SYNERGY™ H7493926038270Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729840404), received between Jan 30, 2017 and Mar 8, 2021 — classified as 2 deaths, 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. FOLLOWING PRE-DILATATION WITH A 2.5X20MM BALLOON CATHETER, A 2.75 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11433388 ↗
• InjuryDec 14, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND PATIENT WAS SENT FOR SURGERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX. A 2.75 X 38 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, WHEN REMOVING THE CATHETER, IT WOULD NOT PULL OUT FROM THE LESION AND IT WAS NOTED THAT THE SHAFT BROKE AT THE JUNCTION BETWEEN THE MID AND DISTAL SHAFT. THE BALLOON END WAS LEFT IN THE PATIENT'S BODY AND THE PATIENT WAS SENT FOR EMERGENCY STERNOTOMY TO REMOVE THE BROKEN PARTS. IT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT'S BODY AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 11004158 ↗
• MalfunctionJul 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THEY REMOVED THE DEVICE, IT WAS NOTICED THAT THE PROXIMAL LINE OF THE STRUTS WERE LIFTED UP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10255811 ↗
• MalfunctionJul 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY CALCIFIED ARTERY. FOLLOWING PRE-DILATATION WITH A WOLVERINE CUTTING BALLOON, A 2.75 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING PROCEDURE, THE STENT BROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10247855 ↗
• InjuryFeb 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.75 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED AND PLACED THROUGH PREVIOUSLY IMPLANTED STENT TO DELIVER IT DISTALLY. HOWEVER, DURING THE PROCEDURE, THE STENT STRIPPED OFF OF THE DELIVERY SYSTEM AND THE DEVICE WAS NOT REMOVED FROM THE PATIENT'S BODY. INFLATION WAS PERFORMED AND THE STENT WAS PLACED OVER TOP OF THE PREVIOUS STENT. THEY ENDED UP TAKING A 6F GUIDEZILLA OVER THAT WIRE THAT WAS ALREADY PLACED, WENT THROUGH THE STENT STRUTS OF BOTH THE PREVIOUS AND NEW STENT AND THEN PLACED AN ADDITIONAL 2.75X38 SYNERGY STENT. A GUIDEZILLA WAS USED TO GO THROUGH THE STENTS AND THEN PLACED THE OTHER STENT DISTALLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9703770 ↗
• MalfunctionNov 6, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, A STRUT THAT WAS LIFTED UP WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9288839 ↗
• MalfunctionSep 30, 2019Break; Deflation Problem; Material Rupture; Break; Deflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE, BALLOON RUPTURE, AND SHAFT DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 38 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, WHEN BALLOON DEFLATION WAS ATTEMPTED, THE STENT BALLOON FAILED TO DEFLATE. AFTER MULTIPLE ATTEMPTS TO PROVIDE NEGATIVE PRESSURE, THE STENT BALLOON RUPTURED. PART OF THE SHAFT OF THE STENT DELIVERY SYSTEM SHEARED OFF AND WAS RETAINED IN THE LAD. SNARING OUT OF THE SHAFT FRAGMENT WAS ATTEMPTED BUT FAILED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9136094 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS RIGHT CORONARY ARTERY (RCA). A 2.75 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER MULTIPLE ATTEMPTS TO PASS THE OSTIUM OF THE RCA, THE SHAFT BENT. THE CATHETER WAS SNAPPED BEFORE PUTTING IN THE DEVICE BOX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811371 ↗
• MalfunctionJul 11, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19JUN2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75X38MM 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 8780365 ↗
• DeathJun 4, 2019Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2018, THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00X38MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE TARGET LESION #2 WAS A LONG LESION EXTENDING FROM PROXIMAL RIGHT CORONARY ARTERY (RCA) TO MID RCA WITH 80% STENOSIS AND WAS 56MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF 2.75X38MM AND 2.75X32MM STUDY STENTS. FOLLOWING POST DILATATION, RESIDUA STENOSIS WAS 0% WITH TIMI 3 FLOW. POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2019, THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM VIA EMERGENCY MEDICAL SERVICES. THE PATIENT WAS FOUND TO BE UNRESPONSIVE, PULSELESS AND APNEIC. THE PATIENT WAS ALSO NOTED TO HAVE SHORTNESS OF BREATH. ON ARRIVAL TO EMERGENCY DEPARTMENT, ELECTROCARDIOGRAM (EKG) REVEALE

