SYNERGY™ XD H7493941816400Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729981121), received between Dec 14, 2020 and Jul 18, 2025 — classified as 1 death, 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Break; Break

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED, AND ADDITIONAL INTERVENTION WAS REQUIRED. A SIGNIFICANT LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, WHILE ADVANCING THE STENT THROUGH THE AORTIC ARCH, APPROXIMATELY 6 INCHES OF THE DISTAL PORTION OF THE STENT DELIVERY SYSTEM BROKE OFF FROM THE SHAFT AND BECAME LODGED INSIDE THE PATIENT. AFTER AN ADDITIONAL SIX HOURS, THE DEVICE FRAGMENT WAS SUCCESSFULLY RETRIEVED INTRAVASCULARLY WITH A SNARE WITHOUT THE NEED FOR OPEN HEART SURGERY. THE PROCEDURE WAS ABORTED AFTER RETRIEVING THE DEVICE FRAGMENT AND THE PATIENT WAS TRANSFERRED TO THE ICU. FOLLOW-UP INDICATED THAT THE PATIENT HAS BEEN EXTUBATED AND IS RECOVERING. PER THE PHYSICIAN, NO FURTHER COMPLICATIONS ARE EXPECTED, AND NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543727 ↗
• MalfunctionJun 3, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, DURING REMOVAL, A BEND IN THE STENT DELIVERY SYSTEM SHAFT AT ABOUT A FOOT FROM THE HUB WAS NOTICED. AFTER LIGHT MANIPULATION, THE SHAFT ENDED UP BROKEN WHERE THE BEND WAS FIRST OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447915 ↗
• MalfunctionMay 21, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT WAS SEPARATED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360366 ↗
• DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT WAS TREATED FOR A CHRONIC TOTAL OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA). THE CTO PROCEDURE WAS INITIALLY SUCCESSFUL, BUT A NON-BOSTON SCIENTIFIC INTERVENTIONAL WIRE DISSECTED THE ARTERY FROM THE PROXIMAL RCA TO THE PROXIMAL POSTERIOR DESCENDING ARTERY (PDA), WHICH WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS). A 2.50X16MM, 3.00X28MM, 3.50X38MM, AND 4.00X16MM SYNERGY XD DRUG-ELUTING STENTS WERE DEPLOYED FROM THE PROXIMAL PDA TO THE OSTIAL RCA, RESPECTIVELY. THERE WAS SLOW FLOW / NO REFLOW, AND THE RIGHT VENTRICLE (RV) MARGINAL AND POSTERIOR LATERAL BRANCH WERE OCCLUDED. THE PATIENT PRESENTED WITH ST SEGMENT ELEVATION, WHICH WAS ATTRIBUTED TO BRANCH LOSS, AND THE FLOW WAS RESTORED TO TIMI 2 / 1. CANGRELOR WAS USED TO TREAT THE EVENT. WHILE THE PATIENT WAS PLACED IN HOLDING FOR AN AVAILABLE INTENSIVE CARE UNIT (ICU) BED FOR OVERNIGHT OBSERVATION, THE PATIENT CODED, RE-STABILIZED AND RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY. THE RCA WAS RE-ACCESSED, AND THE PHYSICIAN PROCEEDED TO PLACE A BALLOON PUMP IN THE PATIENT FOR SUPPORT. THE RV MARGINAL INTERVENTION WAS ATTEMPTED, AND ACCESSED, BUT NO PROGRESS WAS MADE,

  Patient problems: Arrhythmia; Cardiogenic Shock; Hematoma; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 18995785 ↗
• InjuryNov 21, 2023Fracture; Device Damaged by Another Device; Activation Failure; Fracture; Device Damaged by Another Device; Activation Failure

  IT WAS REPORTED THAT STENT FRACTURE AND DAMAGE POST-DEPLOYMENT OCCURRED REQUIRING INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. FOLLOWING PRE-DILATION, A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED IN OSTIAL RIGHT CORONARY ARTERY. THE STENT DELIVERY SYSTEM WAS THEN REMOVED, AND ANGIOPLASTY WAS PERFORMED. DURING THE ANGIOPLASTY, IT WAS OBSERVED THAT THE PROXIMAL STENT WAS IN QUESTION OF EXPANSION, AND IT WAS DECIDED TO PERFORM AN INTRAVASCULAR ULTRASOUND (IVUS) USING NON-BOSTON SCIENTIFIC (BSC) DEVICE. UNDER IVUS, IT WAS NOTED THAT THE STENT HAD NOT FULLY EXPANDED. A 4.5X12 NC QUANTUM APEX WAS THEN PLACED AND WOULD NOT EXPAND THE STENT EITHER, SO THE PHYSICIAN DECIDED TO USE A SHOCKWAVE WITH A 4.0X12 SW BALLOON. UPON INFLATION AND DELIVERY OF THE SHOCKS, IT WAS NOTED THAT THE STENT HAD A MALFORMATION. THE SHOCKWAVE BALLOON WAS REMOVED, AND THE PROXIMAL EDGE PART OF THE STENT WITH THE CROWN WAS SNAPPED IN HALF. THE STENT REMAINED IN THE PATIENT AND WAS SCHEDULED FOR OPEN HEART SURGERY TO RETRIEVE THE BROKEN PART OF THE STENT. THE PATIENT WAS STABLE POST-PROCEDURE AND IS EXPECTED TO FULLY RECO

