SYNERGY™ H7493926028300Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 08714729840299), received between Dec 20, 2016 and Dec 16, 2021 — classified as 3 deaths, 21 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 62 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2021Activation Failure; Activation Failure

  (B)(6) STUDY. IT WAS REPORTED THAT CHRONIC OCCLUSION OF DIAGONAL BRANCH AND STENT UNDER EXPANSION AT OSTIUM OCCURRED. IN (B)(6) 2020, THE INDEX PROCEDURE WAS PERFORMED AND IN (B)(6) 2020, THE SUBJECT INDICATED THE QUALIFYING CONDITION UNSTABLE ANGINA. HENCE, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION 1 WAS LOCATED IN SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MAGINAL (OM) WITH 90% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. TARGET LESION 1 WAS TREATED WITH DIRECT PLACEMENT OF A 4.50 MM X 32 MM STUDY STENT WITH RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, SUBJECT WAS DISCHARGED ON ASPIRIN. THREE WEEKS AND FOUR DAYS LATER, DESPITE IMPROVEMENT OF SYMPTOMS, SUBJECT CONTINUED TO EXPERIENCE ANGINA DUE TO SEVERE STENOSIS NOTED IN SVG TO DIAGONAL ARTERY. HENCE, PERCUTANEOUS CORONARY INTERVENTION (PCI) OF LEFT ANTERIOR DESCENDING (LAD) ARTERY- DIAGONAL ARTERY WERE CONSIDERED. LEFT MAIN CORONARY ARTERY (LMCA), PROXIMAL LAD, MID LAD, DISTAL LAD, 1ST DIAGONAL ARTERY WERE TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND DRUG-ELUTING STENT (DES) STENTING USING 2.50 MM X 24 MM SYNERGY STENT AND 3.00 MM X 28 MM SYNERGY STENT IN AN

  Patient problems: Angina; Obstruction/Occlusion

  MAUDE report 13020173 ↗
• InjuryOct 26, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  EVOLVE_LV_XLV CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2019, THE SUBJECT INDEX PROCEDURE WAS PERFORMED AND QUALIFYING CONDITION WAS UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE SUBJECT WAS ENROLLED IN THE 4.5/5.0 COHORT OF THE EVOLVE LV XLV STUDY. TARGET LESION 1 WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.50 MM X 28 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ADDITIONALLY, NON-TARGET LESION WAS ALSO TREATED. THE NON-TARGET LESION 1 WAS LOCATED IN RIGHT-POSTERIOR DESCENDING ARTERY (R-PDA) WAS TREATED WITH PLACEMENT OF 3.00 MM X 28 MM AND 2.25 MM X 32 MM SYNERGY STENTS. ON THE SAME DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, POST INDEX PROCEDURE, SUBJECT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN, AND NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT. IT IS UNKNOWN WHETHER AUTOPSY WAS PERFORMED OR NOT. IT WAS FURTHER REPORTED THAT PRIMARY CAUSED OF DEATH WAS ANOXIC BRAIN INJURY. FURTHERMORE, IT WAS REPORTED THAT THE PHYSICIAN CONSIDERED

  Patient problems: Anemia; Cardiac Arrest; Chest Pain; Fever; Ischemia; Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Respiratory Failure; Restenosis; Thrombosis/Thrombus

