SYNERGY™ XD H7493941812450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729981183), received between Jul 20, 2021 and Aug 5, 2022 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE PATIENT EVENT OCCURRED. A 4.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE INABILITY TO CROSS THE LESION CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE THAT RESULTED IN AN ADVERSE PATIENT EVENT. DESPITE MULTIPLE EFFORTS, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 15179047 ↗
• InjuryMay 26, 2022Difficult to Remove; Activation Failure; Migration; Difficult to Remove; Activation Failure; Migration

  IT WAS REPORTED THAT REMOVAL DIFFICULTY, STENT NOT FULLY EXPANDED, AND STENT MIGRATION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY TORTUOUS AND NON- TO MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. NO LESION PREPARATION WAS PERFORMED. A 4.50 X 16MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. THE STENT WAS INFLATED AT 11 ATMOSPHERES (ATM) FOR 20 SECONDS AND APPEARED NORMAL AND EXPANDED. THE STENT WAS PLACED; HOWEVER, THE STENT SHIFTED DISTAL TO THE LESION. ANOTHER 4.50 X 12MM SYNERGY XD DES WAS ADVANCED TO COVER THE MISSED LESION AND WAS INFLATED AT 12 ATM FOR 20 SECONDS. PRIOR TO REMOVAL, THE BALLOON WAS DEFLATED; HOWEVER, WHEN THE PHYSICIAN TRIED TO REMOVE THE BALLOON CATHETER, THERE WAS RESISTANCE. THE INFLATION DEVICE WAS CHECKED TO CONFIRM IT WAS DOWN AND THE DOCTOR PULLED TO GET THE CATHETER OUT. AFTER REMOVAL, IT WAS NOTICED THAT THE STENT ITSELF PULLED BACK INTO THE LEFT MAIN ARTERY, AND THE DISTAL EDGE OF THE STENT APPEARED TO BE NOT FULLY EXPANDED AND ALSO WAS NOW PROXIMAL TO THE LESION. SUBSEQUENTLY, ANOTHER 5.0X12 SYNERGY XD DES WAS ADVANCED AND INFLATED AT 16 ATMOSPHERES FOR 10 SECONDS TO PUT BETWEEN THE 2 STENTS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14504002 ↗
• MalfunctionJul 20, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 4.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, RESISTANCE WAS FELT DURING ADVANCEMENT AND THE STENT COULD NOT CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT STRUTS WERE STICKING UP ON THE PROXIMAL EDGE. THE PROCEDURE WAS COMPLETED WITH A 2.5X20MM SYNERGY XD STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199592 ↗