  Patient problems: Foreign Body In Patient

  MAUDE report 18182206 ↗
• MalfunctionJun 8, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION PROBLEM AND REMOVAL DIFFICULTY WERE ENCOUNTERED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, DURING WITHDRAWAL, THE BALLOON WOULD NOT RETRACT. THE PHYSICIAN KEPT TRYING TO DEFLATE THE BALLOON TO REMOVE THE STENT DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087975 ↗
• MalfunctionMay 24, 2023Application Program Problem: Medication Error

  EARLY 80¿S MALE WITH HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE, TYPE II DB, CHRONIC KIDNEY DISEASE AND NEW ONSET CHEST PAIN WITH CHRONIC HEART FAILURE. PROCEDURE: HEART CATHETERIZATION WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE BALLOON WOULD NOT ADVANCE THROUGH THE GUIDE- WHEN IT WAS REMOVED, IT WAS CRUMPLED. NO KNOWN HARM TO PATIENT, DELAY IN TREATMENT. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY¿ XD (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992178 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING INSERTION, IT WAS NOTICED THAT THE DEVICE WAS SMASHED UP/BROKEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16571953 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED OSTIAL LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. THE STENT WAS DEPLOYED AND INFLATED AT 16 ATMOSPHERES WITH NO ISSUES. HOWEVER, UPON DEFLATION OF THE BALLOON DELIVERY SYSTEM, THE DISTAL SHAFT OF THE STENT AT ROUGHLY 10 INCHES FROM THE BLUE/WHITE HUB BROKE. BOTH THE BROKEN PIECE NEAR THE HUB AND THE STENT DELIVERY SYSTEM WERE MANUALLY PULLED AND WERE ABLE TO BE EASILY REMOVED FROM PATIENT'S BODY. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452327 ↗
• MalfunctionJan 3, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS LOADED ONTO WIRE AND WAS MOVING THROUGH THE VESSEL TO THE LESION; HOWEVER, THE PHYSICIAN NOTICED A STENT FRACTURE IN THE MIDDLE OF THE STENT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE STENT WAS DAMAGED IN THE MIDDLE AND THE STENT DELIVERY SYSTEM WAS REMOVED IN ONE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088099 ↗
• MalfunctionAug 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS OPENED AND REMOVED FROM THE HOOP. HOWEVER, IT WAS NOTED THAT THE STENT WAS COMPLETELY OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15269609 ↗
• MalfunctionJul 25, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE STENT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE SHAFT BROKE BEFORE EVEN ENTERING THE PATIENT'S BODY. THE EVENT DID NOT CAUSE ADVERSE EVENT BUT IT DELAYED THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15098257 ↗
• MalfunctionMar 29, 2022Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE PACKAGING WAS DAMAGED AND THE DEVICE WAS BENT WHEN REMOVED OUT OF THE HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939290 ↗
• MalfunctionMar 15, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS FAILED TO CROSS THE LESION. DURING REMOVAL, IT WAS NOTICED THE MID STENT STRUT WAS STICKING STRAIGHT UP TO THE CENTER OF THE STENT. EVENTUALLY, THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776504 ↗
• MalfunctionMar 3, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE PROXIMAL STRUTS OF THE STENT WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664854 ↗
• MalfunctionFeb 11, 2022Obstruction of Flow; Device Dislodged or Dislocated; Obstruction of Flow; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT PLACED ON THE BALLOON CORRECTLY STRAIGHT FROM PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514686 ↗
• MalfunctionJan 20, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, IT WAS NOTED THAT THE DEVICE BROKE. THE DETACHED PORTION WAS PULLED OUT FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309631 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE HYPOTUBE OF THE STENT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13292415 ↗
• MalfunctionNov 8, 2021Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS PLACED, A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS INTRODUCED BUT THERE WAS DIFFICULTY ADVANCING, EVEN WITH THE HAEMOSTATIC VALVE FULLY OPEN. WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT REMAINED FLOATING IN THE ARTERY. THE ENTIRE DELIVERY SYSTEM, WIRE AND GUIDE WERE ALL REMOVED BUT THE STENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THERE WERE TWO SYNERGY XD STENTS INVOLVED IN THE PROCEDURE AND THAT THE 4.00 X 16MM STENT DID NOT BECOME DISLODGED. THE 4.00 X 16MM STENT COULD NOT ADVANCE AND THE STENT BECAME DAMAGED. THE 4.00 X 24MM SYNERGY XD STENT DISLODGED INSIDE THE PATIENT AND WAS CRUSHED AGAINST THE VESSEL WALL WITH ANOTHER STENT. THE PATIENT WAS DOING WELL POST-PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771160 ↗
• MalfunctionSep 9, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. AFTER REMOVAL, IT WAS FOUND THAT THE STENT WAS FLARED IN THE MIDDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450677 ↗
• MalfunctionDec 14, 2020Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN CORONARY ARTERY. AFTER ROTATIONAL ATHERECTOMY WAS PERFORMED WITH A ROTAWIRE, A 4.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND WHEN THE STENT CATHETER WAS OUTSIDE THE PATIENT'S BODY, IT WOULD NOT COME OFF OF THE ROTA FLOPPY WIRE. MORE FORCE WAS APPLIED TO REMOVE THE STENT AND IT BROKE. A NON-BOSTON SCIENTIFIC WIRE WAS INSERTED AND A 4.0X12 SYNERGY XD DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11003167 ↗