SYNERGY™ H7493926038220Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08714729840381), received between Nov 24, 2016 and Oct 26, 2020 — classified as 2 deaths, 14 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE MID SHAFT BROKE WHILE ADVANCING THROUGH THE GUIDE CATHETER. THE DEVICE WAS COMPLETELY REMOVED BY PULLING OFF THE WIRE AND 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 10734472 ↗
• InjuryOct 8, 2020Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT THE STENT WAS DAMAGED POST-DEPLOYMENT, FRACTURED, AND LEFT UNRETRIEVED DEVICE FRAGMENTS REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25X38MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED IN THE LAD OVER A NON-BSC GUIDEWIRE. A 3X20MM SYNERGY WAS THEN INSERTED OVER THE SAME NON-BSC GUIDEWIRE IN THE LAD BUT FAILED TO CROSS THROUGH THE DEPLOYED STENT. THE 3X20MM UNDEPLOYED STENT WAS REMOVED AND A 3X15 EMERGE BALLOON WAS THEN ADVANCED FOR STENT POST DILATION. ANOTHER NON-BSC GUIDEWIRE WAS PASSED DOWN THE LAD THROUGH THE DEPLOYED STENT AS A BUDDY WIRE. ANOTHER ATTEMPT TO CROSS THROUGH THE PREVIOUS DEPLOYED STENT WITH THE 3X20MM SYNERGY STENT ONCE AGAIN FAILED. THE TWO NON-BSC GUIDEWIRES WERE THEN REMOVED WITH RESISTANCE AND FOUND TO BE DAMAGED. ALSO, A PART OF THE DEPLOYED STENT WAS ENTANGLED IN THEM. THE STENT HAD FRACTURED AND SOME OF THE STENT REMAINED BEHIND IN THE LAD. A NEW NON-BSC GUIDEWIRE WAS THEN INSERTED THROUGH THE DEPLOYED STENT AND A 2.5X30MM NON-BSC BALLOON WAS USED FOR DILATION IN THE LESION/STENT AREA, THEN A 2X30MM EMERGE BALLOON WAS USED. TWO NON-BSC STENTS WERE THEN DEPLOYED

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 10653281 ↗
• InjuryDec 17, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS, 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 TAR

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Myocardial Infarction; Thrombosis

  MAUDE report 9484155 ↗
• MalfunctionDec 4, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 2.25X38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ADVANCING OUTSIDE THE PATIENT, IT WAS OBSERVED THAT THE TIP OF THE CATHETER WAS DISLODGED. THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER BACK UNSUCCESSFULLY. ANOTHER ATTEMPT WAS MADE AND THE RED TIP CAME OFF. THE DETACHED TIP WAS REMOVED OFF OF THE WIRE. 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 9410520 ↗
• MalfunctionNov 25, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED. A 2.25X38MM SYNERGY II DRUG-ELUTING STENT WAS LOADED ONTO A NON-BSC GUIDE WIRE AND WAS ADVANCED TOWARDS THE TOUHY. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS LOCKED UP ON THE WIRE AND WOULD NOT GO FORWARD OR BACKWARDS BECAUSE THE WIRE WAS TOO DRY. WHEN THE DEVICE WAS PULLED ON, THE SHAFT BROKE ABOUT 25 CM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369670 ↗
• MalfunctionNov 19, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILD CALCIFIED AND NON TORTUOUS RIGHT CORONARY ARTERY. A 2.25 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THEY PULLED THE STENT OUTSIDE THE PATIENT'S BODY, IT WAS NOTICED THAT THE STRUT WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342700 ↗
• MalfunctionJul 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 2.25X38MM SYNERGY STENT, IT WAS NOTICED THAT THERE WERE BROKEN RAW STRUTS ON THE PROXIMAL END OF THE STENT. THE DEVICE WAS NEVER INTRODUCED INSIDE THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8791955 ↗
• MalfunctionMay 13, 2019Break; Failure to Advance; Break; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED CORONARY ARTERY. A 2.25 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE INSIDE THE GUIDE CATHETER LESS THAN15CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE FRACTURE AND STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8603690 ↗
• MalfunctionApr 3, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13MAR2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.25X38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DELIVERY, A KINK WAS NOTED IN THE CATHETER PART OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25X38 SYNERGY DRUG-ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479667 ↗
• MalfunctionJan 28, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281521 ↗
• InjuryOct 22, 2018Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, SHAFT DETACHMENT, AND VESSEL DISSECTION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS SEGMENTAL WITH A SERIES OF CALCIFIED LESIONS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE OSTIAL LAD WAS 95% STENOSED. THE MID TO DISTAL LAD WAS CALCIFIED WITH 90% STENOSIS. THE PRE-INTERVENTIONAL DISTAL FLOW WAS NORMAL (TIMI-3). A 2.25MMX38MM SYNERGY II DRUG ELUTION STENT WAS DEPLOYED BUT DUE TO THE HEAVILY CALCIFIED LESIONS IT WAS NOT FULLY EXPANDED AND THE DEVICE SHAFT AND BALLOON WERE DETACHED AND REMAINED INSIDE THE LAD, LEFT MAIN (LM), AND AORTA. THE POST-INTERVENTIONAL DISTAL FLOW WAS DECREASED (TIMI 2) AND A DISSECTION WAS NOTED. ATTEMPTS TO WIRE PAST THE OBSTRUCTING DEVICE FRAGMENTS WERE UNSUCCESSFUL. IN ORDER TO PROTECT THE LM, A 7 FR GUIDE WAS INSERTED FROM THE LEFT FEMORAL ARTERY AND WIRED THE LEFT MAIN TO CIRCUMFLEX CORONARY ARTERY (LCX). THE RIGHT FEMORAL 6 FR GUIDE WAS REMOVED. A 10 MM SNARE WAS USED TO SUCCESSFULLY SNARE MOST OF THE DETACHED SHAFT OUT OF THE BODY. IT WAS UNCERTAIN HOW MUCH OF THE DETACHED SHAFT REMAINED. THE LM TO THE OSTIAL LCX WAS SUCCESSFULLY STENTED WITH A 4X16 SYNER

