SYNERGY™ H7493926024350Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729840244), received between Nov 28, 2016 and May 27, 2022 — classified as 2 deaths, 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER, A 3.50 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, IT FAILED TO CROSS THE LESION AND THE SHAFT BROKE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522688 ↗
• MalfunctionMar 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24 SYNERGY II DES DRUG ELUTING STENT WAS SELECTED FOR TREATMENT. AFTER TAKING THE DEVICE OUT OF THE BOX, IT WAS NOTED THAT THE STENT STRUT WAS RAISED. THE DEVICE WAS THEN NOT INSERTED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13709163 ↗
• MalfunctionMar 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24MM SYNERGY DRUG ELUTING STENT WAS SELECTED FOR USE; HOWEVER, IT WAS NOTICED THAT THE DEVICE HAD A STRUT RAISED AFTER TAKING THE IT OUT OF THE BOX. THE PRODUCT WAS NOT INSERTED IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13699767 ↗
• MalfunctionAug 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. PRESSURE WAS APPLIED TO THE DELIVERY SYSTEM WHILE ADVANCING THE DEVICE FROM THE ENTRANCE OF THE 6F GUIDELINER INSIDE THE 6F NON BSC GUIDE CATHETER, AND IT WAS NOTED THAT THE STENT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM. THE DEVICE WAS BALLOONED INTO THE WALL OF THE GUIDE CATHETER AND REMOVED EVERYTHING FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12376190 ↗
• InjuryAug 17, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS DISLODGED FROM THE BALLOON PRIOR TO DEPLOYMENT AND COULD NOT BE RETRIEVED. THE STENT TRAVELED FROM THE OSTIUM OF THE RCA TO THE INTERNAL ILIAC WHERE IT BECAME LODGED IN A CALCIFIED DISEASE. IT WAS DECIDED THAT THE PLACEMENT OF THE DISLODGED STENT IN THE INTERNAL ILIAC DID NOT PRESENT IMMEDIATE DANGER TO THE PATIENT AND THAT THE STENT COULD NOT BE RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT FOLLOWING ROTABLATION, THE PHYSICIAN EXPERIENCED RESISTANCE DELIVERING THE 3.50 X 24 SYNERGY STENT TO OVERLAP THE PREVIOUSLY PLACED STENT IN THE PROXIMAL RCA. THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE GUIDE. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED AND IT WAS THEN NOTICED THAT THE UNDEPLOYED STENT HAD COME OFF FROM THE SDS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12332899 ↗
• MalfunctionJul 30, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT WAS TOO DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256779 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. WHEN THE PHYSICIAN LOADED THE STENT ONTO THE WIRE, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239952 ↗
• MalfunctionJul 6, 2021Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE STENT WAS IN PLACE TO BE DEPLOYED, THE BALLOON DID NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS NOTICED THAT THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120481 ↗
• MalfunctionNov 18, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE STENT CAME OUT OF THE PACKAGE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10859043 ↗
• MalfunctionJun 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USED. HOWEVER, THE DEVICE WAS FOUND TO BE FLARED UPON REMOVAL FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10160107 ↗
• MalfunctionFeb 13, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JAN2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707136 ↗
• InjuryOct 22, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN/CIRCUMFLEX ARTERY. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT; HOWEVER, THE PHYSICIAN LOST PUSHABILITY WITH THE STENT. UPON REMOVAL, IT WAS NOTED THAT THE DEVICE SEPARATED HALFWAY DOWN THE HYPOTUBE. A 3.5 X 20 SYNERGYS DES WAS OPENED TO COMPARE HOW MUCH WAS LEFT IN THE GUIDE. SUBSEQUENTLY, A 4.0 BALLOON CATHETER WAS USED TO TRAP THE SEPARATED PORTION INTO THE GUIDE AND THE WHOLE SYSTEM WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50 X 24 SYNERGY DES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9222006 ↗
• InjuryJul 1, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS AND ST-SEGMENT ELEVATION OCCURRED. THE PATIENT WAS GIVEN TENECTEPLASE (TNKASE) AND BRILINTA. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.50X24MM SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED 80 MINUTES AFTER ADMINISTRATION OF TNKASE. HOWEVER, ELECTROCARDIOGRAM SHOWED ST- SEGMENT ELEVATION 67 MINUTES AFTER STENT PLACEMENT. THE PATIENT WAS SENT BACK TO LAB AND IT WAS NOTED THAT THE IMPLANTED STENT IN THE RCA WAS 100%OCCLUDED DUE TO A THROMBUS FROM UNDETERMINED SITE. ADDITIONAL HEPARIN WAS GIVEN AND A STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED WITH MILD DEPRESSED RIGHT VENTRICULAR FUNCTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: ST Segment Elevation; Thrombosis

  MAUDE report 8749526 ↗
• MalfunctionMay 7, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 3.50X24MM SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WAS WRINKLED AFTER PULLING OFF THE PROTECTIVE COVER. THE PATIENT WAS NOT HARMED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Patient Involvement

