SYNERGY™ H7493926008270Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729839989), received between Jan 17, 2017 and Apr 6, 2021 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 8 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619563 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION, A 2.75 X 8 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, IT WAS NOTICED THAT THE DISTAL PORTION OF THE STENT WAS KINKED. THE DEVICE WAS NEVER USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.75 X 8 SYNERGY STENT. NO ISSUES NOR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617882 ↗
• MalfunctionMar 16, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER A NON-BSC GUIDE CATHETER WAS ADVANCED AND MULTIPLE PRE-DILATION WAS PERFORMED, A 2.75 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. DURING REMOVAL, THE STENT BECAME CAUGHT WITH THE GUIDE AND THE STENT STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426706 ↗
• MalfunctionJan 28, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION FOUR TIMES. THE DEVICE WAS REMOVED AND WHEN THE PHYSICIAN WENT TO ASSESS THE INTEGRITY OF THE STENT WITH HIS FINGERS, THE STENT CAME OFF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8283000 ↗
• MalfunctionJan 17, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AFTER A GUIDE CATHETER AND A GUIDE WIRE CROSSED THE LESION, A 2.75 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION; HOWEVER, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM WAS FRACTURED WHILE IT WAS IN THE GUIDE CATHETER. A BALLOON WAS INFLATED DISTALLY INSIDE THE GUIDE CATHETER AND THEN THE GUIDE WIRE AND THE STENT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7201041 ↗
• MalfunctionDec 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A STENT DISLODGED OUTSIDE THE PATIENT. AS A 2.75 X 8MM SYNERGY II DRUG-ELUTING STENT WAS BEING LOADED ON THE WIRE, A SECOND STENT WAS NOTED ON TOP OF THE STENT THAT WAS CRIMPED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7118254 ↗
• InjurySep 11, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2017-08809. IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. IN (B)(6) 2017, THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (N-STEMI) AND ACUTE CORONARY SYNDROME. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT RADIAL ARTERY UTILIZING MODIFIED SELDINGER TECHNIQUE. A 5FR RADIAL SHEATH WAS INSERTED OVER THE GUIDEWIRE WITHOUT DIFFICULTY. FOLLOWING DIAGNOSTIC CORONARY ANGIOGRAPHY, CORONARY INVENTION WAS PERFORMED USING 6FR GUIDING CATHETER TO CANNULATE THE RIGHT CORONARY ARTERY (RCA). A 0.014 NON-BSC ANGIOPLASTY GUIDEWIRE WAS ADVANCED DISTALLY, AND CROSSED THE SUBTOTAL OCCLUSION OF THE RIGHT POSTEROLATERAL BRANCH AND ADVANCED DISTALLY. DILATATION WAS PERFORMED USING A 2.5 X 12MM EMERGE BALLOON CATHETER FOLLOWED BY STENTING USING 2.50 X 12 SYNERGY II DRUG-ELUTING STENT DEPLOYED AT 14 ATMOSPHERES FOR 30 SECONDS. THE INITIAL 99% IN-STENT RESTENOSIS (ISR) WAS REDUCED RESULTING IN 0% RESIDUAL WITH NORMAL TIMI-3 FLOW AND GRADE 3 PERFUSION. A 6 FR NON-BSC GUIDE CATHETER WAS THEN USED TO CANNULATE THE 90% STENOSED LEFT MAIN CORONARY ARTERY. A 0.014 NON-BSC ANGIOPLASTY GUIDEWIRE WAS USED TO CROSS THE SUBTOTAL OCCLUSION OF THE OSTIAL LEFT MAIN CORONARY AR

  Patient problems: Atrial Fibrillation; Chest Pain; High Blood Pressure/ Hypertension; ST Segment Depression; Thrombosis

  MAUDE report 6855598 ↗
• InjuryApr 24, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL OBTUSE MARGINAL ARTERY. A 2.75 X 8 MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON ADVANCING, THE SHAFT BROKE IN HALVES. THE BREAK WAS APPROXIMATELY 6 TO 8 INCHES FROM THE HUB. THE PROXIMAL END OF THE SHAFT WAS REMOVED HOWEVER, THE PHYSICIAN HAD TO USE A SNARING DEVICE TO REMOVE THE DISTAL PORTION OF THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6516821 ↗
• MalfunctionJan 17, 2017Break; Break

  SAME CASE AS MDR ID: 2134265-2016-12513, 2134265-2016-12515, 2134265-2016-12516 AND 2134265-2016-12517. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE COMPLEX CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE TORTUOUS AND DISSECTED DISTAL RIGHT CORONARY ARTERY(RCA). AFTER A NON BSC GUIDEWIRE CROSSED THE LESION, A GUIDEZILLA GUIDE EXTENSION CATHETER IN THE MID RCA. A 2.75X8, 2.75X16, 3.00X12, 3.00X16 AND 3.00X38 SYNERGY II DRUG-ELUTING STENTS WERE SELECTED TO TREAT THE LESION. HOWEVER, DURING ADVANCEMENT OF EACH OF THE STENTS, WHEN THE PHYSICIAN APPLIED A LOT OF PRESSURE, THE SHAFT OF THE EACH STENT GOT BENT AND BROKEN. THE GUIDEWIRE WAS CHANGED TO A CHOICE PT ES GUIDEWIRE AND A NEW GUIDEZILLA WAS ADVANCED IN THE DISTAL RCA. NUMEROUS SYNERGY STENTS WERE THEN IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6256242 ↗