SYNERGY™ H7493926028350Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729840305), received between Nov 18, 2016 and Dec 6, 2021 — classified as 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL DIAGONAL OF LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING INSERTION, THE PROXIMAL PORTION OF THE SHAFT THAT SITS OUTSIDE THE PATIENT BODY BROKE AT AROUND 8CM FROM THE HUB. THE DEVICE WAS PULLED SAFELY FROM THE PATIENT AND ANOTHER 2.25 X 16 SYNERGY STENT WAS USED. A 3.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, WHILE TRYING TO DO KISSING STENTS, THE STRUT TO VERY DISTAL TIP OF THE STENT WAS NOTED TO BE DAMAGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW 3.50 X 28 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935005 ↗
• MalfunctionMar 9, 2021Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 85-90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 28 SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, WHEN PULLING THE STENT DELIVERY SYSTEM (SDS) BACK INTO THE GUIDE CATHETER, THE DISTAL END OF THE SDS WOULD NOT GO INTO THE GUIDE. THE PHYSICIAN HAD TO PULL EVERYTHING OUT AND IT WAS NOTICED THAT THE BALLOON DID NOT COMPLETELY RE-WRAP AT THE DISTAL TIP OF THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447104 ↗
• InjuryFeb 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE LEFT MAIN (LM) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE FIRST SYNERGY STENT TO TREAT THE LCX BUT THE DEVICE COULD NOT CROSS THE LM DUE TO THE TORTUOSITY AND HEAVY CALCIFICATION AND THE PHYSICIAN DECIDED TO DEPLOY THE FIRST STENT IN THE LM. A 3.50 X 28MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED TO TREAT THE DISTAL LCX BUT IT GOT CAUGHT ON THE FIRST STENT AND THE STENT CAME OFF THE BALLOON. AN ATTEMPT WAS MADE TO SNARE THE DISLODGED STENT BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN ADVANCED A SMALL BALLOON THROUGH THE UNDEPLOYED STENT AND THE STENT WAS EXPANDED WHERE IT WAS STUCK. THE PROCEDURE WAS SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: Insufficient Information

  MAUDE report 11334837 ↗
• MalfunctionSep 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY TORTUOUS ARTERY. A 3.50 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. HOWEVER, THE STENT SHEARED OFF OF THE BALLOON AND WAS RECOVERED IN THE GUIDELINER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567599 ↗
• MalfunctionSep 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY TORTUOUS ARTERY. A 3.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED, BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE STENT SHEARED OFF THE BALLOON, AND WAS RECOVERED IN THE GUIDELINER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10562791 ↗
• InjuryAug 14, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE PATIENT EVENT OCCURRED. A 3.50 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, THE INABILITY TO CROSS THE LESION CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE THAT RESULTED IN AN ADVERSE PATIENT EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 10407557 ↗
• MalfunctionAug 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING AND UPON INSPECTION WHILE FLUSHING, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. A NEW STENT WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10371012 ↗
• MalfunctionMay 1, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT "LOOK DIFFERENT". THE DEVICE WAS REMOVED AND THE STRUTS WERE FOUND UNRAVELING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10019429 ↗
• MalfunctionMar 26, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05MAR2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886593 ↗
• MalfunctionDec 10, 2019Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14NOV2019. A 3.50 X 28 SYNERGY DRUG-ELUTING STENT WAS OPENED AND WAS NOTED TO BE DEFECTIVE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

  Patient problems: No Patient Involvement

  MAUDE report 9444008 ↗
• MalfunctionDec 5, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT DOESN'T PASS THE LESION OF THE VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418051 ↗
• MalfunctionDec 5, 2019Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-NOV-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417167 ↗
• MalfunctionNov 26, 2019Contamination; Contamination