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 7992701 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 38 SYNERGY DRUG-ELUTING STENT SHAFT BROKE DURING ADVANCEMENT TO THE TARGET LESION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO SERIOUS INJURY OR NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7982101 ↗
• MalfunctionMay 29, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 38 SYNERGY II DRUG-ELUTING STENT WAS SELECTED TO TREAT A CHRONIC TOTALLY OCCLUDED TARGET LESION. HOWEVER, UPON ADVANCING THE DEVICE IN THE GUIDE CATHETER THROUGH A NON-BSC GUIDE EXTENSION CATHETER, THE DEVICE GOT CAUGHT INTO THE GUIDE EXTENSION CATHETER. THE STENT STRUTS WERE NOTED TO BE LIFTED OR RAISED AND TANGLED. THE STENT DID NOT GO IN THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25 X 38 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550464 ↗
• MalfunctionMay 24, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING ROTATIONAL ATHERECTOMY, PRE-DILATION WAS PERFORMED AND A STENT WAS DEPLOYED. THE VESSEL APPEARED NOT PREPPED ENOUGH, THUS A 2.25 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED. HOWEVER, WHEN THE DEVICE WAS PULLED OUT, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7540365 ↗
• MalfunctionMar 9, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER PRE-DILATION WAS PERFORMED WITH A 2.0 X 20 EMERGE BALLOON CATHETER, A 2.25 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DEVICE FAILED TO CROSS THE LESION AND IT WAS NOTED THAT ONE OF THE STENT STRUTS WAS LIFTED AWAY FROM THE BALLOON. 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 7328536 ↗
• InjuryJan 11, 2018Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  SAME CASE AS MDR# 2134265-2017-13232. IT WAS REPORTED THAT STENT DISLODGMENT AND DEVICE FRACTURE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX) ARTERIES. A 2.25X38 STENT WAS IMPLANTED IN THE DISTAL LAD AND A 2.25X24 SYNERGY STENT WAS IMPLANTED IN THE PROXIMAL TO OSTIAL LAD. A 2.25X38 SYNERGY STENT WAS INTRODUCED BUT THE STENT WAS DISLODGED FROM THE BALLOON WHILE ATTEMPTING TO CROSS THE DISTAL LCX. THE DISLODGED STENT WAS REMOVED WITH A SNARE. THE PHYSICIANS NOTICED SOMETHING THAT LOOKED LIKE A WIRE IN THE LAD. THE ACCESS PART OF THE STENT WAS ABLE TO BE RETRIEVED. THE LAD WAS THEN RE-ENGAGED AND IT WAS NOTED THAT THE 2.25X24 SYNERGY STENT PREVIOUSLY IMPLANTED IN THE PROXIMA TO OSTIAL LAD HAD MOVED FROM ITS ORIGINAL POSITION AND WAS DEFORMED THE PHYSICIAN COULD NOT CROSS THIS DEFORMED STENT WITH A WIRE AND THE PATIENT WAS SENT FOR BYPASS. FOLLOWING BYPASS THE PATIENT WAS STABLE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7183167 ↗
• InjuryDec 13, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A NON-BSC DEVICE WAS USED TO PREPARE THE LESION. A NON-BSC GUIDEWIRE WAS PLACED AND FOLLOWING PRE-DILATION OF A 2.5 NC EMERGE BALLOON CATHETER, A 2.25 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, A SMALL KINK IN THE DISTAL SHAFT OF THE DEVICE WAS NOTED. THE SAME STENT WAS INSERTED BACK THROUGH THE NON-BSC BLEEDBACK CONTROL VALVE AND IT WAS ABLE TO CROSS THE LESION. WHEN TRYING TO INFLATE THE BALLOON OF THE DEVICE, IT WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS NOTED THAT THE STENT DELIVERY SYSTEM (SDS) WITH MOUNTED UNDEPLOYED STENT HAD SEPARATED AT THE PROXIMAL END OF THE BALLOON AND REMAINED IN THE VESSEL. THE NON-BSC WIRE THAT WAS USED HAD ALSO SHEARED OFF, LEAVING THE DISTAL TIP OF THE WIRE IN THE BODY. IT TOOK TWO HOURS TRYING TO SNARE THE DETACHED COMPONENT OF THE SDS AND WIRE BUT IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7114543 ↗
• InjurySep 27, 2017Occlusion Within Device; Adverse Event Without Identified Device or Use Problem; Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS A LONG LESION LOCATED IN THE PROXIMAL/MID LCX TO THE SECOND OBTUSE MARGINAL (OM2). IN (B)(6) 2017, CHRONIC ATRIAL FIBRILLATION WAS NOTED. NINE DAYS AFTER, FOCAL IN-STENT RESTENOSIS AT THE PROXIMAL EDGE IN MID LCX STENT WAS NOTED AND TREATED. THE NON-BSC STENT IN THE MID LCX JAILED THE OSTIUM OF OM1 AND A 2.75X12MM NON-BSC STENT WAS IMPLANTED IN AN OVERLAPPING MANNER. THERE WAS SMALL STENOSIS AT THE DISTAL EDGE OF 3.5 X 28 MM NON-BSC STENT WHICH WAS TREATED WITH BALLOON ANGIOPLASTY WITH GOOD ANGIOGRAPHIC RESULT.

