SYNERGY™ H7493926008220Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729839965), received between Nov 21, 2016 and Jul 20, 2021 — classified as 1 death, 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.25 X 8 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT DID NOT CROSS THE LESION AND WAS TOO DAMAGED TO BE USED AS THE STENT STRUTS WERE LIFTED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196442 ↗
• MalfunctionOct 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 8 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE DISTAL TIP OF THE STENT ITSELF WAS DEFORMED FROM THE BALLOON BEFORE ENTERING THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10632011 ↗
• MalfunctionApr 25, 2019Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 8 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION AND THEY BENT THE HYPOTUBE AGGRESSIVELY AND IT ENDED UP BROKEN IN TWO. THEY WERE ABLE TO REMOVE THE DEVICE. 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 8549890 ↗
• MalfunctionAug 9, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-JUL-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.25X8MM 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 DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7769611 ↗
• MalfunctionJun 20, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DELIVERY OF THE STENT TO THE LESION, IT WAS NOTED THAT THE SHAFT BROKE OUTSIDE THE PATENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7622473 ↗
• MalfunctionApr 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 8MM SYNERGY II STENT WAS ADVANCED AND HAD DIFFICULTY PASSING THROUGH TWO IMPLANTED STENTS AND ULTIMATELY DID NOT CROSS. UPON DRAWING THE DEVICE BACK, THE STENT MOVED ON THE BALLOON. THE STENT AND DELIVERY SYSTEM WERE ABLE TO BE PULLED OUT AS THE PROXIMAL SECTION OF THE STENT WAS STILL ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426769 ↗
• InjuryMar 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS CORONARY ARTERY IN WHICH A STENT HAD BEEN PREVIOUSLY IMPLANTED. A 2.25 X 8MM SYNERGY II STENT WAS ADVANCED FOR TO TREAT THE LESION AND THE STENT SLIPPED OFF FROM THE BALLOON. ANOTHER BALLOON CATHETER WAS ADVANCED AND THE DISLODGED STENT WAS EXPANDED PROPERLY TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7327700 ↗
• InjuryFeb 9, 2018Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE BIFURCATED TARGET LESION WAS LOCATED IN THE CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM) ARTERY. BOTH LESIONS WERE TREATED WITH PRE-DILATION. A STENT WAS IMPLANTED IN CX ARTERY. POST DILATION WAS THEN PERFORMED. AFTER REWIRING THE OM ARTERY, A 2.25 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED AND PASSED THROUGH THE IMPLANTED STENT IN CX DOWN TO THE OM ARTERY. WHEN THE PHYSICIAN REPOSITIONED THE DEVICE, IT WAS NOTICED THAT THE STENT HAD BEEN DISLODGED FROM THE DELIVERY SYSTEM. THE PHYSICIAN WAS UNABLE TO PASS A BALLOON CATHETER THROUGH THE DISLODGED STENT. THE STENT WAS LEFT IN GOOD POSITION, UNDEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7258919 ↗
• MalfunctionDec 1, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-NOV-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.25X8 SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7077609 ↗
• InjuryOct 20, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE EXTREMELY CALCIFIED AND TORTUOUS CIRCUMFLEX ARTERY. A 2.25 X 8 SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. UPON REMOVING THE DEVICE FOR FURTHER PRE-DILATATION, THE STENT CAME OFF FROM THE BALLOON WHICH WAS THEN SNARED OUT FROM THE PATIENT'S BODY. 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 6967338 ↗
• InjuryAug 23, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 2.25 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED THROUGH A PREVIOUSLY IMPLANTED STENT. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. ANOTHER BALLOON CATHETER WAS ADVANCED INTO THE PROXIMAL RCA AND DEPLOYED THE DISLODGED STENT. THE PROCEDURE WAS THEN COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812837 ↗
• MalfunctionMay 8, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON APRIL 24, 2017. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25 X 8 SYNERGY 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 HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6552482 ↗
• DeathFeb 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2017-01585 AND 2134265-2017-01584. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2016, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00X20MM SYNERGY II DRUG-ELUTING STUDY STENT. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS AND TIMI FLOW 3. TARGET LESION #2 WAS LOCATED IN THE RAMUS BRANCH WITH 85% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X16MM SYNERGY II DRUG-ELUTING STUDY STENT. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS AND TIMI FLOW 3. TARGET LESION #3 WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH WITH 90% STENOSIS AND WAS 5MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.0MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25X8MM SYNERGY II DRUG-ELUTING STUDY STENT. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS AND TIMI FLOW 3. THE FOLLOWING DAY, THE PATIE

  Patient problems: Atrial Fibrillation; Cardiac Enzyme Elevation; Cardiomyopathy; Congestive Heart Failure; Death; Dizziness; Dyspnea; Low Blood Pressure/ Hypotension; Renal Failure; Respiratory Failure

  MAUDE report 6354374 ↗
• MalfunctionFeb 21, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL BRANCH. A 2.25 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING INSERTION, THE SHAFT BROKE APPROXIMATELY THREE QUARTERS FROM THE TIP OF THE CATHETER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6347650 ↗
• InjuryFeb 2, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 2.25 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT WOULD NOT GO OUT OF THE LEFT MAIN INTO THE CIRCUMFLEX. AS THE DEVICE WAS ATTEMPTED TO BE REMOVED, THE STENT CAME OFF OF THE DELIVERY SYSTEM AND WAS LOCATED IN THE LEFT MAIN. A BALLOON CATHETER WAS ADVANCED, ATTEMPTED TO INFLATE AND PULL THE STENT BACK INTO THE GUIDE CATHETER; HOWEVER, THE STENT WENT DOWN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A NON-BSC STENT WAS THEN DEPLOYED AND CRUSHED THE SYNERGY STENT UP AGAINST THE VESSEL WALL. ANOTHER NON-BSC STENT WAS DEPLOYED IN THE CIRCUMFLEX ARTERY TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6298940 ↗
• InjuryDec 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2016-12021. (B)(6). IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2016, THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING UP TO DISTAL LAD WITH 80% STENOSIS AND WAS 18MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 28MM AND 2.25 X 8MM SYNERGY II STENTS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. HOWEVER, POST PROCEDURE, A GRADE A DISSECTION WAS NOTED, WHICH WAS TREATED WITH INTERVENTION. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

  Patient problems: Vascular Dissection

  MAUDE report 6195604 ↗
• MalfunctionNov 21, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE SHAFT OF A 2.25 X 8 SYNERGY II DRUG-ELUTING STENT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118824 ↗