SYNERGY™ H7493926016220Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 08714729840084), received between Nov 16, 2016 and Oct 12, 2021 — classified as 6 deaths, 23 injuries, 33 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED AND THE PATIENT WENT SURGERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. TWO 2.25 X 16 SYNERGY DRUG-ELUTING STENTS WERE ADVANCED AND IMPLANTED. HOWEVER, AFTER THE PROCEDURE WITHIN AN HOUR AFTER THE STENTS WERE DEPLOYED, A CLOT FORMED IN THE STENT. THE PATIENT WAS BROUGHT BACK FOR SURGERY AND THE CLOT WAS REMOVED AND AN ADDITIONAL STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12617395 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED AND THE PATIENT WENT SURGERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. TWO 2.25 X 16 SYNERGY DRUG-ELUTING STENTS WERE ADVANCED AND IMPLANTED. HOWEVER, AFTER THE PROCEDURE WITHIN AN HOUR AFTER THE STENTS WERE DEPLOYED, A CLOT FORMED IN THE STENT. THE PATIENT WAS BROUGHT BACK FOR SURGERY AND THE CLOT WAS REMOVED AND AN ADDITIONAL STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12617158 ↗
• MalfunctionJan 29, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MIDLLY TORTUOUS AND MIDLLY CALCIFIED DIAGONAL VESSEL. A 2.25 X 16 SYNERGY DRUG-ELUTING STENT WAS USED FOR TREATMENT. HOWEVER, THE DEVICE WOULD NOT GO OVER THE WIRE. THE PHYSICIAN TRIED TO WET AND FLUSHED THE CATHETER. DISTAL KINKED AND PARTIALLY DAMAGED STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25 X 16 MM STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254457 ↗
• MalfunctionAug 31, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AN FFR WAS PERFORMED WITH A BOSTON SCIENTIFIC COMET II PRESSURE GUIDEWIRE AND THE FFR RESULT WAS POSITIVE. THE BACK END HANDLE WAS REMOVED FROM THE COMET II PRESSURE GUIDEWIRE SO IT COULD BE USED AS THE INTERVENTIONAL WIRE. A 2.25 X 16 SYNERGY STENT WAS LOADED ONTO THE BACKEND OF THE GUIDEWIRE. WHILE LOADING THE DEVICE, THE WIRE SLIPPED AND CAUSED ONE OF THE STENT STRUTS TO BECOME DAMAGED. THE PROXIMAL STENT STRUT WAS STICKING UP. THE STENT WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE CASE WAS FINISHED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471034 ↗
• MalfunctionAug 17, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 16MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS FRACTURED WHEN IT WAS TRIED TO INTRODUCED IN THE ARTERY. 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 10415710 ↗
• InjuryMar 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY (RCA) WHICH HAD A TIGHT TURN. FOLLOWING PROXIMAL STENTING, TWO 2.25 X 16M DRUG-ELUTING STENTS (DES) WERE ADVANCED FOR TREATMENT IN THE OSTIAL POSTERIOR DESCENDING ARTERY/POSTERO LATERAL ARTERY. BOTH DEVICES FAILED TO CROSS AND THE STENT STRUTS WERE NOTED TO BE FLARED UPON REMOVAL. ANOTHER 2.25 X 16MM SYNERGY DES WAS ADVANCED BUT THE STENT CAME OFF THE BALLOON. A 3.5 SYNERGY DES WAS THEN PLACED PAST THE PROXIMAL STENTS TO TRAP THE DISLODGED STENT BETWEEN THE 3.5 AND A PREVIOUSLY IMPLANTED STENT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9888855 ↗
• MalfunctionMar 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY (RCA) WHICH HAD A TIGHT TURN. FOLLOWING PROXIMAL STENTING, TWO 2.25 X 16M DRUG-ELUTING STENTS (DES) WERE ADVANCED FOR TREATMENT IN THE OSTIAL POSTERIOR DESCENDING ARTERY/POSTERO LATERAL ARTERY. BOTH DEVICES FAILED TO CROSS AND THE STENT STRUTS WERE NOTED TO BE FLARED UPON REMOVAL. ANOTHER 2.25 X 16MM SYNERGY DES WAS ADVANCED BUT THE STENT CAME OFF THE BALLOON. A 3.5 SYNERGY DES WAS THEN PLACED PAST THE PROXIMAL STENTS TO TRAP THE DISLODGED STENT BETWEEN THE 3.5 AND A PREVIOUSLY IMPLANTED STENT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9888679 ↗
• MalfunctionMar 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY (RCA) WHICH HAD A TIGHT TURN. FOLLOWING PROXIMAL STENTING, TWO 2.25 X 16M DRUG-ELUTING STENTS (DES) WERE ADVANCED FOR TREATMENT IN THE OSTIAL POSTERIOR DESCENDING ARTERY/POSTERO LATERAL ARTERY. BOTH DEVICES FAILED TO CROSS AND THE STENT STRUTS WERE NOTED TO BE FLARED UPON REMOVAL. ANOTHER 2.25 X 16MM SYNERGY DES WAS ADVANCED BUT THE STENT CAME OFF THE BALLOON. A 3.5 SYNERGY DES WAS THEN PLACED PAST THE PROXIMAL STENTS TO TRAP THE DISLODGED STENT BETWEEN THE 3.5 AND A PREVIOUSLY IMPLANTED STENT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9888663 ↗
• InjuryFeb 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDWATCH(B)(4) THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL CIRCUMFLEX ARTERY. A 2.25 X 16 SYNERGY DRUG- ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON INSIDE THE CIRCUMFLEX ARTERY. THE PHYSICIAN ENDED UP HAVING TO CRUSH IT AGAINST ANOTHER STENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available

