SYNERGY™ H7493926024300Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 08714729840237), received between Nov 11, 2016 and Oct 19, 2021 — classified as 3 deaths, 14 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Bent” (15 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 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MOVED ON BALLOON OCCURRED. A 3.00 X 24 SYNERGY II DRUG ELUTING STENT WAS SELECTED FOR USED. HOWEVER, DURING THE PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION THE DEVICE WAS DISTALLY SHIFTED FROM BALLOON PRIOR TO LOAD ONTO THE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENTS COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657882 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408971 ↗
• InjuryDec 10, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. THE 90% STENOSED, ECCENTRIC, TARGET LESION CONTAINING A 90 DEGREES BEND WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING PRE-DILATATION WITH A 3.0X20MM BALLOON, A 3.00X24MM SYNERGY II DRUG-ELUTING STENT WAS DELIVERED AND DEPLOYED AT 14 ATMOSPHERES. HOWEVER, THE BALLOON WOULD NOT RETRACT. THE BALLOON INFLATED AND DEFLATED TWICE BUT STILL COULD NOT BE REMOVED. THE PHYSICIAN TRIED REMOVING BY PULLING HARDER WITH GUIDE ENGAGED MORE INTO THE LEFT MAIN BUT THE DISTAL BALLOON WAS SEPARATED FROM THE SHAFT AND REMAINED INSIDE THE ARTERY. THE PHYSICIAN HAD A WIRE IN CIRCUMFLEX ARTERY AND IN LAD ARTERY. THE PHYSICIAN PUT A TORQUER ON BOTH WIRES AND TORQUED UNTIL RESISTANCE WAS FELT ON THE WIRES. THE BALLOON AND BOTH THE WIRES WERE THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10985270 ↗
• MalfunctionDec 8, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00X24MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE DESPITE MULTIPLE ATTEMPTS. 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 10971473 ↗
• InjuryOct 6, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AFTER DEPLOYING A 3.00X24MM SYNERGY DRUG-ELUTING STENT, THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE DELIVERY SYSTEM CAUGHT WITH THE GUIDE AND COULD NOT BE REMOVED. A NON-BSC EXTENSION CATHETER WAS USED TO FREE THE DEVICE FROM THE GUIDE BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED PULL EVERYTHING OUT. NEW ACCESS WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638080 ↗
• MalfunctionSep 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00X24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, RESISTANCE WAS FELT DURING ADVANCEMENT THROUGH THE COLLAR OF THE GUIDEZILLA II GUIDE EXTENSION CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, AND IT WAS NOTED THAT THE STENT WAS SEVERELY DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10510587 ↗
• MalfunctionAug 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE SHAFT FRACTURED WHEN STARTED TO MOUNT ON WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10367124 ↗
• MalfunctionMay 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT WAS ENCOUNTERED. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED UNDEPLOYED, HOWEVER, THE STENT CAME OFF THE BALLOON AND IT WAS FOUND ON THE STERILE FIELD. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10032377 ↗
• MalfunctionMar 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING A PROCEDURE INVOLVING A 3.00 X 24MM SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WAS DAMAGED AT THE TIP. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881455 ↗
• MalfunctionMar 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00 X 24MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT STRUTS WERE CHEWED UP. 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 9836836 ↗