  MAUDE report 8589198 ↗
• InjuryFeb 19, 2019Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED AND THE PATIENT WAS SENT FOR SURGERY. THE PATIENT WAS PRESENTED WITH SIGNIFICANT DISEASE IN THE DISTAL SEGMENT OF A DOMINATE TARGET LESION LOCATED IN THE MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN USED A NON BSC GUIDEWIRE AND PRE-DILATED THE LESION. A 3.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED WITH A LITTLE DIFFICULTY BUT WAS SUCCESSFULLY DEPLOYED. UPON DEFLATION OF THE STENT DELIVERY SYSTEM, THE BALLOON WOULD NOT RELEASE FROM THE STENT. REPEATED INFLATION AND DEFLATIONS OF THE STENT DELIVERY BALLOON WERE ATTEMPTED WITHOUT SUCCESS. THE PHYSICIAN USED A 20CC SYRINGE AND ATTACHED IT TO THE STENT HUB AND ASPIRATED AND THEN TOOK A NON BSC GUIDEWIRE TO WIRED THROUGH THE STENT AND NEXT TO THE TRAPPED BALLOON. HOWEVER, IT WAS UNABLE TO ADVANCE A SMALL BALLOON THROUGH THE STENT. MORE FORCE WAS PERFORMED TO REMOVE THE BALLOON. BUT, DURING THIS ATTEMPT THE GUIDE CATHETER ADVANCED INTO THE LEFT MAIN AND CAUSED A DISSECTION. THE STENT DELIVERY SHAFT ALSO BROKE AT A POINT JUST PROXIMAL TO THE BALLOON. THE DECISION WAS MADE TO SEND THE PATIENT FOR SURGERY. THE PATIENT DID WELL, NO FURTHER COMPLICATIONS WERE REPORTED AND IS CU

  Patient problems: No Code Available; Vascular Dissection

  MAUDE report 8352052 ↗
• MalfunctionNov 7, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 3.50X24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DIFFICULTY ADVANCING WITH THE DEVICE WAS ENCOUNTERED. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047880 ↗
• MalfunctionAug 28, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-AUG-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7823429 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS PULLED OUT FROM A NON-BSC GUIDE CATHETER, THE SHAFT SNAPPED OUTSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED BY HAND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762946 ↗
• MalfunctionApr 27, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 24MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE HYPOTUBE SECTION OF THE DEVICE WAS SEPARATED. THE DEVICE DID NOT ENTER INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7470708 ↗
• MalfunctionApr 26, 2018Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-APRIL-2018. IT WAS REPORTED THAT DEVICE INTERACTION OCCURRED. DURING INTRODUCTION OF A 3.50 X 24MM SYNERGY II DRUG-ELUTING STENT, THE STENT STRUT GOT CAUGHT IN THE HEMOSTATIC VALVE. THE STENT WAS REMOVED AND IT NEVER WENT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS WELL. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROXIMAL STENT DAMAGED.

  Patient problems: No Patient Involvement

  MAUDE report 7465757 ↗
• InjuryMar 26, 2018Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AFTER A NON-BSC GUIDE WIRE WAS PLACED, A 3.50 X 24 MM SYNERGY II STENT WAS ADVANCED AND DEPLOYED TO TREAT THE LESION. FOLLOWING DEPLOYMENT, IT WAS NOTICED THAT THE PROXIMAL AND DISTAL PARTS OF THE STENT WERE FRACTURED. POST-DILATATION WAS THEN PERFORMED TO FIX AND ALIGN THE STENT EDGES AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7371105 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID # 2134265-2018-01738, 2134265-2018-01739, 2134265-2018-01740, 2134265-2018-01742 IT WAS REPORTED THAT AN ALLERGIC REACTION OCCURRED. IN (B)(6) 2018, FIVE SYNERGY II STENTS WERE IMPLANTED IN A PATIENT (4.0X16, 3.0X24, 2.25X16, 3.5X24, 3.0X24). THE NEXT MORNING, THE PATIENT'S THROAT WAS SWOLLEN AND WITHIN ANOTHER 12 HOURS, THE PATIENT'S THROAT AND MOUTH WERE FULL OF ULCERS/SORES. ONE WEEK LATER, THE PATIENT'S CONDITION HAS NOT IMPROVED. THE EAR NOSE THROAT DOCTOR HAS PRESCRIBED TREATMENT OF A TOPICAL LIDOCAINE. THE PATIENT IS NOT GETTING ANY BETTER AND IS ONLY ABLE TO DRINK THINGS BUT CAN'T EAT BECAUSE OF THE OPEN SORES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7336318 ↗
• InjuryFeb 23, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT CAME IN WITH FULL OF THROMBUS IN THE RCA. A 3.50 X 24MM SYNERGY II DRUG-ELUTING STENT (DES) WAS IMPLANTED AND THE FLOW WAS ESTABLISHED. HOWEVER, STENT THROMBOSIS OCCURRED THE FOLLOWING DAY AFTER PLACEMENT. TWO NEW REBEL STENTS WERE PLACED, ONE IN THE DISTAL AND PROXIMAL OF THE PREVIOUSLY IMPLANTED SYNERGY II DES AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Thrombosis

  MAUDE report 7293142 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE-DILATION, A 3.50 X 24MM SYNERGY II DUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. ULTIMATELY, A VESSEL DISSECTION OCCURRED. THE PATIENT WAS THEN SENT TO SURGERY FOR BYPASS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 7081919 ↗
• MalfunctionApr 20, 2017Break; Break

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY BY PULLING IT OFF FROM THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6506717 ↗