SYNERGY™ H7493926032220Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729840329), received between Nov 11, 2016 and Oct 26, 2021 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS PR ID# (B)(4). EVOLVE_LV_XLV CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2019, THE SUBJECT INDEX PROCEDURE WAS PERFORMED AND QUALIFYING CONDITION WAS UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE SUBJECT WAS ENROLLED IN THE 4.5/5.0 COHORT OF THE EVOLVE LV XLV STUDY. TARGET LESION 1 WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.50 MM X 28 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ADDITIONALLY, NON-TARGET LESION WAS ALSO TREATED. THE NON-TARGET LESION 1 WAS LOCATED IN RIGHT-POSTERIOR DESCENDING ARTERY (R-PDA) WAS TREATED WITH PLACEMENT OF 3.00 MM X 28 MM AND 2.25 MM X 32 MM SYNERGY STENTS. ON THE SAME DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, POST INDEX PROCEDURE, SUBJECT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN, AND NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT. IT IS UNKNOWN WHETHER AUTOPSY WAS PERFORMED OR NOT. IT WAS FURTHER REPORTED THAT THAT PRIMARY CAUSED OF DEATH WAS ANOXIC BRAIN INJURY. FURTHERMORE, IT WAS REPORT

  Patient problems: Anemia; Cardiac Arrest; Chest Pain; Fever; Ischemia; Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Respiratory Failure; Restenosis; Thrombosis/Thrombus

  MAUDE report 12699322 ↗
• InjuryNov 19, 2020Obstruction of Flow; Obstruction of Flow

  (B)(6). IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. ON THE NEXT DAY, INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY WITH 80% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.5X 28MM SYNERGY DRUG-ELUTING STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. NON TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) AND WAS TREATED WITH THE PLACEMENT OF A 3.0X 28MM AND A 2.25X 32MM SYNERGY DRUG-ELUTING STENTS. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN 2020, IN-STENT RESTENOSIS WAS NOTED IN THE RIGHT PDA. UNSTABLE ANGINA AND ELECTROCARDIOGRAM CHANGES WERE FOUND. THE PATIENT WAS SENT TO THE CATH LAB AND NO FURTHER COMPLICATIONS WERE REPORTED. IN (B)(6) 2020, 209 DAYS POST INDEX PROCEDURE, THE SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF UNSTABLE ANGINA AND SUBSEQUENTLY ELECTROCARDIOGRAM (EKG) WAS PERFORMED WHICH REVEALED SINUS RHYTHM, LEFT AXIS DE

  Patient problems: Angina; Non specific EKG/ECG Changes; Reocclusion; Restenosis

  MAUDE report 10870107 ↗
• InjuryMay 29, 2019Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 32MM SYNERGY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT DELIVERY SYSTEM (SDS) BALLOON RUPTURED. WHEN TRYING TO REMOVE THE SDS, THE PHYSICIAN WAS UNABLE TO PUSH IT FORWARD OR PULL IT INTO THE GUIDE CATHETER. IN ORDER TO DISLODGE THE SDS, THE HUB WAS CUT OFF AND A 5FR GUIDELINER EXTENSION CATHETER WAS PLACED OVER THE WIRE AND STUCK SDS. THE STENT BALLOON WAS COMPLETELY REMOVED AND THE STENT WAS LEFT IN PLACE WITH NO HARM TO THE PATIENT OR IMPLANTED STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8651964 ↗
• MalfunctionAug 27, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS AND IT WAS ALSO NOTED THAT THE SHAFT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818939 ↗
• MalfunctionApr 17, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-MARCH-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.25 X 32MM 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL STENT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7437754 ↗
• InjuryJan 23, 2018Bent; Migration or Expulsion of Device; Bent; Migration or Expulsion of Device

