SYNERGY™ H7493926008250Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729839972), received between Feb 8, 2017 and May 4, 2021 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL DIAGONAL LESION. A 2.50 X 8 SYNERGY DRUG-ELUTING STENT WAS PLACED BUT MISSED THE OSTIUM SO A SECOND 2.50 X 8 SYNERGY DRUG-ELUTING STENT WAS PLACED MORE PROXIMAL TO COVER THE OSTIAL LESION. AN EMERGE BALLOON CATHETER WAS THEN ADVANCED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND PERFORMED A CRUSH TO THE OSTIUM OF THE DIAGONAL STENT. ANOTHER STENT WAS THEN PLACED IN THE LAD COVERING THE OSTIUM. VIDEO SHOWED THE SECOND OSTIAL STENT IN PLACE AFTER THE LAD STENT WAS DEPLOYED. THERE WAS NO FURTHER INTERVENTION BUT WHEN ANGIOGRAPHY WAS TAKEN, IT WAS NOTED THAT THE OSTIAL DIAGONAL STENT HAD RANDOMLY MOVED DISTALLY, INTO THE FIRST STENT. THE PROCEDURE WAS STOPPED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11771266 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50 X 8MM SYNERGY II DRUG-ELUTING STENT SHAFT SNAPPED IN HALF WHILE BEING INTRODUCED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10242493 ↗
• MalfunctionJun 22, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER THE VESSEL WAS PRE-DILATED WITH A 2.50X15MM NON-BOSTON SCIENTIFIC BALLOON CATHETER, A 2.50 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT COULD NOT CROSS THE LESION AND WHEN IT WAS REMOVED, THE DEVICE WAS FOUND TO BE CRACKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10182471 ↗
• MalfunctionOct 22, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04OCT2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.50 X 8 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS KINKED WHEN CAME OUT FROM THE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGED.

  Patient problems: No Patient Involvement

  MAUDE report 9222077 ↗
• MalfunctionMay 6, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 8 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. AFTER THEY PULLED THE STENT OUT OF THE PATIENT'S BODY, IT CAME OFF THE BALLOON ON THE BACK TABLE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583748 ↗
• MalfunctionMar 26, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 8 SYNERGY STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, UPON REMOVAL IT WAS OBSERVED THAT THE STENT BALLOON WAS STUCK AND IT REQUIRES TOO MUCH FORCE TO REMOVE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454112 ↗
• MalfunctionFeb 7, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 8 SYNERGY DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. AS THE DEVICE WAS INSERTED INTO THE GUIDE, IT WAS NOTED THAT THE DEVICE WAS KINKED. WHEN THE DEVICE WAS PULLED OUT, THE SHAFT EVENTUALLY BROKE IN HALF. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE AT THE WIRE EXIT PORT. THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 8314954 ↗
• MalfunctionJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED IN DEVICE ANALYSIS COMPLETED ON 21-DEC-2018. THE DEVICE WAS RETURNED WITH NO KNOWN COMPLAINT. HOWEVER, DEVICE ANALYSIS REVEALED THE STENT WAS DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8246885 ↗
• InjuryAug 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50 X 8 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE PHYSICIAN USED A SEPARATE BALLOON CATHETER TO CRUSH THE STENT IN PLACE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7812776 ↗
• MalfunctionAug 9, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.50 X 8MM SYNERGY II DRUG-ELUTING STENT, THE SHAFT BROKE PROXIMAL TO THE STENT. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. THE LESION WAS BALLOONED AND THE PROCEDURE 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 7769888 ↗
• MalfunctionMay 29, 2018Defective Device; Defective Device

