SYNERGY™ H7493926012250Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 08714729840039), received between Nov 15, 2016 and Apr 29, 2022 — classified as 4 deaths, 24 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH HEART DISEASE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PROXIMAL SHAFT BROKE WHILE INSERTING THE STENT INTO HEMO VALVE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255059 ↗
• MalfunctionApr 17, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT ADVANCED FOR USE. HOWEVER, WHILE ADVANCING THE CATHETER OVER THE WIRE, THE SHAFT BENT AND BROKE AT 30CM FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14132247 ↗
• MalfunctionAug 13, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12 SYNERGY II DRUG-ELUTING STENT SHAFT BROKE APART COMING OUT OF THE CARRIER TUBE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319058 ↗
• MalfunctionAug 7, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT STRUT WAS OUT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378137 ↗
• MalfunctionApr 27, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10000690 ↗
• MalfunctionFeb 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A SYNERGY II US MR 2.50 X 12 STENT BALLOON EXPANDABLE WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THEY TOOK THE STENT UP TO THE 6F CATHETER, IT DID NOT LOOK AS WELL HUNG OR WELL ATTACHED TO THE STENT. 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 9752919 ↗
• InjuryOct 18, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TIGHTLY STENOSED TARGET LESION WITH A 90-DEGREE BEND WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED MULTIPLE TIMES THROUGH A VERY CALCIFIED LEFT MAIN CORONARY ARTERY. HOWEVER, DURING THE THIRD OR FOURTH TIME, THE SHAFT SNAPPED. A TRAPPING DEVICE WAS USED TO TRAP AND PULL OUT THE ENTIRE SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208821 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT DELIVERY SYSTEM BROKE OFF INSIDE THE PATIENT'S BODY. THE DEVICE WAS SUCCESSFULLY REMOVED THROUGH THE ORIGINAL ACCESS SITE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9107598 ↗
• MalfunctionMay 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. THE PHYSICIAN WAS TRYING TO REMOVE THE STENT THROUGH THE TUOHY BUT THE SHAFT BROKE 33.2CM FROM THE HUB. THE MONORAIL SECTION BROKE AS WELL, IT WAS ALL IN THE GUIDE CATHETER. THIS HAPPENED AFTER THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR SERIOUS INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569364 ↗
• MalfunctionApr 23, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT ITSELF WAS DAMAGED. 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 8540316 ↗
• MalfunctionApr 11, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50X12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. THE STENT WAS LOADED INTO THE HEMOSTASIS VALVE AND WIRE; HOWEVER, IT WAS NOTED THAT THE DEVICE WAS KINKED. WHEN IT WAS PULLED BACK, THE SHAFT WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503140 ↗
• MalfunctionMar 21, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26 FEB 2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441096 ↗
• InjuryMar 12, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE BUT FAILED TO ADVANCED INTO THE LESION. A VESSEL DISSECTION WAS NOTED DURING PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available; Vascular Dissection

  MAUDE report 8412759 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA. A 2.50MM X 12MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON LOADING THE DEVICE ONTO THE WIRE, THE SHAFT BROKE INSIDE THE GUIDE. THE DEVICE WAS COMPLETELY REMOVED TOGETHER WITH THE GUIDE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH A NEW GUIDE CATHETER, GUIDE WIRE AND A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OKAY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387006 ↗
• MalfunctionFeb 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT STRUTS WERE LIFTED UP FROM THE BALLOON CATHETER. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8351952 ↗
• InjuryDec 14, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND PATIENT HAD TO UNDERGO SURGERY. THE TARGET LESION WAS LOCATED IN THE CALCIFIED DIAGONAL ARTERY. A 2.50 X 12 SYNERGY STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. HOWEVER, UPON REMOVAL, THERE WAS DIFFICULTY IN WITHDRAWING THE STENT DELIVERY SYSTEM (SDS). SEVERAL ATTEMPTS WERE MADE TO REMOVE THE SDS, BUT PHYSICIAN STATED THAT THE BALLOON WAS STUCK IN THE CALCIUM AND THE STENT. THE BALLOON CATHETER WAS EVENTUALLY REMOVED; HOWEVER, THE BALLOON MATERIAL WAS MISSING. THE BALLOON WAS RETAINED IN THE DIAG AND A CORONARY ARTERY BYPASS GRAFT HAD TO BE PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT LEFT THE PROCEDURE WITH A BALLOON PUMP IN PLACE, BUT OTHERWISE STABLE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8166767 ↗
• InjuryOct 31, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY AND DIAGONAL BRANCH. A 3.00 X 24MM AND A 2.50X12MM SYNERGY II DRUG-ELUTING STENTS WERE IMPLANTED TO TREAT THE LESION AND THE PROCEDURE WAS COMPLETED. HOWEVER, 24 HOURS AFTER THE PROCEDURE, THE PATIENT CAME BACK TO THE CATH LAB WITH ST SEGMENT AND TROPONINS ELEVATION AND THE STENTS WERE NOTED TO HAVE THROMBOSED. REPEAT ANGIOGRAM WAS PERFORMED AND AN ATTEMPT WAS MADE TO RE-WIRE THE VESSEL BUT THE WIRE WOULD NOT CROSS THE VESSEL. POST PROCEDURE PRIOR TO THE ST-ELEVATION, THE PATIENT THREW UP THEIR BRILINTA.

