SYNERGY™ H7493926032400Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729840374), received between Nov 28, 2016 and Mar 4, 2021 — classified as 1 death, 7 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Bent” (11 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09FEB2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408954 ↗
• InjuryFeb 22, 2021Obstruction of Flow; Obstruction of Flow

  (B)(4) 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 W

  Patient problems: Angina; Myocardial Infarction; Restenosis

  MAUDE report 11359354 ↗
• InjuryNov 12, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED. A 4.00 X 32 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, STENT THROMBOSIS OCCURRED WITHIN THE HOUR AFTER LEAVING THE PROCEDURE ROOM. THE PATIENT HAD THE THERAPEUTIC RANGE FOR ACTIVATED CLOTTING TIME DURING THE CASE AS WELL AS PLAVIX OR BRILLANTA AND ASPIRIN MEDICATIONS ON BOARD. THE PATIENT WAS BROUGHT INTO THE LAB AND THE STENT THROMBOSIS WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Thrombosis

  MAUDE report 10830810 ↗
• InjuryNov 6, 2020Obstruction of Flow; Obstruction of Flow

  (B)(6) STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED CHEST PAIN, MYOCARDIAL INFARCTION, CARDIAC ENZYME ELEVATION AND STENT THROMBOSIS. IN (B)(6) 2019, THE PATIENT PRESENTED WITH ANGINA AND WAS REFERRED FOR CARDIAC CATHERIZATION. FORTY ONE DAYS AFTER, INDEX PROCEDURE WAS PERFORMED. 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 DISCHARGED ON DUAL ANTIPLATELET THERAPY ON THE SAME DAY. IN (B)(6) 2020,

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

  MAUDE report 10802200 ↗
• MalfunctionSep 10, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00X32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10516381 ↗
• MalfunctionDec 18, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11DEC2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 4.00 X 32 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND NO FURTHER INFORMATION AVAILABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491028 ↗
• MalfunctionJun 12, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCE BUT FAILED TO CROSS THE LESION. THE STENT WAS PULLED OUT FROM THE PATIENT'S BODY AND WAS NOTED THAT THE STENT STRUTS WERE FLARED AT THE PROXIMAL END. 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 8693546 ↗
• MalfunctionMar 31, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 4.00 X 32 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON ADVANCING THE DEVICE INTO THE TOUHY, THE PROXIMAL END OF THE STENT WERE CRINKLED AND SMASHED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8468078 ↗
• MalfunctionMar 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 32MM SYNERGY II DES WAS SELECTED FOR USE; HOWEVER, BEFORE ENTERING THE BODY, IT WAS NOTICED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8386042 ↗
• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.00X 28MM PROMUS PREMIER STENT AND A 4.00X 32MM SYNERGY STENT WERE ATTEMPTED TO BE USED DURING THE PROCEDURE; HOWEVER, THE PROXIMAL ENDS OF THE DEVICES SNAPPED DURING INTRODUCTION THROUGH THE NON-BSC GUIDE CATHETER. ANOTHER 4.00X 32MM SYNERGY STENT WAS THEN USED AND COMPLETED THE PROCEDURE WITH AN EXCELLENT RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974742 ↗
• MalfunctionJul 16, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00 X 32 MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT A LESION. HOWEVER, IT WAS NOTED THAT THE DISTAL END STENT STRUT FLARED UP AND WAS BENT BACKWARDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692628 ↗
• MalfunctionJul 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, ACCORDIONED ON THE END OF THE NON-BSC GUIDE AND WHEN THE DEVICE WAS REMOVED FROM THE SHEATH, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00 X 32MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664243 ↗
• DeathFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALSO SAME CASE AS MDR# 2134265-2018-02211. PREVIOUSLY IT WAS REPORTED THAT ST ELEVATION MYOCARDIAL INFARCTION (STEMI) OCCURRED DURING THE PROCEDURE BUT NOW IT IS REPORTED THE PATIENT PRESENTED WITH STEMI. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED, NON-TORTUOUS, MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE 3.0X20MM EMERGE BALLOON WAS USED FIRST, FOLLOWED BY THE 3.0X30MM AND 2.0X20MM EMERGE BALLOONS, AND THE 3.5X15MM NC QUANTUM BALLOON. PRIOR TO THE PATIENT'S DEATH, ANGIOPLASTY, THROMBECTOMY, AND STENTING WITH A 3.5 X 32 SYNERGY II STENT WERE PERFORMED. THE PATIENT DIED DUE TO CARDIAC ARREST. THE PHYSICIAN DID NOT CONSIDER THE PATIENT'S DEATH TO BE RELATED TO THESE DEVICES.

