SYNERGY™ XD H7493941824220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729980742), received between Jul 6, 2021 and Jan 12, 2026 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Fracture; Device Damaged by Another Device

  IT WAS REPORTED VIA MEDWATCH REPORT MW5179565 THAT STENT FRACTURE OCCURRED. A 2.25 X 24MM SYNERGY? XD DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, FOLLOWING DEPLOYMENT, THE STENT WAS FOUND TO BE FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24047717 ↗
• MalfunctionDec 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 2.25 X 24MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT STRUT FRACTURED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745613 ↗
• MalfunctionMay 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.25 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE AND WAS BROKEN. 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 19264975 ↗
• DeathAug 8, 2023Defective Device; Migration; Defective Device; Migration

  IT WAS REPORTED THAT THE PATIENT DIED. A 2.25 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED IN THE LEFT MAIN (LM); HOWEVER, THE STENT MIGRATED INTO THE PROXIMAL LEFT CIRCUMFLEX ARTERY AND WAS DEPLOYED WHERE IT WAS. DURING DEPLOYMENT, THE OSTIAL LM PART OF THE STENT HAD PROXIMAL STENT EDGE SHORTENING AND A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED AT THE ORIGINAL LESION, OVERLAPPING WITH THE FIRST STENT. A RECOMMENDATION WAS MADE FOR COMPLETION OF THE LEFT MAIN BIFURCATION STENTING DUE TO THE BUNCHING OF THE STENT WITHIN THE OSTIAL LEFT MAIN. SEVEN DAYS LATER, THE PATIENT RETURNED TO THE CATH LAB ON VASOPRESSIN AND PHENYLEPHRINE. DURING THIS PROCEDURE, A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY TO LM. DURING PROXIMAL OPTIMIZATION TECHNIQUE ON THE LEFT MAIN PORTION OF THE STENT, THERE WAS AGAIN STENT EDGE SHORTENING. TWO DAYS LATER THE PATIENT DIED. THE PRIMARY CAUSE OF DEATH WAS NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI).

  Patient problems: Myocardial Infarction

  MAUDE report 17484576 ↗
• InjuryJun 24, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT SIGNIFICANT DELAY TO THE PROCEDURE RESULTING IN AN ADVERSE PATIENT EVENT.A 2.25 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE, RESULTING IN AN ADVERSE PATIENT EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14799478 ↗
• MalfunctionOct 20, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT STRUTS LIFTED FROM THE BALLOON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12663162 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING INTRODUCTION THROUGH THE GUIDE, THE MIDSHAFT WAS FRACTURED. THE DETACHED PORTION WAS SUCCESSFULLY REMOVED. 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 12125095 ↗