SYNERGY™ H7493926020270Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729840169), received between Nov 11, 2016 and Feb 22, 2021 — classified as 3 deaths, 8 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2021Obstruction 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) 2020, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHERIZATION. THE INDEX PROCEDURE WAS PERFORMED THAT SAME DAY. THE FIRST TARGET LESION WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 4.50 MM X 32 MM SYNERGY DRUG ELUTING STENT (DES) WITH NO RESIDUAL STENOSIS. A NON-TARGET LESION LOCATED IN OBTUSE MARGINAL (OM1) AND WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 20 MM SYNERGY DES AND WITH CUTTING BALLOON. THE SECOND NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX EXTENDING TO 1ST OB MARG AND WAS TREATED WITH THE PLACEMENT OF 3.50 MM X 32 MM OF SYNERGY DES. THE THIRD NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 32 MM SYNERGY DES. THE FOURTH NON-TARGET LESION WAS LOCATED IN DISTAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 8.00 MM SYNERGY DES. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, SUBJECT WA

  Patient problems: Angina; Myocardial Infarction; Restenosis

  MAUDE report 11359305 ↗
• MalfunctionJan 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING REMOVAL, THE STENT STRUTS WERE DAMAGED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11223112 ↗
• InjuryNov 9, 2020Obstruction of Flow; Obstruction of Flow

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED CHEST PAIN, MYOCARDIAL INFARCTION, CARDIAC ENZYME ELEVATION AND STENT THROMBOSIS OCCURRED. IN (B)(6) 2019, THE PATIENT PRESENTED WITH AN EJECTION FRACTION OF 55%. FORTY ONE DAYS AFTER, INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENT WITH ANGINA AND WAS REFERRED FOR CARDIAC CATHERIZATION TARGET LESION #1 WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF 4.5 MM X 32 MM STUDY STENT FOLLOWING WHICH RESIDUAL STENOSIS WAS NOTED TO BE 0%. NON-TARGET LESION #1 WAS LOCATED IN OBTUSE MARGINAL (OM1) AND WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 20MM SYNERGY DRUG-ELUTING STENT (DES). NON-TARGET LESION #2 WAS LOCATED IN PROXIMAL LCX EXTENDING TO OM1 AND WAS TREATED WITH THE PLACEMENT OF 3.50 MM X 32 MM OF SYNERGY DES. NON-TARGET LESION #3 WAS LOCATED IN PROXIMAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 32MM SYNERGY DES. NON-TARGET LESION #4 WAS LOCATED IN DISTAL LCX (SAME AS THAT OF TARGET LESION) AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 8.00MM SYNERGY DES. THE SUBJECT WAS DI

  Patient problems: Atrial Flutter; Cardiac Enzyme Elevation; Chest Pain; Myocardial Infarction; Thrombosis

  MAUDE report 10810027 ↗
• MalfunctionOct 30, 2020Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A 2.50 X 12 EMERGE BALLOON CATHETER, A 2.75 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE STENT STRUTS WERE NOTED TO BE LIFTED AT THE PROXIMAL PORTION. PART OF THE DELIVERY SYSTEM BROKE OFF AS WELL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10762525 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MYOCARDIAL INFARCTION, RIGHT VENTRICULAR FAILURE AND ACUTE STENT THROMBOSIS OCCURRED. IN (B)(6) 2020, THE PATIENT WAS ADMITTED WITH SPINAL STENOSIS AND UNDERWENT SURGERY. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) WITH 70% STENOSIS, CIRCUMFLEX (CX) WITH 90% STENOSIS, AND RIGHT CORONARY ARTERIES (RCA) WITH 95% STENOSIS. A 2.75X20MM AND 3.0X16MM SYNERGY DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. AFTER THE SURGERY, THE PATIENT WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT (PACU); HOWEVER, THE PATIENT SUFFERED FROM MYOCARDIAL INFARCTION. ON THE FOLLOWING DAY, THE PATIENT WAS TAKEN BACK TO THE CARDIAC CATHERIZATION LAB AND FOUND TO HAVE AN ACUTE STENT THROMBOSIS IN BOTH SYNERGY STENTS IN THE RCA THAT WAS IMPLANTED 1 DAY PRIOR. BALLOON ANGIOPLASTY WAS PERFORMED AND STENTED WITH NON-BOSTON SCIENTIFIC STENTS. THE PATIENT EXPERIENCED RIGHT VENTRICULAR FAILURE AND RECEIVED IMPELLA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND WAS STILL ADMITTED.

  Patient problems: Complaint, Ill-Defined; Myocardial Infarction; Thrombosis

  MAUDE report 10727376 ↗
• DeathSep 2, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT THE PATIENT DIED. A 2.75 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED, BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER TO GET INTO THE UNDEPLOYED STENT, AND INFLATE IT. HOWEVER, AFTER THE PROCEDURE, THE PATIENT DIED. IT WAS FURTHER REPORTED, THAT THE STENT WAS DISLODGED FROM ITS BALLOON. THE DISLODGED STENT COULD NOT BE SNARED, SO THE STENT WAS DEPLOYED USING THE NON-BSC BALLOON CATHETER.

