SYNERGY™ H7493926038250Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 08714729840398), received between Nov 15, 2016 and Apr 26, 2022 — classified as 4 deaths, 15 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Bent” (19 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE SHAFT BROKE AT ABOUT 10-15CM BACK FROM THE STENT, NEAR THE MONORAIL EXIT PORT. THE DEVICE WAS PULLED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213463 ↗
• MalfunctionJun 21, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN THE STENT WAS REMOVED, THE STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038028 ↗
• MalfunctionFeb 17, 2021Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-FEB-2021. IT WAS REPORTED THAT DIFFICULTY LOADING THE WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 2.50 X 38 SYNERGY DRUG-ELUTING STENT WAS USED BUT THE DEVICE COULD NOT LOAD ONTO THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337745 ↗
• MalfunctionDec 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVEMENT ON BALLOON OCCURRED. A 2.50X38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS OBSERVED THAT THE STENT WAS MOVING FROM THE BALLOON WHILE CROSSING BETWEEN THE DISSECTION PLANE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11037391 ↗
• MalfunctionDec 8, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DSCENDING ARTERY. A 2.50X38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT PARTIALLY DEPLOYED FROM THE BALLOON CATHETER BEFORE IT WAS PLACED IN THE CORRECT SPOT IN THE PATIENT. THE STENT WAS ABLE TO BE PULLED BACK TO THE DISTAL END OF THE CATHETER AND WAS REMOVED FROM THE PATIENT'S BODY WITH THE WIRE BEFORE IT WAS FULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10968766 ↗
• InjuryJul 29, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE-DILATATION WITH A 2.25 X 20 NC EMERGE BALLOON, A 2.50 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, A VESSEL DISSECTION WAS NOTED IN THE RCA. FIVE SYNERGY STENTS IN 16 MM INCREMENTS WERE DEPLOYED TO COVER THE DISSECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 10341653 ↗
• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN IT WAS REMOVED FOR PREDILATION, THE STRUTS WERE DEFORMED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312271 ↗
• InjuryJun 24, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER USING A 1.5 ROTABLATOR BURR, A 2.5X15 WOLVERINE AND 2.5MM NC EMERGE BALLOON CATHETER WERE USED FOR PRE-DILATION. A 2.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE BALLOON WAS STUCK INSIDE THE STENT. ANOTHER BALLOON WAS INFLATED TO TRAP THE WIRE AND STENT DELIVERY SYSTEM SHAFT INSIDE THE GUIDE CATHETER. THE STENT BALLOON CAME FREE AS EVERYTHING WAS REMOVED TOGETHER. THE STENT REMAINED IMPLANTED AND WAS POST DILATED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT AFTER STENT DEPLOYMENT, THE SHAFT BROKE WHILE REMOVING THE DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10189966 ↗
• InjuryMar 25, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER DEPLOYMENT OF A 2.50 X 38MM SYNERGY II DRUG-ELUTING STENT, THE BALLOON GOT STUCK INSIDE THE STENT. THE BALLOON COULD NOT BE PULLED OUT AND THE BALLOON BROKE OFF INSIDE THE VESSEL. THE DEVICE COULD NOT BE RETRIEVED AND ANOTHER BALLOON WAS ADVANCED TO TRY TO PUSH THE DEVICE OUT OF THE WAY. IT TURNED INTO AN EIGHT HOUR CASE TO COMPLETE THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

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

  MAUDE report 9881517 ↗
• InjuryMar 5, 2020Break; Difficult to Remove

  STENT BALLOON BECAME STUCK INSIDE PT'S CORONARY ARTERY. BALLOON BROKE OFF OF DELIVERY SHAFT AND REMAINED INSIDE PT'S HEART. CARDIOTHORACIC SURGEON WAS CONSULTED AND SITUATION WAS TREATED BY STENTING THE REMAINING BALLOON FRAGMENT AGAINST THE WALL OF THE CORONARY ARTERY. SUBSEQUENTLY, PT HAD TO UNDERGO TF TAVR (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9800195 ↗
• MalfunctionDec 18, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN VERY CALCIFIED CORONARY ARTERY. A 2.50 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND AFTER REMOVAL THE STENT WAS NOTED TO BE FOLDED. THERE WERE NO COMPLICATIONS AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490411 ↗
• InjuryDec 3, 2019Break; Activation Failure; Migration; Break; Activation Failure; Migration

