SYNERGY™ XD H7493941824300Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729980988), received between Feb 19, 2021 and Aug 6, 2026 — classified as 4 deaths, 4 injuries, 17 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165322 ↗
• MalfunctionJun 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT STENT DISLODGEMENT OCCURRED. A PERCUTANEOUS INTERVENTION (PCI) PROCEDURE WAS BEING PERFORMED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND A SIGNIFICANT CALCIFIED CORONARY ARTERY. A 3.00 X 24MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED. HOWEVER, PRIOR TO THE APPLICATION OF ANY PRESSURE, THE STENT CAME OFF THE BALLOON SYSTEM. THE STENT WAS JAILED INSIDE THE PATIENT USING A 1.50 X 15 NON-BOSTON SCIENTIFIC BALLOON, A 2.00 X 20 EMERGE AND 3.00 X 15 NC EMERGE. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED TO AN SKILLED NURSING FACILITY AND WAS LATER TRANSITIONED HOME WITH HOME HEALTH, PHYSICAL THERAPY, AND OCCUPATIONAL THERAPY. AN EJECTION FRACTION (EF) OF 35% WAS NOTED, AND A CARDIAC RESYNCHRONIZATION THERAPY WITH DEFIBRILLATOR (CRT-D) DEVICE WAS IMPLANTED POST-PCI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364019 ↗
• InjuryFeb 20, 2026Failure to Advance

  IT WAS REPORTED THAT A DISSECTION OCCURRED. A 3.00 X 24MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION, AND A DISSECTION WAS OBSERVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 24403334 ↗
• DeathDec 30, 2025Nonstandard Device; Break; Nonstandard Device; Difficult to Remove

  It was reported that the patient died. A defective Synergy XD was implanted resulting in a heart attack and death.It was further reported that the patient presented for elective left heart catheterization due to chest pain, shortness of breath and abnormal stress test. Angiography revealed patency of the stents previously placed in the left anterior descending artery (LAD). An 80% stenosed and 24 mm long target lesion located in the right coronary artery (RCA) with a vessel diameter of 3.0 mm was noted. A 3.00 x 20 mm Synergy XD was selected for treatment. The device was deployed and inflated at 20 atm for 20 seconds. The procedure was complicated by retention of the delivery system ballon proximal to the deployed stent and iatrogenic occlusion of the RCA/PDA with infarction. Attempts to remove the balloon were unsuccessful. The catheter fractured and the fragment remained in the mid RCA. A TIMI flow of 0 was noted following treatment. The patient became hypotensive and hemodynamically unstable. Cardiogenic shock occurred in the setting of acute myocardial infarction. Acute hypoxemic respiratory failure occurred secondary to shock followed by metabolic acidosis, encephalopathy in t

  Patient problems: Bradycardia; Cardiac Arrest; Cardiogenic Shock; Encephalopathy; Foreign Body In Patient; Insufficient Information; Low Blood Pressure/ Hypotension; Myocardial Infarction; Obstruction/Occlusion; Respiratory Failure; Tachycardia

