SYNERGY™ H7493926038400Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08714729840435), received between Nov 24, 2016 and Aug 3, 2021 — classified as 1 death, 8 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Bent” (11 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.00 X 38MM SYNERGY DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD. HOWEVER, WHEN THE PHYSICIAN REMOVED THE STENT BALLOON, IT GOT STUCK IN THE STRUT AND SEPARATED FROM THE DELIVERY SYSTEM. THE PHYSICIAN USED A DIFFERENT BALLOON TO TRAP THE STENT BALLOON IN THE GUIDE CATHETER AND REMOVED EVERYTHING WHILE LEAVING DEPLOYED STENT INTACT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DETACHED. IT WAS FURTHER REPORTED THAT THE LESION WAS CALCIFIED WITH MINIMAL BENDS. THE BALLLOON WAS INFLATED/ DEFLATED ONCE AFTER THE INITIAL STENT DEPLOYMENT AND THE BALLOON WAS STUCK IN THE STENT STRUT/LAD LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268685 ↗
• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, DURING UNPACKING, THE SHAFT WAS BROKEN. THE DEVICE WAS NOT INSERTED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10938003 ↗
• InjuryNov 16, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A GUIDE EXTENSION CATHETER WAS ADDED BUT STILL IT FAILED TO CROSS THE LESION. THE DEVICE WAS TRIED TO PULL BACK INSIDE THE GUIDE CATHETER AND WAS UNSUCCESSFUL EVEN AFTER MULTIPLE ATTEMPTS. THEN, IT WAS TRIED TO PULL THE WIRE, GUIDE AND STENT BACK THROUGH THE SHEATH BUT WAS ALSO UNSUCCESSFUL. A SECOND SHEATH WAS STARTED IN THE RIGHT FEMORAL ARTERY, JUST DISTAL TO THE 1ST SHEATH. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY BY A SNARE AND OUT OF THE SECOND SHEATH THAT WAS STARTED. THE PROCEDURE WAS COMPLETED WITH A NEW 4X38 SYNERGY STENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10844634 ↗
• MalfunctionOct 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVEMENT ON THE BALLOON OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, THE STENT STARTED COMING OFF THE BALLOON WHEN THE PROTECTIVE SLEEVE WAS PULLED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10720660 ↗
• MalfunctionSep 30, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09SEP2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 4.00 X 38MM SYNERGY DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, THE STENT COULD NOT CROSS THE LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10609752 ↗
• MalfunctionSep 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVING THE STYLET AND SHEATH, RESISTANCE WAS FELT AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THERE WERE MISSING STRUTS IN THE MID TO DISTAL SECTION OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10497659 ↗
• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED VESSEL. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE BUT WAS UNABLE TO ADVANCE INTO LESION EVEN AFTER ROTABLATION WITH A 1.75MM BURR. THE STENT STRUTS WERE DAMAGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313884 ↗
• MalfunctionJul 22, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. POST STENT DEPLOYMENT, THE BALLOON DEFLATED BUT WOULD NOT RE-WRAP AND BECAME STUCK AT THE DISTAL END OF THE CATHETER. THE ENTIRE SYSTEM HAD TO BE TAKEN OUT TO REMOVE THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310305 ↗
• MalfunctionJul 21, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED AND PLACED. HOWEVER, UPON REMOVAL, THE BALLOON WOULD NOT RE-WRAP AND WOULD NOT GO INTO THE GUIDE CATHETER. THE PHYSICIAN USED A NEW GUIDE CATHETER AND THEN REMOVED ALL DEVICES AS A WHOLE. THE BALLOON WAS REMOVED IN A DEFLATED STATE AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE CLACIFIED LESION WAS PRE-TREATED WITH CORONARY ORBITAL ATHERECTOMY SYSTEM AND A NON-COMPLIANT BALLOON BEFORE STENTING. THE BALLOON WAS INFLATED ONCE AT 20 ATMOSPHERES FOR 9 SECONDS AFTER INITIAL STENT DEPLOYMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305942 ↗
• MalfunctionJun 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING GUIDE CATHETER INSERTION, THE STENT WAS DAMAGED. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10190063 ↗
• MalfunctionJun 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185085 ↗
• MalfunctionMar 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS RIGHT CORONARY ARTERY. AFTER ENGAGING A 6F MACH 1AR1 GUIDE CATHETER AND ADVANCING A SAMURAI WIRE, A 4.00X38MM SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE COULD NOT ADVANCED AND THE STENT STRUTS WERE DAMAGED. DILATATION WAS PERFORMED WITH A 4.0X20MM NC QUANTUM BALLOON AND A CHOICE PT BUDDY WIRE WAS PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00X38MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898383 ↗
• MalfunctionDec 5, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.00 X 38 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS BROKE WHEN INTRODUCED INTO THE GUIDE CATHETER. IT WAS FURTHER REPORTED THAT THE PHYSICIAN TRIED TO PASS THE STENT THROUGH THE GUIDELINER BUT FELT RESISTANCE. THE PROXIMAL STENT STRUTS WERE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416214 ↗
• MalfunctionNov 27, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING THE PREPARATION, IT WAS NOTED THAT THE STENT WAS MANGLED. THE DEVICE WAS NEVER ENTERED THE PATIENT'S BODY.