  IT WAS REPORTED THAT STENT INSUFFICIENT APPOSITION AND SHAFT BREAK OCCURRED, AND THAT THE PATIENT HAD A STROKE. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER A WIRE CROSSED THE LESION, A 2.50X38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. WHEN THE STENT WAS BEING INFLATED UP TO 8 ATMOSPHERES, THE PRESSURE WAS LOST WHICH LEFT THE STENT PARTIALLY INFLATED. AS THE STENT DELIVERY SYSTEM (SDS) WAS BEING REMOVED THE SHAFT BROKE PROXIMAL TO THE WIRE EXIT PORT. THE PHYSICIAN WAS ABLE TO REMOVE THE DISTAL SHAFT AND DELIVERY BALLOON BY TRAPPING THE SDS WITH A BALLOON INSIDE THE GUIDE. IT WAS VISUALIZED THAT PART OF THE STENT HAD MIGRATED TO THE AORTA. AFTER REPEATED ATTEMPTS TO REWIRE THROUGH THE STENT, THE DECISION WAS MADE TO STOP THE CASE AND CONSULT OTHER PHYSICIANS FOR OPTIONS. THE PATIENT WAS BROUGHT BACK TO THE LAB WHERE THE INTERVENTIONAL RADIOLOGIST WAS ABLE TO SUCCESSFULLY SNARE THE STENT AND REMOVE IT FROM THE BODY. POST-PROCEDURE, THE PATIENT HAD A STROKE. TWO DAYS LATER, THE PATIENT WAS STILL IN THE HOSPITAL.

  Patient problems: Stroke/CVA

  MAUDE report 9405519 ↗
• InjuryNov 14, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON REMOVAL, THE STENT PARTIALLY DEPLOYED IN THE PATIENT'S ARM AND WAS RETRIEVED WITH A SNARING DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD.

  Patient problems: No Code Available

  MAUDE report 9323426 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY VESSEL. A 2.50X38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING ADVANCING, THE SHAFT WAS KINKED AND BROKE AT ABOUT 15CM FROM THE HUB, OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.50X28MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215670 ↗
• MalfunctionAug 7, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS ALSO NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872370 ↗
• InjuryJul 24, 2019Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated; Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT CATHETER ENTRAPMENT, STENT DISLODGMENT OCCURRED AND PATIENT DIED. A 2.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED, THROUGH A NON BSC MICROCATHETER, TO TREAT A DISSECTION, BUT FAILED TO CROSS THE LESION. DURING REMOVAL THE SYNERGY STENT GOT CAUGHT ON THE MICROCATHETER AND COLLAPSED THE STENT AND PINCHED IT ON THE WIRE AND COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS UNSTABLE AFTER THE PROCEDURE AND LATER DIED.

  Patient problems: Death

  MAUDE report 8824871 ↗
• InjuryMay 31, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE POST-DEPLOYMENT OCCURED. THE PATIENT PRESENTED AS A ST SEGMENT MYOCARDIAL INFARCTION (STEMI) WITH A COMPLETE THROMBOTIC OCCLUSION OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA). VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. AFTER A 6FR NON-BSC GUIDE CATHETER WAS INSERTED AND A NON-BSC GUIDE WIRE WAS DELIVERED TO THE DISTAL RCA, A 2.0 X 12 COMPLIANT BALLOON WAS DELIVERED AND INFLATED IN THE VESSEL WHICH RESTORED TIMI 2 FLOW TO THE RCA. SUBSEQUENT INFLATIONS WITH A 2.0 X 12 AND A 2.5 X 12 UNSPECIFIED BALLOON WERE PERFORMED WITH AND FURTHER IMPROVED TIMI FLOW IN THE RCA. A SECOND BUDDY GUIDE WIRE, WAS INSERTED TO THE DISTAL VESSEL AND A 2.50 X 38 SYNERGY DRUG-ELUTING STENT WAS DELIVERED TO THE PROXIMAL RCA WHICH WAS THEN DEPLOYED AT 16 ATMOSPHERES. THE BUDDY WIRE WAS REMOVED WITH GREAT DIFFICULTY AND UPON INSPECTION WAS FOUND TO HAVE PART OF THE COATING REMOVED FROM THE END OF THE WIRE. THE NEXT ANGIOGRAM OF THE RCA REVEALED THAT THE SYNERGY STENT WAS PULLED AND ELONGATED INTO THE AORTA APPROXIMATELY 15-20MM. THE GUIDE WIRE WAS REMOVED FROM THE RIGHT CORONARY AND ACCESS WITH ANOTHER GUIDE AND GUIDEWIRE WAS ATTEMPTED AGAIN BUT WAS UNSUCCESSFUL

  Patient problems: No Code Available

  MAUDE report 8658321 ↗
• InjuryMay 21, 2019Obstruction of Flow; Activation Failure; Obstruction of Flow; Activation Failure

