SYNERGY™ H7493926016250Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 08714729840091), received between Nov 15, 2016 and Jan 14, 2022 — classified as 6 deaths, 17 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01/12/2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY WHICH CONTAINED A 60 DEGREE BEND. THE 2.50 X 16 SYNERGY II DRUG-EULUTING STENT WAS ADVANCED FOR TREATMENT BUT WAS UNABLE TO CROSS THE TARGET LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261501 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT CATHETER FRACTURED WITHIN THE GUIDE CATHETER AS IT WAS ADVANCED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852094 ↗
• MalfunctionMay 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND ABORTED PROCEDURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 2.50 X 16MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON AND WAS STUCK INSIDE THE GUIDE EXTENSION CATHETER. THE STENT AND THE GUIDE EXTENSION CATHETER WERE REMOVED TOGETHER, AND THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801561 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 16MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE STENT WAS TAKEN OUT THE HOOP, IT WAS NOTED THAT THE WIRE PORT/PUSH ROD WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463334 ↗
• MalfunctionAug 4, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DIAGONAL BRANCH. AFTER PRE-DILATION WAS PERFORMED WITH A 2X12MM EMERGE BALLOON CATHETER. A 2.25 X 12 AND 2.50 X 16 SYNERGY DRUG-ELUTING STENTS WERE SELECTED FOR USE; BUT, DURING INSERTION, THE STENTS LOSE WIRE ACCESS. THE STENTS WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PHYSICIAN DECIDED NOT TO PROCEED AND ABORTED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362996 ↗
• MalfunctionJul 28, 2020Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07JUL-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10333869 ↗
• MalfunctionApr 20, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 16 SYNERGY II DRUG- ELUTING STENT WAS SELECTED FOR USE BUT DEPLOYED UNSUCCESSFULLY. UPON CHECKING THE DEVICE, IT WAS NOTICED THAT THE SHAFT WAS FRACTURED. THE FRACTURE OCCURRED OUTSIDE THE BODY AND WAS ABLE TO FINISH THE PROCEDURE WITHOUT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 9977388 ↗
• MalfunctionMar 31, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, STENT WAS NOT PROPERLY PLACED ON THE RING AND DURING PROCEDURE THE STENT GOT TWISTED ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908473 ↗
• MalfunctionMar 13, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20FEB2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 16MM 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 PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829437 ↗
• MalfunctionFeb 21, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE THE SHAFT BROKE WHEN TRYING TO DELIVER THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9741060 ↗
• MalfunctionFeb 19, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX VESSEL. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE IN THE MIDDLE OF THE HYPOTUBE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729378 ↗
• MalfunctionJan 29, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2020. IT WAS REPORTED THAT DEVICE COULD NOT CROSS LESION. FOLLOWING PRE-DILATATION WITH A 2.5X14MM EMERGE MR BALLOON, A 2.50 X 16 SYNERGY II DRUG ELUTING STENT WAS UNABLE TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642606 ↗
• MalfunctionJan 24, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 16MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS LOADED INTO A GUIDE CATHETER, THE BALLOON SHAFT WAS PINCHED AND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9628276 ↗
• MalfunctionDec 11, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04DEC2019. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIGHTLY TORTUOUS PROXIMAL CIRCUMFLEX ARTERY. A 2.50 X 16 SYNERGY LL DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE IN THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT IS DOING WELL POST PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE AND SHAFT TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9455672 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION THE SHAFT BROKE APPROXIMATELY 20-25 CM FROM THE HUB AND OUTSIDE THE PATIENT'S BODY. THE STENT DELIVERY SYSTEM WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078970 ↗
• MalfunctionJul 9, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER THE STENT WAS EXPANDED AND PLACED, STICKINESS OR RESISTANCE WAS NOTED WHEN THEY WENT TO WITHDRAW THE BALLOON FROM THE STENT. THE DEVICE WAS PULLED A LITTLE HARDER AND WAS REMOVED. THE PROCEDURE WAS NORMALLY COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773856 ↗
• MalfunctionJun 24, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-MAY-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED CIRCUMFLEX ARTERY. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE 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 8728164 ↗
• MalfunctionMay 7, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGED INSIDE PATIENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS A PREVIOUSLY PLACED STENT AND STRIPPED OFF STENT BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0X28 SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587587 ↗
• MalfunctionApr 17, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAR2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.50 X 16 SYNERGY 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 PROXIMAL STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523827 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 16 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THE SHAFT WAS FRACTURED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432093 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 16 SYNERGY DRUG ELUTING-STENT WAS SELECTED FOR TREATMENT. HOWEVER, WHILE ADVANCING ONTO THE WIRE, THE MID PORTION OF THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8401185 ↗
• MalfunctionFeb 12, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND ON THE DEVICE. A 2.50 X 16 SYNERGY STENT WAS SELECTED FOR TREATMENT. HOWEVER, WHEN THE PHYSICIAN OPEN THE DEVICE THERE WAS A HAIR ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8333530 ↗
• MalfunctionFeb 4, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-JAN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 16MM 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 GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8303070 ↗
• MalfunctionJan 22, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT INCORRECT CONTENT OF THE PACKAGE WAS ENCOUNTERED. A 2.5 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, WHEN THE BOX WAS OPENED, A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS INSIDE THE BOX. THE DEVICE WAS NOT USED INSIDE THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8268249 ↗
• InjuryNov 30, 2018Material Deformation; Material Deformation

  IT WAS REPORTED STENT DAMAGE OCCURRED WHICH REQUIRED ADDITIONAL INTERVENTION. THE 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE GUIDEWIRE WAS REPOSITIONED INTO THE LEFT CIRCUMFLEX (LCX) ARTERY AND A SECOND UNKNOWN STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. WHEN THE UNKNOWN STENT WAS REMOVED FROM THE LCX, IT HUNG UP ON THE PREVIOUSLY PLACED STENT IN THE LAD WHICH STRETCHED AND WAS PARTIALLY IN THE LEFT MAIN ARTERY. IT WAS NOTED THE SYNERGY STENT WAS PLACE TO CLOSE TO THE LEFT MAIN AND THERE IS A POSSIBILITY THAT WHEN REPOSITIONING THE GUIDEWIRE, IT WENT THROUGH ONE OF THE SYNERGY STENT STRUTS AND WHEN THE UNKNOWN STENT WAS BEING REMOVED IT GOT HUNG UP AND DAMAGED THE SYNERGY STENT. THE PATIENT UNDERWENT BYPASS SURGERY WHICH WAS SUCCESSFUL AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 8121132 ↗