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 02MAY2018. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. A 2.50 X 8MM SYNERGY II STENT WAS USED IN A PROCEDURE BUT THE DEVICE WAS DAMAGED WHILE INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550219 ↗
• MalfunctionMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-APR-2018. A 2.50 X 8MM SYNERGY II DRUG ELUTING STENT WAS RECEIVED WITH NO ISSUES REPORTED. HOWEVER, UPON REVIEW OF THIS DEVICE, PROXIMAL STENT DAMAGE WAS NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540319 ↗
• MalfunctionJan 26, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 8MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS SELECTED TO TREAT THE LESION HOWEVER; THE SHAFT BROKE IN HALF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221923 ↗
• MalfunctionDec 6, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50 MM X 8 MM SYNERGY II DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE TARGET LESION; HOWEVER, DIFFICULTY ADVANCING WAS ENCOUNTERED AND THE SHAFT WAS BROKEN ABOUT 15 TO 20 CM FROM HUB. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE WITHOUT ANY ISSUE. ANOTHER 3.0 X 16 MM SYNERGY DES WAS PLACED NEAR THE LESION AREA AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088144 ↗
• InjuryNov 15, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  SAME CASE AS MFR REPORT#: 2134265-2017-11206, 2134265-2017-11207, 2134265-2017-11208, 2134265-2017-11213. IT WAS REPORTED THAT THE STENT WAS UNDER EXPANDED AND THE PATIENT HAD CHEST PAIN, AN OCCLUSION AND CARDIAC ARREST. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). PRE-DILATION WAS PERFORMED WITH A 2.5MM NC EMERGE BALLOON TO 28 ATMS, WHICH DIDN'T EXPAND THE LESION. THEN A 1.50MM ROTABLATOR ROTALINK PLUS BURR WAS USED. AFTER THAT A 2.5X8MM NON-BSC STENT WAS IMPLANTED IN THE PROXIMAL RCA AND A 2.50X8MM SYNERGY STENT WAS IMPLANTED IN THE OSTIUM. POST-DILATION WAS PERFORMED WITH A 2.5MM NC EMERGE BALLOON TO 28 ATMS, BUT NEVER FULLY EXPENDED BOTH STENTS. IT WAS DECIDED TO LEAVE IT AT THIS POINT. ABOUT 45 MINUTES LATER THE PATIENT HAD CHEST PAIN IN THE HOLDING AREA AND WAS BROUGHT BACK TO THE LAB. THE RCA WAS FOUND OCCLUDED AND THE PATIENT ARRESTED. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED VIA A NON-BSC CHEST COMPRESSION SYSTEM AND THE RCA WAS RE-WIRED AND RE-BALLOONED. A BLOOD THINNER WAS ADMINISTERED AND THEN THE RCA HAD BETTER FLOW AND THE PATIENT STABILIZED. THE PATIENT WAS ALSO PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). TH

  Patient problems: Cardiac Arrest; Chest Pain; Occlusion

  MAUDE report 7034347 ↗
• MalfunctionNov 14, 2017Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. A 2.50 X 8 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, DURING PREPARATION, THE DEVICE WAS DROPPED ON THE GROUND AND WAS CONTAMINATED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 8 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7031583 ↗
• InjuryAug 11, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR# 2134265-2017-08151, (B)(6) STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS AND STENT THROMBOSIS OCCURRED. IN (B)(6) 2016, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION AS UNSTABLE ANGINA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF 2.75 X 24MM AND 2.50 X 8MM SYNERGY II STUDY STENTS . FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL). IN (B)(6) 2017, PATIENT PRESENTED WITH THE CHIEF COMPLAINTS OF LEFT SIDED CHEST PAIN WHICH WAS RADIATING TO BACK AND DOWN TO LEFT ARM AND MILD SHORTNESS BREATH SINCE 2- 3 WEEKS. PATIENT HAD STATED THAT HE HAD RECURRENT SYMPTOMS OF ANGINA AND DYSPNEA ON EXERTION. ELECTROCARDIOGRAM (EKG) WAS PERFORMED ON THE SAME DAY AND REVEALED SINUS RHYTHM WITH NO ISCHEMIC ABNORMALITIES. THE PATIENT WAS RESTARTED ON ASPIRIN AND WAS SCHED