  MAUDE report 12699314 ↗
• MalfunctionSep 1, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO PERFORM DOUBLE BARREL STENTING ON THE 90% STENOSED PROXIMAL LEFT ANTERIOR ARTERY (LAD), THE 95% STENOSED OSTIAL CIRCUMFLEX (CX), AND 90% STENOSED DISTAL LEFT MAIN (LM) LESIONS. THE VESSELS WERE MODERATELY CALCIFIED AND MILDLY TO MODERATELY TORTUOUS. THE LAD WAS SUCCESSFULLY WIRED WITH A NON-BOSTON SCIENTIFIC (BSC) WIRE AND THE CIRCUMFLEX WAS THEN WIRED WITH A RUNTHROUGH WIRE. THE LAD LESION WAS BALLOONED WITH A 2.0 X 20 COMPLIANT NON-BSC BALLOON. THE CIRCUMFLEX WAS THEN BALLOONED WITH A 2.5 X 15 COMPLIANT NON-BSC BALLOON. THE 3.0 X 28 SYNERGY WAS ADVANCED INTO THE LAD WITHOUT ISSUE. THE 3.0 X 32 SYNERGY WAS UNSUCCESSFUL IN CROSSING THE CIRCUMFLEX LESION. BOTH STENTS MET RESISTANCE WHEN BEING REMOVED FROM THE BODY. WHEN THE 3.0 X 28 SYNERGY WAS REMOVED IT APPEARED THE STENT WAS STILL ON THE BALLOON. WHEN THE 3.0 X 32 SYNERGY WAS REMOVED, IT WAS IDENTIFIED THAT THE STENT WAS NO LONGER ON THE BALLOON. THE STENT WAS LOCATED IN THE TOUHY. UPON FURTHER INSPECTION, THE 3.0 X 28 SYNERGY WAS NOT ON THE STENT DELIVERY SYSTEM. THE STENTS WERE BOTH CONFIRMED AND REMOVED FROM THE INSIDE OF THE TOUHY. A NEW 7F GUIDE CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406349 ↗
• DeathSep 1, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. THE PHYSICIAN ATTEMPTED TO PERFORM DOUBLE BARREL STENTING ON THE 90% STENOSED PROXIMAL LEFT ANTERIOR ARTERY (LAD), THE 95% STENOSED OSTIAL CIRCUMFLEX (CX), AND 90% STENOSED DISTAL LEFT MAIN (LM) LESIONS. THE VESSELS WERE MODERATELY CALCIFIED AND MILDLY TO MODERATELY TORTUOUS. THE LAD WAS SUCCESSFULLY WIRED WITH A NON-BOSTON SCIENTIFIC (BSC) WIRE AND THE CIRCUMFLEX WAS THEN WIRED WITH A RUNTHROUGH WIRE. THE LAD LESION WAS BALLOONED WITH A 2.0 X 20 COMPLIANT NON-BSC BALLOON. THE CIRCUMFLEX WAS THEN BALLOONED WITH A 2.5 X 15 COMPLIANT NON-BSC BALLOON. THE 3.0 X 28 SYNERGY WAS ADVANCED INTO THE LAD WITHOUT ISSUE. THE 3.0 X 32 SYNERGY WAS UNSUCCESSFUL IN CROSSING THE CIRCUMFLEX LESION. BOTH STENTS MET RESISTANCE WHEN BEING REMOVED FROM THE BODY. WHEN THE 3.0 X 28 SYNERGY WAS REMOVED IT APPEARED THE STENT WAS STILL ON THE BALLOON. WHEN THE 3.0 X 32 SYNERGY WAS REMOVED, IT WAS IDENTIFIED THAT THE STENT WAS NO LONGER ON THE BALLOON. THE STENT WAS LOCATED IN THE TOUHY. UPON FURTHER INSPECTION, THE 3.0 X 28 SYNERGY WAS NOT ON THE STENT DELIVERY SYSTEM. THE STENTS WERE BOTH CONFIRMED AND REMOVED FROM THE INSIDE OF THE TOUHY. A NEW 7F GUIDE CATHETER