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT INSUFFICIENT STENT APPOSITION AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2018, THE PATIENT PRESENTED WITH STABLE ANGINA. THE INDEX PROCEDURE WAS PERFORMED THE SAME DAY. TARGET LESION WAS IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO DISTAL RCA WITH 95% STENOSIS AND WAS 70 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 38 MM AND 2.75 X 32 MM SYNERGY STENTS FOLLOWED BY POST-DILATATION WITH 0% RESIDUAL STENOSIS. ON THE SAME DAY, OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND REVEALED STENT MALPOSITION IN FOCAL AREAS THROUGHOUT THE STENT WHICH WAS ADDITIONALLY POST DILATED WITH A 3.25 NC BALLOON DISTALLY AND WITH A 3.5 MM NC BALLOON PROXIMALLY. FINAL OCT ANGIOGRAM REVEALED WELL OPPOSED STENT AND NO RESIDUAL STENOSIS WITH TIMI 3 FLOW. IN (B)(6) 2018, THE PATIENT PRESENTED WITH COMPLAINTS OF RECURRENT EXERTIONAL CHEST PAIN WHICH RESOLVED WITH REST BUT REQUIRED NITROGLYCERIN OCCASIONALLY. THE SYMPTOMS INCREASED IN THE PAST THREE MONTHS. THE PATIENT ALSO COMPLAINED OF CHEST PRESSURE AND SHORTNESS OF BREATH WITH EXERCISE. TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWE

  Patient problems: Chest Pain; Dyspnea; Heart Failure; Reocclusion

  MAUDE report 8628725 ↗
• MalfunctionApr 25, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED WHEN THEY OPENED IT. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552084 ↗
• InjuryJan 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50X38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE STENT WAS DISLODGED IN A PROXIMAL VESSEL. A SMALLER BALLOON WAS INSERTED AND CRUSHED THE DISLODGED STENT AGAINST THE VESSEL WALL AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. VOLUNTARY MEDWATCH/MAUDE REPORT # MW5082039.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8261448 ↗
• MalfunctionJan 17, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT DAMAGE OCCURED. A 2.50 X 38 SYNERGY STENT WAS USED DURING THE PROCEDURE. HOWEVER THE DEVICE WAS NOT ABLE TO CROSS AND THE STENT WAS BENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO INFORMATION PROVIDED AS TO HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257945 ↗
• MalfunctionDec 19, 2018Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT AND SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ACCESS. THE TARGET LESION WAS LOCATED IN THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA). AFTER A 1.50 ROTABLATOR WAS ADVANCED AND INITIALLY BURRED THE LESION, A 2.50 X 38 SYNERGY II STENT WAS ADVANCED THROUGH THE PROXIMAL RCA WITH THE AID OF A 6F NON-BSC EXTENSION CATHETER IN AN 8F GUIDE CATHETER BUT THE DEVICE FAILED TO CROSS. WHEN THE STENT DELIVERY SYSTEM (SDS) WAS PULLED OUT, IT WAS NOTED THAT THE STENT WAS NOT ON THE SDS. THE STENT HAD COME OFF AND WAS INSIDE THE GUIDE. UPON CHECKING FURTHER, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT FROM THE GUIDE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182375 ↗
• MalfunctionNov 8, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 38MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON TRACKING THE GUIDE CATHETER, THE SHAFT BROKE ABOUT 40-50CM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051689 ↗
• DeathOct 31, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED A PATIENT DEATH HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE WAS BEING PERFORMED IN THE RIGHT CORONARY ARTERY. THERE WAS AN OCCLUSION IN THE MIDDLE PORTION OF THE ARTERY AND A DISSECTION IN THE PROXIMAL PORTION OF THE ARTERY. ONE STENT WAS PLACED TO TREAT THE DISSECTION AND ANOTHER WAS NEEDED TO TREAT THE REST OF THE ARTERY. WITH THE PROXIMAL STENT BEING PLACED IN ADDITION TO THE TORTUOSITY OF THE VESSEL, THE TWO SYNERGY DRUG ELUTING STENTS (2.5MM X 38MM AND 3MM X 38MM) COULD NOT PASS THROUGH THE EXISTING STENT AND SUBSEQUENTLY, THE END OF THE STENTS WERE CRUSHED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT SIZED SYNERGY STENTS TO COVER THE ENTIRE RIGHT CORONARY ARTERY. HOWEVER, THE PATIENT DIED DUE TO OTHER CIRCUMSTANCES.

  Patient problems: Death

  MAUDE report 8023893 ↗
• MalfunctionOct 17, 2018Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE, DISSECTION, AND DEATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS MID RIGHT CORONARY ARTERY (RCA), WHERE AN UNKNOWN STENT HAD BEEN PLACED PROXIMALLY. A 2.50 X 38 SYNERGY STENT AND A 3.00 X 38 SYNERGY STENT WERE ADVANCED TO TREAT THE PROXIMAL RCA DISSECTION. HOWEVER, THESE STENTS COULD NOT PASS THROUGH THE EXISTING STENT, AND AS A RESULT THE EXISTING STENT CRUSHED THE SYNERGY STENTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT DIED DUE TO OTHER CIRCUMSTANCES.

  Patient problems: Death; Vascular Dissection

  MAUDE report 7974646 ↗