SYNERGY™ H7493926016400Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729840138), received between Nov 15, 2016 and Apr 8, 2021 — classified as 2 deaths, 12 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. A 4.00 X 16 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT WAS IMPLANTED, SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON. THE GUIDE WAS NEGATIVE AND THE INFLATION DEVICE WAS PULLED NEGATIVE SEVERAL TIMES. THE PARTIALLY DEFLATED BALLOON WAS REMOVED TOGETHER WITH THE GUIDE CATHETER AND THE GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638927 ↗
• MalfunctionMar 16, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT A LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT ONE OF THE STENT STRUTS WAS FLARED OUT POSSIBLY PREVENTING THE DEVICE FROM CROSSING THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497510 ↗
• InjuryDec 1, 2020Failure to Advance; Device Dislodged or Dislocated; Activation Failure; Failure to Advance; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. AFTER A GUIDEWIRE CROSSED THE LESION AND 5.5F NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER WAS PLACED, THE DISTAL LESION WAS DILATED WITH A 2.5X12 COMPLIANT BALLOON. A 4.00 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED IN THE LEFT MAIN BUT FAILED TO CROSS THE LESION. UPON WITHDRAWAL, THE STENT DISLODGED FROM THE STENT DELIVERY BALLOON. AN ATTEMPT WAS MADE TO RECROSS THE UNDEPLOYED STENT WITH THE DELIVERY BALLOON. SUBSEQUENTLY, THE SYSTEM DELIVERY BALLOON WAS REMOVED AND A 2.0X12 COMPLIANT BALLOON WAS ADVANCED WHICH PARTIALLY DEPLOYED THE STENT. A 4.0X12MM COMPLAINT BALLOON WAS ADVANCED AND FULLY EXPANDED THE STENT IN THE LEFT MAIN. AFTER WIRE AND GUIDE REMOVAL, THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10928292 ↗
• InjuryAug 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED PROXIMAL SAPHENOUS VEIN GRAFT. A 4.00X16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO BE DELIVERED TWICE. ON THE THIRD ATTEMPT, THE STENT CAME OFF THE BALLOON SHAFT. SNARING WAS ATTEMPTED BUT FAILED. THE PHYSICIAN WAS ABLE TO ADVANCE A 2.0 MM EMERGE BALLOON CATHETER TO INFLATE THE UNDEPLOYED STENT AND SERIAL INFLATIONS WITH MULTIPLE BALLOONS WAS ALSO PERFORMED TO FULLY DEPLOY STENT. POST INTRAVASCULAT ULTRASOUND CONFIRMED THAT THE STENT WAS FULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449982 ↗
• MalfunctionJul 29, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED WHICH HAPPENED OUTSIDE THE PATIENT'S BODY. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10341222 ↗
• MalfunctionJul 17, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND DIFFICULTY REMOVAL WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. AFTER DEPLOYMENT THE BALLOON APPEARED TO DEFLATE. HOWEVER, THE STENT BALLOON WAS UNABLE TO BE REMOVED BACK INTO THE GUIDE. THE PHYSICIAN SUCKED BACK ON THE INDEFLATOR MULTIPLE TIMES TO GET THE BALLOON DEFLATED BUT UNABLE TO GET THE BALLOON TO DEFLATE COMPLETELY. THE DEVICES WERE THEN REMOVED TOGETHER IN ORDER TO REMOVE THE BALLOON FROM THE PATIENT'S BODY. THE PHYSICIAN THEN ENGAGED THE CORONARY AGAIN AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290274 ↗
• MalfunctionJun 10, 2020Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER IT WAS NOTED THAT THE SHAFT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137481 ↗
• MalfunctionJun 9, 2020Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT WAS DISLODGED UPON REMOVAL OF THE DELIVERY SYSTEM. THE TARGET LESION WAS IN THE SEVERELY TORTUOUS AND CALCIFIED PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY. A 4.00X28 AND 4.00X16 SYNERGY DRUG ELUTING STENT WERE USED FOR TREATMENT TOGETHER WITH THE GUIDEZILLA GUIDE EXTENSION CATHETER. DURING THE PROCEDURE, TWO SYNERGY STENTS WERE DEPLOYED IN THE VESSEL AND A NON-BSC STENT WAS USED DISTAL TO THE TWO SYNERGY. SUBSEQUENTLY, THE 4.00X28 STENT WAS PLACED INTO THE VESSEL BUT COULD NOT ADVANCE TO THE DISTAL LESION. THE STENT WAS REMOVED FROM THE BODY AND IT WAS NOTED TO BE UNRAVELED. THEN, A 4.0X16 STENT WAS ADVANCED IN THE GUIDEZILLA HOWEVER IT COULD NOT PASS THE TRANSITION PART OF THE GUIDEZILLA. THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED BUT THE STENT WAS STUCK IN THE SHAFT OF THE CO-PILOT TUOHY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO HARM TO THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE ON BOTH ISSUES. THE FIRST SYNERGY WOULD NOT PASS THROUGH THE NEWLY DEPLOYED TWO SYNERGY STENTS AS IT MAY HAVE BEEN GETTING CAUGHT ON THE OTHER STRUTS. THE OTHER SYNERGY STENT WOULD NOT PASS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135412 ↗
