SYNERGY™ H7493926012300Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 08714729840053), received between Nov 16, 2016 and Sep 1, 2021 — classified as 2 deaths, 22 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (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 65 reports, in the reporter's own words as published by the FDA.

• DeathSep 1, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT 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 RUN THROUGH 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 WAS SE

  Patient problems: Obstruction/Occlusion

  MAUDE report 12406187 ↗
• MalfunctionJul 8, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE >80% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND SEVERELY CALCIFIED OSTIAL CIRCUMFLEX. A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE COULD NOT CROSS THE LESION AND IT WAS OBSERVED THAT THE MID PART OF THE STENT STRUT WAS DEFORMED AFTER TRYING TO CROSS THE CALCIFIED LESION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135612 ↗
• MalfunctionAug 31, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND MOVE ON BALLOON OCCURRED. A 3.00X12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE STENT WAS MANGLED AND SLIPPED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10473427 ↗
• MalfunctionAug 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION. AFTER REMOVAL, THE STENT STRUTS WAS NOTED TO BE ASKEW. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414486 ↗
• MalfunctionAug 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL IT WAS NOTICED THAT THE STENT STRUTS WERE DISTORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10356769 ↗
• MalfunctionJul 14, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS FOUND OUT THAT THE STENT EDGE WAS DEFORMED ON BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10274135 ↗
• MalfunctionJun 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE MILDY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN RCA AND A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN LAD. BOTH DEVICES FAILED TO CROSS AND THE STENT STRUTS WERE NOTED TO BE FLARED UPON REMOVAL. BOTH THE RCA AND LAD WERE DILATED WITH NC BALLOON CATHETERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191083 ↗
• InjuryMar 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGED INSIDE PATIENT. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL/OSTIAL RIGHT CORONARY ARTERY. STARTED WITH WIRING A CHOICE FLOPPY WIRE AND THEN USED A NON BSC CATHETER TO EXCHANGE FOR A ROTA FLOPPY WIRE. USED A 1.5MM ROTABLATOR BURR AND THEN EXCHANGED THE WIRE BACK TO THE CHOICE FLOPPY WIRE USING THE NON BSC CATHETER. A 2.5 X 10 WOLVERINE CUTTING BALLOON WAS USED TO PRE DILATED THE ENTIRE RIGHT CORONARY ARTERY VESSEL. THEY SUCCESSFULLY PLACED A 2.75 X 28 SYNERGY DRUG ELUTING STENT AND THEN OVERLAPPED WITH A 3.0 X 32 SYNERGY DRUG ELUTING STENT. A MR 3.00 X 12 SYNERGY DRUG ELUTING STENT WAS ATTEMPTED TO DELIVER. HOWEVER, IT FAILED TO GET DELIVER TO THE PROXIMAL/OSTIAL PORTION OF THE RIGHT CORONARY ARTERY. AFTER SEVERAL ATTEMPTS TO PUSH IT DOWN, THE STENT WAS ATTEMPTED TO BE REMOVED AND THE PROXIMAL EDGE CAUGHT ON THE 6F NON BSC GUIDE CATHETER AND STRIPED OFF. THE STENT REMAINED ON THE WIRE, BUT IN THE AORTA. UTILIZING SEVERAL BALLOONS, FIRST A 1.0 X 10 NON BSC BALLOON, THEN A 2.0 X 12 EMERGE MR, AND FINALLY A 3.0 X 12 NC EMERGE BALLOON, THE STENT WAS PULLED DOWN TO THE DISTAL PART OF THE FEMO

