SYNERGY™ H7493926016300Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 08714729840114), received between Nov 29, 2016 and Dec 8, 2021 — classified as 7 deaths, 33 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (24 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE STENT STRUTS APPEARED TO BE LIFTED AND DEFORMED. THE DEVICE WAS REPLACED WITH ANOTHER STENT. A 3.00MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION UPON INTRODUCTION, THE BALLOON SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962230 ↗
• InjuryJul 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 16 SYNERGY II DRUG ELUTING CORONARY STENT SYSTEM WAS ADVANCED FOR TREATMENT IN A MODERATELY TORTUOUS CORONARY ARTERY. HOWEVER, DURING THE PROCEDURE THE STENT DISLODGED WHEN THE DEVICE BECAME IN CONTACT WITH THE CALCIUM IN THE CORONARY ARTERY. THE DEVICE WAS REMOVED AND NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 12128977 ↗
• MalfunctionApr 8, 2021Structural Problem

  ELDERLY MALE WITH HISTORY OF HYPERTENSION, ANEMIA AND NEW ONSET OF CHEST PAIN AND SHORTNESS OF BREATH. HAD PROCEDURE PERCUTANEOUS INTERVENTION IN HEART CATH LAB. WHEN THE DEVICE WAS REMOVED, IT WAS OBSERVED THAT THERE IS A BUILD-UP OF COATING ON THE STENT DELIVERY SYSTEM. THIS DID NOT IMPACT USE OF PRODUCT. THE STENT WAS SUCCESSFULLY DEPLOYED. HAD THIS BUILD UP BEEN FURTHER UP THE DELIVERY SYSTEM, IT WOULD NOT HAVE FIT IN THE GUIDE CATHETER. NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633400 ↗
• MalfunctionDec 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00X16MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN LOADING THE GUIDEWIRE ONTO THE STENT DELIVERY SYSTEM, IT WAS NOTICED THAT THE STENT WAS NOT MOUNTED ON THE DELIVERY SYSTEM OR IN THE BALLOON. THE STENT WAS ON THE FLOOR. 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 11052895 ↗
• InjuryDec 15, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT STENT SHAFT WAS KINKED WHILE ADVANCING AND FOUND THAT THE SHAFT WAS BROKEN DURING REMOVAL. A BUDDY WIRE WAS INTRODUCED. THE PHYSICIAN ADVANCED A BALLOON OVER THE BUDDY WIRE TO TRAP THE SYNERGY DELIVERY SYSTEM IN THE GUIDE CATHETER. ONCE TRAPPED, THE ENTIRE SYSTEM WAS REMOVED. THE LESION WAS REWIRED AND TREATED SUCCESSFULLY WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11012994 ↗
• MalfunctionDec 15, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. DURING DEVICE PREPARATION WHEN REMOVING THE STENT PROTECTION COVER, THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11012938 ↗
• MalfunctionDec 15, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, DEVICE WAS UNABLE CROSS THE LESION AND IT CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE THAT RESULTED IN AN ADVERSE PATIENT EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IT WAS FURTHER REPORTED THAT THE INABILITY TO CROSS THE LESION DID NOT CAUSE A SIGNIFICANT DELAY TO THE PROCEDURE THAT RESULTED IN AN ADVERSE PATIENT EVENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 11011661 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 16 SYNERGY II DRUG-ELUTING STENT WAS PREPPED FOR USE. HOWEVER, THE MID SHAFT WAS FOUND DAMAGED AND BROKE INSIDE THE GUIDE BEFORE ENTERING THE PATIENT'S BODY. THE STENT DID NOT DISLODGE INTO THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Insufficient Information; No Patient Involvement

  MAUDE report 10971670 ↗
• MalfunctionNov 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS CAUGHT ON THE CALCIUM AND WAS PUSHED BACK ONTO THE CATHETER. THE BALLOON WAS INFLATED IN THE LESION BUT NO STENT WAS DEPLOYED BECAUSE THE STENT WAS ON THE STENT CATHETER AND NOT ON THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10831627 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL BIFURCATED LEFT MAIN ARTERY. A 3.00X16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING THE PROCEDURE, A BREAK OCCURRED IN THE MID CATHETER SHAFT. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE PROCEDURE RESTARTED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823998 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MYOCARDIAL INFARCTION, RIGHT VENTRICULAR FAILURE AND ACUTE STENT THROMBOSIS OCCURRED. IN (B)(6) 2020, THE PATIENT WAS ADMITTED WITH SPINAL STENOSIS AND UNDERWENT SURGERY. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) WITH 70% STENOSIS, CIRCUMFLEX (CX) WITH 90% STENOSIS, AND RIGHT CORONARY ARTERIES (RCA) WITH 95% STENOSIS. A 2.75X20MM AND 3.0X16MM SYNERGY DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. AFTER THE SURGERY, THE PATIENT WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT (PACU); HOWEVER, THE PATIENT SUFFERED FROM MYOCARDIAL INFARCTION. ON THE FOLLOWING DAY, THE PATIENT WAS TAKEN BACK TO THE CARDIAC CATHERIZATION LAB AND FOUND TO HAVE AN ACUTE STENT THROMBOSIS IN BOTH SYNERGY STENTS IN THE RCA THAT WAS IMPLANTED 1 DAY PRIOR. BALLOON ANGIOPLASTY WAS PERFORMED AND STENTED WITH NON-BOSTON SCIENTIFIC STENTS. THE PATIENT EXPERIENCED RIGHT VENTRICULAR FAILURE AND RECEIVED IMPELLA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND WAS STILL ADMITTED.

