SYNERGY™ H7493926024400Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 08714729840251), received between Nov 17, 2016 and Aug 26, 2021 — classified as 2 deaths, 7 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2021Break; Break

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE TIP OF THE STENT SYSTEM SHEARED OFF LEAVING THE BALLOON END BEHIND IN THE ARTERY. ANOTHER BALLOON WAS INTRODUCED AND INFLATED A BIT TO TRAP THE DETACHED PIECE AND PULL IT OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371401 ↗
• DeathAug 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT A BROKEN STENT STRUT, PERFORATION AND DEATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A 4.00X24MM SYNERGY II STENT WAS SELECTED FOR USE. DURING THE PROCEDURE THE SYNERGY STENT STRUT BROKE. A PERFORATION IN THE RCA WAS OBSERVED. A STENT WAS PLACED TO COVER THE PERFORATION AND WAS UNSUCCESSFUL. PATIENT DEATH OCCURRED AFTER THE PROCEDURE AND PRIOR TO DISCHARGE.

  Patient problems: Perforation

  MAUDE report 12368459 ↗
• MalfunctionAug 18, 2021Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED VIA A VOLUNTARY MEDWATCH (B)(4) THAT SHAFT BREAK OCCURRED. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE SYNERGY DRUG-ELUTING STENT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE DEVICE WAS SHREDDED IN GUIDE EXTENSION CATHETER. BOTH DEVICES WERE REMOVED AND A NEW 6F GUIDEZILLA II GUIDE EXTENSION CATHETER AND A NEW 4.5MM SYNERGY STENT WAS USED. A 4.5X32MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. WHILE INSERTING THE STENT OVER THE GUIDEWIRE INTO THE GUIDE CATHETER, IT BENT. THE PHYSICIAN TRIED TO STRAIGHTEN IT AND THE CATHETER SNAPPED IN HALF. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT STATUS WAS STABLE AND WAS DISCHARGED HOME ON THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338032 ↗
• MalfunctionJul 29, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-JUL-2020. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A VERY TORTUOUS AND CALCIFIED CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339668 ↗
• MalfunctionJul 28, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-JUL-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CALCIFIED CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 10331726 ↗
• MalfunctionJul 22, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER PLACING THE STENT, IT WAS NOTED THAT THE STENT BALLOON KEPT ON GETTING CAUGHT ON THE GUIDE WHEN ATTEMPTING TO BE REMOVED AND THE BALLOON WOULD NOT DEFLATE PROPERLY. THE PHYSICIAN THEN REMOVED ALL THE DEVICES IN ORDER TO REMOVED THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310521 ↗
• MalfunctionJul 1, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS IN AND OUT OF THE GUIDE CATHETER FIVE TIMES; HOWEVER, DURING THE LAST TIME, THE STENT WAS CAUGHT IN THE GUIDE OR TUOHY BORST. UPON REMOVAL, IT WAS NOTICED THAT THE STENT STRUTS AT THE PROXIMAL END OF THE STENT WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218979 ↗
• MalfunctionJun 24, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATION OF A 3.0MM AND 3.5MM NC EMERGE BALLOON CATHETER, A 4.00 X 24MM SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED PAST THE NOMINAL PRESSURE. HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE DEVICE WAS STUCK AND THE SHAFT BROKE INSIDE THE GUIDE CATHETER WHEN PULLED HARDER. THE GUIDE WAS PUSHED IN AS THE ENTIRE DELIVERY SYSTEM WAS PULLED OUT COMPLETELY. THE STENT WAS POST-DILATED WITH A 5.0MM NC EMERGE BALLOON CATHETER, COMPLETING THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191763 ↗
• MalfunctionMar 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT MAIN ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT STRUT FLARED OUT. THE DEVICE WAS REMOVED AND 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; No Known Impact Or Consequence To Patient

  MAUDE report 9836718 ↗
• InjuryMar 12, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK AND STENT INADEQUATE APPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED CIRCUMFLEX ARTERY. USING A GUIDE EXTENSION CATHETER, A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, THE STENT HAD A DOG BONE IN THE PROXIMAL PORTION OF THE STENT AND UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE SHAFT BROKE APPROXIMATELY 100CM FROM THE HUB. THE PATIENT WENT TO SURGERY FOR REMOVAL AND ALSO GOT BYPASS GRAFTS TO A COUPLE OF DIFFERENT ARTERIES. THE SURGERY COMPLETED THE PROCEDURE ITSELF. THERE WERE NO FURTHER COMPLICATIONS DURING THE SURGERY AND THE PATIENT WAS DOING FINE.

