SYNERGY™ H7493926028220Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729840268), received between Jan 11, 2017 and Nov 18, 2021 — classified as 2 deaths, 6 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 28 SYNERGY STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE STENT ITSELF WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841278 ↗
• InjuryJan 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 2.25 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE CATHETER AND WAS CRUSHED AGAINST THE WALL OF THE PROXIMAL CIRCUMFLEX ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT USING THE SMALL 1.5 BALLOON BUT FAILED TO RETRIEVED DUE TO THE ANGULATION INTO THE CIRCUMFLEX. SINCE THERE WAS ALREADY A STENT DEPLOYED IN THE PROXIMAL STENT AND THE DISTAL END OF THE DISLODGED STENT WAS STUCK IN THE SIDE CELL OF THAT STENT AS IT ENTERED INTO THE SIDE BRANCH, IT WAS DECIDED TO LEAVE THE STENT AND COMPRESS IT INTO THE WALL OF THE VESSEL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAD 80% STENOSIS, WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL WITH 80-90 DEGREES BEND. PRE-DILATATION WAS PERFORMED. STENT STRUTS BECAME WEDGED WHEN PASSING THROUGH SIDE CELLS OF PREVIOUS STENT AS PHYSICIAN'S ASSESSMENT ON THE CAUSE OF THE STENT DISLODGEMENT.

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

  MAUDE report 11156591 ↗
• MalfunctionDec 3, 2020Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-NOV-2020. IT WAS REPORTED THAT ADVANCING DIFFICULTY AND SHAFT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AFTER THE LESION WAS PRE-DILATED, A 2.25 X 28 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT BUT THE PHYSICIAN FELT UNUSUAL RESISTANCE DURING DELIVERY. UPON INSPECTION, THE SHAFT LOOKED STRAINED OR STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10941641 ↗
• InjuryNov 9, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND THE PATIENT WAS SENT FOR SURGERY. THE TARGET LESION WAS LOCATED IN THE DIAGONAL BRANCH. A 2.25X28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED OVER THE WIRE. POST STENT IMPLANTATION, THE STENT DELIVERY SYSTEM WAS REMOVED. HOWEVER, THE DELIVERY SYSTEM BROKE IN HALF LEAVING THE DISTAL HALF WITH THE DEFLATED BALLOON INSIDE THE DIAGONAL. THE PHYSICIAN TRIED SEVERAL TECHNIQUES TO REMOVE THE DISTAL DELIVERY SYSTEM, BUT AFTER TWO HOURS, NOTHING WORKED. THE PATIENT BECAME UNSTABLE AND AN INTRA-AORTIC BALLOON PUMP WAS PLACED. THE PATIENT WAS EMERGENTLY SENT TO OPEN HEART SURGERY TO HAVE THE DEVICE REMOVED. THE PATIENT WAS INTUBATED BUT DOING OKAY. IT WAS FURTHER REPORTED THAT THE LESION HAS 90% STENOSIS, NON TORTUOUS AND MODERATELY CALCIFIED. A 6 FRENCH GUIDE CATHETER WAS USED DURING THE PROCEDURE. THE LESION WAS PREDILATED AND THERE WAS 20% STENOSIS AFTER DILATATION. THE PHYSICIAN WAITED FOR 60 SECONDS FOR BALLOON DEFLATION BEFORE PULLING BACK. THE ABSENCE OF CONTRACT WAS CONFIRMED WITHIN THE BALLOON UNDER FLUOROSCOPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10810155 ↗
• MalfunctionAug 19, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JUL2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.25X28MM 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 10426770 ↗
• MalfunctionAug 3, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-JUL-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 28MM 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 AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10357727 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25X28MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS FRACTURED UPON ENTERING THE ARTERY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879498 ↗
• MalfunctionFeb 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN FIBROUS IN NATURE AND MILDLY TORTUOUS OBTUSE MARGINAL ARTERY. A 2.25 X 28 SYNERGY DRUG-ELUTING STENT WAS OPENED AND SELECTED FOR USE. HOWEVER, UPON LOADING IT ONTO THE WIRE, THE DISTAL END OF THE STENT STRUT WAS DEFORMED. 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 9689476 ↗
• MalfunctionJan 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 28MM SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH 3.0 UNSPECIFIED BALLOON; HOWEVER, THE PHYSICIAN NOTICED THAT THE STENT FRACTURED. THE PROXIMAL PORTION OF THE STENT WAS POST-DILATED AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9602332 ↗
