SYNERGY™ H7493926016270Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729840107), received between Dec 6, 2016 and Nov 6, 2020 — classified as 1 death, 7 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.

• MalfunctionNov 6, 2020Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-OCT-2020. IT WAS REPORTED THAT CROSSING AND ADVANCING DIFFICULTIES OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.75 X 16 SYNERGY DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE THE STENT FAILED TO CROSS AND WAS WITHDRAWN FROM THE BODY WITHOUT ISSUE. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS THEN ADVANCED BUT WHEN THE STENT WAS RE-INSERTED, IT WAS UNABLE TO ADVANCE THROUGH THE GUIDEZILLA. THE CASE WAS NOT LENGTHENED AND THE PATIENT WAS NOT HARMED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10801242 ↗
• MalfunctionOct 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 2.75 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE THE STENT STRUT WAS FOUND LIFTED UPON CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666651 ↗
• MalfunctionAug 21, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29 JUL 2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.75 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE ARTERY WAS HIGHLY CALCIFIED AND THE DEVICE COULD NOT 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 10436998 ↗
• MalfunctionJul 31, 2020Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-JUL-2020. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. PRE-DILATION WAS PERFORMED WITH A 2.5 X 12 EMERGE AND A 2.5 X 10 WOLVERINE BALLOON CATHETERS. A 2.75 X 16 SYNERGY DRUG-ELUTING STENT WAS PLACED OVER THE WIRE INTO THE LESION. THE STENT WAS CONNECTED TO THE INFLATION DEVICE AND INFLATED TO NOMINAL PRESSURE, BUT THE STENT BALLOON DID NOT INFLATE, THE INFLATION DEVICE DID NOT HOLD A PRESSURE, AND THE ATMOSPHERES KEPT DROPPING AS INFLATING. THERE WAS BLOOD BACKING INTO THE CONNECTED DEFLATION DEVICE. THE INFLATION DEVICE WAS DISCONNECTED, AND THE STENT DELIVERY SYSTEM AND WIRE WERE REMOVED AT THE SAME TIME. ONCE REMOVED, THE STENT WAS INTACT ON THE BALLOON. THE LCX WAS REWIRED WITH A NEW WIRE AND INSERTED A NEW 2.75 X 16 SYNERGY STENT AND WAS DEPLOYED WITH THE SAME INFLATION DEVICE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE AND STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10350005 ↗
• InjuryMar 30, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.75X16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. THIS CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE WHICH RESULTED IN AN ADVERSE EVENT.

  Patient problems: Injury

  MAUDE report 9897675 ↗
• MalfunctionDec 4, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SYNERGY DEVICE DISLODGED INSIDE THE GUIDEZILLA II DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 6F GUIDEZILLA II GUIDE CATHETER WAS USE TO ADVANCED A 2.75 X 16 SYNERGRY DRUG-ELUTING STENT TO TREAT THE LESION. HOWEVER, IT FAILED TO CROSS THE LESION EVEN AFTER MULTIPLE ATTEMPTS. WHEN THE STENT WAS PULLED BACK INTO THE GUIDEZILLA, IT HUNG UP AND BROKE OFF THE BALLOON. EVERYTHING WAS REMOVED FROM THE PATIENT'S BODY AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410809 ↗
• MalfunctionApr 11, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75X16MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, RESISTANCE WAS FELT UPON ADVANCING THE DEVICE AS THE WIRE SEEMED DRY AND WHEN THE DEVICE WAS PUSHED A LITTLE TOO HARD, THE SHAFT SNAPPED IN HALF. THE DEVICE WAS COMPLETELY REMOVED WITH THE STENT STILL INTACT. THE PROCEDURE WAS COMPLETED WITH A 2.75X16MM SYNERGY STENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8504533 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 16 SYNERGY WAS BEING USED FOR TREATMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). HOWEVER, DURING ADVANCEMENT, THE SHAFT GOT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8103307 ↗
• MalfunctionOct 4, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER A 5F 3.75 NONBSC GUIDE CATHETER WAS ENGAGED OVER A NONBSC GUIDE WIRE, A 2.75 X 16MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE LENGTH OF THE GUIDE WAS IMAGED, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM HAD DETACHED AT THE BISEGMENTED PORTION OF THE CATHETER AND THE HYPOTUBE. THE STENT WAS SUBSEQUENTLY REMOVED VIA THE GUIDE CATHETER AND WIRE. THE DEVICES WAS REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED WITH A NONBSC STENT. NO PATIENT COMPLICATIONS NO INJURIES WERE REPORTED. SYNERGY II US MR WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE CRIMPED STENT OD (OUTER DIAMETER) WAS MEASURED AND MET SPECIFICATION. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934281 ↗
• MalfunctionAug 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. DURING PREPARATION OF A 2.75X16MM SYNERGY II DRUG-ELUTING STENT, IT WAS OBSERVED THAT THE STENT CAME OFF THE BALLOON OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X16MM SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7748219 ↗
• MalfunctionMay 25, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75X16MM SYNERGY II STENT WAS ADVANCED TO TREAT THE TARGET LESION. HOWEVER, AFTER DEPLOYING THE STENT, THE BALLOON RUPTURED AT 16 ATMOSPHERES. THE DEVICE WAS COMPLETELY REMOVED. POST-DILATATION WAS PERFORMED USING A NON-COMPLIANT BALLOON 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 7545009 ↗
• MalfunctionMay 2, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 2.75 X 16MM SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7479443 ↗
• MalfunctionApr 27, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-APRIL-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 16MM 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 PROXIMAL AND DISTAL STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7470766 ↗
• MalfunctionMar 27, 2018Break; Break

