SYNERGY™ XD H7493941812270Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729980872), received between Feb 10, 2021 and Mar 10, 2025 — classified as 2 deaths, 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.75 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT CAME OFF THE BALLOON WHEN THE PHYSICIAN PULLED OUT THE STYLET. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560500 ↗
• MalfunctionSep 10, 2024

  MIDDLE AGED FEMALE WITH ACUTE ONSET OF CHEST PAIN. PROCEDURE: EMERGENT CARDIAC CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION. END OF STENT BROKEN, SHAFT END. NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY XD (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180747 ↗
• InjuryAug 20, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER THE VESSEL WAS PREPPED PROPERLY, A 2.75 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DUE TO CALCIFIC DISEASE AND TORTUOSITY OF THE VESSEL, THE STENT COULD NOT BE ADVANCED TO THE TARGET LESION. THE UNDEPLOYED STENT WAS REMOVED, AND IT WAS THEN NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON. ANGIOGRAPHY WAS PERFORMED AND IT WAS CONFIRMED THAT THE STENT WAS LEFT IN THE CORONARY UNINTENTIONALLY. THE PHYSICIAN WIRED THE LOOSE STENT AND INFLATED A BALLOON TO SECURE IT, AND THEN REMOVED IT ALL AS ONE UNIT. A NEW STENT OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FINE POST-PROCEDURE. THE INITIAL REPORTER ALSO SUBMITTED A COPY OF THIS EVENT OR REPORT TO FOOD AND DRUG ADMINISTRATION (FDA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004083 ↗
• DeathMay 21, 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 LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. SIX SYNERGY XD DRUG ELUTING STENTS WERE IMPLANTED, A 2.25MM X 12MM, A 2.75MM X 12MM, A 3.00 X 16MM, A 3.00MM X 38MM, A 3.5MM X 28MM AND A 3.5MM X 48MM, WITH NO VISIBLE EDGE DISSECTIONS. TWENTY MINUTES AFTER ARRIVING IN THE RECOVERY UNIT, THE PATIENT COMPLAINED ABOUT CHEST PAIN AND DEVELOPED ST SEGMENT ELEVATION. THE PATIENT WAS BROUGHT BACK TO THE CARDIAC CATHETERIZATION LABORATORY AND THE STENTS IN BOTH THE LAD AND LCX WERE THROMBOSED. THROMBECTOMY WAS PERFORMED IN AN ATTEMPT TO RE-OPEN THE ARTERIES. THE PATIENT CODED FOR SIXTY MINUTES AND EXPIRED.

  Patient problems: Cardiac Arrest; Chest Pain; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 19368004 ↗
• MalfunctionMay 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. THE 2.75 X 12MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. AS IT WAS BEING ADVANCED THROUGH THE VESSEL, THE STENT SLID ON THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264358 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.75 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, THE PROXIMAL SHAFT BROKE BEFORE ENTERING THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY XD DES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152967 ↗
• MalfunctionJun 14, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122970 ↗
• MalfunctionFeb 21, 2023Break; Entrapment of Device; Physical Resistance/Sticking; Break; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DEVICE ENTRAPMENT AND SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 2.75 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO ADVANCE OVER THE WIRE AND BECAME STUCK. THE WIRE WAS IN THE BODY BUT THE STENT NEVER ADVANCED FAR ENOUGH TO ENTER THE BODY. WHEN THE PHYSICIAN TRIED TO PULL THE STENT FROM THE WIRE, THE STENT DELIVERY SYSTEM BROKE OFF. BOTH DEVICES WERE REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH NEW WIRE AND NEW STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410261 ↗
• DeathJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT CAME IN FOR A PLANNED MULTI-VESSEL PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND CIRCUMFLEX ARTERY (CX). THE PHYSICIAN INITIALLY WIRED THE LAD AND DIAGONAL BRANCH. FOLLOWING USE OF A NON-BOSTON SCIENTIFIC (BSC) BALLOON, A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE MID LAD. POST-DILATATION WAS PERFORMED WITH A 3.25 NC QUANTUM APEX BALLOON CATHETER. THE PHYSICIAN THEN PROCEEDED TO WIRE THE CX AND INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH THE OPTICROSS 6 HD. AFTER IMAGING, THE PATIENT EXPERIENCED ST ELEVATION AND WHEN THE PHYSICIAN CHECKED THE LAD, IT SHOWED TIMI 0 FLOW. THE PHYSICIAN BELIEVED THE IVUS MAY HAVE BROKEN OFF A PIECE OF PLAQUE WHICH SHOWERED DOWN THE LAD. THE PHYSICIAN PROCEEDED TO STENT THE CX WITH A 2.75 X 20MM SYNERGY XD DES AND BALLOONED THE LAD STENT AGAIN. A 2.75 X 12MM SYNERGY XD DES WAS THEN PLACED DISTAL TO THE 3.0 IN THE LAD. THE PATIENT WAS CODED AND A NON BOSTON SCIENTIFIC VENTRICULAR ASSIST DEVICE WAS PLACED. DURING THE PROCEDURE THE PATIENT ALSO EXPERIENCED ARRHYTHMIA, THROMBOSIS, VENTRICULAR FIBRILLATION, AND VENTRICULAR TACHYCARDIA. TH

  Patient problems: Arrhythmia; Cardiac Arrest; Non specific EKG/ECG Changes; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 14937813 ↗
• MalfunctionSep 24, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS DAMAGED WHILE TRYING TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524178 ↗
• MalfunctionSep 21, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS DAMAGED WHILE TRYING TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12504730 ↗
• MalfunctionSep 20, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502326 ↗
• MalfunctionFeb 10, 2021Difficult to Advance; Device Contamination with Chemical or Other Material; Material Deformation; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL PRESENT IN DEVICE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 12MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THERE WAS A CLEAR PLASTIC/GLUE NUB ON THE DISTAL END OF THE STENT DELIVERY CATHETER. THE CATHETER GOT CAUGHT IN THE SHEATH AND COULD NOT BE DELIVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE HAD DIFFICULTY IN LOADING INTO 5FR GUIDE CATHETER. IT WAS CAUGHT IN THE HUB AND THE CATCH POINT WAS THE MIDSHAFT BOND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309013 ↗