  Patient problems: Complaint, Ill-Defined; Myocardial Infarction; Thrombosis

  MAUDE report 10727399 ↗
• MalfunctionJul 21, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT COULD NOT BE REMOVED FROM THE WIRE AND HAD TO PULL EVERYTHING OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306033 ↗
• InjuryMay 6, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRIPPED AN ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 10029567 ↗
• MalfunctionApr 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT WAS DAMAGED WHEN OPENING THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 9968952 ↗
• MalfunctionMar 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS AFTER MULTIPLE ATTEMPTS. THE STENT WAS STUCK IN THE LESION AND WHEN IT WAS PULLED BACK INTO THE GUIDE, THE STENT WAS DAMAGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879309 ↗
• MalfunctionMar 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON FLUSHING, IT WAS NOTED THAT SEVERAL STRUTS AT THE PROXIMAL END OF THE STENT WERE LIFTED/FLARED. 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 9836719 ↗
• MalfunctionMar 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY CALCIFIED MID RIGHT CORONARY ARTERY. TWO 3.00 X 16MM SYNERGY II DRUG-ELUTING STENTS WERE USED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION FOR BOTH DEVICE, IT WAS NOTED THAT THE DISTAL EDGES WERE LIFTED. THE DEVICES WERE 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 9825500 ↗
• MalfunctionMar 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY CALCIFIED MID RIGHT CORONARY ARTERY. TWO 3.00 X 16MM SYNERGY II DRUG-ELUTING STENTS WERE USED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION FOR BOTH DEVICE, IT WAS NOTED THAT THE DISTAL EDGES WERE LIFTED. THE DEVICES WERE 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 9825489 ↗
• MalfunctionMar 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED DISTAL RIGHT CORONARY ARTERY. A 3.00 X16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON REMOVAL, FRAYING OF DISTAL STENT END WAS NOTED. THE PROCEDURE WAS ENDED WITH NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820118 ↗
• MalfunctionMar 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 16MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT STRUT WAS OFF OF THE BALLOON OUT OF THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9808625 ↗
• MalfunctionJan 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT 2 OR 3 OF THE STENT STRUTS WERE LIFTED OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9650389 ↗
• MalfunctionDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 15NOV2019: IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 16MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT HOWEVER THE STENT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412150 ↗
• MalfunctionNov 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS AROUND A SHARP (SEVERELY TORTUOUS) AND SEVERELY CALCIFIED TURN IN THE MID CIRCUMFLEX ARTERY. THREE 3.00 X 16 MM SYNERGY DRUG ELUTING STENTS WERE INTRODUCED BUT EACH ONE GOT CAUGHT ON THE CALCIUM RESULTING IN STENT DEFORMATION. THERE WAS NO PATIENT HARM AND THE PATIENT WAS REFERRED TO A LARGER FACILITY FOR ATHERECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9359518 ↗
• MalfunctionNov 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS AROUND A SHARP (SEVERELY TORTUOUS) AND SEVERELY CALCIFIED TURN IN THE MID CIRCUMFLEX ARTERY. THREE 3.00 X 16 MM SYNERGY DRUG ELUTING STENTS WERE INTRODUCED BUT EACH ONE GOT CAUGHT ON THE CALCIUM RESULTING IN STENT DEFORMATION. THERE WAS NO PATIENT HARM AND THE PATIENT WAS REFERRED TO A LARGER FACILITY FOR ATHERECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9359516 ↗
• MalfunctionNov 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS AROUND A SHARP (SEVERELY TORTUOUS) AND SEVERELY CALCIFIED TURN IN THE MID CIRCUMFLEX ARTERY. THREE 3.00 X 16 MM SYNERGY DRUG ELUTING STENTS WERE INTRODUCED BUT EACH ONE GOT CAUGHT ON THE CALCIUM RESULTING IN STENT DEFORMATION. THERE WAS NO PATIENT HARM AND THE PATIENT WAS REFERRED TO A LARGER FACILITY FOR ATHERECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9359514 ↗