SYNERGY™ H7493926008300Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729839996), received between Nov 16, 2016 and May 13, 2021 — classified as 4 deaths, 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Bent” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL PRESENT ON THE DEVICE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 8 SYNERGY STENT WAS SELECTED FOR USE AND WAS OPENED IN STERILE FASHION. UPON REMOVING THE STENT FROM THE HOOP, A CLEAR PIECE OF ADHESIVE WAS NOTED. THE DEVICE NEVER WENT INTO THE PATIENT. A NEW STENT WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE ADHESIVE WAS ON THE MID SHAFT OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821474 ↗
• DeathApr 15, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT HYPOTENSION, THROMBOSIS, AND DEATH OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE 85% STENOSED MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 75% STENOSED NON-CALCIFIED CIRCUMFLEX ARTERY (CX). AT THE BEGINNING OF THE PROCEDURE, THE PATIENT WAS HYPOTENSIVE. A VENTRICULAR SUPPORT DEVICE WAS USED AND PROCEDURE WAS CONTINUED. FOLLOWING ROTABLATION, THREE SYNERGY DRUG ELUTING STENTS, A 3.00 X 32, A 3.00 X 8, AND A 3.50 X 38 RESPECTIVELY WERE IMPLANTED, TWO IN THE LAD AND ONE IN THE CX. A NON-BOSTON SCIENTIFIC STENT WAS ALSO IMPLANTED IN THE CX. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS STABLE. WHEN THE VENTRICULAR SUPPORT DEVICE WAS REMOVED, THE PATIENT BECAME HYPOTENSIVE AGAIN. WHEN THE PHYSICIAN WENT BACK IN WITH THE GUIDE, IT WAS NOTED THAT ALL STENTS HAD STENT THROMBOSIS. BOTH THE LAD AND CX ARTERIES WERE CLOSED OFF AND THE PHYSICIAN WAS UNABLE TO REOPEN EITHER ONE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED BUT THE PATIENT DID NOT SURVIVE. THE OFFICIAL CAUSE OF DEATH WAS CORONARY THROMBUS. NO AUTOPSY WAS PERFORMED.

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 11676198 ↗
• DeathSep 17, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00 X 8 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT WAS UNABLE TO CROSS THE LESION. THE LAD WENT DOWN, THE PATIENT WAS SENT TO THE OPERATING ROOM; HOWEVER, THE PATIENT DIED.

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 10547643 ↗
• DeathSep 16, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING PRE-DILATATION WITH A 3.00 X 12 APEX BALLOON, A 3.00 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE LAD WENT DOWN. THE PATIENT WAS SENT TO OPERATING ROOM FOR SURGERY BUT BEFORE THEY COULD GET THE PATIENT ON BYPASS, HE EXPIRED.

  Patient problems: Death; No Consequences Or Impact To Patient; Obstruction/Occlusion

  MAUDE report 10544478 ↗
• DeathSep 16, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION WITH A 3.00X20 APEX BALLOON, A 3.00 X 8 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE LESION WENT DOWN AND THE PATIENT WENT TO THE OPERATING ROOM WHERE THEY SUBSEQUENTLY DIED.

