SYNERGY™ H7493926032450Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729973393), received between Jul 30, 2019 and May 24, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 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.

• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY: IT WAS REPORTED THAT PATIENT EXPERIENCED UNSTABLE ANGINA PECTORIS. IN (B)(6) 2019, THE SUBJECT WAS ENROLLED IN THE EVOLVE 4.5/5.0 STUDY AND ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN SAPHENOUS VEIN GRAFT (SVG) EXTENDING FROM SVG TO OBTUSE MARGINAL (OM) WITH 80% STENOSIS AND WAS 56 MM LONG WITH A DISTAL VESSEL DIAMETER OF 4.5 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF TWO 4.5 MM X 32 MM STUDY STENTS. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. BASELINE ELECTROCARDIOGRAM (ECG) REVEALED SINUS BRADYCARDIA WITH AXIS DEVIATION, ST AND T WAVE ABNORMALITY, CONSIDER ANTEROLATERAL ISCHEMIA. THE NEXT DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2022, POST INDEX PROCEDURE, SUBJECT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE INVOLVING NATIVE CORONARY ARTERY WITH UNSTABLE ANGINA PECTORIS. AT THE SAME TIME, SUBJECT DID NOT EXPERIENCE SHORTNESS OF BREATH, DYSPNEA ON EXERTION, PALPITATIONS, HEART RACING OR SKIPPED BEATS, LOWER EXTREMITY EDEMA, ORTHOPNEA, WEAKNESS, NUMBNESS OR NEUROLOGICAL SYMPTOMS, SYNCOPE OR PRESYNCOPE. SUBJECT WAS WELL TOLERATING MEDICATIONS WITHOUT ANY SIGNIFICANT

  Patient problems: Angina; Restenosis

  MAUDE report 14490843 ↗
• MalfunctionMar 18, 2021Device-Device Incompatibility; Material Deformation; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND DISTAL RCAWITH 75-80% STENOSIS. THE PHYSICIAN PRE-DILATED THE LESION WITH 1.5X12 SEMI-COMPLIANT (SC), 2.0X 15(SC), 3.0X 15(SC) AND A 3.5 X15 NON-COMPLIANT (NC) BALLOONS. A 6FR GZII GUIDE EXTENSION CATHETER WAS PLACED ACROSS THE MID LESION FOR EASIER DEPLOYMENT. A 4.50 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE FRONT END OF THE STENT WAS GETTING CAUGHT SOMEWHERE IN THE 6FR GUIDE CATHETER. THE PHYSICIAN FLUROED AND DISCOVERED THAT THE STENT WAS GETTING CAUGHT UP AT THE HELICAL COLLAR OF THE GZII. THE STENT BODY WAS EXAMINED AND OBSERVED THAT IT HAD SOME DAMAGED TO IT BECAUSE OF THE COLLAR INTERACTION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT OMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11518643 ↗
• InjuryFeb 22, 2021Obstruction of Flow; Obstruction of Flow

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN JANUARY 2020, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATECHIZATION. THE INDEX PROCEDURE WAS PERFORMED THAT SAME DAY. THE FIRST TARGET LESION WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 4.50 MM X 32 MM SYNERGY DRUG ELUTING STENT (DES) WITH NO RESIDUAL STENOSIS. A NON-TARGET LESION LOCATED IN OBTUSE MARGINAL (OM1) AND WAS TREATED WITH THE PLACEMENT OF 2.75 MM X 20 MM SYNERGY DES AND WITH CUTTING BALLOON. THE SECOND NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX EXTENDING TO 1ST OB MARG AND WAS TREATED WITH THE PLACEMENT OF 3.50 MM X 32 MM OF SYNERGY DES. THE THIRD NON-TARGET LESION WAS LOCATED IN PROXIMAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 32 MM SYNERGY DES. THE FOURTH NON-TARGET LESION WAS LOCATED IN DISTAL LCX AND WAS TREATED WITH THE PLACEMENT OF 4.00 MM X 8.00 MM SYNERGY DES. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN JANUARY 2021, SUBJECT WAS BROUGHT TO

  Patient problems: Angina; Myocardial Infarction; Restenosis

  MAUDE report 11359332 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE 4.5-5.0. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND UNSTABLE ANGINA OCCURRED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED THE TARGET LESION #1 WAS LOCATED IN SAPHENOUS VEIN GRAFT (SVG) EXTENDING FROM SVG TO 2ND MARGINAL WITH 95% STENOSIS AND WAS 50 MM LONG WITH A DISTAL VESSEL DIAMETER OF 4.5 MM. TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF 4.5 MM X 32 MM AND 4.5 MM X 28 MM SYNERGY DRUG-ELUTING STENTS. POST PROCEDURE, RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2020, SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH COMPLAINTS OF LEFT SIDED CHEST PAIN RADIATING TO LEFT ARM THAT BEGAN AT 4AM IN THE MORNING AND WOKE HIM UP FROM SLEEP. SUBJECT HAD SOME SHORTNESS OF BREATH, HOWEVER DENIED NAUSEA, VOMITING, DIAPHORESIS, ORTHOPNEA, EDEMA AND DIFFICULTY BREATHING. SUBJECT TOOK 2 BABY ASPIRINS THAT BROUGHT RELIEF PRIOR TO ARRIVAL TO ED. SUBJECT ALSO ENDORSED SEVERAL MONTHS OF DRY COUGH, HOWEVER NO NEW COUGH OR FEVERS. HE RECEIVED NITROGLYCERINE IN THE ED THAT HELPED WITH HIS PAIN. AN E

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 9985387 ↗
• MalfunctionJul 30, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED AS THE PHYSICIAN WAS TRYING TO DELIVER OR PASS IT THROUGH THE GUIDEZILLA GUIDE EXTENSION CATHETER. NO INFORMATION ON HOW WAS THE PROCEDURE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844127 ↗