  MAUDE report 9750699 ↗
• InjuryJan 17, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION BUT DIFFICULTY CROSSING THE LESION ENCOUNTERED. THE PHYSICIAN WAS TRYING TO PUSH IT FORWARD AND THEN DECIDED TO PULLOUT THE DEVICE THE BALLOON CAME AND THE UNDEPLOYED STENT GOT STUCK IN A PROXIMAL LESION. THE UNDEPLOYED STENT WAS SNARED OUT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Code Available

  MAUDE report 9602364 ↗
• MalfunctionOct 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT THE DEVICE FAILED TO CROSS THE LESION. AFTER SEVERAL ATTEMPTS, A GUIDEZILLA WAS USED TO PROVIDE ADDITIONAL SUPPORT. THE STENT WAS AGAIN UNABLE TO CROSS THE LESION AND AFTER REMOVAL FROM THE BODY, IT WAS NOTED THAT THE STENT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM. THE STENT WAS LOCATED OUTSIDE THE BODY IN A PIECE OF GAUZE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256792 ↗
• MalfunctionJul 31, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT INTERNAL MAMMARY ARTERY. A 2.25 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8845797 ↗
• InjuryJul 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 16 SYNERGY II DRUG-ELUTING STENT CAME OFF THE BALLOON PRIOR TO DEPLOYMENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777369 ↗
• InjuryJun 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESIONS WERE LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. AFTER AN EMERGE 2.0 X 12MM BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION, A 2.25MM X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT WAS UNABLE TO TRACK THE DEVICE THROUGH THE DISTAL LEFT MAIN (LM) INTO THE PROXIMAL CIRCUMFLEX. THE DEVICE WAS THEN REMOVED AND WAS RE-ADVANCED WITH A 6F GUIDEZILLA GUIDE SUPPORT CATHETER BUT STILL FAILED TO CROSS THE DISTAL LM. UPON PULLING THE DEVICE, A STENT STRUT CAUGHT THE EDGE OF A PLAQUE SHIFT IN THE DISTAL LM CAUSING THE STENT TO BE DISLODGED FROM THE BALLOON DELIVERY SYSTEM. SUBSEQUENTLY, THE PHYSICIAN INSERTED A 1.2X10MM NON-BSC BALLOON CATHETER THROUGH THE DISLODGED STENT AND SUCCESSFULLY RETRIEVED IT. THE PROCEDURE WAS THEN COMPLETED BY DEPLOYING TWO 2.25X12MM PROMUS ELITE STENTS INTO THE TARGET LESION. THERE WERE NO PATIENT COMPLICATIONS NOR ADVERSE EVENTS REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8728745 ↗
• InjuryMay 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). AFTER THE 2.5 X 38MM SYNERGY DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL RCA, POST-DILATION WAS PERFORMED WITH A 2.75 X 10 NON-BSC BALLOON CATHETER. A 2.25 X 16MM SYNERGY DRUG-ELUTING STENT WAS ATTEMPTED TO PASS THROUGH THE IMPLANTED STENT, HOWEVER IT WAS NOTED THAT THE STENT HUNG AND THEN DISLODGED FROM STENT DELIVERY SYSTEM. THE DISLODGED STENT WAS DEPLOYED WITH A 2.5X20 NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570119 ↗
• MalfunctionFeb 11, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JAN2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. TWO 2.25 X 16 SYNERGY STENTS WAS ADVANCED FOR TREATMENT. HOWEVER, UPON DELIVERY, THE SHAFT GOT KINKED. THE DEVICE WAS REPLACED AND ANOTHER 2.25 X 16 SYNERGY STENT WAS ADVANCED BUT THE SHAFT ALSO GOT KINKED. THE PROCEDURE WAS COMPLETED WITH A 2.25 X 18 NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROXIMAL STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8326903 ↗
• 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 8143326 ↗
• MalfunctionOct 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTABLE BASED ON ANALYSIS COMPLETED ON ANALYSIS COMPLETED ON 11-OCT-2018. A 2.25X16MM SYNERGY DRUG-ELUTING WAS RECEIVED WITH NO ISSUES REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE FRACTURE. DEVICE EVALUATED BY MANUFACTURER: A SYNERGY II US MR 2.25 X 16 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET EQUIDISTANT BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED AND WAS WITHIN MAXIMUM 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 SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND A HYPOTUBE BREAK AT THE STRAIN RELIEF WITH PART OF THE STRAIN RELIEF AND HUB RETURNED SEPARATE FROM THE REST OF THE DEVICE. MULTIPLE HYPOTUBE KINKS WERE ALSO NOTED. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7983586 ↗
• InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.25X16MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND CAUSED A DELAY OF PROCEDURE THAT RESULTED TO AN ADVERSE EVENT. THE PROCEDURE WAS COMPLETED WITH A 2.5X12MM NON-BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Injury

