SYNERGY™ H7493926016450Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729973355), received between Jan 16, 2020 and Dec 5, 2022 — classified as 2 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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.

• DeathDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV_XLV STUDY: IT WAS REPORTED THAT THE SUBJECT DIED. IN OCTOBER 2020, THE SUBJECT WAS ENROLLED IN THE CLINICAL STUDY AND ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSED LESION AND WAS 16 MM LONG WITH A DISTAL VESSEL DIAMETER OF 4.5 MM AND TIMI FLOW OF 3. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF 4.50 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW OF 3. ON THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN DECEMBER 2021, THE SUBJECT EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916109 ↗
• DeathOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT THE SUBJECT DIED. IN (B)(6) 2020, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. THE 80% STENOSED, 4.50 X 16MM, TARGET LESION WAS LOCATED IN PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND HAD TIMI FLOW OF 2. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF 4.50 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW OF 3. ON THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON AN UNKNOWN DATE, THE SUBJECT EXPIRED. DURING THE SCHEDULING OF THE TWO-YEAR STUDY SPECIFIC FOLLOW UP, THE SITE HAD CONTACTED THE SUBJECT'S SON AND WAS INFORMED THAT THE SUBJECT HAD ORAL CANCER AND EXPIRED AROUND 2 MONTHS PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621603 ↗
• MalfunctionOct 18, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WA REPORTED THAT DIFFICULTY REMOVAL AND DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.50 X 16MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT WAS DEPLOYED IN THE LESION, THE DOCTOR TRIED TO REMOVE THE STENT BALLOON BUT IT COULD NOT COME OUT OF THE GUIDING CATHETER. THE BALLOON WAS DEFLATED FOR ABOUT 30 SECONDS A VACUUM WAS HELD DURING REMOVAL AFTER THE STENT WOULD NOT DEFLATE AND WAS REMOVED PARTIALLY INFLATED. THE PHYSICIAN REMOVE THE GUIDING CATHETER, WIRE AND BALLOON AS ONE UNIT TO GET EVERYTHING OUT SAFELY AND COMPLETED THE PROCEDURE WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650334 ↗
• InjuryMay 18, 2021Activation Failure; Activation Failure

  EVOLVE_LV_XLV REGISTRY: IT WAS REPORTED THAT STENT INCOMPLETE APPOSITION OCCURRED. IN (B)(6) 2020, THE SUBJECT PRESENTED WITH CORONARY ARTERY DISEASE. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED CHRONIC TOTAL OCCLUSION OF MID CORONARY ARTERY WITH LEFT TO RIGHT COLLATERALS AND 80% FOCAL STENOSIS IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). IN ADDITION, ECHOCARDIOGRAM REVEALED SEVERELY REDUCED LEFT VENTRICULAR STROKE VOLUME WITH SEVERELY LOW FLOW GRADIENT AORTIC STENOSIS. TARGET LESION 1 WAS LOCATED IN PROXIMAL LAD WITH 80% LESION AND WAS 14 MM LONG WITH A DISTAL VESSEL DIAMETER OF 4.5 MM. IN (B)(6) 2020, THE 80% STENOSED, 4.5MM X 14MM TARGET LESION IN THE PROXIMAL LAD WAS TREATED WITH PRE-DILATION USING A 3.0 X 12 NC BALLOON, FOLLOWED BY PLACEMENT OF A 4.5 X 16 SYNERGY DRUG ELUTING STENT. THE STENT WAS POST DILATED WITH A 4.5 X 8 MM NC BALLOON. INTRAVENOUS ULTRASOUND (IVUS) REVEALED MILD MALAPPOSITION IN THE DISTAL PORTION OF THE STENT AND THE STENT WAS POST DILATED AGAIN WITH A 5.0 X 8MM NC BALLOON THROUGHOUT THE STENT WITH RESIDUAL STENOSIS NOTED TO BE 0%. COMPLETION ANGIOGRAPHY SHOWED AN EXCELLENT RESULT WITHOUT APPARENT COMPLICATION. FIVE DAYS LATER, SUBJECT WAS DISCHARGED ON

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845722 ↗
• InjuryJan 16, 2020Difficult to Remove; Material Rupture; Activation Failure; Difficult to Remove; Material Rupture; Activation Failure

  IT WAS REPORTED THAT STENT INSUFFICIENT APPOSITION, CATHETER REMOVAL DIFFICULTY, BALLOON RUPTURE, AND VESSEL PERFORATION OCCURRED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY TO POSTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH EMERGE BALLOON CATHETER, BUT THE BALLOON WAS NOT FULLY INFLATING DUE TO CALCIUM OR FIBROTIC LESION. A 4.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THERE WAS STILL A WASTE IN THE MIDDLE OF THE STENT AND IT WOULD NOT FULLY EXPAND. WHEN THE BALLOON WAS ATTEMPTED TO RETRIEVE, THE BALLOON WAS STUCK INSIDE THE STENT. THE STENT BALLOON WAS THEN INFLATED AGAIN TO RELEASE THE STENT, BUT IT BURST. IMMEDIATELY AFTER, A PERFORATION WAS NOTED JUST PROXIMAL TO THE STENT. A STENT WAS PLACED TO SEAL THE PERFORATION AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING FINE.

  Patient problems: Perforation

  MAUDE report 9596622 ↗