SYNERGY™ XD H7493941838350Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729981091), received between Sep 25, 2020 and Mar 30, 2026 — classified as 3 deaths, 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED A DISSECTION AND HEMATOMA OCCURRED. IN (B)(6) 2026, THE PATIENT PRESENTED WITH STENOSIS OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING PRE-DILATION USING A BALLOON, THE LAD WAS TREATED WITH A 3.50 X 38MM SYNERGY XD STENT. DURING TREATMENT, A DISSECTION AND HEMATOMA WERE NOTED, HOWEVER FOLLOWING THE PROCEDURE THE PATIENT SHOWED 0% RESIDUAL STENOSIS WITH TIMI FLOW 3. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IT WAS FURTHER REPORTED THAT STENT MALAPPOSITION OCCURRED DURING THE PROCEDURE.

  Patient problems: Hematoma; Vascular Dissection

  MAUDE report 24731514 ↗
• InjuryFeb 16, 2026Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT IT COULD NOT CROSS THE LESION. HOWEVER, DISSECTION WAS ALSO NOTED.

  Patient problems: Vascular Dissection

  MAUDE report 24344189 ↗
• InjuryOct 16, 2025Break; Nonstandard Device; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Break; Nonstandard Device; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESIONS WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 38MM STENT WAS DEPLOYED IN DIAGONAL BRANCH AND THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED, AND A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ALSO ADVANCED FOR TREATMENT AS PART OF A KISSING TECHNIQUE. HOWEVER, THE 3.50 X 38MM SYNERGY XD DES WAS REPOSITIONED SLIGHTLY PRIOR TO INFLATION BUT IT BECAME STUCK IN THE VESSEL. THE DES WAS RETRIEVED EASILY; HOWEVER, DUE TO THE INTERACTION WITH THE 3.00 X 38MM STENT, IT BECAME STUCK IN THE RUNWAY GUIDE CATHETER. WHEN PULLED BACK, THE STENT SHAFT BROKE AND DETACHED. THE DISTAL PORTION OF THE SDS ALONG WITH THE STENT REMAINED IN PLACE. A SMALL BALLOON WAS THEN USED TO INFLATE AND TRAP THE SDS IN THE GUIDE CATHETER. THE GUIDE CATHETER ALONG WITH THE BROKEN DISTAL PORTION WAS REMOVED, WITHOUT FURTHER ISSUE. UPON EXAMINATION, THE DES BROKE PROXIMAL TO THE MONORAIL PORT. THE STENT ALSO APPEARED DEFORMED AND PARTIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310867 ↗
• MalfunctionFeb 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE POST-DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT CIRCUMFLEX ARTERY (LCX), EXTENDING TO THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED. THE STENT APPEARED WELL POSITIONED AND FULLY EXPANDED UPON BALLOON INFLATION AND DEFLATION. HOWEVER, AFTER THE BALLOON WAS REMOVED FROM THE STENT, CONTRAST WAS INJECTED AND THE ANGIOGRAM REVEALED LONGITUDINAL DEFORMATION OF THE STENT AT THE LEFT MAIN STEM (LMS) OSTIUM. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361558 ↗
• InjuryJan 10, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERFORATION REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN IMPELLA WAS PLACED BY THE PHYSICIAN, AND THE LAD WAS ADVANCED WITH ROTAWIRE AND IVUS AND SHOCKED BEFORE BEING SUCCESSFULLY STENTED. THE CIRCUMFLEX ARTERY WAS THEN ADDRESSED, WITH WIRING, IVUS, SHOCKING, AND NC BALLOONING PERFORMED. A 3.5X38 SYNERGY DRUG-ELUTING STENT WAS ATTEMPTED FOR DELIVERY, BUT AFTER MULTIPLE ATTEMPTS AND RE-BALLOONING, THE STENT FAILED TO PASS THE DISTAL PORTION OF THE LESION. AFTER THE STENT WAS REMOVED, IMAGING REVEALED A PERFORATION. THE PERFORATION WAS TAMPED WITH BALLOONING, AND A 2.5X20 NO-BOSTON SCIENTIFIC DEVICE WAS USED TO COVERED STENT AND WAS PLACED IN THE MID CIRCUMFLEX ARTERY. AN ECHO AND PERICARDIAL TAP WERE PERFORMED TO STABILIZE THE PATIENT. A 3.5X32 SYNERGY WAS THEN CHOSEN FOR THE PROXIMAL, SEALING THE PERFORATION. BOTH DEVICES WERE REMOVED, AND THE PATIENT CURRENTLY REMAINS STABLE.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 21124651 ↗
• DeathJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATION TO THE MID-LAD WITH A 2.5 X 15 NON-BOSTON SCIENTIFIC BALLOON, A 2.75 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THE TARGET LESION WAS FURTHER DILATED WITH A 3.0 X 15 NON-BSC BALLOON, ANOTHER 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED IN THE LAD AND 3.50 X 38MM SYNERGY XD STENT WAS IMPLANTED IN THE CIRCUMFLEX ARTERY. THE PHYSICIAN THEN USED TWO 2.5 X 15 BALLOON KISSING TECHNIQUE TO THE PROXIMAL PORTIONS OF THE STENT. THE PATIENT WAS STABLE AND WAS TAKEN BACK TO THE ROOM. AFTER A WHILE, THE PATIENT WAS CODED AND DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616857 ↗
• DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT WAS TREATED FOR A CHRONIC TOTAL OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA). THE CTO PROCEDURE WAS INITIALLY SUCCESSFUL, BUT A NON-BOSTON SCIENTIFIC INTERVENTIONAL WIRE DISSECTED THE ARTERY FROM THE PROXIMAL RCA TO THE PROXIMAL POSTERIOR DESCENDING ARTERY (PDA), WHICH WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS). A 2.50X16MM, 3.00X28MM, 3.50X38MM, AND 4.00X16MM SYNERGY XD DRUG-ELUTING STENTS WERE DEPLOYED FROM THE PROXIMAL PDA TO THE OSTIAL RCA, RESPECTIVELY. THERE WAS SLOW FLOW / NO REFLOW, AND THE RIGHT VENTRICLE (RV) MARGINAL AND POSTERIOR LATERAL BRANCH WERE OCCLUDED. THE PATIENT PRESENTED WITH ST SEGMENT ELEVATION, WHICH WAS ATTRIBUTED TO BRANCH LOSS, AND THE FLOW WAS RESTORED TO TIMI 2 / 1. CANGRELOR WAS USED TO TREAT THE EVENT. WHILE THE PATIENT WAS PLACED IN HOLDING FOR AN AVAILABLE INTENSIVE CARE UNIT (ICU) BED FOR OVERNIGHT OBSERVATION, THE PATIENT CODED, RE-STABILIZED AND RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY. THE RCA WAS RE-ACCESSED, AND THE PHYSICIAN PROCEEDED TO PLACE A BALLOON PUMP IN THE PATIENT FOR SUPPORT. THE RV MARGINAL INTERVENTION WAS ATTEMPTED, AND ACCESSED, BUT NO PROGRESS WAS MADE,