  Patient problems: Death

  MAUDE report 10482434 ↗
• MalfunctionAug 18, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. THREE SYNERGY DRUG-ELUTING STENTS WITH SIZES 2.75 X 20, 2.75X28MM, 3.0X16MM WERE SIMULTANEOUSLY USED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS FLARED FOR ALL DEVICES WHILE TRYING TO ENTER THE ARTERY. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10419357 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON PUSHING THE DEVICE THROUGH THE GUIDE, THE SHAFT BROKE 20 CENTIMETERS FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 10078587 ↗
• MalfunctionMar 20, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED AND SUCCESSFULLY IMPLANTED. HOWEVER, DURING REMOVAL, THE DEVICE COULD NOT BE EASILY REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE ALBEIT WITH DIFFICULTY. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860032 ↗
• DeathMay 23, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED AND THE PATIENT DIED. THE PATIENT PRESENTED WITH ACUTE NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND CHEST PAIN. THE TARGET LESION WAS LOCATED IN A VERY TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH SEVERAL LESIONS WITHIN THE MID AND DISTAL PORTIONS. AFTER ANGIOMAX WAS GIVEN, A GUIDE WIRE WAS PLACED IN THE DISTAL RCA. THE PATIENT HAD SIGNIFICANT SPASM THAT PROVED TO BE AN ISSUE THROUGHOUT THE MAJORITY OF THE CASE DESPITE LARGE AMOUNTS OF NITROGLYCERIN AS WELL AS CARDIZEM GIVEN THROUGHOUT THE CASE. AFTER A SUCCESSFULLY BALLOON ANGIOPLASTY, A 2.75X20MM SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE TORTUOUS MID SEGMENT OF THE VESSEL. A BUDDY WIRE TECHNIQUE WAS UTILIZED AND PROVED TO BE UNSUCCESSFUL AS WELL. IN THE ATTEMPT TO PASS THE STENT, THE GUIDE CATHETER WAS SUBSEQUENTLY PUSHED OUT OF THE CORONARY ARTERY AND WITH REMOVAL OF THE STENT CAUSED A SPIRAL DISSECTION OF THE OSTIUM OF THE RCA EXTENDING TO THE ASCENDING AORTA. SEVERAL 20MM STENTS WERE THEN PLACED TO COVER THE LESIONS AND EVENTUALLY THE DISSECTION AT THE OSTIUM OF THE RCA. AT THIS POINT THERE WAS SUCCESSFUL BLOOD FLOW AND THE PATIENT WAS DOING FAIRLY WELL. THE PATIENT

  Patient problems: Death; Vascular Dissection

  MAUDE report 8637894 ↗
• MalfunctionMay 3, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 2.75 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, A STENT STRUT WAS LIFTED UP AFTER ENGAGING WITH SOME CALCIUM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577490 ↗
• MalfunctionMar 26, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 2.75 X 20MM SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE HYPOTUBE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8453497 ↗
• MalfunctionMar 20, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05MAR2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A 2.75 X 20 MM SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438023 ↗
• DeathNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2017,THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN MIDDLE RIGHT CORONARY ARTERY WITH 80% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.75 X 20 MM STUDY STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2018 THE SUBJECT WAS HOSPITALIZED WITH CARDIOGENIC SHOCK AND WAS ALSO DIAGNOSED WITH ACUTE CHRONIC HEART FAILURE EXACERBATION. MEDICATION WAS GIVEN IN RESPONSE TO BOTH THE EVENTS. SIX DAYS LATER, THE EVENTS CARDIOGENIC SHOCK AND ACUTE CONGESTIVE HEART FAILURE EXACERBATION WERE CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. IN (B)(6) 2018 THE SUBJECT PRESENTED TO EMERGENCY DEPARTMENT (ED) WITH CHIEF COMPLAINT OF CARDIAC ARREST. A FAMILY MEMBER STATED THAT THE SUBJECT HAD A FALL AND BECAME UNRESPONSIVE. EMERGENCY MEDICAL SERVICE WAS SUMMONED AND THE SUBJECT WAS FOUND TO BE ON PULSELESS ELECTRICAL ACTIVITY (PEA). THE SUBJECT RECEIVED CARDIOPULMONARY RESUSCITA

