SYNERGY™ H7493926024270Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729840220), received between Nov 21, 2016 and Sep 28, 2020 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Bent” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL ARTERY. A 2.75 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION, THE STENT SHAFT BROKE. THE DEVICE NEVER ENTERED INTO THE PATIENT'S BODY 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 10594405 ↗
• MalfunctionJun 2, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS DEVICE WAS RECEIVED WITH A NOTE WRITTEN ON THE BOX "DEFECTIVE- FUZZ ON STENT STRAIGHT OUT HOOP". HOWEVER, UPON REVIEW OF THE DEVICE, IT WAS REVEALED THAT A FOREIGN MATERIAL WAS PRESENT ON THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10111478 ↗
• MalfunctionOct 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT CORONARY ARTERIES. A 2.75 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AND FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182422 ↗
• InjuryJul 1, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS AND ST-SEGMENT ELEVATION OCCURRED. THE PATIENT WAS GIVEN ASPIRIN, PLAVIX 300MG, TENECTEPLASE (TNKASE), HEPARIN BOLUS AND DRIP ADDITIONAL HEPARIN GIVEN IN CENTRAL VENOUS LINE. THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND MID CIRCUMFLEX ARTERY. SUBSEQUENTLY, TWO SYNERGY II DRUG-ELUTING STENTS WERE IMPLANTED IN THE TARGET LESIONS 95 AND 112 MINUTES AFTER TNKASE. HOWEVER, ELECTROCARDIOGRAM SHOWED ST-SEGMENT ELEVATION 5 HOURS AFTER STENT PLACEMENT. THE PATIENT WAS SENT BACK TO LAB AND IT WAS NOTED THAT BOTH STENTS WERE OCCLUDED. THE CLOT WAS REMOVED, STENTS WERE PLACED AND PATIENT WAS GIVEN AN INTEGRILIN AND BRILINTA. EJECTION FRACTION (EF) IS 20-25% AND NO FURTHER CHEST PAIN WAS EXPERIENCED PRIOR TO DISCHARGE FOLLOW-UP CLINIC VISIT STATED THAT PATIENT IS WEARING A LIFEVEST. IT WAS FURTHER REPORTED THAT THE PATIENT ALSO EXPERIENCED CHEST PAIN POST STENT PLACEMENT.

  Patient problems: Chest Pain; ST Segment Elevation; Thrombosis

  MAUDE report 8749203 ↗
• MalfunctionJun 20, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.75 X 24 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, A KINK ON THE SHAFT OF THE STENT WAS NOTED. ANOTHER OF THE SAME DEVICE WAS OPENED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Patient Involvement

  MAUDE report 8716181 ↗
• MalfunctionJan 17, 2019Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 2.75 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS STUCK ON THE NON BSC GUIDEWIRE AND WOULD NOT DETACH. THE DEVICE WAS SIMPLY REMOVED AS A WHOLE FROM THE PATIENT'S BODY. 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 8256382 ↗
• MalfunctionDec 18, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTEROLATERAL (PL) BRANCH OF THE RIGHT CORONARY ARTERY (RCA). A 2.75X24MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO PASS THE MODERATE TO SEVERE CALCIUM IN THE MID RCA. IT WAS FELT THAT THE STRUTS WERE LIFTED WHEN TRYING TO ADVANCE THE DEVICE IN THE MID AREA OF THE RCA. THE DEVICE WAS REMOVED AND TOOK ANOTHER OF THE SAME DEVICE. THE NEW STENT WAS ABLE TO PASS THE MID VESSEL AND WAS SUCCESSFULLY PLACED IN THE PL OF THE RCA AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174805 ↗
• InjuryOct 11, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT LATE STENT THROMBOSIS OCCURRED. IN (B)(6) 2017, A 2.75 X 24 SYNERGY DRUG-ELUTING STENT WAS IMPLANTED INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. IN (B)(6) 2018, THE PATIENT HAD A SUBSEQUENT HEART CATHETERIZATION AND IT WAS NOTED THAT STENT THROMBOSIS HAD OCCURRED.