• MalfunctionApr 15, 2020Device 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 4.00X16MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT CAME OFF FROM THE DELIVERY SYSTEM OUTSIDE THE PATIENT'S BODY. SUBSEQUENTLY, A 3.5X12MM SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE STENT STRUTS HAD FRACTURED. THE PROCEDURE WAS COMPLETED WITH 3 ADDITIONAL SYNERGY STENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9962175 ↗
• MalfunctionDec 3, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 16 SYNERGY II DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE BALLOON WOULD NOT DEFLATE AND KEPT ON GETTING STUCK. THEY WERE ABLE TO REMOVE THE DEVICE INTACT. THE PROCEDURE WAS COMPLETED USING THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404800 ↗
• MalfunctionSep 5, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS DAMAGED DURING ADVANCEMENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8964277 ↗
• MalfunctionJul 10, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 16MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, THE HYPOTUBE BROKE INSIDE THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779006 ↗
• MalfunctionMay 13, 2019Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. THE PHYSICIAN PLACED A 3.5 X 38MM SYNERGY DRUG-ELUTING STENT (DES) AND POST DILATED IT WITH A 4.0 X 20 NC EMERGE BALLOON CATHETER. A 4.00 X 16 SYNERGY DES WAS ADVANCED IN THE PROXIMAL PART OF THE PREVIOUSLY PLACED STENT. HOWEVER, DIFFICULTIES WERE ENCOUNTERED IN GETTING THE STENTS TO OVERLAP BUT WAS DEPLOYED EVENTUALLY AT 18 ATMOSPHERES. THE BALLOON WAS DEFLATED AND THEN EXTREME DIFFICULTIES UPON REMOVING THE DEVICE. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, THE STENT WAS STILL ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITHOUT PLACING ANY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604494 ↗
• MalfunctionApr 8, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE. THE DEVICE WAS FULLY RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491811 ↗
• InjuryFeb 27, 2019Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY AS WELL AS THE LEFT MAIN ARTERY. A 4.00 X 16 SYNERGY STENT WAS SELECTED FOR USE. DURING PERCUTANEOUS CORONARY INTERVENTION, THERE WERE TWO BALLOONS THAT WERE DOWN AND THE STENT EXPANDED WELL. AS THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE CIRCUMFLEX ARTERY, IT WAS NOTED THAT THE DISTAL SEGMENT OF THE DEVICE BROKE PROBABLY ABOUT 60 CM FROM THE DISTAL END, AND THE BROKEN PIECE REMAINED INSIDE THE PATIENT. SUBSEQUENTLY, THE PHYSICIAN WAS ABLE TO TAKE A 2.5 X 15 BALLOON PAST THE SYNERGY DELIVERY DEVICE, TRAPPED IT AND PULLED THE PIECE THAT WAS BROKEN OFF BACK INTO THE GUIDE CATHETER AND REMOVED THE WHOLE SYSTEM TO RETRIEVE THE BROKEN PART. FURTHERMORE, THE BROKEN PART OF THE SYNERGY WAS REMOVED, THE CASE WAS ABLE TO CONTINUE AFTERWARDS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 8374886 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 16 SYNERGY STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE SHAFT BROKE WHEN THE DEVICE WAS REMOVED FROM THE HOOP. THE DEVICE WAS REPLACED WITH ANOTHER SYNERGY STENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. A SYNERGY II US MR 4.00 X 16MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE STENT. THERE WERE NO SIGNS OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKER BANDS. THE CRIMPED STENT OUTER DIAMETER WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. 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 DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND A HYPOTUBE BREAK 2MM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. DAMAGE WAS ALSO NOTED IN THE HOOP WHICH WAS RETUNED ALONG WITH THE DEVICE. A VISUAL AND TACTILE EXAM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086435 ↗
