SYNERGY™ XD H7493941820400Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729981138), received between Dec 15, 2020 and Dec 8, 2025 — classified as 1 death, 10 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Break; Deformation Due to Compressive Stress; Difficult to Advance; Break; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AFTER A NON-BOSTON SCIENTIFIC GUIDEWIRE AND GUIDEZILLA II GUIDE EXTENSION CATHETER CROSSED THE LESION, A 4.00 X 20MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT DELIVER THROUGH THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT WAS WITHDRAWN, DURING WHICH THE WIRE WAS LOST, AND IT WAS THEN NOTED THAT THE STENT SHAFT WAS FRACTURED. BOTH DEVICES WERE REMOVED. THE VESSEL WAS REWIRED, THE GUIDEZILLA WAS REINTRODUCED, AND AGAIN DELIVER THE 4.0 20 MM SYNERGY? XD STENT WAS ATTEMPTED; HOWEVER, DELIVERY WAS STILL UNSUCCESSFUL. A NON-BSC CATHETER WAS THEN UTILIZED, BUT THE NEW SYNERGY? DES AGAIN COULD NOT BE DELIVERED. FINALLY, THE PROCEDURE WAS COMPLETED WITH A 3.5 16 MM SYNERGY? STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743031 ↗
• MalfunctionSep 5, 2025Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO FULLY DEFLATE, AND IT WOULD NOT GO BACK INTO GUIDE CATHETER. MULTIPLE DEFLATION ATTEMPTS WERE MADE, BUT THE BALLOON DID NOT COMPLETELY DOWN. THE PHYSICIAN THEN REMOVED THE GUIDE CATHETER, BALLOON AND THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974961 ↗
• InjuryJul 9, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT AN INFLATION ISSUE RESULTED IN A DISSECTION. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS INITIALLY DEPLOYED. HOWEVER, DURING INFLATION WITH THE ENCORE INDEFLATOR, THE PROXIMAL END OF THE BALLOON APPEARED TO INFLATE HIGHER THAN THE DISTAL EDGE, RESULTING IN A PROXIMAL EDGE DISSECTION. THE DISSECTION WAS NON-FLOW LIMITING AND GRADED AS TYPE A. SUBSEQUENTLY, A SECOND 4.00 X 20MM SYNERGY XD DES WAS DEPLOYED, BUT IT ALSO CONTRIBUTED TO ADDITIONAL DISSECTION IN THE DISTAL RCA. AN ADDITIONAL STENT WAS THEN PLACED TO COVER THE DISSECTED AREA AND COMPLETE THE PROCEDURE. THE PATIENT MADE A FULL RECOVERY, REMAINED STABLE, AND NO OTHER ISSUES WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 22457984 ↗
• InjuryJun 24, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE POST-DEPLOYMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 99% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. THE PHYSICIAN PLACED A 2.25MM-3.5MM FILTERWIRE EZ IN THE DISTAL VEIN GRAFT. THE LESION WAS DILATED WITH A BALLOON, AND A 4.0 X 20 MM SYNERGY DRUG-ELUTING STENT WAS DEPLOYED WITHOUT INCIDENT. DURING RETRIEVAL OF THE FILTERWIRE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RETRIEVAL SHEATH COMPLETELY THROUGH THE NEWLY IMPLANTED STENT. WHILE ATTEMPTING TO RETRACT THE FILTER, IT BECAME CAUGHT ON THE DISTAL END OF THE SYNERGY STENT. UPON SUCCESSFUL REMOVAL OF THE FILTER, THE DISTAL END OF THE STENT WAS NOTED TO BE DEFORMED. A NEW GUIDEWIRE WAS USED TO RECROSS THE DAMAGED STENT, FOLLOWED BY MULTIPLE BALLOON DILATIONS. A 4.5 X 20 MM MEGATRON STENT WAS DEPLOYED WITHIN THE DEFORMED PORTION OF THE STENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. NO PATIENT HARM OR ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319887 ↗
• MalfunctionFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421098 ↗