  Patient problems: Thrombosis

  MAUDE report 7956288 ↗
• InjuryAug 17, 2018Activation Failure; Activation Failure

  IT WAS REPORTED THAT CHEST PAIN, VENTRICULAR FIBRILLATION, ST SEGMENT ELEVATION AND STENT INADEQUATE APPOSITION OCCURRED. THE PATIENT WITH ST-ELEVATION MYOCARDIAL INFARCTION ARRIVED VIA THE EMERGENCY ROOM AND WAS FOUND TO HAVE A 100% OCCLUDED LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH THROMBUS PRESENT AT THE DISTAL END OF A NON-BSC STENT THAT HAD BEEN IMPLANTED YEARS EARLIER, AND NO DISTAL FLOW IN THE ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY WITH A 6FR SHEATH AND A 6FR Q4 GUIDE CATHETER WAS USED TO CANNULATE THE LEFT MAIN CORONARY ARTERY. THE PATIENT WAS ANTICOAGULATED WITH HEPARIN AND ACT OF 275 THAT WAS MEASURED PRIOR TO STENT IMPLANT. THE PATIENT WAS GIVEN BRILINTA PER ORAL ADMINISTRATION AS WELL AT THIS TIME. THE OCCLUSION WAS WIRED AND THEN DILATED WITH A 2.5 X 12MM BALLOON CATHETER AND FLOW WAS RESTORED TO THE ARTERY. A 2.75 X 24MM SYNERGY DRUG-ELUTING STENT WAS PLACED JUST DISTAL TO THE PREVIOUSLY IMPLANTED NON-BSC STENT. THE INITIAL ANGIOGRAMS APPEARED TO SHOW ADEQUATE OVERLAP BETWEEN THESE TWO STENTS AND EXCELLENT FLOW TO THE DISTAL LAD. THE PATIENT WAS REMOVED FROM THE CATH LAB TABLE. WITHIN 10 MINUTES THE PATIENT'S SYMPTOMS BEGAN TO RETURN INCLUD

  Patient problems: Chest Pain; ST Segment Elevation; Ventricular Fibrillation

  MAUDE report 7794833 ↗
• MalfunctionJun 11, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS PUT INTO THE GUIDE, WHILE INSIDE THE PATIENT, THE SHAFT BROKE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DISTAL STENT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7588669 ↗
• MalfunctionJun 8, 2018Bent; Difficult to Remove; Bent; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND STENT DAMAGE OCCURRED. A 2.75 X 24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. THE DEVICE WAS REMOVED TO PERFORM FURTHER DILATATION. UPON REMOVAL, THE DEVICE SNAGGED ON THE GUIDE CATHETER AND THE STENT STARTED TO PULL FROM THE BALLOON AND APPEARED TO HAVE FOLDED OVER ON ITSELF. THE GUIDE CATHETER WAS PULLED INTO THE AORTA AND THROUGH WIRE MANIPULATION, THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7583640 ↗
• MalfunctionMay 28, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 24 SYNERGY II DRUG-ELUTING STENT WAS INSERTED OVER A NON-BSC GUIDE WIRE INTO THE GUIDE CATHETER. THERE WAS A SECONDARY NON-BSC GUIDE WIRE ALREADY PLACED IN THE GUIDE CATHETER AND DURING ADVANCING OF THE DEVICE, THERE WAS SOME RESISTANCE AND THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7547663 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT QUALIFYING CONDITION AS UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80 % STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75MMX24MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT PRESENTED TO HOSPITAL FOR THE PLANNED CATHETERIZATION AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT HAS STATED THE PHYSICIAN THAT SHE HAS BEEN HAVING MORE FATIGUE AND SHORTNESS OF BREATH FOR ONE MONTH. CORONARY ANGIOGRAPHY REVEALED MID LAD WITH 40 -60% NARROWING PROXIMAL TO STUDY STENT, PATENT STUDY STENT, 40-50% OSTIAL NARROWING IN 1ST DIAGONAL. ON THE SAME DAY, 60% STENOSIS IN PROXIMAL LAD EXTENDING TO MID LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3.0X24MM SYNERGY STENT IN AN OVERLAPPING FASHION WITH THE STUDY STENT. FOL

  Patient problems: Dyspnea; Fatigue; Reocclusion

  MAUDE report 7465275 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2018-01765, 2134265-2018-01766, 2134265-2018-01767, 2134265-2018-01776 & 2134265-2018-01778. IT WAS REPORTED THAT DECREASED BLOOD FLOW OCCURRED. IN (B)(6) 2017, THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMII). A 2.25X28MM SYNERGY STENT AND A 2.5016 SYNERGY STENT WERE IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2018, THE PATIENT PRESENTED WITH AN 85-99% STENOSED MID RCA AND A 90% RESTENOSED DISTAL RCA. NO CALCIFICATION WAS NOTED. A 185CM STR PT²¿ GUIDE WIRE WAS INTRODUCED. THE MID RCA WAS TREATED WITH TWO SYNERGY II DRUG-ELUTING STENTS, A 2.75X16MM AND A 2.75X24MM. THE DISTAL RCA WAS TREATED WITH A 2.50X12MM SYNERGY II DRUG-ELUTING STENT. A 3.0X20MM NC QUANTUM BALLOON CATHETER WAS USED FOR POST DILATATION. WHEN THE PHYSICIAN PULLED THE PT²¿ GUIDE WIRE BACK, THE WIRE CAUGHT BEHIND A STENT STRUT AND APPROXIMATELY 10MM OF THE TIP BROKE OFF IN THE DISTAL RCA STENT. THE PHYSICIAN ATTEMPTED TO REWIRE THE VESSEL SO THE DETACHED TIP COULD BE COVERED WITH A STENT, BUT THE PHYSICIAN WAS UNABLE TO ADVANCE AN EMERGE BALLOON CATHETER TO THE AREA AND THE RCA BEGAN TO HAVE A DECREASED FLOW. THE PATIENT WAS TRANSFERRED BY AN AMB

