SYNERGY™ H7493926024220Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729840206), received between Nov 11, 2016 and May 25, 2021 — classified as 1 death, 10 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Bent” (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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25X24MM SYNERGY DRUG-ELUTING STENT WAS INTRODUCED TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT ACROSS THE LESION, THE PROXIMAL SHAFT BROKE COMPLETELY. THE SHAFT AND THE UNDEPLOYED STENT WERE REMOVED COMPLETELY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881762 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ALLERGIC REACTION WAS SUSPECTED. ON (B)(6) 2020, A 2.25 X 24 SYNERGY STENT WAS ADVANCED AND DEPLOYED AT THE TARGET LESION. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT. IN (B)(6) 2020, FOLLOWING THE PROCEDURE AND WITHIN 30 DAYS OF THE STENT IMPLANT, THE PATIENT BROKE OUT IN A RASH AND EXPERIENCED SHORTNESS OF BREATH. THE RASH WAS NOTED TO COME AND GO AND APPEARED AS A ROUND RED CIRCLE, WHICH ITCHED AND WAS SOMETIMES PAINFUL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Pain; Rash

  MAUDE report 11856424 ↗
• MalfunctionMar 4, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10FEB2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 24MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11408955 ↗
• MalfunctionNov 5, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. THE PATIENT CAME IN WITH ST-ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.25X24MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVING THE DEVICE, IT WAS NOTICED THAT THERE WAS A BUBBLE OR A METAL RING FORMATION ON THE STENT HYPOTUBE. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10791300 ↗
• MalfunctionAug 31, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 24MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED WITH THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474021 ↗
• MalfunctionApr 15, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24MAR2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A VERY CALCIFIED CORONARY ARTERY. A 2.25 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT RESISTANCE WERE ENCOUNTERED AND SO COULDN'T PASS THROUGH THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962497 ↗
• MalfunctionSep 2, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO PROCEDURE, IT WAS NOTICED THAT THE STENT STRUTS WERE DAMAGED. 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 8953751 ↗
• InjuryJul 1, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH ST- ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING. A 2.25 X 24MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. AFTER DEPLOYMENT, THE BALLOON WAS DEFLATED. HOWEVER, UPON REMOVAL, IT WAS NOTED THAT THE DEFLATED BALLOON WAS STUCK IN THE DEPLOYED STENT. THE PHYSICIAN PULLED THE GUIDE INTO THE LEFT MAIN AND A FEW TUGS OF THE DELIVERY SYSTEM WERE PERFORMED AND FINALLY, THE DEFLATED BALLOON WAS RELEASED. IMMEDIATELY AFTER THE IMPLANTATION, A THROMBUS WAS NOTED. A IIB IIIA INHIBITOR WAS THEN STARTED AND POST DILATATION AT 16 ATMOSPHERES WAS PERFORMED WITH A 2.24X15 NC EMERGE BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: Thrombosis

  MAUDE report 8749852 ↗
• MalfunctionMay 6, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15 APR 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY NOR COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583201 ↗
• MalfunctionDec 17, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DEFORMATION HAD BEEN PRESENT. A PERCUTANEOUS CORONARY INTERVENTION OF THE DISTAL CIRCUMFLEX WAS BEING PERFORMED. A 2.25 X 24 SYNERGY DRUG-ELUTING CORONARY STENT SYSTEM WAS BEING USED, BUT WAS UNABLE TO BE DELIVERED TO THE TARGETED AREA. IT WAS NOTED THAT IT LOOKED LIKE THERE WAS DEFORMATION ON THE UNDEPLOYED STENT. THE SYSTEM WAS REMOVED FROM THE PATIENT AND A DIFFERENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO FURTHER ISSUES OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171609 ↗