• MalfunctionNov 15, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT CIRCUMFLEX ARTERY. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. POST-DEPLOYMENT, THE BALLOON FAILED TO FULLY DEFLATE. AFTER SEVERAL ATTEMPTS TO DEFLATE THE BALLOON, IT BECAME NECESSARY TO REMOVE THE BALLOON WITH CATHETER. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698267 ↗
• MalfunctionNov 15, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT FAILURE TO DEFLATE OCCURRED. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS POSITIONED AND DEPLOYED IN THE VESSEL. AFTER DEPLOYMENT, THE DELIVERY BALLOON FAILED TO RECAPTURE/DEFLATE AFTER UPWARDS OF TWO MINUTES. NEGATIVE PRESSURE WAS DRAWN ON THE INFLATION DEVICE MULTIPLE TIMES BUT IT DID NOT WORK TO DEFLATE THE BALLOON. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698253 ↗
• DeathJun 24, 2024Device Damaged by Another Device; Positioning Problem; Device Damaged by Another Device; Positioning Problem

  IT WAS REPORTED THAT PATIENT COMPLICATIONS AND DEATH OCCURRED. THE PATIENT PRESENTED WITH TRIPLE VESSEL DISEASE AND HAD TURNED DOWN SURGERY. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE MID RCA WAS PREPARED USING AN NC BALLOON, AND A 3.50 LITHOTRIPSY BALLOON; THE PROXIMAL/OSTIUM RCA WAS TREATED WITH A SEMI-COMPLIANT BALLOON AND A 3.50 LITHOTRIPSY BALLOON. A 3.00 X 28 SYNERGY XD STENT WAS DEPLOYED, FOLLOWED BY A 4.00 X 20 SYNERGY XD STENT DEPLOYED IN THE RCA OSTIUM. REPOSITIONING WAS PERFORMED SEVERAL TIMES BEFORE THE 4.00 X 20 STENT WAS IMPLANTED. THE STENTS WERE DEPLOYED WITHOUT ISSUE AND ANGIOGRAPHY SHOWED THE STENTS APPEARED TO BE SUFFICIENTLY OVERLAPPED AND THE VESSEL LOOKED OPEN. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). SHORTLY AFTER, THE PATIENT COMPLAINED OF CHEST PAIN AND BECAME BRADYCARDIC. THE PATIENT WAS PUT UNDER ANESTHESIA AND INTUBATED AND WAS RETURNED TO THE CATH LAB. THE RCA WAS RE-ENGAGED WITH DIFFICULTY; THE GUIDE COULD NOT FULLY ENGAGE, LIKELY DUE TO THE STENT STRUTS AT THE OSTIUM. THE VESSEL WAS WIRED AND MECHANICAL THROMBECTOMY WAS ATTEMPTED BUT IT WAS UNSUCCESSFUL. IT

  Patient problems: Bradycardia; Cardiac Arrest; Chest Pain; Thrombosis/Thrombus

  MAUDE report 19595846 ↗
• MalfunctionJun 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 20MM SNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING INSERTION, WHEN LOADING THE STENT ONTO THE WIRE, THE WIRE POPPED OUT WHERE THE STENT BALLOON WAS ATTACHED TO THE SHAFT. THE BALLOON WAS NEVER INFLATED, AND NO VISIBLE HOLE WAS NOTED ON THE BALLOON. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449195 ↗
• InjuryMay 3, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 20MM SYNERGY XD MONORAIL DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE CROSSING THE LESION, THE STENT SHAFT FRACTURED AT THE GUIDEWIRE EXIT PORT. THE DEVICE WAS REMOVED WITH A SNARE. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243506 ↗
• InjuryApr 9, 2024Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THAT INSUFFICIENT APPOSITION, CATHETER ENTRAPMENT, AND UNRETRIEVED DEVICE FRAGMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT ANGIOPLASTY IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA) USING AN OPTICROSS HD 5FR CATHETER BEFORE STENT IMPLANTATION. PRE-DILATATION WAS PERFORMED WITH A 3.0 EMERGE BALLOON CATHETER, FOLLOWED BY A 3.0 X 6 WOLVERINE BALLOON CATHETER. A 3.0 X 16MM AND 3.5 X 16MM SYNERGY DRUG-ELUTING STENT (DES) WERE DEPLOYED, RESPECTIVELY, FROM DISTAL TO PROXIMAL LESION. THE DOCTOR ATTEMPTED TO DEPLOY A 4.0 X 20MM SYNERGY AT THE PROXIMAL LESION, GUIDED BY IVUS INDICATING A VESSEL DIAMETER OF 3.0 TO 5.0 DISTAL TO PROXIMAL. HOWEVER, DURING STENT DEPLOYMENT, THE PHYSICIAN DID NOT GET GOOD EXPANSION WITH THE STENT BALLOON. THE BALLOON WAS DEFLATED, AND WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BALLOON, IT BECAME STUCK ON THE STENT IN AN AREA THAT WAS STILL TIGHT AND HAD NOT BEEN EXPANDED WELL. A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER WAS USED, AND DUE TO MULTIPLE BACK-AND-FORTH MOVEMENTS WITH THE GUIDE EXTENSION CATHETER, IT CAUSED THE BALLOON TO SHEAR OFF FROM THE CATHETER. THEY ATTEMPTED TO GET A NON-BOSTON SCIENTIF

