SYNERGY™ H7493926024250Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08714729840213), received between Nov 30, 2016 and Aug 18, 2020 — classified as 5 deaths, 9 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT FELL OFF WHEN THE PHYSICIAN REMOVED THE COVER OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10422270 ↗
• InjuryJun 30, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE STENT WAS EXPLANTED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, A NON-BSC GUIDE WIRE BECAME ENTANGLED WITH THE NEWLY PLACED STENT AND WHEN TRYING TO RETRACT THE WIRE, THE STENT DISLODGED FROM THE CORONARY ARTERY AND STAYED ON THE WIRE UNTIL THE WIRE WAS RETRACTED TO THE FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DEPLOYED STENT OUT WITH A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214451 ↗
• MalfunctionJun 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AFTER PRE-DILATION WAS PERFROMED WITH A 2.50X15MM EMERGE BALLOON CATHETER , A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS ALSO NOTED THAT THE STENT STRUTS WERE DAMAGED WHEN TRYING TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME. IT WAS FURTHER REPORTED THAT WRONG STENT SIZE WAS PULLED. SUBSEQUENTLY, AN ADDITIONAL STENT WAS ADVANCED AND THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143976 ↗
• MalfunctionFeb 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT FAILED TO CROSS THE LESION AND IT WAS NOTICED THAT THE STENT ITSELF WAS DAMAGED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION IS LOCATED IN THE NON-TORTUOUS AND HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763789 ↗
• MalfunctionFeb 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE STENT STRUTS WERE DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763658 ↗
• MalfunctionFeb 26, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON ENTERING THE ARTERY, THE STENT WAS DEFORMED ON THE SHAFT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9753491 ↗
• MalfunctionDec 9, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28NOV2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50X24MM 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 WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9442129 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50X24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. DURING REMOVAL THE STENT CATHETER KINKED ON THE HEAVY CALCIUM AND TORTUOUS VESSEL AND BROKE IN HALF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371439 ↗
• MalfunctionNov 5, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50X24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WOULD NOT PASS THROUGH A PREVIOUSLY DEPLOYED SYNERGY STENT AND IT WAS NOTICED THAT A STRUT GOT CAUGHT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282980 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE STENT DELIVERY DEVICE BROKE AT THE MONORAIL JUNCTION INSIDE THE GUIDE, LEAVING THE STENT IN THE GUIDE. THE GUIDE CATHETER AND DEVICE WERE REMOVED ALL TOGETHER AND THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE, WIRE AND STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258514 ↗
• MalfunctionOct 24, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT THE STENT HUNG UP IN THE GUIDE CATHETER. WHEN THE DEVICE WAS REMOVED, THE SHAFT BROKE AT THE MONORAIL JUNCTION INSIDE THE GUIDE. 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 WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236641 ↗
• MalfunctionOct 24, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 2.50X24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT BROKE AT APPROXIMATELY 15-20CM FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50X24MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235212 ↗
• MalfunctionAug 5, 2019Failure to Advance; Failure to Advance