• MalfunctionSep 18, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00X16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STRUTS AT THE MOST PROXIMAL END WAS DEFORMED AND POINTED UPWARDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER .00X16MM SYNERGY 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 7887844 ↗
• InjuryJul 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 4.00X16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON RIGHT AT THE END OF THE SHEATH IN THE FEMORAL ARTERY. THE STENT HAD TO BE RETRIEVED BY ACCESSING THE OTHER GROIN. EVENTUALLY, THE STENT WAS ABLE TO BE RETRIEVED AND ANOTHER OF THE SAME STENT WAS DEPLOYED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHED/SEPARATED AND STENT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733167 ↗
• InjuryJul 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS FURTHER REPORTED THAT THE STENT DISLODGEMENT OCCURRED INSIDE THE PATIENT. THE STENT STAYED ON THE DELIVERY SYSTEM AND WAS REMOVED WITH IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655143 ↗
• MalfunctionMay 15, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 16 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WOULD NOT LOAD ALL THE WAY ON THE WIRE; IT WAS HARD, LIKE SOMETHING WAS WRONG WITH THE STENT STRUTS. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00 X 16 SYNERGY II DRUG-ELUTING STENT WITH NO ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513845 ↗
• MalfunctionMay 11, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN. AFTER PRE-DILATION WAS PERFORMED WITH A 2.5X12MM NC EMERGE BALLOON CATHETER, A 4.00 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE MID PORTION OF THE STENT STRUTS WERE LIFTED. A 4.0X20MM SYNERGY STENT WAS THEN DEPLOYED WITH THE SUPPORT OF NON-BSC GUIDE EXTENSION CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507043 ↗
• MalfunctionMay 7, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-APRIL-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X16MM SYNERGY DRUG ELUTING STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490080 ↗
• MalfunctionMar 28, 2018Defective Component; Defective Component

  SAME CASE AS MDR ID#: 2134265-2018-02261 AND 2134265-2018-03092. IT WAS REPORTED THAT THE BALLOON LOOKED LARGER ON EITHER SIDE OF THE STENT. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AFTER ENGAGING THE LESION WITH A NON-BSC GUIDE CATHETER AND A GUIDEZILLA GUIDE EXTENSION CATHETER, A 4.00X12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS NOT PLACED CORRECTLY AND THE PHYSICIAN THEN PULLED THE STENT BACK THROUGH BOTH DEVICES. AS THE PHYSICIAN PUT THE STENT BACK IN, THE STENT GOT STRIPPED OFF THE BALLOON AT THE TRANSITION, AT THE COLLAR OF THE GUIDEZILLA. THE STENT WAS REMOVED WITH THE BALLOON TOGETHER. FURTHERMORE, A 4.00X16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED; HOWEVER AT SOME POINT DURING THE PROCEDURE, THE PHYSICIAN CLAIMED THAT WHEN THE DEVICE WAS REMOVED THE BALLOON LOOKED LARGER ON EITHER SIDE OF THE STENT. THUS, THE PHYSICIAN OPTED NOT TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7376832 ↗
• MalfunctionMar 22, 2018Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED OVER A NON BSC GUIDEWIRE AND THROUGH A NON BSC GUIDE CATHETER. THE SYNERGY II STENT WAS SUCCESSFULLY IMPLANTED, REMOVAL DIFFICULTIES WERE ENCOUNTERED DURING THE REMOVAL OF THE STENT DELIVERY BALLOON. THE STENT DELIVERY SYSTEM, GUIDEWIRE AND GUIDE CATHETER WERE REMOVED TOGETHER. IT WAS NOTED THAT THE BALLOON CAME APART ON THE GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362398 ↗
• InjuryMar 20, 2018Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY. A 4.00 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. THE STENT WAS DEPLOYED FINE. HOWEVER, UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE SHAFT BROKE. THE PHYSICIAN PULLED THE BROKEN PIECE BACK INTO THE SUBCLAVIAN AND BECAME STUCK. IT TOOK A VERY LONG TIME OF TRYING TO SNARE THE BROKEN PIECE FROM THE RADIAL. GROIN ACCESS WAS OBTAINED AND THE BROKEN PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT AFFECTED BY THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352538 ↗