  Patient problems: No Code Available

  MAUDE report 9825984 ↗
• MalfunctionMar 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATE TO SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE OSTIUM HAD A SEVERE ACUTE TAKE OFF. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT A LONGER STENT WAS NEEDED AND WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT SOME OF THE STRUTS WERE DEFORMED OR HAD MOVED OFF THE STENT DELIVERY BALLOON. THE PROCEDURE WAS COMPLETED WITH A 4.0X28 NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9783358 ↗
• InjuryFeb 20, 2020Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X24MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN PULLBACK WAS ATTEMPTED FOR CORRECT PLACEMENT OF THE DEVICE, THE STENT DID NOT COME BACK AND THE SHAFT BROKE INSIDE THE GUIDE. THE GUIDE WAS REMOVED AND THE STENT WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DID NOT SNARED THE STENT. THE SHAFT BROKE INSIDE THE GUIDE BEFORE ENTERING THE CORONARY ARTERY AND USED A BALLOON TO TRAP ALL DEVICES AND PULLED EVERYTHING OUT AS ONE UNIT INSIDE THE GUIDE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9734248 ↗
• MalfunctionDec 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN TO LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING STENT DEPLOYMENT IN THE LEFT MAIN-CIRCUMFLEX ARTERY, A 4.00X24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT SOME STENT STRUTS HAD LIFTED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451133 ↗
• MalfunctionDec 5, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-NOV-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 4.00 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416889 ↗
• MalfunctionNov 5, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10/23/2019. IT WAS REPORTED THAT FOLLOWING PREDILITATION WITH AN EMERGE BALLOON, A 4.00X24MM SYNERGY DRUG ELUTING STENT WAS UNABLE TO CROSS THE TARGET LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282735 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. WHILE ADVANCING A 4.00 X 24 SYNERGY DRUG-ELUTING STENT, THE DEVICE WAS PUSHED HARDER AND THE CATHETER KINKED. THE SHAFT BROKE OUTSIDE OF THE GUIDE AND OUTSIDE OF THE BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130498 ↗
• MalfunctionJul 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20 JUL 2019. IT WAS REPORTED THAT THE STENT GOT CAUGHT AND STUCK ON THE GUIDEZILLA LL. A 4.00 X 24 SYNERGY DRUG ELUTING STENT WAS USED FOR TREATMENT. DURING PROCEDURE, THE STENT WAS TRIED TO RUN THROUGH THE 6F GUIDEZILLA II CATHETER. HOWEVER, THE STENT GOT CAUGHT AND WAS STUCK AT THE COLLAR; WHOLE SYSTEM WAS THEN REMOVED. DOUBLE WIRING WAS PERFORMED AND ANOTHER STENT WAS USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THERE WERE NO PATIENT INJURIES OF ANY KIND. HOWEVER, DEVICE ANALYSIS REVEALED STENT STRUTS LIFTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794526 ↗
• InjuryJul 2, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS AND ST-SEGMENT ELEVATION OCCURRED. THE PATIENT WAS GIVEN ASPIRIN, HEPARIN AND BRILINTA. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00X24MM SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED 6 MINUTES AFTER ADMINISTRATION OF WEIGHT BASED HEPARIN AND BRILINTA GIVEN 3 MINUTES AFTER STENT PLACEMENT. HOWEVER, FOLLOW-UP ELECTROCARDIOGRAM SHOWED ST- SEGMENT ELEVATION 57 MINUTES FOLLOWING STENT PLACEMENT. THE PATIENT WAS SENT BACK TO LAB AND IT WAS NOTED THAT THE IMPLANTED STENT WAS OCCLUDED. A SECOND STENT WAS PLACED, INTEGRILIN AND ANGIOMAX WERE STARTED AND COMPLETED THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT AND WAS DISCHARGED WITH NO FURTHER PATIENT COMPLICATIONS REPORTED. FOLLOW-UP CLINIC VISIT STATED THAT THE PATIENT WAS NOTED TO HAVE SINUS BRADYCARDIA WITH FIRST- DEGREE ATRIOVENTRICULAR BLOCK AND EVIDENCE OF INFERIOR INFARCT.