  Patient problems: Angina; Atrial Fibrillation; Chest Tightness/Pressure; Congestive Heart Failure; Dyspnea; Fatigue; Occlusion; Reocclusion

  MAUDE report 6899745 ↗
• InjurySep 5, 2017Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A SERIES OF INFLATIONS WITH DIFFERENT TYPES OF BALLOONS AND LASERING THE VESSEL, A 2.25 X 38 SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE PHYSICIAN COULD NOT ADVANCE THE DEVICE TO WHERE HE INTENDED IT TO BE. THE DEVICE WAS ATTEMPTED TO BE REMOVED TO PERFORM FURTHER INFLATIONS BUT THE DEVICE BECAME STUCK IN THE VESSEL AND THE BALLOON HAD STRETCHED AS THE PHYSICIAN CONTINUE TO PULL THE DEVICE HARDER. MOREOVER, THE BALLOON WITH THE STENT STILL INTACT GOT DETACHED FROM THE SHAFT AND WAS LEFT IN THE LAD. THE PHYSICIAN THEN REMOVED THE REMAINING PROXIMAL PORTION OF THE DEVICE AND THE PROCEDURE WAS DISCONTINUED. ON THE FOLLOWING DAY, THE PATIENT WAS SCHEDULED FOR CORONARY ARTERY BYPASS GRAFT VIA LEFT MAIN ARTERY TO LAD TO TREAT THE OCCLUSION BUT THE BALLOON AND STENT WERE LEFT IN PLACE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE ALL THROUGHOUT THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6843807 ↗
• DeathAug 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-09001 AND 2134265-2017-09003. IT WAS FURTHER REPORTED THAT ROTATIONAL ATHERECTOMY WAS PERFORMED WITH ROTABLATOR. THE LESION WAS THEN PRE-DILATED AND A SYNERGY STENT WAS IMPLANTED. THE STENT WAS THEN POST-DILATED. THE PATIENT WENT INTO AN ARRHYTHMIA. CONTRAST INJECTION WAS PERFORMED AND NO FLOW WAS OBSERVED IN THE LAD. THE PATIENT BEGAN TO CRASH. CHEST COMPRESSIONS WERE PERFORMED, THE PATIENT WAS INTUBATED, AND A LEFT VENTRICULAR ASSIST DEVICE WAS IMPLANTED. ANOTHER 2.25 X 38 SYNERGY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE DISTAL LAD; HOWEVER IT WAS NOT ABLE TO CROSS THE LAD AND WAS REMOVED. THE PHYSICIAN ATTEMPTED ANOTHER BALLOON BUT IT WOULD NOT ADVANCE INTO THE GUIDE. IT WAS THEN NOTED THE STENT HAD DISLODGED IN THE HUB OF THE GUIDE CATHETER. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS TAKEN TO THE ICU ON LIFE SUPPORT, BUT IN "STABLE" CONDITION. THE PATIENT PASSED AWAY A FEW HOURS LATER IN THE ICU. THE DISLODGED STENT WAS NOT RELATED TO THE PATIENT COMPLICATIONS AND OUTCOME. AN AUTOPSY HAS NOT BEEN PERFORMED.