  ON 02AUG2019 REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-JUL-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED ARTERY. A SYNERGY II US MR 2.50 X 24 DES WAS ADVANCED BUT ENCOUNTERED DIFFICULTY CROSSING THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861567 ↗
• MalfunctionJul 3, 2019Failure to Advance; Device-Device Incompatibility; Material Deformation; Failure to Advance; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY ADVANCING AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50 X 24 SYNERGY STENT WAS ADVANCED THROUGH A WATCHDOG HEMOSTASIS VALVE DEVICE, BUT RESISTANCE WAS FELT, WOULD NOT DELIVER, AND WOULD NOT OVERLAP INTO THE STENT PLACED DISTALLY. THE STENT WAS REMOVED AFTER THE RESISTANCE WAS FELT, AND IT WAS NOTICED THAT THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND WAS ABLE TO WORK. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8758372 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND CHEST PAIN OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE VERY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LENGTH WAS ABOUT 23MM. THE VESSEL SIZE WAS APPROXIMATELY 25MM IN DIAMETER AND THE PATIENT WAS REFERRED FOR AN ATHERECTOMY WHERE A NON BSC DEVICE WAS USED. AFTER THE ATHERECTOMY WAS DONE, A 10 MM X 2.50 MM WOLVERINE CORONARY CUTTING BALLOON WAS ADVANCED TO DILATE THE PROXIMAL LAD AND WAS INFLATED TWICE FOR 15 SECONDS AT NOMINAL PRESSURE AND RESULTED IN A TIMI 3 FLOW. A 2.50 X 24 SYNERGY STENT WAS ADVANCED AND IMPLANTED IN THE PROXIMAL LAD. A TIMI 3 FLOW RESULTED AFTER THE CASE AND EVERYTHING WAS OPEN. THE PATIENT WAS TAKEN OFF THE TABLE AND APPROXIMATELY 30 MINUTES LATER, THE PATIENT WAS HAVING CHEST PAIN. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AND A THROMBUS DISTAL TO THE STENT WAS NOTICED. A BALLOON DEVICE WAS USED TO INFLATE THIS AREA, AND THE PATIENT WAS GIVEN HEPARIN TO GET THE ACTIVATED CLOTTING TIME (ACT) UP ABOVE 300. AN ASPIRATION CATHETER WAS USED AND PUMPED UP AND RESULTED IN TIMI 3 FLOW AGAIN. THE PATIENT WAS STABLE AND DOING FINE. THE ACT THAT WAS ACHIEVED DURING THE PROCEDURE W

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 8684273 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, DURING PREPARATION, THE HYPOTUBE BROKE OFF AND SPLIT IN HALF IN THE STERILE FIELD BUT NOT INSIDE THE PATIENT'S BODY. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353359 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50X24MM SYNERGY STENT WAS USED IN A PROCEDURE. HOWEVER, THE SHAFT GOT FRACTURED WHEN THE STENT WAS DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286840 ↗
• DeathJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT ARTERIAL HYPOTENSION, IN-STENT RESTENOSIS AND CARDIAC ARREST WHICH LED TO DEATH OCCURRED. ON (B)(6) 2017, THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. THE TARGET LESION WAS 95% STENOSED, 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM LOCATED IN THE FIRST OBTUSE MARGINAL ARTERY (OM1). THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 X 24 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL). ON (B)(6) 2018, THE PATIENT EXPERIENCED CHEST PAIN DUE TO CHRONIC POLYMYALGIA RHEUMATICA AND PULMONARY EMBOLISM. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED DUE TO ARTERIAL HYPOTENSION AND WAS TREATED WITH MEDICATION. ON THE SAME DAY, THE PATIENT WAS ALSO DIAGNOSED WITH IN-STENT RESTENOSIS IN THE FIRST OBTUSE MARGINAL ARTERY (OM1) AND HAD "AN" ELEVATED TROPONIN LEVELS BUT DID NOT MEET CRITERIA OF MYOCARDIAL INFARCTION (MI). EIGHT DAYS LATER, THE PATIENT WAS TREATED WITH MEDICATIONS IN RESPONSE TO OM1 IN-STENT RESTENOSIS AND ELEVATED TROPONIN LEVEL. THE PATIENT WAS NOT A GOOD CANDIDATE FOR CORONARY ARTERY BYPASS GRAFTING (CABG) SURGERY AND PERCUTANEOUS CO

  Patient problems: Cardiac Arrest; Death; Heart Failure; Respiratory Distress; Stenosis; Tachycardia