  Patient problems: ST Segment Elevation; Thrombosis

  MAUDE report 8024721 ↗
• InjurySep 28, 2018Obstruction of Flow; Obstruction of Flow

  (B)(6) STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2017, THE SUBJECT HAD ABNORMAL STRESS TEST AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION; ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) WITH 90% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 12MM STUDY STENT WITH 0% STENOSIS. ON THE NEXT DAY THE PATIENT WAS DISCHARGE ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT WAS PRESENTED AS A CARDIOLOGY REFERRAL FOR FURTHER ASSESSMENT PRIOR TO RENAL TRANSPLANT. THE PATIENT WAS NUCLEAR STRESS TEST DID NOT REVEAL ANY LOCALIZED ISCHEMIA; HOWEVER, HOWEVER TID WAS 1.3. THE PATIENT HAS COMPLAINTS OF NON-SEVERE SHORTNESS OF BREATH WITH EXERTION. THE PATIENT WAS REFERRED FOR LEFT HEART CATHETERIZATION. ON THE SAME DAY, 90% IN-STENT RESTENOSIS IN THE PROXIMAL LCX AND 70% STENOSIS IN PROXIMAL LCX TO MID LCX WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2 NON-BSC DRUG ELUTING STENTS FOLLOWING WHICH NO RESIDUAL STENOSIS AND TIMI 3 FLOW WAS NOTED. THE FOLLOWING DAY SUBJECT WAS DISCHARGED IN STABLE CON

  Patient problems: Reocclusion

  MAUDE report 7920626 ↗
• InjurySep 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT MAIN ARTERY. A 2.50 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF FROM THE BALLOON. THE STENT WAS THEN RETRIEVED USING A SNARING DEVICE AND A 2.0MM BALLOON CATHETER. A 2.25X12MM, 2.5X20MM, 2.25X12MM AND 2.25X16 WERE THEN DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7878098 ↗
• MalfunctionSep 3, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER A GUIDE WIRE WAS ADVANCED IN THE LESION. A 2.50 X 12MM SYNERGY II DRUG-ELUTING STENT (DES) AND A 3.00 X 8MM SYNERGY II DES WERE NOTED TO BE DEFECTIVE. WHEN THE PHYSICIAN ADVANCED THE SAID STENTS ON THE WIRE, HE NOTED THAT THE STENTS WERE SLIGHTLY BENT AND HE FELT THAT IT WOULD NOT CROSS WELL. THE PHYSICIAN IMPLANTED THREE STENTS AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840675 ↗
• InjuryAug 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL APPROACH THROUGH A 6FR 3.5 NON-BSC GUIDE CATHETER AND A SAMURAI GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ALREADY STENTED MOST OF THE LAD. HOWEVER, WHILE ATTEMPTING TO ADVANCE A 2.50X12MM SYNERGY DRUG-ELUTING STENT THROUGH THE DISTAL LAD, THE NON-BSC GUIDE EXTENSION CATHETER STRIPPED THE STENT OF THE DELIVERY CATHETER AND THE DEVICE MIGRATED TO THE DISTAL LAD. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A 2.5X16MM SYNERGY STENT AND STENTED THE MIGRATED STENT AGAINST THE WALL OF THE DISTAL LAD. NO PATIENT COMPLICATION WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799073 ↗
• MalfunctionJul 23, 2018Material Twisted/Bent; Material Twisted/Bent

  SAME CASE AS MDR ID: 2134265-2018-06647. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED MID RIGHT CORONARY ARTERY. A 2.50 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE DEVICE WAS REMOVED AND A 2.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT STILL FAILED TO CROSS THE LESION AND DAMAGED WAS ALSO NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7711884 ↗
• MalfunctionMay 30, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS ALSO NOTED THAT THE STENT WAS BROKEN AT THE TIP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555604 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID CIRCUMFLEX ARTERY. A 2.50 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. UPON INSERTION, THE PHYSICIAN NOTED THAT THEY HAD SLIGHTLY KINKED THE CATHETER SHAFT AND ATTEMPTED TO STRAIGHTEN THE SHAFT. THE DEVICE WAS INSERTED AND AS IT ENTERED INTO THE TARGET VESSEL, THE HYPOTUBE OF THE CATHETER FRACTURED SEPARATING ITSELF FROM THE PROXIMAL PORTION OF THE CATHETER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS EXCELLENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550559 ↗
• MalfunctionMay 29, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A 2.50 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS PULLED OUT OF THE HOOP, IT WAS NOTED THAT THE SHAFT WAS FRACTURED. THE DEVICE WAS NEVER USED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 12 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7550503 ↗