  Patient problems: Foreign Body In Patient

  MAUDE report 19075806 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND CHEST PAIN REQUIRING ADDITIONAL INTERVENTION. FOLLOWING PRE-DILATATION, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. FOLLOWING POST-DILATATION, IVUS WAS AGAIN PERFORMED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS, AND THE PATIENT WAS TRANSFERRED TO THE PATIENT CARE UNIT. THE PATIENT COMPLAINED OF CHEST PAIN, AND ELECTROCARDIOGRAM (EKG) CHANGES WERE SHOWN APPROXIMATELY 60 MINUTES POST-IMPLANTATION. IT WAS NOTED THAT THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND ISCHEMIA. THE PATIENT WAS BROUGHT BACK TO THE CARDIAC CATHETERIZATION LAB, IVUS WAS COMPLETED AND BALLOON ANGIOPLASTY WAS PERFORMED TO EXPAND THE STENT. THE PATIENT RETURNED TO THE PATIENT CARE UNIT AND TOLERATED THE PROCEDURE WELL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Chest Pain; Ischemia; Myocardial Infarction; Non specific EKG/ECG Changes

  MAUDE report 18672724 ↗
• MalfunctionDec 8, 2023Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT BECAME STUCK IN THE GUIDEZILLA AND CAME OFF THE BALLOON. A 4.00 X 20MM SYNERGY AND 6F GUIDEZILLA II WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING INSERTION, THE STENT BECAME STUCK IN THE GUIDEZILLA CAUSING IT TO BEND AND COME OFF THE BALLOON. THE STENT WAS REMOVED WITH THE GUIDEZILLA ALTOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295641 ↗
• InjuryOct 18, 2023Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE, THE SHAFT BECAME BENT AND FRACTURED INTO TWO PIECES. THE DEVICE WAS REMOVED BY UTILIZING SNARES AND OTHER DEVICES, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957916 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND A NODULE WAS PRESENT. IN (B)(6)2023, A 4.00 X 20MM SYNERGY XD DRUG ELUTING STENT WAS SUCCESSFULLY IMPLANTED. HOWEVER, AFTER FEW DAYS POST PROCEDURE, THE PATIENT NOTICED A WHITE NODULE AND PAIN IN THE INJECTION SITE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17175055 ↗
• MalfunctionJun 2, 2023Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. UPON REMOVAL OF A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT FROM THE BOX, A POSSIBLY SMALL TEAR WAS FOUND ON THE FOIL PACKAGING. IT WAS NOTED THAT THE INNER POUCH WAS OPENED WITH THE DEVICE COMPROMISED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052427 ↗
• InjuryJun 1, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. THE 98-99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL ARTERY. THERE WAS NO PRE-DILATION PERFORMED PRIOR TO ADVANCEMENT OF A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT. HOWEVER, THE STENT WOULD NOT CROSS THE LESION AND WHEN THE DEVICE WAS PULLED BACK TO THE PROXIMAL SVG, IT WAS NOTICED THAT THE STENT MOVED ON THE BALLOON. AN ATTEMPT TO REMOVE THE STENT WAS MADE, BUT THE STENT COULD NOT BE REMOVED WITHOUT SLIDING OFF THE BALLOON. THE STENT WAS DEPLOYED IN THE PROXIMAL SVG TO AVOID LOSING IT ANY FURTHER. AFTER STENTING, A BALLOON WAS ADVANCED TO DILATE THE LESION. AN ADDITIONAL SYNERGY XD WAS DEPLOYED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043346 ↗