• InjuryJul 18, 2019Device 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 STENT EXPLANTATION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY, A 2.25MM X 28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. AFTER POST DILATATION, THE STENT CAME OUT OF ARTERY ATTACHED AND WRAPPED AROUND THE NON-BSC BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804081 ↗
• MalfunctionMar 29, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS DISTAL LEFT POSTERIOR DESCENDING ARTERY. AFTER ENGAGING THE LESION WITH A 7FR CONVEY LBU3.75 GUIDE CATHETER AND A 7FR GUIDEZILLA2 GUIDE EXTENSION CATHETER, A 2.5X12MM BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. THEN A 2.25X28MM SYNERGY II DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, AS THE PHYSICIAN WAS PUSHING THE DEVICE, THE PROXIMAL SHAFT OF THE STENT DELIVERY SYSTEM GOT SNAPPED. THE DEVICE WAS REMOVED SAFELY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465018 ↗
• MalfunctionJan 15, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS DAMAGED AND MOVED ON THE BALLOON. A MR 2.25 X 28MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED, HOWEVER UNABLE TO CROSS THE LESION. DURING REMOVAL OF THE STENT THROUGH A WATCHDOG HEMOSTASIS VALVE, THE STENT WAS NOTED TO BE DEFORMED AND CAME OFF THE BALLOON A LITTLE BIT. THE PROCEDURE WAS COMPLETED USING THE SAME WATCHDOG HEMOSTASIS VALVE AND ANOTHER SYNERGY STENT OF THE SIZE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249173 ↗
• MalfunctionOct 4, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.25 X 28 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.   SYNERGY II US MR 2.25 X 28 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND PROXIMAL STENT DAMAGE, STENT STRUTS WERE PUSHED AND BUNCHED DISTALLY LEAVING A SECTION OF THE PROXIMAL BALLOON BODY EXPOSED. THE UNDAMAGED DISTAL SECTION STENT OUTER DIAMETER WAS MEASURED AND THE RESULT 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 NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7934240 ↗
• InjuryAug 31, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25X28MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT FELL OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837095 ↗
• MalfunctionAug 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. DURING PREPARATION OF A 2.25 X 28 SYNERGY STENT, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 7835143 ↗
• 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 7790264 ↗
• MalfunctionJun 11, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.25 X 28MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, RESISTANCE WAS ENCOUNTERED UPON LOADING THE DEVICE ON THE WIRE. WHEN THE PHYSICIAN USED A LITTLE BIT MORE FORCE, THE DEVICE STARTED TO LOAD; HOWEVER, IT WAS NOTED THAT THE STENT STRUT WAS BENT. THE DEVICE WAS PUSHED A LITTLE BIT HARDER AND IT WAS NOTED THAT IT KIND OF FOLDED A LITTLE BIT WITH THE STENT STILL ON THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.5X28MM STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7588592 ↗
• MalfunctionMay 9, 2018Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  SAME CASE AS MDR ID: 2134265-2018-03970. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED VESSEL. AFTER AN 8F GUIDEZILLA¿ II GUIDE EXTENSION CATHETER WAS POSITIONED, A 2.25 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, AS THE STENT WAS BEING PULLED BACK INTO THE GUIDEZILLA, IT WAS NOTED THAT THE GUIDEZILLA CRUNCHED UP THE STENT. BOTH ENDS OF THE STENT STRUTS WERE SHORTENED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7499556 ↗
• MalfunctionMar 30, 2018Break; Failure to Advance; Break; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-MAR-2018. IT WAS REPORTED THAT CROSSING DIFFICULTY AND A SHAFT BREAK ON A PORTION THAT CANNOT ENTER THE BODY OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIGHT CALCIFIED RIGHT CORONARY ARTERY. A 2.25 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. SUBSEQUENTLY, THE SHAFT SNAPPED AT LESS THAN 15CM FROM THE HUB. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL BALLOON DILATION AND A STENT WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK 225MM DISTAL FROM THE DISTAL END OF THE STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384879 ↗