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A 3.50 X 28 SYNERGY DRUG-ELUTING STENT, THE DEVICE WAS NOTED TO BE CONTAMINATED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378784 ↗
• MalfunctionNov 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 3.50 X 28 SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT STRUTS WERE POKING OUT OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9345018 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN INSERTING THE SHAFT OF THE STENT CATHETER, IT BROKE INHALF. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884703 ↗
• MalfunctionAug 2, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION SLOW AND DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER CROSSING A NON-BSC GUIDE WIRE, PRE-DILATATION WAS PERFORMED WITH A 3X30MM EMERGE BALLOON. A 3.50X38MM SYNERGY STENT WAS THEN DEPLOYED. HOWEVER, IT WAS NOTED THAT THE BALLOON DEFLATION WAS SLOW BUT WAS ABLE TO WITHDRAW THE BALLOON SYSTEM AFTER ABOUT 20 SECONDS. SUBSEQUENTLY, A 3.50X28MM SYNERGY STENT WAS THEN DEPLOYED, OVERLAPPING THE FIRST STENT ABOUT 3-4 MM. HOWEVER, BALLOON DEFLATION WAS SLOW AND ONCE IT DEFLATED, THE STENT SYSTEM COULD NOT BE REMOVED. THE TECH PULLED NEGATIVE, A COUPLE TIMES ON THE BALLOON SYSTEM AND THEN WENT TO TUG ON IT THE GUIDE DID COME INTO THE OSTIUM OF THE VESSEL A LITTLE BIT BUT EVENTUALLY IT WAS ABLE TO BE REMOVED. POST-DILATATION WAS PERFORMED WITH A 3.5 X 30 NON-BSC BALLOON AND THEN SWITCHED TO A 3.5X15 NC EMERGE BALLOON WAS ATTEMPTED BUT FAILED TO CROSS THE PREVIOUSLY IMPLANTED STENTS. THE DEVICE WAS REMOVED AND A 3.5X15MM EMERGE BALLOON WAS ABLE TO DILATE THE PROXIMAL AREA OF 3.5X25 STENT. FURTHER DILATATION WAS PERFORMED WITH A NEW 4.0X15MM NC EMERGE BALLOON AND THE PROCEDURE WAS COMPLETED WITH GOOD FLOW AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854750 ↗
• MalfunctionJul 30, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT HEART. A 3.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, AFTER PLACING THE STENT INTO THE NON-BSC GUIDE WIRE, THE STENT WAS NOTED WITH A LITTLE ROLLED UP AND PEELED UP OFF THE BALLOON. THE DEVICE WAS REMOVED FROM THE GUIDE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841247 ↗
• MalfunctionFeb 27, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. FOLLOWING PREDILITATION WITH AN EMERGE MR BALLOON, A 3.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT ITSELF WAS KINKED AND DAMAGED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. 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 8376451 ↗
• MalfunctionFeb 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY. A 3.5 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THE PROXIMAL PART OF THE STENT WAS UNRAVELED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY ALONG WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SYNERGY DRUG-ELUTING STENT. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302200 ↗
• MalfunctionJan 3, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, A 3.50X28MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED BUT UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE LESION WAS DILATED AGAIN. THE DEVICE WAS RE-ADVANCED BUT THE STENT DID NOT LOOK RIGHT ON THE BALLOON DUE TO CALCIFICATION DURING THE FIRST ATTEMPT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212116 ↗
• MalfunctionDec 14, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 3.50 X 28MM SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT LOOKED DAMAGED UPON REMOVAL. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8166855 ↗
• MalfunctionSep 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED AND TORTUOUS CIRCUMFLEX ARTERY. A 3.50 X 28MM SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS DUE TO TORTUOSITY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS THEN ADVANCED FOR SUPPORT. HOWEVER, WHEN THE DEVICE WAS ADVANCED OUT OF THE GUIDEZILLA TOWARDS THE LESION, THE STENT SHEARED OFF FROM THE BALLOON. AN EMERGE BALLOON WAS INFLATED TO PIN THE STENT IN PLACE. BIFEMORAL ACCESS WAS STUCK AND A SECOND 7F NON-BSC GUIDE CATHETER WAS USED WITH A GOOSENECK SNARE. THE SNARE CAPTURED THE END OF THE STENT FLOATING IN THE AORTA, AND THE INFLATED BALLOON PINNING THE STENT WAS DEFLATED AFTER THE GOOSENECK CAPTURED THE STENT. THE STENT WAS PULLED THROUGH THE NON-BSC GUIDE CATHETER AND OUT OF THE BODY. A 3.0 X 15MM NC QUANTUM APEX WAS ADVANCED FOR DILATATION AND THE PROCEDURE WAS COMPLETED WITH A 3.5X28MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895643 ↗
• MalfunctionAug 30, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. A 2.0X10MM NON-BSC BALLOON CATHETER WAS ADVANCED FOR DILATION AND A GUIDEZILLA GUIDE CATHETER EXTENSION WAS USED. A 3.0X28MM STENT WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833501 ↗
• InjuryJul 5, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED VIA FACILITY MEDWATCH # 5077592 THAT STENT THROMBOSIS OCCURRED. IN (B)(6) 2017, THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND WAS THEN ADMITTED. THE PATIENT WAS SENT TO CARDIAC CATHETERIZATION LAB WHICH REVEALED TOTAL OCCLUSION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH LARGE AMOUNT OF THROMBUS. OVERLAPPING INFLATIONS WAS THEN PERFORMED USING 2.5X15 EMERGE BALLOON CATHETER PROVIDING SLUGGISH FLOW. THROMBECTOMY WAS PERFORMED AND BRISK FLOW RETURNED WITH MINIMAL RESIDUAL DEFECT. SUBSEQUENTLY, A 3.5X28MM SYNERGY STENT WAS DEPLOYED IN THE RCA WITH GOOD RESULTS. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE PATIENT DID WELL AND WAS DISCHARGED ON ACETYLSALICYLIC ACID (ASA) AND BRILINTA. IN (B)(6) 2018, THE PATIENT EXPERIENCED CHEST PAIN AND CALLED EMERGENCY MEDICAL SERVICES (EMS). PATIENT TAKES ASA AND BRILINTA BEFORE ARRIVING IN THE ER WITH STEMI. CARDIAC CATHETERIZATION REVEALED TOTAL THROMBOTIC OCCLUSION OF THE PREVIOUSLY PLACED STENT IN THE MID RCA WHICH WAS THEN TREATED WITH THROMBECTOMY AND 3.5X20 NC EMERGE BALLOON. TIMI III FLOW WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID WELL AN

  Patient problems: Chest Pain; Myocardial Infarction; Thrombosis

  MAUDE report 7663867 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND A DISSECTION WAS NOTED. ONCE THE DISSECTION HEALS REPEAT ANGIOGRAPHY WILL BE PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 7594460 ↗