  Patient problems: Arrhythmia; Cardiogenic Shock; Hematoma; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 18996938 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT (DES), 3.50 X 38MM SYNERGY XD DES, AND A 3.50 X 48MM SYNERGY XD DES WERE ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE THREE DEVICES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949288 ↗
• InjuryFeb 23, 2024Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. BEFORE THE STENT COULD BE DEPLOYED, THE BALLOON POPPED WITH NO VISIBLE PINHOLE NOTED ON THE BALLOON, AND THE STENT CAME OFF OF THE BALLOON IN THE VESSEL. A SNARE WAS USED TO RETRIEVE THE STENT AND IT WAS PULLED OUT SUCCESSFULLY. ANOTHER 3.5X38 SYNERGY XD DES WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772885 ↗
• MalfunctionFeb 21, 2024Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT WAS NOT INFLATED, AND PHYSICIAN FELT PRESSURE UNDER HIS FINGERS. THE PHYSICIAN DECIDED TO REMOVE THE STENT DELIVERY SYSTEM (SDS) FROM THE BODY TO INSPECT, BUT THE BACK PORTION OF THE SDS WAS FRACTURED AT ABOUT 8 TO 10 INCHES FROM THE HUB WHERE THE INFLATION UNIT WAS ATTACHED. THE DEVICE WAS PULLED OUT AND COMPLETELY REMOVED FROM THE GUIDE CATHETER AND THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747362 ↗
• DeathJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ACUTE THROMBOSIS AND DEATH OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATION WITH A 2.50 X 20 NON-BOSTON SCIENTIFIC (NON-BSC) BALLOON, INTRAVASCULAR ULTRASOUND WAS PERFORMED. A 3.50 X 38MM SYNERGY XD DRUG ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT AND IMPLANTED AT 14 ATM FOR 12 SECONDS. THE STENT WAS POST-DILATED FOR 7 SECONDS AND 4 SECONDS EACH AT 12 ATM, AND THEN FOR 6 SECONDS AT 16 ATM, USING A 4.00 X 15 NC NON-BSC BALLOON. INTRAVASCULAR ULTRASOUND WAS AGAIN PERFORMED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS, AND THE PATIENT WAS TRANSFERRED TO THE PATIENT CARE UNIT. THE PATIENT STARTED HAVING ACUTE CHEST PAIN WITHIN 30-60 MINUTES POST PROCEDURE AND WAS BROUGHT BACK TO THE CATHETER LAB. IT WAS DISCOVERED THAT THE STENT WAS CLOTTED AT THE PROXIMAL EDGE. THE PHYSICIAN BALLOONED AND PLACED TWO MORE SYNERGY STENTS AS WELL AS A HEART PUMP AND A TEMPORARY PACER. THE PATIENT RETURNED TO THE PATIENT CARE UNIT AND DIED SOMETIME THAT NIGHT. CAUSE OF DEATH WAS ACUTE VESSEL CLOSURE LEADING TO VEN

