SYNERGY™ H7493926024500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729973454), received between Sep 18, 2019 and Feb 18, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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.

• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY . IT WAS REPORTED THAT A DISSECTION OCCURRED. IN (B)(6) 2020, THE SUBJECT EXPERIENCED CONTINUOUS RUNS OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION REQUIRING DEFIBRILLATION BY HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH DID NOT RESPOND TO CHANGES IN MEDICATION. CORONARY ANGIOGRAPHY REVEALED A 95% STENOSED PROXIMAL RIGHT CORONARY ARTERY (RCA) WHICH WAS TREATED WITH THE PLACEMENT OF A 5.0X24MM STUDY STENT. FOLLOWING STENT PLACEMENT, A DISSECTION IN THE DISTAL EDGE OF THE RCA WAS NOTED AND TREATED WITH PLACEMENT OF ANOTHER 5.0X12MM STUDY STENT. IN ADDITION, THE 90% STENOSED PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WERE TREATED WITH PLACEMENT OF 4.0 X 28 MM AND 3.5 X 38 MM SYNERGY STENTS RESPECTIVELY IN OVERLAPPING MANNER AND THE 90% STENOSED POSTERIOR DESCENDING ARTERY (PDA) WAS TREATED WITH A 3.0 X 20 MM SYNERGY STENT. WHILE TREATING THE PROXIMAL LAD WITH THE 4.0 X 28 MM SYNERGY STENT, THE FIRST DIAGONAL ARTERY WAS JAILED AND HAD A TIMI FLOW OF 0. FURTHER INTERVENTION WAS DEFERRED. TWO DAYS LATER THE SUBJECT HAD MILD SHORTNESS OF BREATH WITH HEAVINESS ON HIS CHEST AND WAS ALSO NOTED TO HAVE LOW BLOOD PRESSURE. THE SUBJECT BECA

  Patient problems: Vascular Dissection

  MAUDE report 9722030 ↗
• MalfunctionNov 21, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A LARGE SAPHENOUS VEIN GRAFT. A NON-BSC GUIDE WIRE AND 6FR GUIDE CATHETER WERE PLACED, AND A 5.0X24MM SYNERGY DRUG ELUTING STENT WAS DEPLOYED. WHEN THE STENT DELIVERY SYSTEM (SDS) WAS BEING REMOVED, THE SDS GOT STUCK ON THE GUIDEWIRE IN THE GUIDE CATHETER AND THE SOFT PART OF THE BALLOON STARTED TO STRETCH. THE DEVICES WERE ALL REMOVED TOGETHER. THE GUIDE CATHETER WAS REINSERTED AND ANOTHER GUIDEWIRE PLACED. THE STENT WAS POST DILATED WITH A 5.0X14MM APEX BALLOON. EVERYTHING LOOKED GOOD AND THE PATIENT DID GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9359219 ↗
• MalfunctionSep 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 5.00 X 24 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS DEFORMED INSIDE THE GUIDELINER AND WOULD NOT EXIT. A 4.50 X 20 SYNERGY DES WAS THEN ADVANCED, BUT IT ALSO FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT BROKE INSIDE THE GUIDELINER. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9083430 ↗