• MalfunctionDec 12, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-DEC-2018. IT WAS REPORTED THAT DIFFICULTY LOADING WIRE OCCURRED. DURING INTRODUCTION OF A 2.25 X 24MM SYNERGY II DRUG-ELUTING STENT INTO THE WIRE, THE DEVICE WOULD NOT GO OVER THE WIRE. ANOTHER 2.25 X 24MM SYNERGY STENT WAS USED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS OR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE. A SYNERGY II US MR 2.25 X 24MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS WITHOUT A STENT. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED IDENTIFIED STENT DAMAGE. THE CRIMPED STENT OUTER DIAMETER (OD) OF THE UNDAMAGED SECTION OF THE CRIMPED STENT WAS MEASURED AND IS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON WAS 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 TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE HYPOTUBE KINKS. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT POLYMER EXTRUSION REVEALED NO ISSUES. THE DEVICE WAS LOADED ONTO AND TRACKED OVER A 0.014 GUIDEWIRE WITHOUT ISSUE. A VISUAL AND MICROSCOPIC EXAMINATION FOUND DAMAGE TO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156767 ↗
• MalfunctionOct 8, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-SEP-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 24MM SYNERGY II DRUG-ELUTING 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'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE. A SYNERGY II US MR 2.25 X 24 MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND PROXIMAL STENT DAMAGE ON THE 4TH PROXIMAL STENT STRUT ROW, A STENT STRUT WAS LIFTED. THE UNDAMAGED DISTAL SECTION STENT OUTER DIAMETER (OD) WAS MEASURED AND IS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. STENT DAMAGE MOST LIKELY OCCURRED DURING WITHDRAWAL ATTEMPTS. 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 SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945004 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT JAILING OCCURRED. IN (B)(6) 2017, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: 4) WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. TARGET LESION #1 WAS LOCATED IN THE SECOND OBTUSE MARGINAL BRANCH (OM2) WITH 99% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.25X 24 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. FOLLOWING STENT IMPLANTATION IN THE PROXIMAL OM2, JAILING OF THE DISTAL LEFT CIRCUMFLEX ARTERY WITH 95%-99% STENOSIS WAS NOTED AND TREATED WITH BALLOON ANGIOPLASTY. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 7763362 ↗
• MalfunctionJul 10, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 24 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674318 ↗
• InjuryMay 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25 X 24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE ADVANCING THE DEVICE TO THE MID LAD, THE STENT FELL OFF THE DELIVERY SYSTEM. A 2.0 X 20MM EMERGE BALLOON CATHETER WAS THEN ADVANCED THROUGH THE DISLODGED STENT AND IT WAS THEN INFLATED. AFTER USING LARGER BALLOONS, THE STENT WAS EMBEDDED TO THE ARTERY WALL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7540148 ↗
• MalfunctionMar 26, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25X24MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT COUPLE OF STENT STRUTS WERE DAMAGED. THE DEVICE WAS NEVER ENTERED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7370577 ↗
• MalfunctionFeb 27, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL BRANCH OF THE CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATATION, A 2.25 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT STRUTS WERE STICKING UP. THE PROCEDURE WAS COMPLETED WITH A 2.5 X 24 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299327 ↗
• MalfunctionDec 18, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT ON THE SHAFT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED OBTUSE MARGINAL CIRCUMFLEX ARTERY. WHEN A 2.25 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED, IT WAS NOTED THAT THERE WAS A FOREIGN MATTER ON THE SHAFT WHICH COULD NOT BE REMOVED. THE PRODUCT WAS COMPLETELY REMOVED FROM THE PATIENT AND 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 7126410 ↗
• MalfunctionNov 20, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25 X 24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. RESISTANCE WAS NOTED UPON DELIVERING THE DEVICE AND UPON ATTEMPTING TO INFLATE THE BALLOON FOR STENT DEPLOYMENT, THE STENT WOULD NOT INFLATE. THE INFLATION DEVICE WAS REPLACED BUT STILL THE SAME ISSUE WAS NOTED. THE DEVICE WAS COMPLETELY REMOVED WITH THE STENT INTACT ON THE BALLOON. ONCE THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY, THE DISTAL END OF THE SHAFT SNAPPED BUT WAS STILL ON THE BLACK HYPOTUBE PORTION OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A 2.25X24MM SYNERGY STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046038 ↗