  MAUDE report 8286295 ↗
• MalfunctionJan 25, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE HYPOTUBE SEPARATED INSIDE THE GUIDE CATHETER. WHEN PHYSICIAN REMOVED THE DEVICE OUTSIDE THE GUIDE CATHETER, THE DEVICE WAS NOT FULLY SEPARATED, IT WAS ONLY HANGING ON BY A VERY SMALL AMOUNT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8278598 ↗
• DeathJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION, THROMBOSIS, AND DEATH OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS PERFORMED. HEPARIN WAS USED TO ANTI-COAGULATE THE PATIENT. A 3.00 X 38 SYNERGY STENT WAS PLACED IN THE MID LAD. FOLLOWING THE PLACEMENT OF THE FIRST STENT, A2.50 X 24 SYNERGY STENT WAS PLACED DISTALLY, BUT OVERLAPPING THE FIRST STENT. A 3.50 X 16 SYNERGY STENT WAS THEN PLACED PROXIMALLY AND OVERLAPPING THE FIRST STENT. PRIOR TO THE FIRST STENT PLACEMENT, THERE WAS A FAIRLY LARGE DISSECTION OF THE MID-LAD. IT WAS NOTED THAT THIS WAS ASSESSED TO HAVE OCCURRED DURING LESION PREPARATION. IT WAS FURTHER NOTED THAT THERE WAS A LARGE DIAGONAL BRANCH IN MID-LAD WHICH KEPT CLOSING OFF, AND THERE LIKELY WAS A THROMBUS FORMING DURING THE PROCEDURE. THE PATIENT BECAME UNSTABLE AS THE PROCEDURE WENT ON, COMPRESSIONS WERE STARTED, BUT THE PATIENT DIED.

  Patient problems: Death; Thrombosis; Vascular Dissection

  MAUDE report 8278530 ↗
• MalfunctionDec 11, 2018Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, AS SOON AS THE PACKAGE WAS OPENED, IT WAS NOTED THAT THE TIP OF THE STENT WAS COILED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151190 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING "PREPARATION" OF A 2.50 X 24 SYNERGY DRUG-ELUTING STENT IT WAS NOTED THAT THE SHAFT KINKED AND SNAPPED IN HALF. THE DEVICE NEVER ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. A SYNERGY II US MR 2.50 X 24MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE STENT. THERE WERE NO SIGNS OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKER BANDS. THE CRIMPED STENT OUTER DIAMETER WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE FULL LENGTH OF THE CATHETER. A HYPOTUBE BREAK WAS ALSO NOTED 620MM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND

  Patient problems: No Patient Involvement

  MAUDE report 8092573 ↗
• MalfunctionJun 4, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50 X 24 SYNERGY II STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON ADVANCING THE DEVICE, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE STENT DID NOT LOOK RIGHT. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED. 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 7567603 ↗
• DeathApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2016, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: 2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS LOCATED IN THE 1ST POSTEROLATERAL BRANCH (RPL) WITH 99% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 24 MM STUDY STENT WITH 1% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. A FAMILY MEMBER HAD INFORMED ON THE TELEPHONE FOLLOW-UP CALL THAT THE PATIENT PASSED AWAY AT HOME DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD )WHILE RECEIVING HOSPICE CARE.

  Patient problems: Death

  MAUDE report 7437116 ↗
• InjuryFeb 13, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2018-00981 AND 2134265-2018-00947. IT WAS REPORTED THAT STENT THROMBOSIS AND CHEST PAIN OCCURRED. THE PATIENT PRESENTED WITH AN ACUTE ST ELEVATED MYOCARDIAL INFARCTION AND RECEIVED BIVALIRUDIN THERAPY (BLOOD THINNER). TARGET LESION #1 WAS LOCATED IN THE CIRCUMFLEX ARTERY. FOLLOWING PREDILATION USING A 2.50 MM X 20 MM EMERGE BALLOON, A 2.50 X 24 MM SYNERGY II STENT WAS SUCCESSFULLY DEPLOYED. TARGET LESION #2 WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS PERFORMED WITH A 2.50 MM X 15 MM EMERGE BALLOON. A 2.75 X 12 MM SYNERGY II STENT SYSTEM DEPLOYED IN THE LAD AND A 2.75 X 20 MM SYNERGY II EVEROLIMUS STENT WAS DEPLOYED IN THE DISTAL LAD. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS THEN TRANSFERRED FROM CATH LAB HOWEVER, THE PATIENT STARTED HAVING CHEST PAIN. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AND IT WAS NOTED THAT A FOCAL CLOT WAS PRESENT IN BOTH THE MID CIRCUMFLEX AND MID LAD. A 2.50 MM X 15 MM EMERGE BALLOON WAS USED TO DILATE THE CLOT PRESENT INSIDE THE SYNERGY STENTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS LATER.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 7267967 ↗