SYNERGY™ H7493926012220Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 08714729840022), received between Nov 11, 2016 and Sep 20, 2023 — classified as 6 deaths, 25 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 72 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Obstruction of Flow; Obstruction of Flow

  EVOLVE_LV_CLV CLINICAL STUD. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 5.3 MM AND TIMI FLOW OF 3. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00 MM X 20 MM STUDY STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW OF 3. IN ADDITION, A NON-TARGET LESION LOCATED IN MID LAD EXTENDING TO DISTAL LAD WAS TREATED WITH PLACEMENT OF A 2.50 MM X 16 MM SYNERGY DRUG ELUTING STENT (DES). A SECOND NON-TARGET LESION LOCATED IN 1ST DIAGONAL ARTERY WAS TREATED WITH A 2.25 MM X 12 MM SYNERGY DES. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, THE SUBJECT PRESENTED IN THE EMERGENCY DEPARTMENT (ED) WITH PRESSURE-LIKE SUBSTERNAL CHEST PAIN RADIATING TO BILATERAL ARMS AND LASTING 40 MINUTES IN DURATION WITH ASSOCIATED SHORTNESS OF BREATH. THE SUBJECT TOOK NITROGLYCERINE WHICH DID NOT PROVIDE COMPLETE PAIN RELIEF AND PARAMEDICS HAD GIVEN THE

  Patient problems: Dyspnea; Myocardial Infarction; Restenosis

  MAUDE report 17780482 ↗
• MalfunctionAug 23, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE MIDDLE OF THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE FRACTURE OCCURRED OUTSIDE THE PATIENT'S BODY AND THE DEVICE WAS SIMPLY PULLED FROM THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353599 ↗
• MalfunctionJul 8, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 12 SYNERGY II DRUG ELUTING CORONARY STENT SYSTEM WAS ADVANCED TO THE LESION. THE SYNERGY STENT FAILED TO CROSS THE LESION. IT WAS OBSERVED THAT THE SHAFT BROKE. THE SYNERGY STENT WAS REMOVED. AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140421 ↗
• MalfunctionJan 7, 2021Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT STENT DEFECT WAS ENCOUNTERED. A 2.25 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, BEFORE USING THE DEVICE INTO THE PATIENT, IT WAS NOTED THAT STENT HAS A DEFECT ON IT AND COULD NOT BE USED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Patient Involvement

  MAUDE report 11131729 ↗
• MalfunctionNov 18, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-OCT-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 12 SYNERGY 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 10860552 ↗
• MalfunctionOct 26, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 12MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE MID SHAFT BROKE AS IT WAS BEING ADVANCED THROUGH THE GUIDE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10735917 ↗
• MalfunctionSep 28, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT FRACTURE AND STENT DAMAGE OCCURRED. A 2.25 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT IN A SIDE BRANCH OF A CORONARY VESSEL. AFTER AN UNSUCCESSFUL ATTEMPT TO DELIVER THE STENT, THE CATHETER SHAFT FRACTURED 7 TO 8 INCHES FROM THE HUB DURING REMOVAL. THE FRACTURED PORTION OF THE DEVICE WAS PULLED OUT WITH THE UNDEPLOYED DAMAGED STENT STILL ATTACHED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10597916 ↗
• InjurySep 15, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO EXCESSIVE RADIATION. THE 85% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MILDLY CALCIFIED VESSEL, WITH A 90% BEND. FOLLOWING PRE-DILATION WITH A 2.0 X 12 EMERGE BALLOON, A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THIS CAUSED A SIGNIFICANT DELAY OF THE PROCEDURE WHICH RESULTED TO EXCESSIVE RADIATION EXPOSURE OF THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10536093 ↗
• MalfunctionAug 26, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED OSTIAL FIRST DIAGONAL ARTERY. AFTER PLACING A STENT IN THE LAD (LEFT ANTERIOR DESCENDING), A 2.25 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT COULD NOT CROSS LAD STENT. THE DEVICE WAS REMOVED AND NOTED A DAMAGED TO THE STENT STRUTS. IT WAS NOTED THAT IT WAS ASSUMED THE STENT HIT THE LAD STENT. THE LESION WAS THEN PRE-DILATED AND THE PROCEDURE WAS COMPLETED BY PLACING A NON-BSC STENT. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10455688 ↗
• InjuryAug 25, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DIED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND SEVERELY TORTUOUS LEFT INTERNAL MAMMARY ARTERY TO DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25X16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. SUBSEQUENTLY, A 2.25X12MM SYNERGY II DRUG-ELUTING STENT WAS USED BUT HAD DIFFICULTY ADVANCING. THE DEVICE WAS ATTEMPTED TO REMOVE BUT THE STENT WAS DISLODGED AT THE ANASTOMOSIS. A 2.0X12MM EMERGE BALLOON CATHETER WAS ADVANCED AND DEPLOY THE STENT WITH TWO INFLATIONS AT 18 ATMOSPHERES FOR 16 SECONDS EACH. AFTERWARDS, A SLOW FLOW DOWN IN THE VESSEL WAS OBSERVED. NITROGLYCERIN WAS GIVEN TO RESTORE NORMAL BLOOD FLOW; HOWEVER, THE VESSEL STILL HAD SLOW FLOW. THE PHYSCIAN TRIED GOING BACK IN WITH AN INTERVENTIONAL WIRE TO BALLOON IT UP BUT IT ENDED LEAVING IT AS IS. THE PATIENT WAS TRANSFERRED TO THE FLOOR AND LATER IN THE AFTERNOON, THE PATIENT CODED AND EXPIRED LATER THE SAME NIGHT.

