SYNERGY™ H7493926012500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729973423), received between Mar 20, 2019 and Nov 10, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryNov 10, 2020Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY WAS ENCOUNTERED AND STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN (LM) ARTERY. A 5.00 X 12 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, WHEN BALLOON WAS DEFLATED IT WAS NOT ABLE TO BE RETRACTED INTO THE GUIDE CATHETER. THE BALLOON BECAME STUCK IN THE DISTAL END/OPENING OF THE GUIDE CATHETER. THE ENTIRE GUIDE CATHETER WAS THEN REMOVED AND A NEW ONE WAS INSERTED. IT WAS THEN NOTED THAT THE DEPLOYED STENT WAS NO LONGER IN THE LM AND WAS FOUND TO BE IN THE ILIAC ARTERY UPON COMPUTERIZED TOMOGRAPHY (CT) IMAGING. THE PATIENT WAS OKAY AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10815770 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE 4.5-5.0 CLINICAL STUDY. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2019, CLINICAL STATUS ASSESSMENT INDICATES THE PATIENT'S QUALIFYING CONDITION AS UNSTABLE ANGINA. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION #1 WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY WITH 85% STENOSIS AND WAS 4 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 5.2MM. THE LESION WAS TREATED WITH PLACEMENT OF A 5.00X12MM STUDY STENT. FOLLOWING STENT PLACEMENT, A GRADE B DISSECTION WAS NOTED AT THE DISTAL TO TARGET LESION WHICH WAS TREATED WITH AN ADDITIONAL STENT PLACEMENT. AFTER POST DILATATION, RESIDUAL STENOSIS WAS NOTED 0% WITH TIMI 3 FLOW. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IT WAS FURTHER REPORTED THAT THE DISSECTION EXTENDED INTO THE CICUMFLEX AND WAS TREATED WITH ANOTHER 3.5X12MM SYNERGY STENT FROM THE DISTAL END OF THE STENT INTO THE OSTIAL PORTION OF THE CIRCUMFLEX.

  Patient problems: Vascular Dissection

  MAUDE report 8748687 ↗
• MalfunctionJun 25, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VEIN GRAFT. A 5.00 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED AND PLACED. HOWEVER, THE BALLOON DID NOT DEFLATE. THE PHYSICIAN TRIED TO DEFLATE THE BALLOON WITH NEGATIVE PRESSURE AND PULLED IT SEVERAL TIMES UNTIL IT FINALLY CAME OUT. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733047 ↗
• MalfunctionJun 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. AFTER DEPLOYING A 5.00 X 12MM SYNERGY DRUG-ELUTING STENT, THE BALLOON RUPTURED. THE STENT WAS SUCCESSFULLY IMPLANTED. THE CATHETER WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687809 ↗
• MalfunctionMar 20, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN AN ASCENDING AORTIC ARCH. AFTER A GUIDE CATHETER WAS ADVANCED, A 6F GUIDEZILLA II GUIDE CATHETER EXTENSION WAS ADVANCED INTO THE GUIDE CATHETER. HOWEVER, IT GOT LODGED OR JAMMED AND COULD NOT ADVANCED FURTHER. THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER AND A NON BSC GUIDE EXTENSION CATHETER WAS ADVANCED IN THE LESION. A 5.0X16MM SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED AND IMPLANTED IN THE LESION. A SECOND 5.00 X 12MM SYNERGY (DES) WAS ADVANCED FOR TREATMENT; HOWEVER, DURING ADVANCING, THE STENT WENT UP AND AROUND THE ASCENDING ARCH IN THE GUIDE CATHETER AND THE HYPOTUBE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8437666 ↗