SYNERGY™ H7493926038300Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 08714729840411), received between Nov 15, 2016 and Dec 2, 2022 — classified as 8 deaths, 25 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (29 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 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF AND FAILED TO CROSS THE LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906308 ↗
• MalfunctionJul 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. AFTER PRE-TREATING THE LESION WITH A ROTABLATOR, A 3.00 X 38 SYNERGY II DRUG ELUTING STENT WAS INSERTED TO TREAT THE LESION. HOWEVER, THE STENT STRUTS WERE DAMAGED. THE DEVICE WAS REMOVED INTACT AND IT WAS FOUND THAT THE DISTAL EDGE WAS CRIMPED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947147 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 3.00 X 38 SYNERGY II DRUG-ELUTING STENT WAS LOADED ONTO THE GUIDEWIRE AND WAS ADVANCED TO THE SHEATH FOR TREATMENT. HOWEVER, THE BALLOON AND THE STENT PORTION OF THE DEVICE SEPARATED FROM THE MAIN DELIVERY SYSTEM SHAFT. THE BREAK OCCURRED AT ABOUT 15 CM FROM THE DISTAL TIP OF THE DEVICE. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310784 ↗
• InjuryJan 11, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS AND ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION OCCURRED. A 3.00 X 32 AND TWO 3.00 X 38 SYNERGY DRUG-ELUTING STENTS WERE IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). SIX HOURS POST STENT IMPLANTATION, THE PATIENT PRESENTED WITH CHEST PAIN SYMPTOMS AFTER THE AGGRASTAT DRIP WAS DISCONTINUED. AN ANGIOGRAM WAS PERFORMED WHICH INDICATED THROMBUS WAS PRESENT AND INTRAVASCULAR ULTRASOUND (IVUS) INDICATED THE STENTS WERE WELL APPOSED BUT WERE A LITTLE UNDERSIZED. THE PHYSICIAN POST DILATED WITH A 3.25 NON-BOSTON SCIENTIFIC BALLOON. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS FULLY RECOVERED WITH A GOOD PROGNOSIS AFTER THE PROCEDURE.

  Patient problems: Chest Pain; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 13232678 ↗
• InjuryJan 11, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS AND ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION OCCURRED. A 3.00 X 32 AND TWO 3.00 X 38 SYNERGY DRUG-ELUTING STENTS WERE IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). SIX HOURS POST STENT IMPLANTATION, THE PATIENT PRESENTED WITH CHEST PAIN SYMPTOMS AFTER THE AGGRASTAT DRIP WAS DISCONTINUED. AN ANGIOGRAM WAS PERFORMED WHICH INDICATED THROMBUS WAS PRESENT AND INTRAVASCULAR ULTRASOUND (IVUS) INDICATED THE STENTS WERE WELL APPOSED BUT WERE A LITTLE UNDERSIZED. THE PHYSICIAN POST DILATED WITH A 3.25 NON-BOSTON SCIENTIFIC BALLOON. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS FULLY RECOVERED WITH A GOOD PROGNOSIS AFTER THE PROCEDURE.