• MalfunctionMar 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT FAILED TO CROSS THE LESION AND THE EDGES FRAYED WHILE GOING THROUGH THE GATEWAY ADAPTER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9826053 ↗
• MalfunctionMar 5, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. THE DEVICE WAS PULLED OUT OF THE BODY; HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE BENT. THE PROCEDURE WAS LATER COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9792279 ↗
• InjuryFeb 19, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT VESSEL DISSECTION AND ACUTE THROMBOSIS OCCURRED AND PATIENT EXPERIENCED CHEST PAIN. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN THE BLOCKAGE AT 16 ATMOSPHERES AND WAS POST DILATED WITH A 3.5X12 NC QUANTUM APEX TO 16 ATM. ANOTHER STENT WAS ALSO PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY. APPROXIMATELY 30 MINUTES AFTER THE PATIENT WENT TO RECOVERY, THE PATIENT BEGAN HAVING SEVERE CHEST PAIN AND WAS RETURNED TO THE CATH LAB. IT WAS FOUND THAT THE RCA STENT WAS OCCLUDED. THE STENT WAS WIRED WITH A CHOICE PT EXTRA SUPPORT AND A 3.0X12 NC QUANTUM APEX BALLOON CATHETER WAS USED TO REOPEN THE ARTERY. ANGIOJET WAS USED TO REMOVE CLOT FROM STENT AND DISTAL ARTERY AND A NON-BSC INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO INTERROGATE THE STENT. A SMALL DISSECTION WAS NOTED ON IVUS AT THE VERY PROXIMAL END OF THE STENT. A 3.5X8 SYNERGY WAS PLACED IN AN OVERLAPPING FASHION TO THE 3.0X24 SYNERGY AND BOTH STENTS WERE POST DILATED WITH A 3.5X8 NC QUANTUM BALLOON CATHETER. THE STENT WAS VIEWED AGAIN THROUGH IVUS TO CONFIRM APPOSITION,

  Patient problems: Chest Pain; Thrombosis; Vascular Dissection

  MAUDE report 9728646 ↗
• MalfunctionJan 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE BENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553189 ↗
• MalfunctionDec 2, 2019Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 3.00X24MM SYNERGY STENT WAS USED IN A PROCEDURE. HOWEVER, THE STENT WAS CONTAMINATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395344 ↗
• MalfunctionNov 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OUTSIDE THE PATIENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WHEN IT WAS NOTED THAT THE STENT WAS ON THE CATHETER JUST OUTSIDE THE TUOHY. THE STENT NEVER ENTERED THE PATIENT. THE SDS BALLOON WAS USED TO PRE-DILATE THE LESION AND 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 9391922 ↗
• InjuryNov 18, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT, SUB- ACUTE THROMBOSIS AND CHEST PAIN OCCURRED. THE TARGET LESION WAS LOCATED IN THE SIGNIFICANTLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS TREATED WITH PLACEMENT OF 3.00X24MM, 3.00X38MM AND 3.50X12MM SYNERGY II DRUG-ELUTING STENTS WHICH WERE POST DILATED. THREE DAYS LATER, THE PATIENT HAD SUB-ACUTE THROMBOSIS IN THE LAD WHICH NEEDED TO BE EXPANDED IN THE MID LAD. THE FOLLOWING DAY, THE PATIENT EXPERIENCED CHEST PAIN. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED THAT THE STENTS WERE UNDER DEPLOYED. THE LAD WAS LASERED AND A QUANTUM BALLOON WAS INTRODUCED TO DILATE THE STENTS. IVUS REVEALED THE STENTS HAD APPROPRIATE APPOSITION AND EXPANSION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 9336415 ↗
• MalfunctionAug 30, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00 X 24MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE TRYING TO CROSS THE LESION, THE STENT WAS DAMAGED. 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 8952715 ↗
• MalfunctionAug 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT APPEARED CRIMPED AND HAS SOMETHING WEIRD ON THE EDGE OF THE STENT. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8933197 ↗