  MAUDE report 7965761 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 2.25 X 16MM SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7866321 ↗
• DeathAug 16, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THROMBOSIS OCCURRED, THE PATIENT HAD CHEST PAIN, DYSPNEA, ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND DIED. LEFT HEART CATHETERIZATION WAS PERFORMED AND FOUR SYNERGY II STENTS WERE IMPLANTED (LOT # 22004570 RAMUS, LOT # 21857814 RAMUS, LOT #21929876 CIRCUMFLEX, LOT # 21644587 LEFT ANTERIOR DESCENDING ARTERY). INTRAVASCULAR ULTRASOUND WAS NOT USED PRE OR POST INTERVENTION. WITHIN 4 HOURS, THE PATIENT HAD CHEST PAIN, DYSPNEA AND STEMI AND WAS BROUGHT BACK TO THE CATHETERIZATION LAB. ACCESS WAS OBTAINED AND AN ATTEMPT WAS MADE TO VISUALIZE THE CORONARY ARTERIES; ONLY THE LEFT MAIN ARTERY WAS VISIBLE DUE TO A LARGE THROMBUS AT THE LEFT MAIN ARTERY (LM). NONE OF THE STENT WERE BELIEVED TO BE OPEN. THE PHYSICIAN WAS NOT ABLE TO GET THE GUIDEWIRE DOWN ANY OF THE VESSELS EXCEPT THE CIRCUMFLEX. THROMBUS WAS SEEN IN THE STENT IMPLANTED IN THE CIRCUMFLEX. THE CIRCUMFLEX WAS BALLOONED. THE PATIENT DIED DURING THE PROCEDURE.

  Patient problems: Chest Pain; Death; Dyspnea; Myocardial Infarction; ST Segment Elevation; Thrombosis

  MAUDE report 7790190 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE SHAFT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773505 ↗
• InjuryAug 6, 2018Obstruction of Flow; Obstruction of Flow

  SAME CASE AS MDR ID: 2134265-2018-07227 AND 2134265-2018-07229. IT WAS REPORTED THAT PATIENT EXPERIENCED CHEST PAIN AND ACUTE THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.75X12 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD. THE MID LAD WAS TREATED WITH 2.25 X 16MM AND A 2.25 X 12MM SYNERGY II DRUG-ELUTING STENTS. THE FINAL ANGIOGRAM LOOKED GREAT. WHILE THE PATIENT WAS BEING REMOVED FROM THE TABLE, THE PATIENT EXPERIENCED NAUSEA AND CHEST PAIN. THE PHYSICIAN HAD ORDERED THE PATIENT TO BE LOADED WITH ASPIRIN AND PLAVIX BUT THE PATIENT REFUSED TO TAKE ANY MEDICATION. SOME TIME LATER, THE PATIENT DID RECEIVE ASPIRIN AND PLAVIX. THE PATIENT CONTINUED TO HAVE CHEST PAIN AND SOME ST ELEVATION. AN ECHO WAS PERFORMED WHICH CAME BACK CLEAR BUT THE PATIENT STARTED TO SHOW MORE PROMINENT ST ELEVATION. ANOTHER ANGIOGRAM WAS PERFORMED WHICH REVEALED THE STENTED AREA HAD STENT THROMBOSIS. THE PATIENT WAS LOADED WITH AN INTEGRILIN BOLUS AND STARTED ON AN INTEGRILIN DRIP. A SECOND INTEGRILIN BOLUS WAS GIVEN DIRECTLY IC AND THE STENTED AREA DILATED WITH A 2.0X12 BALLOON. THE PATIENT'S ST ELEVATION DISAPPEARED,

  Patient problems: Chest Pain; Nausea; ST Segment Elevation; Thrombosis

  MAUDE report 7753521 ↗
• MalfunctionJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2.25 X 16MM SYNERGY II DRUG-ELUTING STENT WAS RECEIVED WITH NO ISSUES REPORTED. HOWEVER, UPON REVIEW OF THIS DEVICE, STENT DAMAGE OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7728382 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BROKEN OCCURRED. A 2.25 X 16MM SYNERGY II STENT WAS ADVANCED TO TREAT THE TARGET LESION. HOWEVER, DURING ADVANCING, IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7677606 ↗