  Patient problems: Obstruction/Occlusion

  MAUDE report 12406322 ↗
• MalfunctionJul 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATATION WITH A SEMI-COMPLIANT AND NON-COMPLIANT BALLOONS, A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC STENT WHICH ALSO FAILED TO CROSS. THEN, A 3.00 X 16 SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AS WELL. A 1.5 MM ROTAPRO BURR WAS USED AND FURTHER DILATATION WAS PERFORMED WITH A 3.00 NON-COMPLIANT BALLOON CATHETER. ANOTHER 3.00 X 28 WAS ADVANCED BUT WOULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT A STENT STRUT WAS LIFTED. THE SAME NON-BOSTON SCIENTIFIC STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193669 ↗
• MalfunctionApr 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WOULD NOT ADVANCE THROUGH THE LESION. THE DEVICE WAS REMOVED AND A GUIDEZILLA GUIDE EXTENSION CATHETER WAS PLACED. WHEN THE DEVICE WAS RE-INSERTED, IT WAS FOUND THAT THE STENT WAS UNRAVELED FROM THE BALLOON. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE EVENT WAS REPORTED VIA MEDWATCH 300840000-2021-8047. THE PATIENT PRESENTED WITH A NEW ONSET OF CHEST PAIN. DURING THE PROCEDURE, THE SYNERGY STENT IMPACTED A CALCIUM BUILDUP AND WAS REMOVED. WHEN ATTEMPTING TO REINSERT THE DEVICE IT WAS NOTED THAT THE DEVICE UNRAVELED DISTALLY ON THE BALLOON WITH A FRAGMENT OF THE STENT PROTRUDING FROM THE DEVICE ITSELF. A NEW DEVICE WAS USED WITH NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688998 ↗
• MalfunctionApr 9, 2021Unraveled Material; Material Protrusion/Extrusion

  A (B)(6) YEARS OLD PATIENT WITH A HISTORY OF HYPERTENSION, DIABETES MELLITUS, A NEW ONSET OF CHEST PAIN UNDERWENT A DIAGNOSTIC CARDIAC CATHETERIZATION. DURING THE PROCEDURE, THE BOSTON SCIENTIFIC EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM IMPACTED A CALCIUM BUILDUP, PROMPTING ITS RETRIEVAL FROM THE PATIENT. WHEN ATTEMPTING TO REINTRODUCE THE EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT, THE HEALTH CARE PROVIDERS NOTICED THAT THE DEVICE UNRAVELED DISTALLY ON THE BALLOON WITH A FRAGMENT OF THE METAL TUBULAR MESH PROTRUDING FROM THE DEVICE ITSELF. SUBSEQUENTLY, A NEW DEVICE WAS USED WITH NO KNOW HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640618 ↗
• MalfunctionMar 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE PACKAGE AND INSPECTING THE STENT, IT WAS NOTED THAT A STENT STRUT WAS STICKING OUT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517095 ↗
• MalfunctionFeb 23, 2021Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-FEB-2021. IT WAS REPORTED VIA VOLUNTARY MEDWATCH/MAUDE REPORT #: (B)(4) THAT GUIDEWIRE LOADING DIFFICULTY AND TIP DAMAGE OCCURRED. POST TRANSCATHETER AORTIC VALVE REPLACEMENT, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN AND NON-ST ELEVATION MYOCARDIAL INFARCTION. WHEN A 3.00 X 28MM SYNERGY II DRUG-ELUTING STENT WAS OPENED, TIP WAS DAMAGED AND UNABLE TO LOAD INTO THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368624 ↗
• InjuryNov 19, 2020Obstruction of Flow; Obstruction of Flow

  S2357 EVOLVE 4.5-5.0 CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. ON THE NEXT DAY, INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY WITH 80% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.5X 28MM SYNERGY DRUG-ELUTING STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. NON TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) AND WAS TREATED WITH THE PLACEMENT OF A 3.0X 28MM AND A 2.25X 32MM SYNERGY DRUG-ELUTING STENTS. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN 2020, IN-STENT RESTENOSIS WAS NOTED IN THE RIGHT PDA. UNSTABLE ANGINA AND ELECTROCARDIOGRAM CHANGES WERE FOUND. THE PATIENT WAS SENT TO THE CATH LAB AND NO FURTHER COMPLICATIONS WERE REPORTED. IN (B)(6) 2020, 209 DAYS POST INDEX PROCEDURE, THE SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF UNSTABLE ANGINA AND SUBSEQUENTLY ELECTROCARDIOGRAM (EKG) WAS PERFORMED WHICH REVEAL