  Patient problems: No Code Available

  MAUDE report 9825325 ↗
• MalfunctionFeb 27, 2020Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping; Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. THE BOX OF AN EMERGE MR BALLOON WAS OPENED. HOWEVER, UPON OPENING THE PACKAGE, THERE WAS A 3.0 X 12 SYNERGY STENT INSIDE OF IT. IT WAS A BALLOON BOX BUT A SYNERGY STENT IN A FOIL PACKAGE WAS INSIDE. THE DEVICE NEVER WENT INTO THE PATIENT'S BODY AND PROCEDURE WAS COMPLETED WITH ANOTHER 2.5MMX12MM BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 9763542 ↗
• MalfunctionFeb 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X12 SYNERGY DRUG- ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, ONE OF THE STENT STRUTS LIFTED OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671597 ↗
• MalfunctionJan 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE STENT STRUTS WERE FLARED. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9551110 ↗
• MalfunctionDec 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED FROM THE BALLOON. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, THE PHYSICIAN FELT THE STENT WAS LOOSE FROM THE BALLOON, SO THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9473182 ↗
• InjuryDec 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA USER/FACILITY MEDWATCH# (B)(4) THAT STENT DISLODGEMENT OCCURRED. AFTER THE FIRST UNKNOWN STENT WAS DEPLOYED, A 3.00X12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED. HOWEVER, IT WAS OBSERVED THAT THE SYNERGY STENT WAS DISLODGED IN THE RIGHT CORONARY ARTERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411260 ↗
• MalfunctionDec 4, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18NOV2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED VESSEL. A 3.00X12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT COULD NOT 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410989 ↗
• InjuryOct 28, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO DEPLOY THE STENT, THE SHAFT BROKE. THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT'S BODY USING A SNARE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 9247018 ↗
• MalfunctionOct 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00X12MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHILE LOADING THE DEVICE OVER THE WIRE, THE RED TIP ON THE DISTAL END OF THE STENT DELIVERY WAS SEPARATED. THE PHYSICIAN WAS ABLE TO SLIDE IT BACK ONTO THE STENT DELIVERY SYSTEM AND REMOVED IT FROM THE WIRE. 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 9218792 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE UPON ADVANCING DEVICE TO THE BLOCKAGE. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.5X12MM STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739059 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA) AND MID RCA. A 3.00 X 8MM SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION BUT HAD DIFFICULTIES IN DELIVERING THE DEVICE. THE PHYSICIAN WAS TRYING TO GET TO A DISTAL LESION IN THE RCA BUT THE SHAFT SNAPPED 8 INCHES FROM THE HUB. THE DEVICE WAS REMOVED OUT OF THE PATIENT AND CONTINUED THE CASE WITH A DIFFERENT DEVICE. A 3.00 X 12 SYNERGY DRUG-ELUTING STENT WAS THEN ADVANCED IN THE MIDDLE OF THE RCA TO GET A SECOND STENT PLACED; HOWEVER, WHEN THE DEVICE WAS PUSHED, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 3.0X12MM NON BSC STENT AND A 4.00X16MM SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588434 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY. ROTABLATION WAS PERFORMED WITH A 1.75MM ROTABLATOR BURR AND CORONARY GUIDEWIRES WERE CROSSED THE LESION. PRE-DILATION WITH 1.5MM, 2.5MM AND 3.0X12MM EMERGE BALLOON CATHETERS IN THE PROXIMAL CIRCUMFLEX AND DISTAL LEFT MAIN ARTERY AND A 2.5X10MM WOLVERINE BALLOON CATHETER WAS DILATED IN THE PROXIMAL ARTERY. A 4.0X24MM SYNERGY DRUG-ELUTING STENT (DES) WAS THEN ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND A 3.0X12MM SYNERGY DES WAS ADVANCED TO THE PROXIMAL AND DEPLOYED FOLLOWED BY A 4.0X12MM STENT DEPLOYED IN THE DISTAL LEFT MAIN AND PROXIMAL CIRCUMFLEX ARTERY. HOWEVER, IT WAS OBSERVED VIA ANGIOGRAM THAT PERFORATION OCCURRED AT THE PROXIMAL CIRCUMFLEX ARTERY. ANOTHER BALLOON CATHETER FOLLOWED BY A 3.0X16MM GRAFTMASTER NON-BSC STENT WAS USED TO COVER MOST OF THE PERFORATION. ANOTHER 4.0X12MM SYNERGY DES WAS DEPLOYED AND POST-DILATED WITH A 5.0X8MM NC EMERGE BALLOON CATHETER LIMITING THE PERFORATION TO A SMALL TRICKLE. THE PATIENT'S ANTICOAGULATION WAS REVERSED WITH PROTAMINE TO FURTHER PROMOTE CLOSURE OF THIS PERFORATION. THE PATIENT WAS FOLLOWED CL