• MalfunctionMar 26, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER WAS FROZE ON THE WIRE. A 2.25 X 28MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. THE STENT WAS DELIVERED OVER A NON-BSC GUIDE WIRE. THE WIRE APPEARED TO BE KINKED AT THE END WHERE THE STENT WAS LOADED. THE STENT WAS ADVANCED A FEW INCHES UNTIL THE MONORAIL PORTION WAS STUCK ON THE WIRE. THE PHYSICIAN THEN TRIED TO REMOVE THE STENT AND THE TIP OF THE CATHETER WAS STUCK ON THE WIRE OUTSIDE THE PATIENT. THE ENTIRE WIRE AND STENT DELIVERY SYSTEM WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT WIRE AND ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7370929 ↗
• InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND JAILING OCCURRED. IN (B)(6) 2016, THE PATIENT¿S QUALIFYING CONDITION WAS UNSTABLE ANGINA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION AS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 75% STENOSIS AND WAS 15MM LONG WITH REFERENCE VESSEL DIAMETER OF 2.50MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 28 SYNERGY II DRUG-ELUTING STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT PRESENTED TO EMERGENCY ROOM VIA EMERGENCY MEDICAL SERVICES WITH THE CHIEF COMPLAINT OF NAUSEA, VOMITING AND WEAKNESS. THE PATIENT HAD A LOWER BACK PAIN FOR WHICH THE PATIENT TOOK ACETAMINOPHEN / HYDROCODONE ON AN EMPTY STOMACH AND BECAME NAUSEATED WITH AN EPISODE OF VOMITING WITH GENERALIZED WEAKNESS. THE PATIENT DENIED CHEST PAIN OR SHORTNESS OF BREATH. THE PATIENT¿S ECG (ELECTROCARDIOGRAM) REVEALED ATRIAL PACED RHYTHM WITH PROLONGED ATRIOVENTRICULAR (AV) CONDUCTION AND LEFT BUNDLE BRANCH BLOCK. THE PATIENT¿S CARDIAC ENZYMES WERE FOUND T

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 7259308 ↗
• MalfunctionJan 26, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 28MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SHAFT BROKE. BOTH THE SEGMENTS OF THE DEVICE WERE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7221880 ↗
• InjuryJan 23, 2018Bent; Migration or Expulsion of Device; Bent; Migration or Expulsion of Device

  SAME CASE AS MFR REPORT#: 2134265-2018-00213. IT WAS REPORTED THAT STENT DAMAGE, MIGRATION AND EXPLANT OCCURRED. THE PATIENT PRESENTED WITH ACUTE SPONTANEOUS DISSECTION OF THE RAMUS ARTERY. THE TARGET LESION WAS 40 MM LONG, EXTREMELY TORTUOUS AND HAD MILD CALCIFICATION IN PROXIMAL SEGMENT. A NON-BSC GUIDEWIRE WAS PLACED AND AN OVER-THE-WIRE NON-COMPLIANT BALLOON CATHETER WAS ADVANCED INTO THE PROXIMAL SECTION OF THE VESSEL. THEN THE NON-BSC GUIDEWIRE WAS TAKEN OUT AND INJECTED THROUGH THE LUMEN TO CONFIRM THAT IT WAS LUMINAL WITH THE BALLOON. THE WIRE WAS PUT BACK INTO THE BALLOON CATHETER. AFTER PRE-DILATION, A 2.25 X 32 MM SYNERGY DRUG ELUTING STENT WAS PLACED IN THE DISTAL RAMUS AND THEN ANOTHER 2.25 X 28 MM SYNERGY STENT WAS PLACE IN THE PROXIMAL RAMUS. A NON-BSC EXTRA SUPPORT GUIDEWIRE WAS PLACED TO STRAIGHTEN OUT THE VESSEL, THEN POST-DILATION WAS PERFORMED WITH A 2.50 X 15 MM APEX BALLOON IN THE OVERLAPPING SEGMENT OF BOTH STENTS. WHEN IT WAS DILATING, UNDER FLUOROSCOPY THEY COULD SEE THE TORTUOUS VESSEL THAT STRAIGHTENED, IT TWISTED. WHEN PULLING THE EXTRA SUPPORT GUIDEWIRE, IT WAS LOCKED DOWN BOTH STENTS AND COULD NOT BE REMOVED FROM THE STENT. THE STENTS SEEMED TWISTED LI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213790 ↗
• MalfunctionJun 12, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY (RCA). WITH A SUPPORT OF A NON-BSC GUIDE EXTENSION CATHETER, A 2.25X28MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. HOWEVER, DELIVERING DIFFICULTIES WERE ENCOUNTERED. THE PHYSICIAN THEN PULLED THE ENTIRE DELIVERY SYSTEM BACK INTO THE GUIDE EXTENSION CATHETER. WHEN THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE DEVICE, IT WAS NOTICED THAT THE STENT HAD DISLODGED FROM THE BALLOON AND WAS INSIDE THE GUIDE EXTENSION CATHETER. THE PHYSICIAN REMOVED THE ENTIRE SYSTEM TOGETHER WITH THE DISLODGED STENT IN THE GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6633796 ↗
• MalfunctionMay 1, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 2.25 X 28 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER IT WAS NOTED THAT NO STENT WAS MOUNTED ON THE STENT DELIVERY SYSTEM. THE STENT DISLODGED PRIOR TO ENTERING THE PATIENT'S BODY. THE DEVICE WAS THEN REMOVED AND 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 6534960 ↗