  SAME CASE AS MFR REPORT#: 2134265-2018-00152. IT WAS REPORTED THAT STENT DAMAGE, MIGRATION AND EXPLANT OCCURRED. THE PATIENT PRESENTED WITH ACUTE SPONTANEOUS DISSECTION OF THE RAMUS ARTERY. THE TARGET LESION WAS 40MM LONG, EXTREMELY TORTUOUS AND HAD MILD CALCIFICATION IN PROXIMAL SEGMENT. A NON-BSC GUIDEWIRE WAS PLACED AND AN OVER-THE-WIRE NON-COMPLIANT BALLOON CATHETER WAS ADVANCED INTO THE PROXIMAL SECTION OF THE VESSEL. THEN THE NON-BSC GUIDEWIRE WAS TAKEN OUT AND INJECTED THROUGH THE LUMEN TO CONFIRM THAT IT WAS LUMINAL WITH THE BALLOON. THE WIRE WAS PUT BACK INTO THE BALLOON CATHETER. AFTER PRE-DILATION, A 2.25X32MM SYNERGY DRUG ELUTING STENT WAS PLACED IN THE DISTAL RAMUS AND THEN ANOTHER 2.25X28MM SYNERGY STENT WAS PLACE IN THE PROXIMAL RAMUS. A NON-BSC EXTRA SUPPORT GUIDEWIRE WAS PLACED TO STRAIGHTEN OUT THE VESSEL, THEN POST-DILATION WAS PERFORMED WITH A 2.50X15MM APEX BALLOON IN THE OVERLAPPING SEGMENT OF BOTH STENTS. WHEN IT WAS DILATING, UNDER FLUOROSCOPY THEY COULD SEE THE TORTUOUS VESSEL THAT STRAIGHTENED, IT TWISTED. WHEN PULLING THE EXTRA SUPPORT GUIDEWIRE, IT WAS LOCKED DOWN BOTH STENTS AND COULD NOT BE REMOVED FROM THE STENT. THE STENTS SEEMED TWISTED LIKE A CANDY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213789 ↗
• MalfunctionNov 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATTER WAS FOUND ON THE DEVICE. A 2.25X32MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. WHEN THE PHYSICIAN WAS GOING TO LOAD THE DEVICE UNTO THE CORONARY WIRE, IT WAS NOTICED THAT THERE WAS A LONG STRING LIKE PIECE OF PLASTIC STUCK ON THE CATHETER OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7072963 ↗
• MalfunctionNov 15, 2017Break; Break

  IT WAS REPORTED THE SHAFT BREAK OCCURRED. THE TARGET LESION WITH A 45 DEGREES BEND WAS LOCATED IN THE HIGHLY CALCIFIED CIRCUMFLEX ARTERY. A 2.25 X 32MM SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON ADVANCING, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7033839 ↗
• MalfunctionOct 26, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 10-OCT-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED CIRCUMFLEX ARTERY. A 2.25X32MM 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 STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6982295 ↗
• MalfunctionSep 21, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE CIRCUMFLEX (CX) ARTERY. A 2.25X32MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION; HOWEVER, THE DEVICE WAS STUCK IN THE LESION. THE PHYSICIAN HAD TO DEPLOY THE STENT TO REMOVE THE SHAFT. A 2.25X32 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS THEN ADVANCED BUT FAILED TO CROSS THE PREVIOUSLY PLACED STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881806 ↗
• MalfunctionJul 27, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FIRST OBTUSE MARGINAL OF CIRCUMFLEX ARTERY. A 2.25 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS PULLED OUT, IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A 2.25X28MM STENT. THERE WERE NO PATIENT COMPLICATIONS NOR ISSUES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747613 ↗
• MalfunctionJul 5, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 32 SYNERGY II DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER DURING THE PROCEDURE, WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE DISTAL STENT STRUTS WERE DEFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6688657 ↗
• MalfunctionApr 28, 2017Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. DURING PREPARATION OF A 2.25 X 32 SYNERGY II DRUG-ELUTING STENT, THE DEVICE WAS WIPED WITH A 4X4 GAUZE PAD AND THE STENT WAS TAKEN OFF THE BALLOON. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25 X 32 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6530949 ↗
• MalfunctionApr 25, 2017Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 32 SYNERGY II STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, UPON REMOVING THE STENT PROTECTOR, THE STENT WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 6521083 ↗
• MalfunctionApr 14, 2017Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER PLACING A NON-BSC GUIDE EXTENSION CATHETER, A 2.25 X 32 SYNERGY II DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON REMOVAL, THE DEVICE WAS STUCK IN THE GUIDE CATHETER. THE GUIDE CATHETER AND THE STENT WERE REMOVED AS A UNIT. THE PROCEDURE WAS THEN COMPLETED WITH SYNERGY STENT OF DIFFERENT SIZE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494270 ↗
• MalfunctionFeb 28, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 32 SYNERGY II STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE STENT STRUTS WERE STICKING UP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6364254 ↗
• InjuryFeb 10, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.25 X 32 SYNERGY II DRUG ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE ATTEMPTING TO CROSS THE LESION, THE SHAFT BROKE INTO TWO PIECES. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6321219 ↗
• MalfunctionDec 15, 2016Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. DURING PREPARATION OF A 2.25 X 32 SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT MOVED ON THE BALLOON WHEN THE STENT PROTECTOR WAS BEING REMOVED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6176079 ↗
• MalfunctionDec 9, 2016Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 32 SYNERGY II DRUG ELUTING STENT WAS SELECTED TO TREAT THE LESION. DURING PREPARATION, WHEN THE PHYSICIAN WAS LOADING THE DEVICE ONTO A GUIDE WIRE, IT WAS NOTICED THAT THE STENT WAS MANGLED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6157745 ↗
• MalfunctionNov 11, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 32 SYNERGY II DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS DISLODGED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A 2.25X32MM SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6096613 ↗