  Patient problems: Death; Obstruction/Occlusion

  MAUDE report 10544450 ↗
• MalfunctionDec 6, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED MID RIGHT CORONARY ARTERY. FOLLOWING PREDILITATION WITH A 2.0X8MM NON-BSC BALLOON, A 3.00 X 8 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION AND WAS REMOVED. A GUIDEZILLA WAS ADVANCED OVER THE WIRE AND THE 3.0X8MM SYNERGY STENT ADVANCED ONCE MORE BUT THE STENT STILL FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PHYSICIAN NOTICED THAT THE STENT STRUT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH OTHER DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9427935 ↗
• MalfunctionSep 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 3.00 X 8 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, IT WAS NOTED THAT THE STENT SEPARATED FROM THE PLATFORM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8982293 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA) AND MID RCA. A 3.00 X 8MM SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION BUT HAD DIFFICULTIES IN DELIVERING THE DEVICE. THE PHYSICIAN WAS TRYING TO GET TO A DISTAL LESION IN THE RCA BUT THE SHAFT SNAPPED 8 INCHES FROM THE HUB. THE DEVICE WAS REMOVED OUT OF THE PATIENT AND CONTINUED THE CASE WITH A DIFFERENT DEVICE. A 3.00 X 12 SYNERGY DRUG-ELUTING STENT WAS THEN ADVANCED IN THE MIDDLE OF THE RCA TO GET A SECOND STENT PLACED; HOWEVER, WHEN THE DEVICE WAS PUSHED, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 3.0X12MM NON BSC STENT AND A 4.00X16MM SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588486 ↗
• MalfunctionSep 3, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER A GUIDE WIRE WAS ADVANCED IN THE LESION. A 2.50 X 12MM SYNERGY II DRUG-ELUTING STENT (DES) AND A 3.00 X 8MM SYNERGY II DES WERE NOTED TO BE DEFECTIVE. WHEN THE PHYSICIAN ADVANCED THE SAID STENTS ON THE WIRE, HE NOTED THAT THE STENTS WERE SLIGHTLY BENT AND HE FELT THAT IT WOULD NOT CROSS WELL. THE PHYSICIAN IMPLANTED THREE STENTS AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840685 ↗
• MalfunctionApr 3, 2018Bent; Difficult to Remove; Bent; Difficult to Remove

  IT WAS REPORTED THAT STENT DAMAGE AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00X8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN TRYING TO REMOVE THE STENT FROM THE PATIENT'S BODY, THE PROXIMAL PORTION OF THE STENT GOT SNAGGED ON THE GUIDE AND WAS MINGLED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393662 ↗
• MalfunctionMar 17, 2018Bent; Bent

  SAME CASE AS MDR ID: 2134265-2018-02021. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE-DILATION WITH 3.0X20MM AND 3.5X15MM NC EMERGE BALLOON CATHETERS, A 3.00 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT WOULD NOT CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. X-RAY WAS PERFORMED AND IT WAS CONFIRMED THAT THE STENT STRIPPED OFF THE BALLOON IN THE RCA, A GUIDE WIRE WAS USED TO WRAP AROUND THE STENT. THE STENT, GUIDE CATHETER AND GUIDE WIRE WERE REMOVED AS ONE UNIT. A 3.00 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, IT WAS NOTED THAT THE STENT STRUTS GOT BANGED UP AND RAISED OFF OF THE BALLOON. MULTIPLE ADDITIONAL INFLATIONS WERE THEN PERFORMED USING A 3.0X20MM NC EMERGE BALLOON CATHETER AND A GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00 X 8MM SYNERGY STENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7347613 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2017-11815. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA AND THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WITH 75% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF 3.00X24MM AND 3.00X8MM STUDY STENTS. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, A DISSECTION WAS NOTED AT THE PROXIMAL LAD AND AN INTERVENTIONAL PROCEDURE WAS PERFORMED. ONE DAY, POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

  Patient problems: Intimal Dissection

  MAUDE report 7081895 ↗
• MalfunctionOct 13, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN (LM) EXTENDING TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER LASER AND PRE-DILATION WAS PERFORMED, A 3.00 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SHAFT NEAR THE HUB BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6949036 ↗
• InjurySep 8, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID 2134265-2017-08903. IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 0.014 NON-BSC GUIDEWIRE ANGIOPLASTY WAS INTRODUCED TO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT HAS 100% ACUTE TOTAL OCCLUSION, MOSTLY DUE TO WHAT APPEARED TO BE SPONTANEOUS PLAQUE RUPTURE. THE DEVICE ABLE TO CROSS THE 100% TOTAL OCCLUSION SUCCESSFULLY AND THE NON-BSC GUIDEWIRE ANGIOPLASTY WAS ADVANCED DISTALLY TO THE FIRST DIAGONAL BRANCH. SUBSEQUENTLY, A SECOND WIRE OF 0.014 NON-BSC GUIDEWIRE ANGIOPLASTY WAS ADVANCED AND CROSSED AGAIN THE PROXIMAL LAD ARTERY AND ADVANCED ALL THE WAY DISTALLY INTO THE DISTAL LAD ARTERY. NEXT, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF THE PROXIMAL LAD ARTERY WAS PERFORMED USING 2.5X12MM NON-BSC BALLOON CATHETER WHICH IMPROVED THE ANTEGRADE FLOW AND NOW, IT IS CLEAR THAT THERE IS SEVERE DIFFUSE DISEASE IN THE EARLY MID LAD ARTERY, IN ADDITION TO THE PROXIMAL TOTAL OCCLUSION. SUBSEQUENTLY, BALLOON ANGIOPLASTY OF THE OSTIAL DIAGONAL BRANCH WAS PERFORMED USING A 2.5 BALLOON CATHETER. THIS WAS FOLLOWED BY DELIVERING 2.75X38MM SYNERGY DRUG-ELUTING STENT THAT WAS USED TO COVER TH