  Patient problems: Angina; Dyspnea; Intimal Dissection; Reocclusion; Thrombosis

  MAUDE report 6789596 ↗
• MalfunctionJul 31, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 8 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. SUBSEQUENTLY, A SMALL KINK WAS NOTED IN THE CATHETER AND THE DEVICE WAS PUSHED FORWARD INTO THE GUIDE CATHETER; HOWEVER, THE CATHETER BROKE IN TWO. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 8 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6755091 ↗
• InjuryJul 24, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID# 2134265-2017-07635. IT WAS REPORTED VIA USER/FACILITY MEDWATCH# 5070686 THAT MYOCARDIAL INFARCTION AND STENT THROMBOSIS OCCURRED. THE PATIENT ARRIVED AT THE EMERGENCY ROOM (ER) WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS EMERGENTLY TRANSFERRED TO THE CARDIAC CATH LAB (CCL) AND FILMS REVEALED A 90% STENOSED TARGET LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). AFTER PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15 EMERGE MR BALLOON CATHETER, TWO SYNERGY II DRUG-ELUTING STENTS, 2.50 X 20 AND 2.50 X 8, WERE DEPLOYED IN OVERLAPPING MANNER WITH GOOD RESULTS. TIMI 3 FLOW AND 0% RESIDUAL STENOSIS WERE CONFIRMED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED WITH INSTRUCTIONS FOR ACETYLSALICYLIC ACID (ASA) 81MG, PLAVIX 75MG, AND COUMADIN 5MG, AND TO DISCONTINUE XARELTO. THE PATIENT RETURNED TO THE ER WITH RIGHT FEMORAL PSEUDOANEURYSM WHICH WAS TREATED MEDICALLY. THE PATIENT WAS DISCHARGED WITH INSTRUCTED TO CONTINUE ONLY ASA AND PLAVIX AT THIS TIME DUE TO GROIN COMPLICATIONS. THE PATIENT GOT CONFUSED AT HOME REGARDING THE MEDICATIONS AND TOOK NO MEDICATIONS. THE PATIENT RETURNED AGAIN TO THE ER WITH STEMI. THE PATI

  Patient problems: Myocardial Infarction; Pseudoaneurysm; Thrombosis

  MAUDE report 6736930 ↗
• MalfunctionApr 24, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 8 SYNERGY II DRUG ELUTING STENT (DES) WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, THE STENT WAS DAMAGED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS FINE AND WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6516450 ↗
• InjuryFeb 15, 2017Device Or Device Fragments Location Unknown; Device Dislodged or Dislocated; Device Or Device Fragments Location Unknown; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-01106 AND 2134265-2017-01107. IT WAS REPORTED THAT STENT DISLODGMENT AND CHEST PAIN OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. THE LONG TARGET LESION WAS LOCATED IN THE MID TO DISTAL CIRCUMFLEX ARTERY. TWO SYNERGY DRUG-ELUTING STENTS WERE DEPLOYED TO TREAT THE LESION. AN ADDITIONAL 2.50 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE DEVICE WAS REMOVED. THE LESION WAS THEN DILATED AND THE 2.50 X 8 SYNERGY II STENT WAS ADVANCED AGAIN BUT IT STILL FAILED TO CROSS THE LESION AND THE DEVICE WAS REMOVED. HOWEVER, AFTER THE DEVICE WAS REMOVED, THE STENT WAS NO LONGER ON THE BALLOON AND COULD NOT BE LOCATED ANYWHERE. THE DISTAL PORTION WAS ONLY TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CHEST PAIN PERSISTED AND THE PATIENT WAS KEPT OVERNIGHT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Chest Pain

  MAUDE report 6331681 ↗
• MalfunctionFeb 8, 2017Bent; Bent

  SAME CASE AS MDR ID: 2134265-2017-00717. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVILY CALCIFIED AND LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATION WITH A NON BSC BALLOON CATHETER, A 2.50X8 AND A 2.50X24 SYNERGY II DRUG-ELUTING STENTS WERE SELECTED BUT FAILED TO CROSS THE LESION AND WERE NOTED TO BE DAMAGED. BOTH STENTS WERE REMOVED FROM THE PATIENT. NO OTHER STENTS WERE ABLE TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6310810 ↗