  Patient problems: Obstruction/Occlusion

  MAUDE report 7339529 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2016, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION AS UNSTABLE ANGINA AND WAS FURTHER REFERRED FOR ELECTIVE 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 22 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.75 X 24 MM AND 2.50 X 8 MM STUDY STENTS. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS. A CLEAR CUT HAZY DISTAL STENT EDGE DISSECTION WAS NOTED POST DEPLOYMENT OF INITIAL STUDY DEVICE (2.75 X 24 MM) AND SUBSEQUENTLY A DISTAL OVERLAPPING STENT (2.50 X 8 MM) WAS DEPLOYED ADDITIONALLY. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

  Patient problems: Intimal Dissection

  MAUDE report 7286824 ↗
• InjuryAug 11, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING UP TO MID LAD. POST 2.75 X 24 MM STUDY STENT PLACEMENT, THERE WAS A CLEAR CUT HAZY DISTAL STENT EDGE DISSECTION FOR WHICH, 2.50 X 8 MM STUDY STENT WAS DEPLOYED IN AN OVERLAPPING MANNER IN MID LAD. IN (B)(6) 2017, CORONARY ANGIOGRAPHY REVEALED TUBULAR FOCAL 70% IN-STENT RESTENOSIS OF STUDY STENT IN MID PORTION AND NOT 80% MID LAD AS PREVIOUSLY REPORTED.

  Patient problems: Angina; Dyspnea; Reocclusion; Thrombosis

  MAUDE report 6789610 ↗
• MalfunctionMay 25, 2017Bent; Difficult to Remove; Bent; Difficult to Remove

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE STENT STRUTS WERE BURRED AND THE DEVICE COULD NOT BE REMOVED FROM THE NON-BSC GUIDE CATHETER. SUBSEQUENTLY, THE STENT, GUIDE CATHETER, AND GUIDE WIRE WERE REMOVED TOGETHER, AND THE PHYSICIAN RE-WIRED THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6590503 ↗
• MalfunctionMay 10, 2017Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-APR-2017. IT WAS REPORTED THAT INSERTION DIFFICULTIES WERE ENCOUNTERED. DURING INTRODUCTION OF A 2.75 X 24 SYNERGY II DRUG-ELUTING STENT INTO A PT GRAPHIX GUIDE WIRE, THE DEVICE WAS UNABLE TO FEED OVER THE GUIDE WIRE. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75 X 24 SYNERGY II DRUG-ELUTING STENT AND THE SAME PT GRAPHIX GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Patient Involvement

  MAUDE report 6556837 ↗
• MalfunctionApr 25, 2017Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.75 X 24 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, DURING PREPARATION WHEN THE STYLET WAS PULLED, THE PHYSICIAN ACCIDENTALLY GRIPPED THE STENT OFF UPON WITHDRAWING. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75 X 24 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6520478 ↗
• MalfunctionFeb 8, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. NO PRE-DILATATION WAS PERFORMED. A 2.75 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROXIMAL END OF THE STENT WAS NOTED TO BE A LITTLE FLAYED. THE LESION WAS PRE-DILATED 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 6312403 ↗
• InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. IN (B)(6) 2016, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY EXTENDING TO SECOND OBLIQUE MARGINAL ARTERY(OM) WIH 90% STENOSIS AND WAS A 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 20 MM SYNERGY II DRUG-ELUTING STENT (DES). FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. TARGET LESION #2 WAS LOCATED IN PROXIMAL LCX EXTENDING TO DISTAL LCX WITH 80% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 20 MM SYNERGY II DES WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. TARGET LESION #3 WAS LOCATED IN MID RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM..TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 12 MM SYNERGY II DES WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. HOWEVER, A PERFORATION WAS NOTED POST INDEX PROCEDUR

  Patient problems: Perforation of Vessels

  MAUDE report 6117874 ↗