  Patient problems: Death

  MAUDE report 8106711 ↗
• MalfunctionNov 8, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.75 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROXIMAL EDGE OF THE STENT WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75 X 20 STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8053657 ↗
• MalfunctionJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-MAY-2018. THIS DEVICE WAS RECEIVED WITH NO REPORTED ISSUES. HOWEVER, UPON REVIEW OF THIS DEVICE, HYPOTUBE WAS BROKEN AND THE SHAFT POLYMER EXTRUSION WAS DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7599079 ↗
• MalfunctionMay 31, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED CIRCUMFLEX ARTERY. A 2.75 X 20 SYNERGY II DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON INTRODUCTION, THE CATHETER BROKE AT THE MONORAIL PART, OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED FROM THE GUIDE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7559113 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON PUTTING THE STENT IN THE TUOHY, IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 7549474 ↗
• MalfunctionApr 9, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED UPON ENTERING THROUGH THE SHEATH. THE DEVICE WOULD NOT PASS THROUGH THE SHEATH EASILY. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7407982 ↗
• InjuryMar 30, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 2.75 X 20 SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. DURING DEFLATION OF THE BALLOON, THE FIRST HALF OF THE ARTERY WAS NICE AND OPEN; HOWEVER, THE LOWER HALF LOOKED LIKE THE STENT HAD PROLAPSED OR COLLAPSED AS THERE WAS KIND OF A NARROWING. THERE WAS NO FURTHER INTERVENTIONS PERFORMED 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 7385960 ↗
• MalfunctionMar 22, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL DIAGONAL AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER IMPLANTING A 3.0X28MM SYNERGY STENT IN THE LAD, A 2.75 X 20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED THROUGH THE SIDE STRUTS OF THE FIRST STENT BUT FAILED TO CROSS THE DIAGONAL. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND WHEN GATHERING THE PRODUCT THE SHAFT BROKE 240MM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X20MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362795 ↗
• InjuryMar 12, 2018Device Or Device Fragments Location Unknown; Device Damaged by Another Device; Device Dislodged or Dislocated; Device Or Device Fragments Location Unknown; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE LEFT MAIN ARTERY AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE PROXIMAL LAD LESION BUT DIFFICULTIES WERE ENCOUNTERED IN DELIVERING THE DEVICE. SO, THE PHYSICIAN TREATED THE LEFT MAIN ARTERY FIRST WITH A 2.5 X 16 SYNERGY DRUG-ELUTING STENT. SUBSEQUENTLY, THE 2.75 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED AGAIN BUT THE PHYSICIAN STILL HAD SOME DIFFICULTIES DELIVERING THE DEVICE. DURING REMOVAL, THE PHYSICIAN FELT LIKE THE STENT STRUTS BECAME STUCK TO THE PREVIOUSLY IMPLANTED STENT AND AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE STENT WAS NOWHERE TO BE FOUND AND THE PHYSICIAN DECIDED TO END THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS AT THE MOMENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7331397 ↗
• InjuryMar 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). DIAGNOSTIC PICTURES WERE TAKEN AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. AFTER A 6F FL4 NON-BSC GUIDE CATHETER AND A NON-BSC GUIDE WIRE CROSSED THE LESION, A 2.75X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO THE LESION BUT THE PHYSICIAN WAS NOT ABLE TO GET A GOOD PICTURE AND SO HE PULLED THE STENT TOGETHER WITH THE STENT DELIVERY SYSTEM (SDS) BACK. THE PHYSICIAN AGAIN ADVANCED THE STENT BUT IT WOULD NOT CROSS. IT WAS THEN NOTICED THAT THE STENT WAS NO LONGER ON THE BALLOON BUT ON THE WIRE IN THE OSTIAL/PROXIMAL LAD AND LEFT MAIN ARTERY (LM) UNDEPLOYED. THE PHYSICIAN REMOVED THE SDS AND THE STENT REMAINED ON THE WIRE BUT UNDEPLOYED. A 2.0MM APEX BALLOON CATHETER WAS THEN ADVANCED INTO THE UNDEPLOYED STENT AND SLIGHTLY INFLATED THE LESION. THE PHYSICIAN PLANNED TO DRAG THE STENT BACK INTO THE GUIDE AND REMOVE IT FROM THE PATIENT'S BODY. HOWEVER, THE STENT AND THE 2.0MM BALLOON CATHETER WAS TOO LARGE TO BE PULLED INTO THE 6F GUIDE CATHETER. AT THIS TIME, THE STENT WAS IN THE LM AND PARTIALLY HANGING INTO THE AORTA BUT STILL ON THE WI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7331143 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2016, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS AND WAS 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75MM X 20MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT VISITED THE STUDY HOSPITAL REPORTING INTERMITTENT PALPITATIONS, SUBSTERNAL CHEST PRESSURE (NITROGLYCERIN 5-6 TIMES OVER LAST MONTH) AND WAS IN SINUS. THE PATIENT ALSO REPORTED INCREASING FATIGUE OVER THE LAST 6 MONTHS. IN (B)(6) 2017, THE PATIENT PRESENTED WITH CHEST PAIN AND ABNORMAL STRESS TEST. THE PATIENT WAS HOSPITALIZED FOR SCHEDULED CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY REVEALED 80% STENOSIS IN MID LAD, IMMEDIATELY PRIOR TO THE STUDY STENT WHICH WAS OPEN. THE 80% STENOSIS AT MID LAD WAS TREATED WITH 3.0X16MM SYNERGY STENT IMPLANTED WITHIN 5MM OF THE STUDY STENT. POST-DILATATION THE RESIDUAL STENOSIS

  Patient problems: Chest Pain; Fatigue; Occlusion

  MAUDE report 7136283 ↗
• MalfunctionAug 28, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 20 MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE STENT STRUTS WERE LIFTED FROM THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6824056 ↗