  Patient problems: Cardiac Arrest; Death; Myocardial Infarction

  MAUDE report 7278279 ↗
• MalfunctionNov 7, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 4.00 X 32 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS SELECTED TO TREAT THE LESION. WHEN THE STENT WAS ADVANCED INTO THE GUIDE CATHETER, IT WAS NOTED THAT THE SHAFT BROKE 24 INCHES FROM THE DISTAL TIP. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00 X 32 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7007285 ↗
• MalfunctionOct 19, 2017Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A GUIDEZILLA¿ II GUIDE EXTENSION CATHETER WAS POSITIONED AND THEN A 4.00X32MM SYNERGY II STENT WAS INSERTED INTO THE GUIDEZILLA. THE STENT BECAME STUCK ON THE HEILOC TRANSITION POINT OF THE GUIDEZILLA II AND WAS DAMAGED. EVERYTHING HAPPENED INSIDE OF THE ORIGINAL GUIDE CATHETER AND EVERYTHING WAS REMOVED AS ONE SYSTEM WITH EASE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963023 ↗
• MalfunctionOct 4, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 4.00X32MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED. HOWEVER, WHEN THEN DEVICE WAS REMOVED, DIFFICULTIES RETRIEVING THE BALLOON WERE ENCOUNTERED. THE DEVICE WAS REMOVED BUT WITH A SNAG ON THE END PORTION OF THE BALLOON. THE PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6913697 ↗
• MalfunctionAug 7, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 4.00 X 32 SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT STRUTS WERE MANGLED DURING REMOVAL OF THE PROTECTIVE CAP. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6770397 ↗
• MalfunctionJul 7, 2017Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  SAME CASE AS MDR ID# 2134265-2017-06728. IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. DURING THE UNPACKING OF TWO SYNERGY II DRUG-ELUTING STENTS (4.00 X 32 AND 4.00 X 38), THE STENTS DISLODGED FROM THEIR STENT DELIVERY BALLOON DUE TO GLOVE INTERACTION. THE DEVICES NEVER ENTERED THE PATIENT'S BODY AND ANOTHER 4.00 X 32 SYNERGY II DRUG-ELUTING STENT WAS SUCCESSFULLY REMOVED FROM THE PACKAGING AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6695704 ↗
• MalfunctionJul 6, 2017Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 32 SYNERGY II STENT WAS SELECTED TO TREAT THE LESION. HOWEVER UPON REMOVING THE STYLET AND COVER FROM THE TOP, THE STENT UNRAVELED AND CAME OFF THE BALLOON. THE DEVICE WAS NOT USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6691967 ↗
• InjuryJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2017-05440 AND 2134265-2017-05441. (B)(6). IT WAS REPORTED THAT VESSEL DISSECTION AND CHEST PAIN OCCURRED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSIS AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.00 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 4.00 X 38 MM AND 3.50 X 38 MM STUDY STENTS. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE MID RCA WITH 60% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.00 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00 X 32 MM STUDY STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. POST PROCEDURE, FOLLOWING TREATMENT OF THE TARGET LESION, GRADE D DISSECTION WAS NOTED. THE DISSECTION WAS TREATED WITH INTERVENTION. CARDIAC CHEST PAIN HAD ALSO OCCURRED DURING PERCUTANEOUS CORONARY INTERVENTION (PCI). THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPI

  Patient problems: Chest Pain; Intimal Dissection

  MAUDE report 6607784 ↗
• MalfunctionMay 31, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 MM X 32 MM SYNERGY II STENT WAS SELECTED FOR USE. DURING PREPARATION, UPON PULLING THE STENT FROM THE HOOP, IT WAS NOTICED THAT THE STENT WAS MANGLED ON THE DELIVERY BALLOON. NOTHING WENT INSIDE THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6602686 ↗
• MalfunctionMay 23, 2017Break; Break

  IT WAS FURTHER REPORTED THAT THE STENT WAS IMPLANTED AND THE EVENT HAPPENED UPON REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6584133 ↗
• MalfunctionMay 8, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00X32MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING UNPACKING, THE PHYSICIAN NOTICED THAT A STENT STRUT WAS "FLARED UP". THE DEVICE NEVER WENT INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 6552501 ↗
• InjuryMay 3, 2017Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-04629. IT WAS REPORTED THAT STENT DISLODGEMENT AND CATHETER REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00MM X 20MM EMERGE¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION BUT WOULD NOT HOLD PRESSURE. THE DEVICE WAS REMOVED AND INFLATED OUTSIDE THE PATIENT¿S BODY AND IT WAS NOTED THAT THERE WAS A HOLE IN THE SHAFT OF THE CATHETER CAUSING CONTRAST LEAKAGE. THE PHYSICIAN USED A NEW BALLOON CATHETER. A 4.00 X 32 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. WHILE TRYING TO DEPLOY THE STENT, THE STENT BECAME DISLODGED FROM THE BALLOON AND WOULD NOT PULL BACK INTO THE GUIDE CATHETER OR THE INTRODUCER SHEATH. EVENTUALLY, THE GUIDE CATHETER, THE BALLOON CATHETER AND THE STENT WERE PULLED BACK TO GROIN LEVEL WHERE IT WON¿T STILL COME OUT. THE PHYSICIAN THEN USED A SNARE FROM THE LEFT FEMORAL ARTERY (LFA) TO REMOVE THE DEVICES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6540953 ↗
• MalfunctionApr 17, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.00 X 32 SYNERGY II DRUG ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SHAFT BROKE 6 INCHES FROM THE PROXIMAL END. THE DEVICE WAS PULLED OUT FROM THE GUIDE CATHETER. THE DETACHED FRAGMENT WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6498527 ↗