SYNERGY™ H7493926028250Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08714729840275), received between Dec 16, 2016 and Mar 24, 2021 — classified as 5 deaths, 11 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE BENT. THE PHYSICIAN OPENED ANOTHER STENT WHICH DELIVERED AND DEPLOYED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564176 ↗
• MalfunctionDec 1, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USED; HOWEVER; THE STENT WAS NO LONGER MOUNTED ONTO THE CATHETER WHEN THE STYLET WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10928146 ↗
• InjuryNov 19, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS PLACED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT BECAME CLOTTED OFF. THE ACTIVATED CLOTTING TIME WAS ABOVE 300 AND THE CLOT FORMED DURING THE TIME OF THE 2ND STENT PLACEMENT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS UNHARMED.

  Patient problems: Thrombosis

  MAUDE report 10870960 ↗
• MalfunctionNov 17, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FIRST OBTUSE MARGINAL ARTERY. FOLLOWING PRE-DILATATION, A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, DURING REMOVAL, IT WAS NOTICED THAT THE DISTAL EDGE OF THE STENT STRUT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10849839 ↗
• InjuryOct 23, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT, THROMBOSIS, CHEST PAIN AND ELEVATED TROPONIN OCCURRED. ON (B)(6) 2020, THE 95% IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PATIENT EXPERIENCED CHEST PAIN AND ACUTE STENT THROMBOSIS WAS NOTED IN THE MID LAD AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED. THREE DAYS LATER, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AND PRESENTED WITH CHEST PAIN AND ELEVATED TROPONIN. INTRAVASCULAR ULTRASOUND SHOWED THAT THERE WAS A MALPOSITION OF THE STENT. PTCA WAS THEN PERFORMED WITH A NON COMPLIANT BALLOON AT HIGH PRESSURE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Thrombosis

  MAUDE report 10727326 ↗
• MalfunctionJun 30, 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 28 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR USE. HOWEVER, THE STENT WAS DAMAGED WHILE DELIVERING TO THE LESION OVER SAMURAI GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A 2.5X24MM SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS DOING GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213580 ↗
• InjuryJun 17, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK AND EMBOLIZATION OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN, RISING TROPONINS, AND ELECTROCARDIOGRAM CHANGES WHICH IS CONSISTENT WITH ISCHEMIA. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DIAGONAL (DIAG) BRANCH. DUE TO DISEASE OF THE LAD AND ENLARGEMENT OF THE DIAG BRANCH, DOUBLE KISSING CRUSH TECHNIQUE WAS PERFORMED. AFTER A NON-BSC WIRE WAS USED TO CROSS THE LESION, PRE-DILATATION WAS PERFORMED. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED THROUGH THE DIAG; HOWEVER, IT HAD AN ISSUE WITH THE GUIDER AND COULD NOT PASS THE STENT INTO THE LAD. THE STENT WAS FROZEN IN PLACE AND WAS WRAPPED AROUND THE LAD BALLOON. THEY HAD TO BE DEPLOYED THE STENT IN THE DIAG. UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE SHAFT FRACTURED IN THE GUIDER AND THE BALLOON SEPARATED FROM THE CATHETER. A PORTION OF THE DETACHED FRAGMENT REMAINED IN THE GUIDER WHERE IT WAS TRAPPED AND REMOVED. THE OTHER PORTION OF THE BALLOON EMBOLIZED TO THE DESCENDING AORTA AND WAS SUCCESSFULLY REMOVED USING A BIOPTOME DESPITE NUMEROUS UNSUCCESSFUL ATTEMPTS. AN 8F SHEATH WAS THEN PLACED AND WITH GUIDE LINER SUPPORT, A 1.25MM BA

  Patient problems: Embolism

  MAUDE report 10164230 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, AND CARDIAC ARREST OCCURRED. THE MULTIVESSEL PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH MULTIPLE STENOSIS TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, FIRST DIAGONAL BRANCH (D1) AND SECOND OBTUSE MARGINAL BRANCH (OM2). A PCI WAS PERFORMED ON THE 80% STENOSED, 20MM LONG, TARGET LESION BETWEEN THE PROXIMAL LAD TO MID LAD. A NON-BSC WIRE PASSED THROUGH THE LESION, ANGIOPLASTY WAS PERFORMED USING A 2.25MM X 15MM NC EMERGE BALLOON CATHETER AT 14 ATMOSPHERES FOR 15 SECONDS. HOWEVER, THE BALLOON RUPTURED AND GOT SEPARATED. THE PHYSICIAN DEPLOYED THE 2.75MM X 32MM SYNERGY DRUG-ELUTING STENT TO THE AFFECTED AREA. POST-STENT ANGIOPLASTY WAS PERFORMED USING A 3.00MM X 15MM NC EMERGE AT 18 ATMOSPHERES FOR 10 SECONDS, BUT THE BALLOON GOT STUCK ON THE WIRE. ANOTHER NON-BSC BALLOON WAS USED FOR ANGIOPLASTY. THE STENT BECAME THROMBOSED AND WAS TREATED WITH ANGIOPLASTY AND A 2.5MM X 28MM SYNERGY DRUG-ELUTING STENT DEPLOYED TO OVERLAP THE FIRST PLACED STENT. ANGIOPLASTY WAS PERFORMED USING A NON-BSC BALLOON. THERE WAS A 0% RESIDUAL STENOSIS POST INTERVENTION. A PCI WAS PERFORMED ON THE 90% STENOSED TARGET LESION LOCATED