• MalfunctionApr 20, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED WITHIN THE GUIDE CATHETER. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE >80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. DURING REMOVAL, THE STENT CAME OFF THE BALLOON COMPLETELY WITHIN THE GUIDEZILLA II GUIDE CATHETER. BOTH THE GUIDEWIRE AND GUIDEZILLA II HAD TO BE PULLED OUT TO REMOVE THE DISLODGED STENT. 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 16780325 ↗
• MalfunctionFeb 26, 2023Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. THE DEVICE WAS PULLED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441249 ↗
• MalfunctionDec 7, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL IN THE RIGHT CORONARY ARTERY. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS DEPLOYED, HOWEVER, THE BALLOON OF THE STENT DELIVERY SYSTEM BECAME STUCK ON THE STENT. THE GUIDE, WIRE AND STENT DELIVERY SYSTEM WERE PULLED OUT OF THE BODY INTRA PROCEDURE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936563 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS USED, HOWEVER, DURING INSERTION THE SHAFT CLEANLY BROKE UP. IT APPEARED TO BREAK AT THE TRANSITION POINT OF HYPOTUBE AND DISTAL PORTION OF STENT DELIVERY SYSTEM. THE DETACHED PORTION WAS PULLED OUT OF THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429357 ↗
• MalfunctionMay 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). AFTER THE LESION WAS PREPPED WITH SEMI-COMPLIANT BALLOONS, THE 4.00 X 20MM SYNERGY XD MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ON THE GUIDEWIRE THROUGH THE GUIDE CATHETER AND NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER. ONCE THE SDS WAS AT THE APPROPRIATE LOCATION, IT WAS NOTICED THAT THE STENT WAS NO LONGER ON THE BALLOON. X-RAY WAS THEN USED TO TRACE BACK AND LOCATE THE STENT, WHICH WAS FOUND INSIDE THE GUIDE CATHETER JUST DISTAL TO THE SHEATH. ALL DEVICES WERE REMOVED FROM THE PATIENT AND THE STENT WAS REMOVED FROM THE GUIDE CATHETER BY FORCING IT OUT WITH A WIRE. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A 4.0 X 38MM SYNERGY XD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438656 ↗
• InjuryMar 29, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 99% IN-STENT RE-STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND FIBROTIC RIGHT CORONARY ARTERY (RCA). A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS INTRODUCED FOR TREATMENT. HOWEVER, AS THE DEVICE WAS BEING ADVANCED DOWN THE ARTERY, IT WAS NOTED THAT THE STENT WAS COMING OFF THE BALLOON. THE PHYSICIAN PULLED THE DEVICE BACK INTO THE GUIDE CATHETER AND TRIED TO REMOVE THE ENTIRE SYSTEM TOGETHER. WHEN THEY GOT TO THE SHEATH, THEY REALIZED THE STENT WAS LEFT IN THE RADIAL ARTERY. THE PHYSICIAN ADVANCED A WIRE FROM THE SHEATH THROUGH THE STENT AND PERFORMED A CUT DOWN AND SNARE TO RETRIEVE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT A DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935064 ↗
• MalfunctionFeb 25, 2022Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND WAS CAUGHT INSIDE THE GUIDEZILLA. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13605727 ↗
• MalfunctionFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE WHEN ATTEMPTING TO DEPLOY THE STENT, THE STENT CAME OFF THE DEPLOYMENT SYSTEM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480995 ↗