• MalfunctionOct 9, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 2.25 X 24 SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT ONE OF THE STENT STRUTS WAS STICKING OUT. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6929089 ↗
• InjurySep 7, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID 2134265-2017-08815 AND 2134265-2017-08817. IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. IN (B)(6) 2017, THE PATIENT PRESENTED THROUGH THE EMERGENCY ROOM WITH COMPLAINTS OF SHORTNESS OF BREATH AND CHEST PAIN. THE PATIENT WAS FOUND TO HAVE NO ACUTE ST-T CHANGES, BUT HAD SIGNIFICANT METABOLIC ABNORMALITIES. THE PATIENT HAD BORDERLINE TROPONIN ELEVATION. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) WITH A WHITE COUNT OF 23,000 AND LACTIC ACIDOSIS. BROAD-SPECTRUM ANTIBIOTICS WAS THEN STARTED. EARLY IN THE MORNING, THE PATIENT'S PAIN STARTED TO GET WORSE AND DESPITE BEING ON INTRAVENOUS (IV) HEPARIN DRIP AND TOPICAL NITRATES, THE PATIENT WAS HAVING MORE CHEST PAIN AND WAS ADVISED CARDIAC CATHETERIZATION. HIS TROPONIN WAS ELEVATED. THE PATIENT WAS TAKEN TO THE CARDIAC CATH LAB. LEFT WRIST WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. AFTER LOCAL ANESTHESIA, LEFT RADIAL ARTERY WAS PUNCTURED WITHOUT DIFFICULTY AND A 6-FRENCH NON-BSC SHEATH WAS PLACED. CORONARY ANGIOGRAM WAS THEN PERFORMED. THE RIGHT AMPLATZ GUIDE CATHETER WAS ENGAGED WITHOUT DIFFICULTY AND A LONG NON-BSC GUIDEWIRE WAS PASSED ACROSS THE LESION. A NON-BSC GUIDE EXTENSION CATHETER WAS ALS

  Patient problems: Bradycardia; Chest Pain; Low Blood Pressure/ Hypotension; Thrombosis; Ventricular Tachycardia

  MAUDE report 6848636 ↗
• InjuryJul 20, 2017Bent; Device Damaged by Another Device; Device Dislodged or Dislocated; Bent; Device Damaged by Another Device; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-07348. IT WAS REPORTED THAT STENT DAMAGED AND STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND VERY CALCIFIED LEFT MAIN ARTERY TO RAMUS. A 3.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO THE DISTAL RAMUS HOWEVER; THE LEFT MAIN KEPT PREVENTING THE DEVICE FROM BEING DELIVERED. THE 3.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS THEN DEPLOYED IN THE LEFT MAIN. A 2.25X12 MM STENT WAS THEN ADVANCED AND SUCCESSFULLY DEPLOYED IN THE DISTAL RAMUS. A 2.25 X 24MM SYNERGY II DRUG-ELUTING STENT WAS THEN ADVANCED BUT HAD DIFFICULTY ADVANCING. A NON-BSC GUIDE EXTENSION WAS CATHETER WAS USED AND THE SYNERGY STENT WAS RE-ADVANCED. HOWEVER, IT WAS NOTED THAT THE PROXIMAL EDGE WAS DAMAGED BY THE NON-BSC GUIDE EXTENSION CATHETER. THE GUIDE EXTENSION CATHETER AND THE SYNERGY STENT WERE REMOVED TOGETHER AND IT WAS NOTED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT HAD STRIPPED OFF ONTO THE LEFT MAIN INSIDE THE PREVIOUSLY IMPLANTED PROMUS PREMIER¿ STENT. A NON-BSC GUIDE WIRE WAS THEN ADVANCED HOWEVER, IT BECAME TANGLED UP WITH THE DISLODGED STENT. THE TANGLED GUIDE WIRE WAS REMOVED HOWEVER BOTH THE DISLODGED SYNERGY STENT A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6727518 ↗
• MalfunctionJun 7, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL CIRCUMFLEX ARTERY. A 2.25 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND A STENT STRUT ON THE PROXIMAL PORTION OF THE STENT WAS NOTED TO BE LIFTED. SUBSEQUENTLY, A 2.25 X 28 SYNERGY DRUG-ELUTING STENT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX ARTERY AND ANOTHER 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS IMPLANTED IN THE MID CIRCUMFLEX ARTERY, 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 6619983 ↗
• MalfunctionMay 1, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE PROXIMAL EDGE OF THE STENT WAS CRUMPLED ABOUT 5MM DISTAL TO THE PROXIMAL RADIOPAQUE MARKER. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF TWO DIFFERENT SYNERGY STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6534062 ↗
• MalfunctionApr 24, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 24 SYNERGY II DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE STENT WAS FRAYED AT THE END. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6516749 ↗