SYNERGY™ H7493926020350Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 08714729840183), received between Nov 17, 2016 and Jun 7, 2021 — classified as 3 deaths, 10 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT MAIN ARTERY INTO THE CIRCUMFLEX ARTERY. PRE-DILATION WAS PERFORMED WITH A 3.5 X 15 APEX BALLOON CATHETER FOLLOWING A 3.50 X 20 SYNERGY II DRUG ELUTING CORONARY STENT ADVANCED FOR TREATMENT. HOWEVER, DURING POST-DILATATION WITH 3.5 X 12 NC QUANTUM APEX THE STENT WAS FRACTURED NEAR THE BIFURCATION OF LEFT MAIN AND CIRCUMFLEX CARINA. THEY PLACED THE SECOND SYNERGY STENT 3.5X8 INSIDE TO COVER THE FRACTURED PART. THE FRACTURED DEVICE WAS NOT REMOVED BUT THE BALLOON WAS REMOVED OVER THE WIRE IN THE NORMAL FASHION AND NO ISSUES REPORTED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947779 ↗
• MalfunctionJun 3, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY ARTERY (PCI). FOLLOWING PRE-DILATATION OF A 2.5X10MM AND 2.5X6MM NON-BSC BALLOON CATHETERS, A 3.50 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED DURING DELIVERY. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11926509 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS ADVANCED INTO THE GUIDE CATHETER, IT SNAPPED IN HALF. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499000 ↗
• MalfunctionDec 14, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED PER USER FACILITY MEDWATCH THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.50X20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, POST-DEPLOYMENT, THE BALLOON DELIVERY SYSTEM WOULD NOT GO BACK OVER THE WIRE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND 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 11003201 ↗
• MalfunctionNov 19, 2020Failure to Advance

  ELDERLY MALE WITH HISTORY OF CHRONIC HEART FAILURE AND COLON RESECTION. WHILE HAVING A DIAGNOSTIC HEART CATH, THE STENT WAS DEPLOYED BUT THE BALLOON WOULD NOT GO BACK OVER THE WIRE. DEVICE REMOVED WITHOUT KNOWN HARM TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10867557 ↗
• InjuryNov 12, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED. A 3.50 X 20 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, STENT THROMBOSIS OCCURRED WITHIN THE HOUR AFTER LEAVING THE PROCEDURE ROOM. THE PATIENT HAD THE THERAPEUTIC RANGE FOR ACTIVATED CLOTTING TIME DURING THE CASE AS WELL AS PLAVIX OR BRILLANTA AND ASPIRIN MEDICATIONS ON BOARD. THE PATIENT WAS BROUGHT INTO THE LAB AND THE STENT THROMBOSIS WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Thrombosis