  Patient problems: Death; No Code Available; Stenosis

  MAUDE report 10449978 ↗
• MalfunctionAug 4, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DIAGONAL BRANCH. AFTER PRE-DILATION WAS PERFORMED WITH A 2X12MM EMERGE BALLOON CATHETER. A 2.25 X 12 AND A 2.50 X 16 SYNERGY DRUG-ELUTING STENTS WERE SELECTED FOR USE; BUT, DURING INSERTION, THE STENTS LOSE WIRE ACCESS. THE STENTS WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PHYSICIAN DECIDED NOT TO PROCEED AND ABORTED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362997 ↗
• MalfunctionJul 8, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHILE ADVANCING THE STENT DELIVERY SYSTEM IN THE GUIDE CATHETER, THE SHAFT BROKE IN HALF MID-WAY. BOTH PIECES OF THE DELIVERY SYSTEM WAS RETRIEVED INTACT. 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 10246484 ↗
• MalfunctionJun 10, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE SHAFT WAS BROKEN. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10139641 ↗
• InjuryMar 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS FOUND THAT THE STENT FRACTURED INSIDE THE PATIENT. THE PATIENT WAS TREATED BY IMPLANTING ANOTHER STENT OVER THE FRACTURED STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9794761 ↗
• MalfunctionFeb 14, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT ADVANCED FOR TREATMENT. THE PHYSICIAN TRIED TO TWIST AND TORQUE THE DEVICE PASSED THE LESION BUT, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT BROKE MID SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712918 ↗
• InjuryOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THROUGH STENT STRUTS, THE STENT CAME OFF THE BALLOON. 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

  MAUDE report 9206013 ↗
• InjurySep 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, PRIOR TO DEPLOYMENT, THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS TRAPPED BY ANOTHER STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9009958 ↗
• MalfunctionAug 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.25 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN TRYING TO PLACE THE STENT IN THE ARTERY, IT WAS OBSERVED THAT THE PROXIMAL END OF THE STENT WAS DAMAGED. THE STENT STAYED INTACT WITH THE BALLOON AND WAS REMOVED SAFELY FROM THE PATIENT'S BODY. THE PHYSICIAN FELT THAT THE STENT DAMAGE OCCURRED WHEN TRYING TO ADVANCE IT THROUGH A PREVIOUSLY PLACED STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25 X 12MM SYNERGY II DRUG-ELUTING STENT WITH THE ASSISTANCE OF USING A GUIDEZILLA EXTENSION GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8905559 ↗
• MalfunctionAug 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON LOADING THE STENT ONTO THE WIRE, IT WAS NOTED THAT THE STENT WAS STRIPPED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854859 ↗
• InjuryMay 29, 2019Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AND RETRIEVAL DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS DISLODGED IN THE OSTIAL CIRCUMFLEX AND IT WAS UNABLE TO BE RETRIEVED. THE PATIENT WAS SENT FOR BYPASS SURGERY. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8650555 ↗
• MalfunctionApr 19, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28MAR2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.25MM X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531450 ↗
• MalfunctionMar 26, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 12MM SYNERGY STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, UPON REMOVAL IT WAS OBSERVED THAT THE STENT BALLOON WAS STUCK AND IT REQUIRES TOO MUCH FORCE TO REMOVE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454110 ↗
• MalfunctionMar 26, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 12MM SYNERGY STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, UPON REMOVAL IT WAS OBSERVED THAT THE STENT BALLOON WAS STUCK AND IT REQUIRES TOO MUCH FORCE TO REMOVE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454103 ↗
• MalfunctionDec 17, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-NOV-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE DETACHED/SEPARATED. A SYNERGY II US MR 2.25 X 12MM STENT DELIVERY SYSTEM (SDS) 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 (OD) WAS MEASURED AND IS 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 EX

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170037 ↗
• DeathDec 7, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS AND DEATH OCCURRED. A 2.25 X 12MM SYNERGY II DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE POSTERIOR "DESCEDING" ARTERY (PDA). TWO STENTS WERE PLACED IN THE LEFT CIRCUMFLEX ARTERY, A 2.25 X 16MM SYNERGY II DES AND A 2.25 X 12MM SYNERGY II DES. TWENTY MINUTES AFTER THE PATIENT WAS TAKEN OFF THE TABLE, THE PATIENT EXPERIENCED CHEST PAIN. ELECTROCARDIOGRAPHY REVEALED STENT THROMBOSIS ON THE THREE IMPLANTED STENTS. THE PHYSICIAN PLACED A 2.25 X 8MM STENT DISTAL TO PREVIOUSLY IMPLANTED STENT IN THE PDA. THE FOLLOWING DAY, A NON-BSC TEMPORARY VENTRICULAR SUPPORT DEVICE WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY BECAUSE THE PATIENT WAS IN SHOCK. AFTER ONE DAY, THE PATIENT DIED. THE PHYSICIAN BELIEVES THAT THE PATIENT HAD A NEUROLOGICAL EVENT PRIOR TO REMOVING THE NON-BSC DEVICE.

  Patient problems: Chest Pain; Death; Thrombosis

  MAUDE report 8143337 ↗