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Myocardial Infarction

  MAUDE report 9484225 ↗
• InjuryOct 21, 2019Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH PERSISTENT STENOSIS IN THE OBTUSE MARGINAL. THE LESION WAS DILATED AND IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PASS A 2.25 X 12MM SYNERGY DRUG-ELUTING STENT, THE LOT NUMBER REPORTED WAS OF A 2.50X28MM SYNERGY STENT, INTO THE OBTUSE MARGINAL TO OVERLAP WITH THE PREVIOUSLY PLACED STENT. DESPITE GUIDE AND GUIDE EXTENSION CATHETER SUPPORT, THERE WAS CONSIDERABLE DIFFICULTY ENCOUNTERED. SEVERAL DIFFERENT CONFIGURATIONS OF WIRE AND GUIDE CATHETER SUPPORT WERE ATTEMPTED TO DELIVER THE STENT. AS THE STENT WAS BEING REMOVED, THERE WAS CONSIDERABLE DIFFICULTY RETURNING THE STENT DELIVERY SYSTEM INTO THE GUIDE AND WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT IT WAS NOTED THAT THE STENT HAD BEEN LOST. ON FLUOROSCOPY, THE UNDEPLOYED STENT WAS IN THE PROXIMAL CIRCUMFLEX. DURING REMOVAL OF THE STENT DELIVERY THERE WAS ALSO INADVERTENT REMOVAL OF THE WIRE FROM THE CIRCUMFLEX AND FROM THE UNDEPLOYED STET. THE PHYSICIAN INITIALLY ATTEMPTED TO WIRE INTO THE CIRCUMFLEX WITH A PLAN OF STENTING THE UNDEPLOYED STENT AGAINST THE WALL. SEVERAL WIRES WERE ATTEMPTED, BUT THE WIRES WOULD NOT TRAVERSE THE PROXIMAL VES