  Patient problems: Perforation

  MAUDE report 8515688 ↗
• MalfunctionApr 5, 2019Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT THE SHAFT BROKE IN A PORTION THAT COULD NOT ENTER THE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00 X 12MM SYNERGY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON ATTEMPTING TO DEPLOY THE STENT, THE SHAFT BROKE AT ABOUT 5-10CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE SHAFT BROKE 18.2CM DISTAL TO THE STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487018 ↗
• MalfunctionMar 13, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-FEB-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 12MM 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417666 ↗
• MalfunctionOct 8, 2018Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. AFTER PERFORMING ROTATIONAL ATHERECTOMY IN THE LEFT ANTERIOR DESCENDING ARTERY, FORTE GUIDEWIRE WAS INSERTED TO TAKE PLACE THE ROTA WIRE. A 3.00 X 12 SYNERGY DRUG-ELUTING STENT WAS USED TO TREAT THE LESION. HOWEVER, IT WAS UNABLE TO ADVANCE OVER THE GUIDEWIRE DUE TO LACK OF GUIDE CATHETER SUPPORT. THEY TRIED TO PULLOUT THE DEVICE, BUT THE STENT WOULD NOT COME OFF THE WIRE. THE PHYSICIAN REMOVED BOTH WIRE AND THE STENT TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944502 ↗
• MalfunctionOct 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. AFTER A NON-BSC GUIDE EXTENSION CATHETER WAS PLACED, A 3.00 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT DISLODGED FROM THE BALLOON INSIDE THE GUIDE EXTENSION CATHETER. THE WIRE, STENT, GUIDE EXTENSION CATHETER, WAS THEN REMOVED FROM THE BODY ALL AT THE SAME TIME AND THE STENT WAS FOUND INSIDE THE GUIDE EXTENSION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED BY STENTING SUCCESSFULLY THE DISTAL, MID, AND PROXIMAL RCA WITH A DIFFERENT DEVICE. SYNERGY II US MR 3.00 X 12MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THAT THE STENT HAD DETACHED FROM THE SDS AND WAS SEVERELY DAMAGED THE WHOLE LENGTH AND BUNCHED. THE CRIMPED STENT OD (OUTER DIAMETER) AT THE TIME OF MANUFACTURE WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. A VISUAL EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. 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 PRE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922293 ↗
• MalfunctionAug 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY TIGHT ANGLE IN THE CIRCUMFLEX ARTERY. A 3.00X12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DELIVERY, IT WAS NOTED THAT THE STENT STRUTS LIFTED OFF OF THE BALLOON. THE STENT DELIVERY SYSTEM WITH THE ENTIRE STENT WAS COMPLETELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797650 ↗
• InjuryAug 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SKIP PORTION OF THE GRAFT FROM THE OBTUSE MARGINAL (OM) TO THE CIRCUMFLEX ARTERY (CX). THE BRIDGING PORTION OF THE GRAFT FROM THE OM TO THE CX WAS EXTREMELY TORTUOUS AND THE PROXIMAL PORTION OF THE GRAFT HAD MULTIPLE LAYERS OF UNDER-DEPLOYED STENTS. THE MULTIPLE STENT LAYERS IN THE GRAFT MADE IT NEARLY IMPOSSIBLE FOR CORRECT PLACEMENT SO THE DECISION WAS MADE TO USE A 6FR NON-BSC GUIDE EXTENSION CATHETER. THERE WAS DIFFICULTY DELIVERING THE EXTENSION CATHETER PAST THE PROXIMAL PORTION OF THE GRAFT AS IT CONTINUED TO MAKE CONTACT WITH THE GRAFT'S PROXIMAL STENT STRUTS. THE PREVIOUSLY IMPLANTED STENTS HAD ALREADY LOOKED DEFORMED ALONG WITH BEING UNDER-DEPLOYED SO DELIVERING ANY EQUIPMENT WAS VERY DIFFICULT. ONCE IT CAME TIME TO DELIVER THE 3.00 X 12MM SYNERGY II STENT IT WAS NOT ABLE TO CROSS THE PROXIMAL PORTION OF THE GRAFT. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO AGGRESSIVELY PUSH FORWARD TENSION ON THE STENT DELIVERY SHAFT TO ADVANCE THE STENT. WHEN THE STENT WAS PULLED BACK OUT OF THE BODY THERE WAS A QUESTION AS TO WHETHER THE STENT WAS STILL ON THE BALLOON. AFTER CLOSELY EXAM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7789349 ↗