SYNERGY™ H7493926032350Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729840367), received between Mar 21, 2017 and Apr 12, 2021 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN, LEFT ANTERIOR DESCENDING AND CIRCUMFLEX ARTERIES. A 3.50 X 32 SYNERGY DRUG-ELUTING STENT AND A 2.00MM X 12MM APEX BALLOON CATHETER WERE ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE SHAFTS BROKE OUTSIDE OF THE BODY. THE DEVICES WERE COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651911 ↗
• InjuryFeb 18, 2021Obstruction of Flow; Obstruction of Flow

  S2357 EVOLVE 4.5-5.0 CLINICAL STUDY: IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2020, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHERIZATION. THE INDEX PROCEDURE WAS PERFORMED THAT SAME DAY. THE FIRST TARGET LESION WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 4.50 MM X 32 MM SYNERGY DRUG ELUTING STENT (DES) WITH NO RESIDUAL STENOSIS. A NON-TARGET LESION LOCATED IN OBTUSE MARGINAL (OM1) AND WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 20 MM SYNERGY DES AND WITH CUTTING BALLOON. THE SECOND NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX EXTENDING TO 1ST OB MARG AND WAS TREATED WITH THE PLACEMENT OF 3.50 MM X 32 MM OF SYNERGY DES. THE THIRD NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 32 MM SYNERGY DES. THE FOURTH NON-TARGET LESION WAS LOCATED IN DISTAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 8.00 MM SYNERGY DES. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, SUBJECT WA

  Patient problems: Angina; Myocardial Infarction; Restenosis

  MAUDE report 11343771 ↗
• InjuryDec 2, 2020Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED WHICH RESULTED IN A SURGERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 32 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND TWO 3.50 X 16 SYNERGY DES WERE IMPLANTED IN THE PROXIMAL LAD. THE 3.50 X 32 SYNERGY DES WAS THEN ADVANCED AND CROSSED THE PREVIOUSLY IMPLANTED STENTS; HOWEVER, UPON DEPLOYMENT, IT STOPPED INFLATING AT 4 ATMOSPHERES. UPON REMOVAL, THE BALLOON SHAFT BROKE NEAR THE HYPOTUBE AND REMAINED IN THE BODY. THE PATIENT WAS SENT TO A SUCCESSFUL BYPASS SURGERY THE FOLLOWING DAY AND THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10934955 ↗
• InjuryNov 9, 2020Obstruction of Flow; Obstruction of Flow

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED CHEST PAIN, MYOCARDIAL INFARCTION, CARDIAC ENZYME ELEVATION AND STENT THROMBOSIS OCCURRED. IN (B)(6) 2019, THE PATIENT PRESENTED WITH AN EJECTION FRACTION OF 55%. FORTY ONE DAYS AFTER, INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENT WITH ANGINA AND WAS REFERRED FOR CARDIAC CATHERIZATION TARGET LESION #1 WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF 4.5 MM X 32 MM STUDY STENT FOLLOWING WHICH RESIDUAL STENOSIS WAS NOTED TO BE 0%. NON-TARGET LESION #1 WAS LOCATED IN OBTUSE MARGINAL (OM1) AND WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 20MM SYNERGY DRUG-ELUTING STENT (DES). NON-TARGET LESION #2 WAS LOCATED IN PROXIMAL LCX EXTENDING TO OM1 AND WAS TREATED WITH THE PLACEMENT OF 3.50 MM X 32 MM OF SYNERGY DES. NON-TARGET LESION #3 WAS LOCATED IN PROXIMAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 32MM SYNERGY DES. NON-TARGET LESION #4 WAS LOCATED IN DISTAL LCX (SAME AS THAT OF TARGET LESION) AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 8.00MM SYNERGY DES. THE SUBJECT WAS DI

  Patient problems: Atrial Flutter; Cardiac Enzyme Elevation; Chest Pain; Myocardial Infarction; Thrombosis