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9215694 ↗
• MalfunctionAug 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO OVERLAP THE PROXIMAL EDGE OF A PREVIOUSLY IMPLANTED SYNERGY STENT. HOWEVER, THE STENT STRUT GOT CAUGHT AND STENT MOVED DOWN 1-2MM OUTSIDE THE STAND MARKERS OF THE BALLOON CATHERER. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO DEPLOY THE STENT BEFORE IT CAME OFF. A 2.5X8MM STENT WAS PLACED IN BETWEEN THE TWO STENTS FOR ADEQUATE STENT COVERAGE AND THE PROCEDURE WAS COMPLETE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8916242 ↗
• MalfunctionAug 20, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ADVANCING INTO THE BODY, IT WAS NOTED THAT THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910755 ↗
• MalfunctionJul 12, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-JUN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785826 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50X28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE SENT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8739116 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. FOLLOWING PRE-DILATION, A 2.50MM X 28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. PRE-DILATION WAS PERFORMED AGAIN BUT STILL UNABLE TO CROSS. WHILE TRYING TO REMOVE THE UN-DEPLOYED STENT, IT WAS NOTED THAT THE SHAFT BROKE MORE THAN 15CM FROM THE HUB. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE BY PULLING THE HYPOTUBE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737077 ↗
• MalfunctionJun 11, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 2.50MM X 28MM AND 3.5MMX38MM SYNERGY DRUG-ELUTING STENTS WERE DEPLOYED IN THE TARGET LESION. HOWEVER, POST-DEPLOYMENT, THE DELIVERY BALLOONS WERE STUCK IN THE DEPLOYED STENTS AND IT TOOK A LOT OF FORCE TO REMOVE THEM. UPON INSPECTION, IT WAS NOTICED THAT THE BALLOON SEEMED TO WAD UP AT THE DISTAL END OF THE SHAFTS. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687916 ↗
• MalfunctionJun 3, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON INTRODUCTION OF THE DEVICE INTO THE BODY, THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8662869 ↗
• MalfunctionMay 22, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 28 MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE STENT STRUT PROTRUDED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634787 ↗
• MalfunctionMay 10, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50X28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS AND THE STENT STRUT GOT RAISED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600846 ↗
• MalfunctionMar 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). BOTH LAD AND DIAGONAL BRANCH ARTERY WERE WIRED WITH A NON BSC GUIDE WIRE. A 2.50 X 28 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. THE DEVICE WAS PREPARED BY FLUSHING WITH SALINE THROUGH THE TIP OF THE STENT FOR 5 SECONDS TO THE WIRE LUMEN OF THE MONORAIL SEGMENT. THE SCRUB DID NOT APPLIED NEGATIVE PRESSURE OR A SYRINGE ON THE STENT BEFORE HANDLING IT TO THE PHYSICIAN. THE STENT WAS INSERTED INTO THE GUIDEWIRE THROUGH THE TUOHY IN THE LAD ARTERY. THE DEVICE WAS ADVANCED BUT THE PHYSICIAN FELT RESISTANCE APPROXIMATELY HALFWAY DOWN. THE SCRUB PULLED A SLIGHT NEGATIVE PRESSURE ON THE STENT WITH THE ENDOFLATOR TO AID THE RESISTANCE. HOWEVER, THE TIP OF THE STENT NEVER EXITED THE GUIDE TO ENTER INTO THE CORONARY ARTERY. SO, THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE GUIDE CATHETER AND IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE DELIVERY SYSTEM AFTER IT WAS PULLED OUT FROM THE PATIENT'S BODY. THE PHYSICIAN USED FLUOROSCOPY TO LOOK FOR THE STENT IN T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463915 ↗
• MalfunctionFeb 13, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT WAS UNABLE TO DELIVER OVER THE ENTIRE NON BSC GUIDEWIRE PLACED IN THE LAD. THE WIRE BECAME STUCK IN THE RAPID EXCHANGE JUNCTION. WHEN RESISTANCE WAS ENCOUNTERED, THE PHYSICIAN TRIED TO PULL THE SYNERGY STENT BACK AND SHEARED THE WIRE OFF IN THE MONORAIL SECTION WHILE STILL INSIDE THE GUIDE CATHETER. THE WIRE WITH THE STENT DELIVERY SYSTEM ALONG WITH THE PORTION OF THE GUIDEWIRE THAT SHEARED OFF WAS ALL REMOVED FROM THE PATIENT'S BODY. THE PHYSICIAN ATTEMPTED TO RE-WIRE THE SYSTEM AND UTILIZE A DIFFERENT STENT TO COMPLETE THE PROCEDURE BUT IT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ELECTED TO DISCONTINUE THE PROCEDURE AND TREAT THE PATIENT MEDICALLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8334903 ↗
• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY AND DIAGONAL BIFURCATION LESION. FOLLOWING PRE-DILATION WITH 6 DIFFERENT BALLOONS, A 2.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT A SPIRAL DISSECTION. THE DEVICE WAS PUSHED VERY HARD CAUSING THE HYPOTUBE TO BREAK IN HALF. ANOTHER 2.50X28MM SYNERGY STENT WAS USED BUT ALSO BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184752 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY AND DIAGONAL BIFURCATION LESION. FOLLOWING PRE-DILATION OF 6 DIFFERENT BALLOONS, A SPIRAL DISSECTION WAS NOTED AND A 2.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION DISTALLY. IT WAS PUSHED HARD CAUSING THE HYPOTUBE TO BREAK. ANOTHER 2.50X28MM SYNERGY STENT WAS USED BUT HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8182283 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT RESTENOSIS AND MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2017, PATIENT CLINICAL STATUS ASSESSEMENT INDICATED THE PATIENT QUALIFYING CONDITION AS UNSTABLE ANGINA. THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN 1ST DIAGONAL BRANCH WITH 75% STENOSIS AND WAS 22 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH PREDILATATION AND PLACEMENT OF A 2.50 X 28 MM SYNERGY STENT WITH 0% RESIDUAL STENOSIS. ON THE NEXT DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT VIA EMERGENCY MEDICAL SERVICES (EMS) WITH INTERMITTENT ANTERIOR CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH AND DIAPHORESIS LASTING FROM PAST TWO WEEKS. PRIOR TO EMS ARRIVAL, THE PATIENT HAD INTENSE PAIN OF SCALE 12/10 WHICH WAS LOCATED IN THE MIDDLE OF HIS CHEST AND IT RADIATES INTO HIS BACK AND WORSENS ON EXERTION. THE PATIENT TOOK 3 BABY ASPIRIN AND SUB-LINGUAL NITROGLYCERIN AT HOME. POST MEDICATION, THE PAIN RESOLVED TO 4/10. PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ELECT

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Dyspnea; Myocardial Contusion; Myocardial Infarction; Occlusion; Reocclusion; Thrombosis

  MAUDE report 8180251 ↗
• MalfunctionJun 18, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 28MM SYNERGY II DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS AND IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS DAMAGED. A 2.50 X 15MM EMERGE BALLOON CATHETER WAS THEN ADVANCED TO PRE-DILATE THE LESION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 28MM SYNERGY II DES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7612093 ↗
• MalfunctionJun 4, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS IN THE CIRCUMFLEX ARTERY. A 2.50 X 28 SYNERGY II STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND WAS ADVANCED AGAIN FOR THE SECOND TIME. HOWEVER, IT GOT CAUGHT IN THE LESION AND IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED. THE DEVICE WAS REMOVED 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 7566996 ↗