  Patient problems: No Patient Involvement

  MAUDE report 9387241 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AS THE PHYSICIAN TRIED TO CROSS THE LESION, THE STENT STARTED TO ACCORDION ON ITSELF WHILE ATTACHED TO THE BALLOON. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9250825 ↗
• DeathSep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT CAME TO HOSPITAL AFTER A STRENUOUS SOCCER GAME. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE PHYSICIAN DECIDED THE ISSUE WAS ATHEROSCLEROSIS AND NOT SPONTANEOUS CORONARY ARTERY DISSECTION (SCAD), LOCATED IN THE IN THE STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS IMPLANTED AND POST IVUS WAS COMPLETED. THE NEXT MORNING, THE PATIENT RETURNED TO THE LAB WHILE CODING. THERE WAS SLOW BLOOD FLOW THROUGH ARTERY. A WIRE AND BALLOONS WERE ADVANCED THROUGH THE STENT. AN AREA OF HAZINESS WAS OBSERVED AT PROXIMAL AREA OF THE STENT. HOWEVER, THE PATIENT DIED. PHYSICIAN NOTED TO BE UNSURE OF CAUSE OF DEATH.

  Patient problems: Death; Occlusion; Vascular Dissection

  MAUDE report 9106556 ↗
• MalfunctionSep 17, 2019Entrapment of Device; Difficult to Remove; Difficult to Advance; Entrapment of Device; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARET LESION WAS LOCATED IN THE CALCIFIED MID RIGHT CORONARY ARTERY. A 4.00 X 38MM SYNERGY II DRUG ELUTNG STENT WAS SELECTED, HOWEVER THE DEVICE WAS UNABLE TO BE ADVANCED THROUGH THE CALCIUM. DURING REMOVAL THE STENT GOT CAUGHT INSIDE THE GUIDEZILLA ON THE DISTAL AREA WHEN IT WAS PULLED BACK. BOTH THE STENT AND THE GUIDEZILLA WAS REMOVED FORM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078730 ↗
• InjurySep 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATION IN THE MODERATELY TORTUOUS, MILDLY CALCIFIED, PROXIMAL RIGHT CORONARY ARTERY. FOLLOWING PREDILATATION WITH A 3.5X12MM NON-BSC BALLOON, A 4.00X38MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. THE DEVICE FAILED TO CROSS THE LESION AND WHILE BEING RETRIEVED INTO THE GUIDE CATHETER, THE STENT GOT DISLODGED IN THE RIGHT FEMORAL ARTERY AND WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962217 ↗
• MalfunctionJul 31, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 4.00X38MM SYNERGY STENT, IT WAS OBSERVED THAT ONE OF THE STENT STRUTS WAS SLIGHTLY LIFTED. 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 8847047 ↗
• MalfunctionApr 11, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-MAR-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X38MM SYNERGY 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 8504739 ↗
• MalfunctionFeb 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL RIGHT CORONARY ARTERY. A 4.00X38MM SYNERGY STENT WAS USED TO TREAT THE LESION. HOWEVER, WHILE ADVANCING, THE DEVICE GOT STUCK AT THE TIP OF THE GUIDE CATHETER. WHEN THE GUIDE AND THE DEVICE WERE REMOVED, IT WAS NOTICED THAT THE STENT WAS OFF THE BALLOON AND IN THE GUIDE. THE PROCEDURE WAS COMPLETED AFTER REPLACING BOTH DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367628 ↗
• MalfunctionJan 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X38MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS DAMAGED AFTER HITTING ANOTHER BALLOON IN A DIFFERENT VESSEL. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261339 ↗
• MalfunctionNov 15, 2018Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00X38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT BECAME STUCK IN THE GUIDEZILLA EXTENSION GUIDE CATHETER. WHEN THE DEVICE WAS PULLED OUT, IT CAME OFF THE STENT DELIVERY SYSTEM. THE DISLODGED STENT WAS RETRIEVED AND ANOTHER 4.0X38MM STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073403 ↗
• MalfunctionSep 28, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.0 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED THROUGH THE 6F GUIDEZILLA II GUIDE CATHETER BUT FAILED TO CROSS THE CALCIFIED LESION. WHEN THE STENT DELIVERY SYSTEM WAS BROUGHT BACK INTO THE GUIDEZILLA, THE DISTAL END OF THE STENT CAUGHT ON THE DISTAL END OF THE GUIDEZILLA, DEFORMING THE STENT. THE STENT DELIVERY SYSTEM AND GUIDEZILLA WERE REMOVED TOGETHER AND COMPLETELY INTACT. A SECOND GUIDEZILLA AND STENT WERE USED SUCCESSFULLY. THE PATIENT SUFFERED NO COMPLICATIONS AND LEFT THE LAB IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918430 ↗
• MalfunctionSep 4, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE VERY DISEASED TARGET LESION. HOWEVER, AS THE DEVICE WAS PUSHED, THE STENT DELIVERY SYSTEM BROKE IN TWO. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7843598 ↗