  Patient problems: Angina; Non specific EKG/ECG Changes; Reocclusion; Restenosis

  MAUDE report 10870945 ↗
• MalfunctionNov 13, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY, A 3.00 X 28MM SYNERGY II DRUG ELUTING STENT WAS SELECTED FOR USE BUT IT COULD NOT CROSS THE LESION AND REMOVED FROM THE PATIENT. HOWEVER, WHEN THE STENT WAS INSPECTED OUTSIDE THE BODY PRIOR TO REATTEMPT, IT WA FOUND THAT THE STENT STRUTS WAS FLARED ON THE DISTAL STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10838614 ↗
• MalfunctionOct 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. FOLLOWING PRE-DILATATION USING A 2.5 X 12 NON-BOSTON SCIENTIFIC BALLOON CATHETER, A 3.00 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, THE STENT STRIPPED OFF OF THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10741892 ↗
• InjuryOct 19, 2020Break; Inflation Problem; Leak/Splash; Difficult to Remove; Failure to Advance; Material Deformation; Break; Inflation Problem; Leak/Splash; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK AND VESSEL OCCLUSION OCCURRED AND PATIENT WENT TO SURGERY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING DEPLOYMENT, THE BALLOON FAILED TO INFLATE AND BLOOD WAS RETURNED WHEN THE INFLATOR WAS DEPLOYED. WHEN THE DEVICE WAS REMOVED, THE STENT SHEARED OFF AND REMAINED IN THE LAD CAUSING AN ACUTE OCCLUSION. THE PATIENT UNDERWENT EMERGENCY AORTIC CORONARY BYPASS GRAFT AND SAPHENOUS VEIN GRAFT TO EXTENDED LAD ARTERIOTOMY TO EXTRACT THE RETAINED STENT AND BALLOON. THE PATIENT HAD AN UNEVENTFUL POST-OPERATIVE COURSE AND 6 DAYS LATER, THE PATIENT WAS DISCHARGED IN STABLE CONDITION. IT WAS FURTHER REPORTED THAT WHEN THE BROKEN SHAFT WAS LEFT IN THE ARTERY IT CAUSED AN ACUTE OCCLUSION REQUIRING THE SURGERY. SIX DAYS LATER, THE PATIENT WAS DISCHARGED IN STABLE CONDITION. IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS MODERATELY ANGULATED AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH SEVERAL EMERGE BALLOONS. DURING THE FOURTH ATTEMPT TO ADVANCE THE STENT, THE SHAFT WAS KINKED I

  Patient problems: Occlusion

  MAUDE report 10695567 ↗
• MalfunctionOct 16, 2020Break; Difficult to Advance

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE, STATUS POST TRANSCATHETER AORTIC VALVE REPLACEMENT. TO EMERGENCY DEPARTMENT WITH CHEST PAIN, NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. WHILE HAVING A HEART CATH, BALLOON ANGIOPLASTY, THE STENT OPENED BUT TIP WAS OBSERVED TO BE DAMAGED WHEN TRYING TO ADVANCE. THE DEVICE WAS REMOVED WITHOUT KNOW HARM TO THE PATIENT.

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 10689817 ↗
• InjuryOct 8, 2020Break; Inflation Problem; Leak/Splash; Difficult to Remove; Failure to Advance; Material Deformation; Break; Inflation Problem; Leak/Splash; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT WAS UNDEPLOYED. THE DEVICE WAS REMOVED INTACT OVER THE WIRE FROM THE PATIENT'S BODY. THE STENT WAS ADVANCED AGAIN TWICE BUT STILL FAILED TO DEPLOY AND WAS REMOVED. ON THE FOURTH ATTEMPT, THE STENT BALLOON WAS ADVANCED AND WAS INFLATED TO 7 ATMOSPHERES FOR 11 SECONDS BUT LOST PRESSURE AND WAS NOT ABLE TO BE RETRIEVED FROM THE GUIDE CATHETER. THE DISTAL SHAFT, INCLUDING THE STENT AND BALLOON WAS LEFT IN THE ARTERY. THE PATIENT UNDERWENT CABG SURGERY AND REMOVAL OF THE REMAINING STENT SYSTEM. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY AND IT WAS NOTICED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT WHEN THE BROKEN SHAFT WAS LEFT IN THE ARTERY IT CAUSED AN ACUTE OCCLUSION REQUIRING THE SURGERY. SIX DAYS LATER, THE PATIENT WAS DISCHARGED IN STABLE CONDITION. IT WAS FURTHER REPORTED THAT THE TARGET