  IT WAS FURTHER REPORTED THAT THE SHAFT BROKE OUTSIDE THE PATIENT'S BODY AND OUTSIDE THE NON-BSC BLEED-BACK CONTROL VALVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374259 ↗
• MalfunctionMar 19, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.75 X 16 SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING ADVANCING THE DEVICE THROUGH THE GUIDE CATHETER, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75 X 16 SYNERGY II STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7348957 ↗
• 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, 2134265-2018-01777 AND 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 2.25 X 28 MM 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 185 CM STR PT²¿ GUIDE WIRE WAS INTRODUCED. THE MID RCA WAS TREATED WITH TWO SYNERGY II DRUG-ELUTING STENTS, A 2.75 X 16 MM AND A 2.75 X 24 MM. THE DISTAL RCA WAS TREATED WITH A 2.50 X 12 MM SYNERGY II DRUG-ELUTING STENT. A 3.0 X 20 MM 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 10 MM 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 TR

  Patient problems: Obstruction/Occlusion

  MAUDE report 7339487 ↗
• InjuryFeb 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). A 2.75 X 16 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND WAS PULLED BACK INTO THE GUIDE. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE UNDEPLOYED STENT WAS IN THE LEFT MAIN/PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. IT WAS THEN VERIFIED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM. THE PROXIMAL GUIDE CATHETER WAS NOTED TO BE KINKED AND WAS EXCHANGED. AN UNSUCCESSFUL SNARING ATTEMPT WAS MADE USING A NON-BSC SNARE KIT. ACCESS TO THE LCX WAS REGAINED USING A NON-BSC WIRE AND 1.2 X 8 MM BALLOON. THE WIRE WAS EXCHANGED AND A 2.5 X 15 MM NC EMERGE BALLOON CATHETER WAS USED TO PIN THE STENT AGAINST THE VESSEL WALL. THE PROCEDURE WAS COMPLETED BY DEPLOYING A 3.0X16 SYNERGY STENT IN THE PROXIMAL LCX. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7264639 ↗
• MalfunctionJan 24, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A HEAVILY CALCIFIED CORONARY ARTERY. AFTER ROTABLATION WAS PERFORMED, A 2.75 X 16 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO THE HEAVY CALCIUM AND THE STENT GOT JAMMED UP ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING A SHORTER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7215310 ↗
• MalfunctionMay 31, 2017Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75X16MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, AS THE PHYSICIAN WAS PULLING THE STENT PROTECTOR OFF TO THE DISTAL END, THE SHAFT BROKE INTO TWO. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 6601011 ↗
• MalfunctionMay 19, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 16 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT CATHETER TOWARDS THE PROXIMAL END WAS BROKEN. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6580189 ↗
• InjuryMay 2, 2017Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-04630 IT WAS REPORTED THAT STENT MOVED ON BALLOON AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 3.00 X 16 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION BUT CAME OFF OF THE BALLOON. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE STENT AND A SMALL BALLOON WAS USED TO DEPLOY THE STENT IN THE CORONARY ARTERY. SUBSEQUENTLY, A 2.75 X 16 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED BUT MOVED ON THE BALLOON ON THE DISTAL END AND SOME STRUTS WERE "JETTED OUT". THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE AND GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6538091 ↗
• InjuryApr 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TISSUE PROLAPSE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.75 X 16 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED AND SUCCESSFULLY DEPLOYED. FOLLOWING IMPLANTATION, TISSUE PROLAPSE WAS NOTED. A 2.75X8MM SYNERGY STENT WAS SELECTED TO RESOLVE THE ISSUE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Prolapse

  MAUDE report 6516564 ↗
• InjuryApr 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2017, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND CORONARY ANGIOGRAPHY WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 95% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 16 STUDY STENT. HOWEVER, POST STENT DEPLOYMENT, A DISTAL EDGE DISSECTION WAS NOTED WHICH WAS TREATED WITH PLACEMENT OF A 2.75 X 12MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING TO MID RCA WITH 99% STENOSIS AND WAS 25MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 24MM AND 2.25 X 16MM STUDY STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (ASA AND PLAVIX).

  Patient problems: Intimal Dissection

  MAUDE report 6511121 ↗
• DeathMar 17, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT POTENTIAL STENT THROMBOSIS HAD OCCURRED.

  Patient problems: Death; Thrombosis

  MAUDE report 6412688 ↗
• InjuryFeb 15, 2017Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY. A 2.75 X 16 SYNERGY II DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER BEFORE DEPLOYMENT, THE STENT CAME OFF THE BALLOON AND THE PROXIMAL END ACCORDIONED INSIDE THE BODY. THE PHYSICIAN WAS ABLE TO DELIVER A SMALL SIZE BALLOON AND INFLATED THE STENT, AND ALSO PLACED A NON-COMPLIANT BALLOON TO DILATE THE STENT ONCE. A PROMUS STENT WAS THEN DEPLOYED OVER THE SYNERGY STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6334696 ↗