SYNERGY™ XD H7493941820270Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729980896), received between Jul 6, 2022 and Jul 16, 2024 — classified as 2 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON CROSSING THE LESION, THE SHAFT WAS BROKEN AT THE MID PART. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747605 ↗
• 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 19618812 ↗
• MalfunctionJan 31, 2024Device Dislodged or Dislocated; 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 NON-TORTUOUS AND MODERATELY CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE DELIVERING THE STENT DOWN TO THE LESION, THE STENT COMPLETELY DISLODGED FROM THE BALLOON UNDEPLOYED AND TRAVEL INTO THE PROXIMAL SIDE TO THE LESION SITE. A BALLOON CATHETER WAS THEN DELIVERED INSIDE THE UNDEPLOYED STENT, THE BALLOON WAS THEN INFLATED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619390 ↗
• MalfunctionApr 17, 2023Break; Inflation Problem; Material Separation; Failure to Advance; Device Dislodged or Dislocated; Break; Inflation Problem; Material Separation; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 2.75 X 20MM SYNERGY XD WAS ADVANCED BUT FAILED TO CROSS LESION. HOWEVER, THE BALLOON DID NOT EXPAND; THE STENT CAME OFF THE BALLOON AND WAS DISLODGED IN THE GUIDER. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE STENT CAME OFF THE DELIVERY SYSTEM INSIDE THE GUIDE CATHETER PRIOR TO DEPLOYMENT. THE BALLOON AND STENT BROKE OFF FROM THE DISTAL SHAFT AND WERE DETACHED FROM THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AS A WHOLE UNIT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756088 ↗
• 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; Embolism/Embolus; Non specific EKG/ECG Changes; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 14939316 ↗