• MalfunctionMay 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PHYSICIAN ATTEMPTED A STENT PROCEDURE ON A PATIENT WITH A 90% LESION IN A CALCIFIED AND TORTUOUS RCA. THE VESSEL WAS WIRED WITH THE HELP OF A NON BSC MICROCATHETER AND NON BSC WIRE. THE WIRE WAS REMOVED AND REPLACED WITH A ANOTHER WIRE. A 2.0 X 12 BALLOON WAS ADVANCED AND USED TO PRE-DILATE THE LESION. A 3.0 X 24 SYNERGY WAS ATTEMPTED, BUT WAS UNABLE TO CROSS THE LESION. A GUIDEZILLA II EXTENSION CATHETER WAS ADVANCED TO THE OSTIUM OF THE RCA, BUT UNABLE TO ADVANCE DUE TO PREVIOUSLY PLACED STENT IN THE OSTIUM. THE 3.0 X 24 SYNERGY WAS AGAIN ATTEMPTED TO CROSS. AS THE BALLOON CATHETER EXITED THE GUIDE IT APPEARED THE STENT HAD BECOME DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS LOCATED AT THE COLLAR OF THE GUIDEZILLA II. THE GUIDEZILLA WAS REMOVED AND THE STENT SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW GUIDEZILLA II CATHETER WAS ADVANCED. A NEW 3.0 X 24 SYNERGY WAS ATTEMPTED TO ADVANCE. THE SECOND 3.0 X 24 SYNERGY DID NOT CROSS THE LESION. UPON REMOVAL FROM THE PATIENT IT WAS NOTICED THE STENT WAS NOT ON THE DELIVERY SYSTEM. FLURO CONFIRMED THE STENT WAS AT THE END OF THE GUIDEZILLA II. A 2.0 X 12 BALLOON WAS ADVANCED THR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8613166 ↗
• MalfunctionMay 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PHYSICIAN ATTEMPTED A STENT PROCEDURE ON A PATIENT WITH A 90% LESION IN A CALCIFIED AND TORTUOUS RCA. THE VESSEL WAS WIRED WITH THE HELP OF A NON BSC MICROCATHETER AND NON BSC WIRE. THE WIRE WAS REMOVED AND REPLACED WITH A ANOTHER WIRE. A 2.0 X 12 BALLOON WAS ADVANCED AND USED TO PRE-DILATE THE LESION. A 3.0 X 24 SYNERGY WAS ATTEMPTED, BUT WAS UNABLE TO CROSS THE LESION. A GUIDEZILLA II EXTENSION CATHETER WAS ADVANCED TO THE OSTIUM OF THE RCA, BUT UNABLE TO ADVANCE DUE TO PREVIOUSLY PLACED STENT IN THE OSTIUM. THE 3.0 X 24 SYNERGY WAS AGAIN ATTEMPTED TO CROSS. AS THE BALLOON CATHETER EXITED THE GUIDE IT APPEARED THE STENT HAD BECOME DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS LOCATED AT THE COLLAR OF THE GUIDEZILLA II. THE GUIDEZILLA WAS REMOVED AND THE STENT SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW GUIDEZILLA II CATHETER WAS ADVANCED. A NEW 3.0 X 24 SYNERGY WAS ATTEMPTED TO ADVANCE. THE SECOND 3.0 X 24 SYNERGY DID NOT CROSS THE LESION. UPON REMOVAL FROM THE PATIENT IT WAS NOTICED THE STENT WAS NOT ON THE DELIVERY SYSTEM. FLURO CONFIRMED THE STENT WAS AT THE END OF THE GUIDEZILLA II. A 2.0 X 12 BALLOON WAS ADVANCED THR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8613087 ↗
• MalfunctionMay 14, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 8608522 ↗
• MalfunctionMar 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 24MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTICED THAT THE STENT STRUTS WERE DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00 X 24MM SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430994 ↗
• MalfunctionFeb 1, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. RESISTANCE WAS FELT WHEN ADVANCING THE 3.0MM X 24MM SYNERGY II DES THROUGH THE WATCHDOG HEMOSTASIS VALVE. WHEN THE STENT WAS REMOVED IT WAS NOTED TO BE SEVERELY DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE THROUGH THE SAME WATCHDOG HEMOSTASIS VALVE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297228 ↗
• MalfunctionDec 13, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X24MM SYNERGY II DRUG-ELUTING WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT HAD DAMAGED TO THE STRUTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160659 ↗