  Patient problems: Cardiopulmonary Arrest; Death; Thrombosis

  MAUDE report 8668992 ↗
• MalfunctionApr 24, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 38MM SYNERGY II DRUG ELUTING STENT (DES) WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN WAS ADVANCING THE STENT IN THROUGH A 6 FR NON-BSC GUIDE EXTENSION CATHETER OVER A NON-BSC GUIDE WIRE, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. A NEW 2.75 X 38MM SYNERGY II DES WAS ADVANCED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547580 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY(LAD). TWO STENTS WERE PLACED IN THE LAD, A 2.75X38MM SYNERGY IN MID LAD, OVERLAPPED PROXIMALLY WITH 3.0X32MM SYNERGY II DRUG-ELUTING STENT. PATIENT WAS NOTED TO BE FINE POST PROCEDURE. HOWEVER, SEVERAL HOURS LATER, THE PATIENT WAS SYMPTOMATIC AND HAD TO BE RE-CATHED WHICH REVEALED THROMBUS IN THE LAD STENTS. THE PHYSICIAN PREFORMED A THROMBECTOMY TREATMENT PROCEDURE, ADMINISTERED DOSE OF AGGRASTAT ALONG WITH MORE BALLOONING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Thrombosis

  MAUDE report 8282445 ↗
• MalfunctionNov 13, 2018Fracture; Fracture

  IT WAS REPORTED THE STENT STRUTS WERE BROKEN. A 2.75 X 38 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE DEFECTIVE AND BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063957 ↗
• InjuryJun 4, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT STENT UNDER EXPANSION AND RECOIL OF STENT OCCURRED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT¿S QUALIFYING CONDITION AS STABLE ANGINA AND WAS FURTHER REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. TARGET LESION #1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF A 3.00 X 20MM STUDY STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 5%. TARGET LESION #2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 75% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.75 X 38MM STUDY STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 5%. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT VISITED FOR FOLLOW UP OF ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH OTHER FORMS OF ANGINA PECTORIS. THE PATIENT REPORTED CLASSIC CHEST DISCOMFORT WHILE WALKING ONE FOUR

