUTS WERE DAMAGED. ANOTHER STENT OF THE SAME SIZED WAS ADVANCED TO THE LESION. SUBSEQUENTLY, A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT IT FAILED TO CROSS THE LESION. ANOTHER 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PHYSICIAN GRABBED ANOTHER BALLOON AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429520 ↗
• MalfunctionFeb 25, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50X20MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS AND THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8366090 ↗
• MalfunctionFeb 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.50 X 20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT ADHERED TO THE BALLOON PROPERLY. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361647 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. A 2.50 X 20 SYNERGY STENT WAS USED TO PERFORM INTERVENTION OF THE RAMUS. THE PHYSICIAN USED HEPARIN (8000 UNITS) DURING THE PROCEDURE. BEFORE THE PATIENT CAME OFF THE PROCEDURE TABLE, THE PATIENT BECAME SYMPTOMATIC AND HAD TO BE RE-CATHED AND REVEALED THROMBUS IN THE STENT. THE PHYSICIAN "PEFORMED" THROMBECTOMY, BALLOONING, AND GAVE AGGRASTAT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

  Patient problems: Thrombosis

  MAUDE report 8282793 ↗