  Patient problems: Chest Pain; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 18611173 ↗
• MalfunctionJan 4, 2024Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. A 3.50 X 38 MM SYNERGY XD WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE STENT WAS REMOVED, THE HYDROPHILIC COATING WAS PARTIALLY STRIPPED. PER THE PHYSICIAN, NONE OF THE COATING WAS LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL SYNERGY XD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444131 ↗
• MalfunctionMay 11, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT DISLODGED IN THE VESSEL. IT WAS NOTED THAT THE PREVIOUSLY IMPLANTED STENT MIGHT HAVE CAUSED THE DISLODGEMENT DUE TO MUCH FRICTION WHEN ADVANCING THE STENT. THE PATIENT IS FINE AND NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911014 ↗
• MalfunctionJul 22, 2022Break; Difficult to Insert; Failure to Advance; Break; Difficult to Insert; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER THE 6FR NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS USED, A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. MULTIPLES ATTEMPTS WERE MADE TO PLACE THE STENT, HOWEVER, IT WOULD NOT CROSS THE LESION. DURING THE FINAL INSERTION, SIGNIFICANT RESISTANCE WAS FELT WHILE INSERTING INTO THE GUIDE CATHETER AND THE SHAFT BROKE 20 CENTIMETER FROM THE TRANSITION. THE DEVICE WAS REMOVED BY DISCONNECTING THE TUOHY BORST OPENING AND PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084319 ↗
• InjuryJul 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE AND STENT THROMBOSIS OCCURRED; THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN MIDDLE RIGHT CORONARY ARTERY. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. THE PATIENT EXPERIENCED ARRHYTHMIA, MYOCARDIAL INFARCTION, ISCHEMIA, AND ST ELEVATION. IT WAS NOTED THAT STENT FRACTURE OCCURRED AND CAUSED STENT THROMBOSIS. SUBSEQUENTLY, THE PATIENT WAS BROUGHT BACK TO CATHETERIZATION LABORATORY AFTER HAVING ST ELEVATION AND STENTING WAS PERFORMED USING A 3.50 X 38MM NON-BOSTON SCIENTIFIC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT FULLY RECOVERED.