  MAUDE report 10831970 ↗
• MalfunctionSep 16, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN ATTEMPTED TO PUT STENT THROUGH THE GUIDE, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND 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 10540597 ↗
• MalfunctionSep 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT DEVICE WOULDN'T PASS THROUGH A NON-BSC GUIDE EXTENSION CATHETER AS THE STENT STRUT WAS FLARED AND POKING OUT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518696 ↗
• MalfunctionSep 10, 2020Break; Difficult to Remove; Difficult to Advance; Material Deformation; Break; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING ADVANCEMENT, THE PROXIMAL SHAFT OF THE CATHETER BENT OR KINKED TO ABOUT 30 DEGREES NEAR THE HEMOSTATIC VALVE. THE STENT WAS INTO THE GUIDE CATHETER BY ABOUT ONE-THIRD TO ONE-HALF OF ITS LENGTH. THE PHYSICIAN DECIDED TO REMOVE THE STENT. THE BENT AREA STRAIGHTENED DURING WITHDRAWAL BUT THERE WAS RESISTANCE THROUGH THE HEMOSTATIC VALVE. THE CATHETER SHAFT BROKE AT THIS TIME. THE DEVICE WAS IN THE PATIENT'S BODY AND THE OTHER HALF OF THE CATHETER WAS PULLED OUT WITH HEMOSTATS. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515123 ↗
• MalfunctionFeb 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS UPACKED, ONE OF THE STENT STRUTS WAS STICKING UP A LITTLE BIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9716716 ↗
• MalfunctionJan 23, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION FAILURE AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. HOWEVER, DURING REMOVAL, THE DELIVERY SYSTEM BALLOON TIP TELESCOPED UNTO ITSELF OR KIND OF TURNED OVER ONCE IT REACHED THE GUIDE CATHETER. THE PHYSICIAN THOUGHT THERE WAS A LITTLE CONTRAST LEFT IN THE BALLOON AFTER DEFLATION WHICH MADE IT DIFFICULT TO PULL THE BALLOON INTO THE GUIDE CATHETER. THE PROCEDURE WERE COMPLETED WITH NO PATIENT COMPLICATIONS AND EVERYTHING WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9623215 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESIONW AS LOCATED IN A CORONARY ARTERY. A 3.50X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE CATHETER BROKE INTO 2 SEPARATE PIECES. THE PROCEDURE WAS ENDED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9319566 ↗
• InjuryNov 7, 2019Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BALLOON RUPTURE AND STENT DISLODGEMENT OCCURRED. THE 3.5X20MM SYNERGY II DRUG ELUTING STENT CROSSED THE LESION BUT ON INFLATION TO FOUR ATMOSPHERES, THE BALLOON RUPTURED. THE STENT CAME OFF THE DELIVERY SYSTEM AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9292740 ↗
• DeathOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT THE DIED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESIONS WERE LOCATED IN THE VESSELS IN THE LEFT HEART. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED AND PLACED IN THE CIRCUMFLEX ARTERY (CX). ANGIOGRAPHY REVEALED THROMBUS PROXIMAL TO THE STENT LEADING INTO THE LEFT MAIN WHERE A 3.50 X 16 SYNERGY DES WAS THEN PLACED. THERE WAS MORE THROMBUS PRESENT DISTAL TO THE FIRST STENT IMPLANTED. ANOTHER 3.50 X 20 SYNERGY DES WAS IMPLANTED FOR TREATMENT. ALL ACTIVATED CLOTTING TIMES WERE REPORTED TO BE WITHIN THERAPEUTIC RANGE. HOWEVER, THE PATIENT'S VESSEL SHUT DOWN AND THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 9187151 ↗
• MalfunctionAug 26, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT BROKE. BOTH SECTIONS OF THE CATHETER WERE REMOVED 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 8932755 ↗
• InjuryJul 31, 2019Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON FAILED TO DEFLATE AND BALLOON DETACHMENT WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT MAIN ARTERY. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED AND WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE BALLOON FAILED TO DEFLATE. WHEN TRIED TO REMOVED, THE BALLOON DEVICE BROKE. PHYSICIAN USED A SNARE TO REMOVED THE BROKEN PIECES FROM THE PATIENT'S BODY AND ALL BALLOON SEGMENTS WERE COMPLETELY REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846922 ↗
• MalfunctionJun 26, 2019Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGED POST-DEPLOYMENT OCCURRED AND THE STENT WAS EXPLANTED. THE TARGET LESION WAS LOCATED IN A VEIN GRAFT TO OBTUSE MARGINAL BRANCH SEGMENT. A 190 CM FILTERWIRE WAS ADVANCED AND SITUATED IN THE LESION. THEN, A 3.50 X 20MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED IN THE OSTIUM FOR TREATMENT. HOWEVER, WHEN THE FILTERWIRE WAS ATTEMPTED TO BE RETRIEVED, THE RETRIEVAL DEVICE WOULD NOT GO THROUGH THE DEPLOYED STENT. A NON-BSC GUIDE WIRE WAS ADVANCED AS A BUDDY WIRE AND WAS TRIED TO REMOVE THE RETRIEVAL DEVICE. WHEN THE BUDDY WIRE AND FILTERWIRE WERE REMOVED, THE DEPLOYED STENT WAS PHYSICALLY PULLED OUT AND MANGLED. THE PROCEDURE WAS COMPLETED WITH A 3.5 X 24MM SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735699 ↗
• InjuryMay 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED AND ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT DISLODGED FROM THE DELIVERY SYSTEM IN THE CORONARY ARTERY. THE PHYSICIAN USE ANOTHER STENT TO CRUSH THE INITIAL STENT INTO THE VESSEL WALL AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596615 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50X20MM SYNERGY STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT WAS NOTED TO BE BENT AND WHEN ATTEMPTING TO STRAIGHTEN IT, THE SHAFT BROKE OUTSIDE THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515934 ↗
• MalfunctionApr 10, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.50X20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION SEVERAL TIMES AND IT WAS ALSO NOTED THAT STENT STRUTS WERE STICKING OUT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501683 ↗
• MalfunctionMar 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.50 X 20MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON SPLIT. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8467440 ↗
• InjuryMar 27, 2019Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED VIA MEDWATCH MW5084867 THAT BALLOON RUPTURE OCCURRED, THE STENT FAILED TO DEPLOY, AND INTERVENTION WAS REQUIRED. IT WAS FURTHER REPORTED THAT A SHAFT BREAK ALSO OCCURRED AND THE PATIENT WAS SENT FOR SURGERY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. UPON DEPLOYMENT THE BALLOON RUPTURED DURING FIRST INFLATION AT 6 ATMOSPHERES. THE STENT BECAME TRAPPED INSIDE THE VESSEL AND THE DELIVERY SYSTEM CATHETER BROKE APPROXIMATELY 10 CM FROM THE TIP. THE DEVICE WAS UNABLE TO BE RETRIEVED AND THE PATIENT WAS SENT FOR SURGERY. THE DEVICE WAS REMOVED AND CARDIAC BYPASS WAS PERFORMED TO OPEN UP THE ARTERY THAT WAS CLOSED.

  Patient problems: No Code Available

  MAUDE report 8457695 ↗
• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER ENGAGING THE MILDLY TORTUOUS LESION WITH A GUIDE CATHETER, A 3.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE DELIVERING THE DEVICE INTO THE PATIENT'S BODY THE FIRST TIME, THE SHAFT BROKE ABOUT 20 CENTIMETERS FROM THE HUB. THE FRACTURED POINT WAS NOTED STILL ON THE OUTSIDE OF THE PATIENT'S BODY. THE DEVICE WAS EASILY REMOVED AS THERE WAS A PART OF THE SHAFT STILL HANGING OUT FROM THE GUIDE. 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 8443700 ↗
• MalfunctionJan 23, 2019Break; Detachment of Device or Device Component

  DURING THE CASE, DOCTORS WERE INTRODUCING THE STENT AND IT BROKE OFF AS IT WAS GOING IN. FORTUNATELY IT WAS BEFORE IT REACHED THE ARTERY AND WAS ABLE TO EASILY BE REMOVED, WE THEN OPENED ANOTHER STENT AND PROCEEDED ON, THERE WAS A SHORT DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270247 ↗
• MalfunctionJan 7, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X20MM SYNERGY STENT WAS ADVANCED TO TREAT A TARGET LESION. HOWEVER, BEFORE REACHING THE ARTERY, THE STENT BROKE OFF. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH THE DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8223542 ↗