  Patient problems: Chest Pain; ST Segment Elevation; Thrombosis

  MAUDE report 6852455 ↗
• InjuryMay 19, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.00 X 8 SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS ATTEMPTED TO BE RETRIEVED BY SNARING, BUT ENDED UP BEING CRUSHED AGAINST THE RCA WALL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6580184 ↗
• MalfunctionMay 15, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-APR-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.00 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROXIMAL STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567375 ↗
• MalfunctionApr 11, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS DAMAGED WHILE TRYING TO PASS THROUGH A PREVIOUSLY IMPLANTED STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6479544 ↗
• MalfunctionMar 3, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 8 SYNERGY II DRUG ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE MOST DISTAL END OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6376281 ↗
• InjuryDec 2, 2016Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  SAME CASE AS MDR ID: 2134265-2016-11284, 2134265-2016-11285. IT WAS REPORTED VIA FACILITY MEDWATCH# MW5065811 THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION. SUBSEQUENTLY, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WITH PERCUTANEOUS INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER PRE-DILATION WAS PERFORMED USING A 2.5X12MM BALLOON, A 3.5X16MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. THE PROXIMAL PORTION OF THE RCA WAS TREATED WITH A 3.5X8MM SYNERGY II DRUG-ELUTING STENT OVERLAPPING THE 3.5X16MM SYNERGY II STENT. A 3.0X8MM SYNERGY II DRUG-ELUTING STENT WAS ALSO IMPLANTED DISTALLY AND OVERLAPPING THE 3.5X16MM SYNERGY II STENT. THE STENTS WERE POSTULATED WITH A 3.5MM NON COMPLIANT BALLOON CATHETER FOLLOWED BY A 4.0MM NON COMPLIANT BALLOON CATHETER. ANGIOGRAPHY WAS PERFORMED AND REVEALED THAT THE STENTS APPEARED TO BE WELL-EXPANDED WITH NO EVIDENCE OF DISSECTIONS AND TIMI 3 FLOW THROUGHOUT THE CORONARY ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE NON-BSC GUIDEWIRE FOR FINAL ANGIOGRAPHY UNDER FLUOROSCOPY. AFTER INITIAL WITHDRAWAL OF THE GUIDEWIRE, THE VERY DISTAL PORTION OF THE RADIOPAQUE TIP OF T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6141645 ↗
• InjuryNov 16, 2016Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2016-10081. IT WAS REPORTED THAT STENT MOVED ON BALLOON AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.00X8MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT COULD HAVE MOVED ON THE BALLOON AND THE PHYSICIAN NOTICED THAT THE STENT HAD A LONGITUDINAL DEPRESSION SO THE PHYSICIAN DEPLOYED THE STENT IN PROXIMAL RCA. BECAUSE OF THE CRUNCHING OF THE FIRST STENT, THE PHYSICIAN ADVANCED A 3.00X12MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND THE STENT COULD ALSO HAVE MOVED ON THE BALLOON AND ALSO HAD SOME LONGITUDINAL DEPRESSION SO THE PHYSICIAN DEPLOYED THE SECOND STENT AS WELL IN PROXIMAL RCA. BOTH STENTS WERE POST DILATED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT IMPLANTED IN THE OSTIUM OF THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE AND FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6106803 ↗