  Patient problems: Chest Pain; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 13232408 ↗
• MalfunctionSep 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06SEP2021. IT WAS REPORTED THAT LOADING DIFFICULTY WAS ENCOUNTERED. A 3.00 X 38 SYNERGY II DRUG-ELUTING STENT WAS PULLED OUT OF THE PACKAGE AND PREPPED IN NORMAL FASHION. HOWEVER, THE PHYSICIAN WAS UNABLE TO LOAD THE STENT ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514103 ↗
• MalfunctionJul 22, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. AFTER A 2.5 X12 MM NON BOSTON SCIENTIFIC BALLOON CATHETER, A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND IT WAS NOTICED THAT THE STENT WAS DAMAGED. THE DEVICE REMOVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12209669 ↗
• MalfunctionMay 5, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775588 ↗
• MalfunctionApr 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, IT FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED AND NO STENT DAMAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691200 ↗
• MalfunctionApr 5, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND FLAW IN STENT STRUT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE STENT STRUT ON PROXIMAL END OF THE STENT WAS LARGER THAN THE REST OF THE BODY OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616587 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, AS THE PROTECTIVE SLEEVE WAS BEING REMOVED, THE SHAFT CAME APART AROUND THE RAPID EXCHANGE POINT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11323305 ↗
• MalfunctionNov 25, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE LESION WAS DILATED AGAIN WITH A 3.0 X 20 BALLOON CATHETER. HOWEVER, UPON EXAMINATION FOR RE-INSERTION OF THE STENT, THE PHYSICIAN NOTICED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10905218 ↗
• MalfunctionNov 3, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND STRUT CAME LOOSE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10781868 ↗
• InjuryOct 30, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT PROCEDURAL DELAY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. IT TOOK A WHILE TO TRY TO CROSS THE LESION WHICH MADE THE CASE GO LONGER. NO COMPLICATIONS NOR INJURIES WERE REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10763150 ↗
• InjuryOct 28, 2020Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED AND VERY TORTUOUS RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION FROM THE DISTAL TO PROXIMAL RCA AND WITHIN THE PREVIOUSLY IMPLANTED STENT USING A 2.75 X 20MM BALLOON, A 3.00 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO THE CALCIFICATION AND TORTUOSITY. THE STENT WAS PULLED BACK INTO THE GUIDE CATHETER BUT WAS DEFORMED AND DISLODGED. THE STENT WAS HELD ON BY A WIRE WITHIN THE AORTA. IT WAS SUCCESSFULLY SNARED AND THE PROCEDURE WAS COMPLETED USING A GUIDE EXTENSION CATHETER AND THREE NON-BOSTON SCIENTIFIC STENTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751694 ↗
• MalfunctionOct 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 38 SYNERGY II DRUG-ELUTING STENT WAS USED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS PREPPED ON THE TABLE, THE COVERING WAS REMOVED AND WHILE WIPING DOWN THE DEVICE WITH A 4X4 CLOTH A STENT STRUT BECOME RAISED. THIS WAS NOTICED BEFORE INSERTING IT TO THE PATIENT'S BODY. PATIENT WAS SEDATED CONSCIOUSLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10700404 ↗
• InjuryOct 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED, TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN AND LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING DELIVERY, THE STENT STRIPPED OFF THE DELIVERY BALLOON AND HAD TO BE RETRIEVED USING A NON-BOSTON SCIENTIFIC SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT OF A DIFFERENT LENGTH. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10622035 ↗
• MalfunctionSep 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. WHILE OUTSIDE THE PATIENT, AN ATTEMPT TO ADVANCE A 3.00 X 38 SYNERGY II DRUG ELUTING STENT THROUGH A WATCHDOG HEMOSTASIS VALVE WAS MADE, BUT THE STENT BECAME SNAGGED INSIDE THE WATCHDOG. THE STENT WAS REMOVED AND WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541214 ↗
• InjuryAug 17, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. A 3.00 X 38MM SYNERGY DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE PATIENT CONTINUE TO HAVE CHEST PAIN.

  Patient problems: Chest Pain

  MAUDE report 10414399 ↗
• MalfunctionJun 25, 2020Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT ONE OF THE STRUTS APPEARED TO BE DISLODGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10194989 ↗
• MalfunctionJun 18, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR LEFT HEART CATHETERIZATION. THE STENT WAS DEPLOYED; HOWEVER, AS THE STENT DELIVERY SYSTEM WAS BEING REMOVED, THE BALLOON GOT STUCK ON THE GUIDEWIRE AND WAS STRETCHED. THE GUIDEWIRE AND STENT DELIVERY SYSTEM WERE REMOVED TOGETHER WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10169393 ↗
• MalfunctionApr 2, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 38 SYNERGY DRUG- ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE STENT WAS DEFORMED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9914676 ↗
• MalfunctionMar 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STENT WAS STRIPPED OFF FROM THE BALLOON. THE TARGET LESION WAS IN THE CORONARY ARTERY. A 3.00X38 SYNERGY DRUG ELUTING STENT AND A GUIDEZILLA II GUIDE EXTENSION CATHETER WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS STRIPPED OFF FROM THE BALLOON AT THE COLLAR OF THE GUIDEZILLA. THE STENT DELIVERY SYSTEM WAS THEN REMOVED TO THE COLLAR OF THE GUIDEZILLA AND WERE REMOVED TOGETHER. HOWEVER, A CRACK AT THE COLLAR OF THE GUIDEZILLA WAS NOTED AFTER REMOVAL. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9903237 ↗
• MalfunctionMar 27, 2020Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06MAR2020. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. DURING USE OF A 3.00 X 38 SYNERGY DRUG-ELUTING STENT IT WAS NOTED THAT THE DEVICE DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9889526 ↗
• MalfunctionMar 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DEVICE FAILED TO CROSS THE LESION AND WHEN IT WAS REMOVED, THE STENT STRUTS WERE FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841302 ↗