  Patient problems: Arrhythmia; Bradycardia; ST Segment Elevation; Thrombosis

  MAUDE report 8754434 ↗
• MalfunctionJun 28, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING A RIGHT RADIAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, DURING WITHDRAWAL OF THE STENT DELIVERY SYSTEM, IT SHEARED OFF AT THE SITE WHERE IT CAME OUT OF THE GUIDE. IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY VIA THE GUIDE CATHETER AND GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS UNHARMED AND IS RECOVERING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8743586 ↗
• MalfunctionMay 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. DURING AN ANGIOPLASTY PROCEDURE, A A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS NOT DEPLOYED AS IT GOT FRACTURED FROM A LESION WITHIN THE VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8613236 ↗
• MalfunctionMay 9, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS ADVANCED INTO THE GUIDE CATHETER, IT WAS NOTED THAT THE STENT STRUTS WERE STICKING UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8594104 ↗
• MalfunctionFeb 15, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE STENT WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND IT WAS THEN NOTED THAT THE EDGE OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345467 ↗
• MalfunctionSep 20, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00MM X 24MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS DEPLOYED AT 12 ATMOSPHERES AND THE BALLOON WAS DEFLATED. HOWEVER, IT WAS OBSERVED THAT THE BALLOON WAS STICKING TO THE STENT. WHEN THE BALLOON WAS INFLATED AGAIN TO 16 ATMOSPHERES, IT WAS STILL STUCK. THE BALLOON WAS TUGGED HARD AND REMOVED FROM THE PATIENT'S BODY. NO ISSUE WAS NOTED WITH THE IMPLANTED STENT AND IT WAS FULLY DEPLOYED AND EXPANDED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895645 ↗
• MalfunctionAug 20, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHILE REMOVING THE DEVICE FROM THE VESSEL, IT WOULD NOT COME OUT. THE WIRE AND STENT WERE ABLE TO BE REMOVED AFTER MULTIPLE ATTEMPTS. IT WAS THEN NOTED THAT THE STENT WAS FRACTURED 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 7799817 ↗
• DeathJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS: 2134265-2018-04903 AND 2134265-2018-04904. IT WAS REPORTED THAT INTERVENTION HAD TAKEN PLACE FROM THE SELECTIVE SAPHENOUS VEIN GRAFT (SVG) TO RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN HAD DECIDED TO STENT DUE TO STENOSIS IN THE MID PORTION OF THE VESSEL. A 4.00X24MM SYNERGY II STENT WAS IMPLANTED, AND THEN POST DILATED WITH A 5.50X15MM BALLOON CATHETER TO 20 ATM, AT WHICH POINT THE BALLOON STILL SHOWED "WAISTED." A 6.00MM X 15MM NC EMERGE® WAS THEN ADVANCED AND INFLATED TO A LOW PRESSURE TO FULLY EXPAND THE STENT. THE BALLOON HAD FULLY EXPANDED AND A PICTURE WAS TAKEN OF THE FINAL RESULT, WHICH WAS NOTED TO HAVE LOOKED LIKE A GREAT RESULT. AS THE PHYSICIAN WAS COMMENTING ON THE RESULT, THE PATIENT COMPLAINED OF PAIN. ANOTHER PICTURE WAS TAKEN AT WHICH POINT A PERFORATION WAS NOTICED IN THE SVG. THE PHYSICIAN PLACED A 5.50MM X 15MM NC EMERGE® AT VERY HIGH PRESSURE TO SEAL THE PERFORATION. THE PHYSICIAN ATTEMPTED TO DELIVER A COVERED STENT BUT THE GUIDE WAS TOO LONG. THE GUIDE WAS SHORTENED AND THEY TRIED TO DELIVER THE STENT AGAIN, HOWEVER IT WOULD NOT DEPLOY SUGGESTING IT WAS DEFECTIVE. AFTER DEFLATING THE BALLOON, IT APPEARED THE PERFORATION WAS SEALED. THE PATIENT

  Patient problems: Death; Hematoma; Perforation of Vessels

  MAUDE report 7586766 ↗