  Patient problems: No Known Impact Or Consequence To Patient; Occlusion

  MAUDE report 10648335 ↗
• MalfunctionAug 14, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23JUL2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407375 ↗
• MalfunctionJun 26, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED AND HIGHLY TORTUOUS LEFT CIRCUMFLEX (LCX). A 3.00 X 28 SYNERGY II STENT WAS UNABLE TO CROSS THROUGH A WATCHDOG HEMOSTASIS VALVE AND THE STENT BECAME DAMAGED. THE WATCHDOG WAS REMOVED AND REPLACED WITH EXCHANGED WITH ANOTHER WATCHDOG. IT WAS NOTED THAT THE STENT WAS DAMAGED BY THE FIRST WATCHDOG, THUS CAUSING STENT TO DEFORM UPON PLACEMENT IN THE LCX. THE STENT WAS SUCCESSFULLY DEPLOYED AFTER MULTIPLE BALLOONS AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT A 2.5 X 20 APEX BALLOON WAS USED TO DILATE THE TARGET LESION. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200877 ↗
• InjuryJun 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVEMENT ON THE BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVILY CALCIFIED CIRCUMFLEX ARTERY. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT SLIGHTLY SHIFTED OFF THE BALLOON. THE STENT WAS DEPLOYED PROXIMAL TO THE LESION AND WAS FULLY EXPANDED. AN ADDITIONAL SYNERGY STENT WAS DEPLOYED IN THE CIRCUMFLEX AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10169619 ↗
• InjuryFeb 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS HUNG UP ON SOME CALCIUM AND A GUIDE EXTENDER WAS PLACED IN THE ARTERY. WHEN THE SYNERGY WAS PULLED BACK, THE STENT CAME OFF AND LODGED IN THE ARTERY AND HAD TO BE SNARED TO RETRIEVE. THIS CAUSED THE PROCEDURE TO BE EXTENDED FOR A LONG TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9760317 ↗
• InjuryJan 27, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DELAY OF FLOW IN THE VESSEL OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00X28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND DELAYED FLOW IN THE VESSEL WAS NOTED. SUBSEQUENTLY, THE PATIENT WAS PLACED ON SUPPORT DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 9632637 ↗
• DeathJan 24, 2020Break; Deflation Problem; Difficult to Remove; Break; Deflation Problem; Difficult to Remove

  IT WAS REPORTED VIA MEDWATCH THAT A SHAFT BREAK, DEFLATION FAILURE AND REMOVAL DIFFICULTIES AND A PATIENT DEATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY(LCX). A 3.00 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT BALLOON WAS UNABLE TO BE REMOVED FROM THE LCX AFTER THE STENT WAS DEPLOYED. MULTIPLE TECHNIQUES WERE TRIED TO USE TO DISLODGE THE BALLOON. EVENTUALLY, THE SHAFT OF THE CATHETER BROKE AT THE WIRE EXIT SITE FROM THE MONORAIL CATHETER. THE PATIENT RETAINS THE FOREIGN BODY FOLLOWING PROCEDURE AND WAS SENT FOR OPEN HEART SURGERY TO TRY AND PREVENT FURTHER INJURY. HOWEVER, THE PATIENT PASSED AWAY FEW DAYS LATER.

  Patient problems: Death

  MAUDE report 9627300 ↗
• MalfunctionNov 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED TO USE FOR TREATMENT. HOWEVER, WHEN THE STENT WENT TO LOAD ON THE WIRE, IT WAS NOTICED THAT THERE WAS A BENT STENT STRUT. THE DISTAL END STENT STRUT WAS LIFTED OFF THE BALLOON. THE DEVICE WAS NEVER ACTUALLY WENT INTO THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9355652 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, UPON ENTERING THE DEVICE INTO THE TUOHY, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00 X 28 SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284354 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00 X 28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE APPROXIMATELY 20 CM FROM THE PROXIMAL END OF THE DEVICE WHILE REMOVING IT FROM THE GUIDE AFTER THE STENT DID NOT CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251002 ↗
• MalfunctionJul 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00 X 28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THE STENT STRUT GOT FRACTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831146 ↗