  MAUDE report 10810029 ↗
• MalfunctionAug 27, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-AUG-2020 IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 32MM SYNERGY II DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DUE TO HIGHLY CALCIFIED LESION, THE STENT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459057 ↗
• InjuryAug 4, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DEVICE WAS EXPLANTED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE DISTAL LAD AND A 3.50 X 32MM SYNERGY II DES WAS IMPLANTED PROXIMAL LAD. HOWEVER, DURING CATHETER REMOVAL OF THE DISTALLY IMPLANTED STENT, IT CAUGHT THE PROXIMALLY IMPLANTED STENT. THE PROXIMAL STENT WAS THEN PULLED OUT OF THE PATIENT'S BODY AND WAS NOTED THROUGH THE IMAGES THAT STENT DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362794 ↗
• MalfunctionJul 27, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND SHAFT BREAK OCCURRED. A 3.50 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT THE STENT DELIVERY SYSTEM BROKE WHEN TRYING TO CROSS THE LESION. WHEN THEY PULLED IT OUT FROM THE GUIDE CATHETER, THE STENT FELL OFF THE BALLOON AND GOT LOST. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10328842 ↗
• MalfunctionFeb 13, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICE THAT THE STRUT ON STENT WAS PULLED OUT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707810 ↗
• MalfunctionNov 5, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS MID RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILTATION OF A DISTAL RCA LESION, A 3.50 X 32 SYNERGY II DRUG ELUTING STENT WAS INTRODUCED BUT WOULD NOT ADVANCE AROUND THE BEND AT THE OSTIUM. AN ATTEMPT WAS MADE TO PULL THE DEVICE BACK INTO THE GUIDE CATHETER BUT IT WOULD NOT PULL BACK. THE DECISION WAS MADE TO DEPLOY THE STENT WHERE IT WAS IN THE PROXIMAL RCA IN ORDER TO HELP PULL BACK THE DEVICE. THE STENT WAS DEPLOYED AT 12 ATMOSPHERES WITH NO ISSUES. THE STENT BALLOON STILL WOULD NOT PULL BACK INTO THE GUIDE CATHETER UNTIL ANOTHER PHYSICIAN WAS ABLE TO PULL BACK THE BALLOON SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282720 ↗
• MalfunctionOct 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50X32MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT A PIECE BROKE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205993 ↗
• InjurySep 20, 2019Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT RADIAL ARTERY. A 3.50 X 32 SYNERGY DRUG ELUTING STENT AND 6F GUIDEZILLA II WERE ADVANCED BUT IT WAS NOTED THAT THE STENT GOT STUCK IN THE GUIDEZILLA AND CAME OFF THE BALLOON. THE STENT BECAME LODGED IN LEFT RADIAL ARTERY AND WILL BE LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9098456 ↗
• MalfunctionSep 13, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND SHAFT BREAK OCCURRED. FOLLOWING PRE-DILATATION, A 3.50 X 32MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED. HOWEVER, WHILE ATTEMPTING TO REMOVE THE DELIVERY SYSTEM, RESISTANCE WAS ENCOUNTERED. ON THE SECOND ATTEMPT, THE SHAFT BROKE. THE BROKEN DEVICE WAS ABLE TO BE RETRIEVED INTO THE GUIDE AND WAS COMPLETELY REMOVED TOGETHER WITH THE GUIDE CATHETER. THE IMPLANTED STENT WAS NOT DAMAGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDE WITH GOOD FINAL RESULT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PHYSICIAN REPORTED HE MIGHT HAVE PULLED BACK ON THE DEVICE PRIOR TO THE BALLOON BEING FULLY DEFLATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035375 ↗
• MalfunctionAug 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 32MM SYNERGY DRUG-ELUTING STENT WAS USED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT WAS FLARED OUT AND THE DEVICE COULDN'T ADVANCE. THE DEVICE WAS THEN REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE. IT WAS FURTHER REPORTED THAT THE LESION WAS LOCATED IN A 70% MILDLY CALCIFIED AND NON TORTUOUS LESION. DURING THE PROCEDURE THE MIDDLE PORTION OF THE STENT FLARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8873941 ↗
• MalfunctionJun 22, 2018Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  SANE CASE AS MDR ID: 2134265-2018-05633. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 6F GUIDEZILLA¿ II LONG GUIDE EXTENSION CATHETER WAS IN USE WHILE A 3.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, IT WAS SNAGGED BY THE GUIDEZILLA¿ AND BECAME UNUSABLE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7630846 ↗
• MalfunctionJun 21, 2018Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  SAME CASE AS MDR ID# 2134265-2018-05466. IT WAS REPORTED THAT THE SHAFT OF THE SYNERGY BROKE UPON REMOVAL FROM THE GUIDEZILLA. THE TARGET LESION WAS EXTREMELY TORTUOUS. A 6F GUIDEZILLA¿ II GUIDE EXTENSION CATHETER AND 4.00 X 24 SYNERGY II DRUG-ELUTING STENT WERE SELECTED FOR THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. AFTER DEPLOYING THE STENT, AND UPON REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) THROUGH THE DISTAL PORTION OF THE GUIDEZILLA, THE SHAFT OF THE SDS BROKE. DUE TO HAVING AN UNSPECIFIED BUDDY WIRE IN THE GUIDEZILLA , THERE WAS VERY LITTLE HEAD ROOM. ALSO WHILE TRYING TO PULL THE SDS OUT, DRAG WAS ENCOUNTERED DUE TO THE EXTREMELY TORTUOUS VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626981 ↗
• InjuryMar 21, 2017Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT WAS EXPLANTED. THE TWO TARGET LESIONS WERE LOCATED IN THE DIAGONAL AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.50X32MM SYNERGY II DRUG-ELUTING STENT WAS INITIALLY PLACED IN THE DIAGONAL. A 2.75X16MM SYNERGY STENT WAS ADVANCED BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND REPLACED WITH A 2.5X23MM NON-BSC STENT; HOWEVER THE DEVICE WAS UNABLE TO FULLY CROSS THE LESION. UPON REMOVAL OF THE NON-BSC STENT, IT BECAME ENTANGLED WITH THE IMPLANTED SYNERGY STENT AND WAS EXPLANTED. BOTH, THE NON-BSC AND SYNERGY STENTS WERE SNARED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH PLACEMENT OF 3.5X24MM AND 2.5X24MM SYNERGY STENTS IN THE LAD AND DIAGONAL. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6421712 ↗