  Patient problems: Arrhythmia; Ischemia; Myocardial Infarction; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 15029303 ↗
• MalfunctionJun 5, 2022Break; Device Dislodged or Dislocated; Material Deformation; Break; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE DUE TO RESISTANCE AND THE STENT CAME OFF THE STENT SHAFT AND WAS FLOATING IN THE GUIDE CATHETER. THE WHOLE SYSTEM WAS REMOVED TO RETRIEVE THE STENT. A NEW STENT WAS OPEN TO COMPLETE THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599653 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE PHYSICIAN TRIED TO INSERT THE STENT OVER THE GUIDEWIRE AND WITHOUT MUCH PUSH FORCE, THE DELIVERY SHAFT WAS FRACTURED AT ABOUT 35CM FROM THE HUB OF THE CATHETER OUTSIDE THE HEMOSTASIS VALVE. THE PHYSICIAN WAS ABLE TO GRAB THE REMAINING SHAFT OUTSIDE THE HEMOSTASIS VALVE AND PULL IT OUT OF THE GUIDE CATHETER BY HAND WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469817 ↗
• MalfunctionApr 12, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.50 X 38MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, ADVANCING DIFFICULTIES WERE ENCOUNTERED. DURING REMOVAL OF THE DEVICE, THE STENT CAME OFF THE STENT DELIVERY SYSTEM INSIDE THE GUIDE. THE PHYSICIAN REMOVED THE GUIDE AND STENT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088755 ↗
• MalfunctionMar 15, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. AFTER A WIRE CROSSED THE LESION AND PRE-DILATATION WAS PERFORMED WITH NON COMPLIANT BALLOONS, A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. WHEN THE PHYSICIAN REMOVED THE STENT FROM THE HOOP, THE STENT DELIVERY CATHETER WAS KINKED. HOWEVER, THE TECHNOLOGISTS LOADED THE STENT INTO THE WIRE AND AS THE PHYSICIAN INSERTED THE DEVICE INTO THE GUIDE CATHETER, THE SHAFT FRACTURED ABOUT 100CM FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13767256 ↗
• MalfunctionFeb 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LONG, TORTUOUS, AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.00 X 20MM AND 3.5 X 38MM SYNERGY XD DRUG-ELUTING STENTS WERE ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, BOTH STENTS GOT DISLODGED FROM STENT DELIVERY SYSTEM (SDS) PRIOR TO INFLATION. BOTH STENTS WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH SHORTER SYNERGY STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447821 ↗
• MalfunctionSep 8, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18AUG2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440697 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. AS A 3.50 X 38MM SYNERGY XD DRUG ELUTING STENT WAS BEING INSERTED, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980218 ↗
• InjuryMay 13, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. A 3.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED AFTER NON-BOSTON SCIENTIFIC(BSC) INTRAVASCULAR LITHOTRIPSY (IVL) AS WELL AS OTHER NON-BSC REVASCULARIZATION TECHNIQUES WERE PERFORMED. DURING THE PROCEDURE, THE ACTIVATED CLOTTING TIME(ACT) WAS THERAPEUTIC, HOWEVER; THE SUBJECT CAME BACK TO THE LAB WITH PAIN A FEW HOURS LATER. INTRAVASCULAR ULTRASOUND(IVUS) VERIFIED THAT THE STENT HAD THROMBUS AND IT WAS ALSO UNDERSIZED. THE STENT WAS THEN POST DILATED TO PROPERLY SIZE IT WITHIN THE LESION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 11822649 ↗
• MalfunctionNov 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON AN 80% STENOSED AND MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY (RCA) ARTERY. THE TARGET LESION WAS SUCCESSFULLY PREDILATED. DURING THE PROCEDURE IT WAS NOTICED THAT THERE WAS RESISTANCE WHILE ADVANCING THE 3.5 X 38MM SYNERGY XD DRUG ELUTING STENT THROUGH THE 6FR GUIDE CATHETER. THE STENT WAS DAMAGED BY THE GUIDE SO IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT FURTHER ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780224 ↗
• MalfunctionSep 25, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT FAILURE TO CROSS A LESION AND STENT DAMAGE OCCURRED. A 3.50 X 38MM SYNERGY XD STENT WAS ADVANCED TO THE CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA), BUT THE STENT WAS NOT ABLE TO CROSS THE DISTAL LESION. THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS NOTICED THAT A STENT STRUT HAD BEEN PULLED BACK. THE PROCEDURE WAS COMPLETED WITH A ROTA, A 20MM SYNERGY XD WAS SUCCESSFULLY DEPLOYED IN THE DISTAL RCA, AND IVUS ENSURED STENT APPOSITION. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10588449 ↗