  Patient problems: Angina

  MAUDE report 7567246 ↗
• MalfunctionFeb 28, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  SAME CASE AS MDR ID: 2134265-2018-01403. IT WAS REPORTED THAT THE RO MARKER BAND COULD NOT BE VISUALIZED DURING DEPLOYMENT. THE 80% TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATATION, A 2.75 X 28MM SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, DURING DEPLOYMENT, THE STENT COULD NOT BE VISUALIZED. AFTER THAT A 2.75 X 38MM SYNERGY II STENT WAS ADVANCED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED DURING DEPLOYMENT. THE PHYSICIAN DOUBLE CHECKED EVERYTHING AND THE STENT STILL COULD NOT BE VISUALIZED. A THIRD STENT WAS THEN DEPLOYED WITHOUT ANY PROBLEMS WITH VISUALIZING AND THE PROCEDURE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303957 ↗
• MalfunctionFeb 28, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRODUCT STERILITY WAS COMPROMISED. A 2.75 X 38MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, WHEN THE DEVICE WAS TAKEN OUT OF THE HOOP, THE MONORAIL PORTION CAUGHT THE SCRUB TECHNICIAN'S GLOVE AND RIPPED THE GLOVE. NO PATIENT COMPLICATIONS WERE NOTED AS THIS OCCURRED OUTSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302226 ↗
• MalfunctionJan 17, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON DEFLATION, THE DELIVERY BALLOON GOT CAUGHT IN THE STENT. AS THE PHYSICIAN PULLED THE DEVICE WITH SOME EXTRA EFFORT, THE WIRE AND GUIDE CATHETER WERE ALSO PULLED OUT. THE STENT WAS DEPLOYED FINE 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 7202393 ↗
• DeathDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR#: 2134265-2017-11610. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2017, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 50 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.4 MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF 3.00 X24 MM AND 2.75 X38 MM STUDY STENTS FOLLOWING WHICH RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT FELT DIZZY, DIAPHORETIC AND WEAKNESS IN BOTH LEGS WHILE AMBULATING IN WITH FRONT WHEEL WALKER AT HOME. THE PATIENT SUBSEQUENTLY FELL TO THE FLOOR AND WAS UNRESPONSIVE FOR 10-12 MINUTES. THE PATIENT HAD A HISTORY OF FALL FROM THE WEEK PRIOR. THE PATIENT¿S RADIAL PULSE WAS 40BPM AND AN ATTEMPT TO OBTAIN THE BLOOD PRESSURE AT HOME WAS UNSUCCESSFUL AS THE BLOOD PRESSURE WAS UNREADABLE ON THE AUTOMATIC BLOOD PRESSURE CUFF. THE EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND BY THE TIME EMS ARRIVED, THE PATIENT WAS MORE ALERT AND ORIENTED. PER EMS, THE SUBJECT DID NOT SEEMS TO BE POSTICTAL

  Patient problems: Cardiac Arrest; Death; Respiratory Failure

  MAUDE report 7081885 ↗
• MalfunctionNov 22, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75X38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, AFTER DEVICE WAS INSERTED INTO THE GUIDE CATHETER, IT WAS NOTICED THAT THE STENT STRUTS WERE DEFORMED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7053022 ↗
• MalfunctionSep 26, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN AN IN-STENT RESTENOSIS OF A NON-BSC STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AT THE BIFURCATION OF THE POSTERO-LATERAL ARTERY (PLA) AND POSTERIOR DESCENDING ARTERY (PDA). AFTER PRE-DILATATION WAS PERFORMED WITH AN EMERGE BALLOON CATHETER, A GUIDEZILLA GUIDE EXTENSION CATHETER WAS POSITIONED IN THE MID RCA FOR SUPPORT. SUBSEQUENTLY, A 2.75 X 38 SYNERGY II STENT WAS ATTEMPTED TO BE ADVANCED TO TREAT THE LESION; HOWEVER, THE PROXIMAL PORTION OF THE STENT SHAFT BROKE OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 3.0X38 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6893001 ↗
• MalfunctionSep 19, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 30-AUG-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.75 X 38 MM 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 DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6876776 ↗
• InjurySep 8, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID 2134265-2017-08904. 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 6852390 ↗
• MalfunctionJun 19, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 2.75 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS PASSING THROUGH A NON-BSC GUIDE EXTENSION CATHETER, THE SHAFT BROKE APPROXIMATELY 60CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND 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 6650207 ↗
• MalfunctionMay 3, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 38 SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON INTRODUCING THE DEVICE INTO THE KINKED AREA OF THE GUIDE CATHETER, THE PHYSICIAN PUT A FORCE ON SHAFT UNTIL THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6540747 ↗
• InjuryApr 13, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS AND CHEST PAIN OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER PREDILATION, A 2.75 X 38 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED AND POST DILATION WAS DONE. HOWEVER, THE PATIENT HAD CHEST PAIN. ABOUT 45 MINUTES LATER, IT WAS NOTED THAT THE LAD WAS OCCLUDED. A NON-BSC ASPIRATION CATHETER WAS USED TO ASPIRATE THE THROMBUS AND THE PATIENT WAS GIVEN INTEGRILLIN AND WAS TRANSFERRED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 6490116 ↗