  Patient problems: Death

  MAUDE report 6772881 ↗
• MalfunctionAug 1, 2017Break; Break

  SAME CASE AS MDR ID# 2134265-2017-07853. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION AS SILENT ISCHEMIA AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 95% STENOSIS AND WAS 20.0MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 5%. SUBSEQUENTLY, A 2.50 X 38 SYNERGY II DRUG-ELUTING STENT WAS ATTEMPTED TO BE IMPLANTED IN AN UNKNOWN LESION. HOWEVER, DUE TO BROKEN STENT SHAFT ON A PORTION THAT WAS OUTSIDE OF THE PATIENT'S BODY, THE DEVICE WAS REMOVED AND WAS NOT DEPLOYED. A SECOND 2.25 X 38 SYNERGY II DRUG-ELUTING STENT AS ALSO ATTEMPTED TO BE IMPLANTED IN AN UNKNOWN LESION. HOWEVER, DUE TO BROKEN STENT SHAFT ON A PORTION THAT WAS OUTSIDE OF THE PATIENT'S BODY, THE DEVICE WAS REMOVED AND WAS NOT DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6758125 ↗
• InjuryJul 12, 2017Material Rupture; Activation, Positioning or Separation Problem; Material Rupture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BALLOON RUPTURE AND PARTIAL DEPLOYMENT OF STENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25 X 38 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. WHEN THE STENT WAS ATTEMPTED TO BE DEPLOYED AT ABOUT 3-4 ATMOSPHERES, THE STENT DELIVERY BALLOON RUPTURED PARTIALLY DEPLOYING THE STENT. THE STENT, DELIVERY BALLOON, AND GUIDEWIRE WERE REMOVED INTACT AS THE PARTIALLY INFLATED DELIVERY BALLOON HELD THE STENT. THE TARGET LESION WAS RE-WIRED AND A NEW 2.25 X 38 SYNERGY STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6705926 ↗
• MalfunctionJul 5, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 38 SYNERGY II DRUG ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE EDGE OF THE STENT WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687518 ↗
• InjuryJun 19, 2017Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MIGRATION AND INADEQUATE APPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER A 6F 275 NON-BSC GUIDE CATHETER AND A 300 IN LENGTH NON-BSC GUIDE WIRE WERE ADVANCED TO THE LESION, A 2.25 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION AND DEPLOYED. UPON REMOVAL OF THE DELIVERY SYSTEM THE DELIVERY BALLOON BECAME CAUGHT IN THE PROXIMAL PORTION OF THE LESION. AFTER REMOVAL, THE STENT WAS UNABLE TO BE VISUALIZED IN THE MID LAD AND WAS FOUND IN THE PROXIMAL LAD. IT IS BELIEVED THAT THE STENT WAS NOT FULLY DEPLOYED AND THEN BECAME STUCK IN THE PROXIMAL PORTION OF THE LESION DURING REMOVAL OF THE DELIVERY SYSTEM. THE STENT WAS EVENTUALLY DEPLOYED IN THE PLAD. THE PROCEDURE WAS COMPLETED BY STENTING OVER THE OSTIUM OF THE LESION WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN RECOVERY AND BEING MONITORED FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6652053 ↗
• InjuryJun 5, 2017Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE FIRST DIAGONAL IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN OCCLUSION HAD OCCURRED PROXIMAL TO A STENT IMPLANTED A MONTH AGO. SUBSEQUENTLY, PROXIMAL OCCLUSION WAS SUCCESSFULLY STENTED. AFTER THAT, THE PHYSICIAN WAS GOING TO FIX THE DIAGONAL LAD AND WHEN THE DEVICE WAS ADVANCED WITH THE AID OF A GUIDEZILLA GUIDE EXTENSION CATHETER, THE DEVICE WAS ABLE TO CROSS THE PREVIOUS STENTS; HOWEVER, COULD NOT CROSS THE LESION MUCH FURTHER. UPON ATTEMPTING TO REMOVE THE DEVICE, THE STENT GOT CAUGHT WITH THE PREVIOUSLY IMPLANTED STENT AND GOT STRIPPED OFF. A SMALL BALLOON WAS THEN ADVANCED AND SMASHED THE DISLODGED STENT AGAINST THE VESSEL WALL AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6613136 ↗