  MAUDE report 23924839 ↗
• MalfunctionJun 12, 2025Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS CORONARY ARTERY. A GUIDEZILLA II WAS IN PLACE THROUGH THE GUIDE CATHETER AND SEPARATELY, A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT AND A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WERE ADVANCED FOR TREATMENT, BUT THEY WOULD NOT CROSS THE LESION. UPON ATTEMPT TO REMOVE THE STENTS, THEY BOTH BECAME CAUGHT ON THE GUIDEZILLA HELICAL COLLAR. EACH STENT WAS SIMPLY REMOVED FROM THE PATIENT, BUT WHEN THEY WERE OUT OF THE GUIDE CATHETER, THEY WERE NOT FULLY INTACT OR FULLY CRIMPED ON TO THE BALLOON AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198749 ↗
• MalfunctionFeb 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 24MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT DISLODGED FROM THE BALLOON UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636794 ↗
• DeathDec 7, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE STENT WAS UNDER EXPANDED AND THE PATIENT DIED. THE PATIENT PRESENTED IN CRITICAL, UNSTABLE CONDITION AND WAS ON SUPPORT. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED WITH A 2.0 BALLOON IN THE TOTALLY OCCLUDED LAD, FLOW WAS PARTIALLY RESTORED. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, IT APPEARED THAT THE STENT WAS EXTREMELY UNDER EXPANDED. THIS PREVENTED THE 2.50 X 24MM SYNERGY XD AND 2.50 X 12MM SYNERGY XD STENTS FROM CROSSING THE PLACED STENT FOR DISTAL PLACEMENT IN THE LAD. THE PHYSICIAN WAS UNABLE TO RE-ESTABLISH FLOW TO THE TOTALLY OCCLUDED LAD. THE PATIENT DETERIORATED QUICKLY AND DIED ON THE TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287855 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 24MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE PART OF SHAFT THAT HAS THE STENT WAS NOT ATTACHED TO THE REST OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149924 ↗
• MalfunctionNov 6, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN PUTTING SOME FORCE TO IT, THE SHAFT WAS FRACTURED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074274 ↗
• DeathAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. A 2.25 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED IN THE LEFT MAIN (LM); HOWEVER, THE STENT MIGRATED INTO THE PROXIMAL LEFT CIRCUMFLEX ARTERY AND WAS DEPLOYED WHERE IT WAS. DURING DEPLOYMENT, THE OSTIAL LM PART OF THE STENT HAD PROXIMAL STENT EDGE SHORTENING AND A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED AT THE ORIGINAL LESION, OVERLAPPING WITH THE FIRST STENT. A RECOMMENDATION WAS MADE FOR COMPLETION OF THE LEFT MAIN BIFURCATION STENTING DUE TO THE BUNCHING OF THE STENT WITHIN THE OSTIAL LEFT MAIN. SEVEN DAYS LATER, THE PATIENT RETURNED TO THE CATH LAB ON VASOPRESSIN AND PHENYLEPHRINE. DURING THIS PROCEDURE, A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY TO LM. DURING PROXIMAL OPTIMIZATION TECHNIQUE ON THE LEFT MAIN PORTION OF THE STENT, THERE WAS AGAIN STENT EDGE SHORTENING. TWO DAYS LATER THE PATIENT DIED. THE PRIMARY CAUSE OF DEATH WAS NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI).

  Patient problems: Myocardial Infarction

  MAUDE report 17484745 ↗
• MalfunctionApr 20, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUES OCCURRED AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. DURING DEPLOYMENT, THE PHYSICIAN FELT LIKE THE BALLOON WAS STICKING TO THE STENT AND DEFLATION TOOK 30 SECONDS. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, RESISTANCE WAS FELT. THE BALLOON WAS EVENTUALLY REMOVED IN A FULLY DEFLATED STATE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16780973 ↗
• MalfunctionJan 26, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 24MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT DELIVERY SYSTEM BROKE DURING INSERTION. THE DEVICE WAS REMOVED INTACT OVER THE WIRE AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249983 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN FEEDING THE STENT OVER THE WIRE AND BEFORE IT EVEN ENTERED THE SHEATH, THE CATHETER BENT. WHEN PULLING IT BACK, THE SHAFT WAS BROKEN. THE DEVICE WAS REMOVED BY HAND OUTSIDE THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628667 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VASCULAR DISSECTION AND VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED AND NARROWED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER ROTABLATION, A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT AND A 6F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS ADVANCED INTO THE PROXIMAL LAD. HOWEVER, WHILE PREPARING TO INFLATE THE STENT, THE PATIENT SUDDENLY MOVED AND DISSECTION AND PERFORATION IN THE PROXIMAL LAD OCCURRED. THE PHYSICIAN ASKED FOR A COVERED STENT AND DELIVER IT INTO THE LAD WITHOUT SUCCESS. EVENTUALLY, THE PATIENT WAS STABLE AND AN ECHOCARDIOGRAM CONFIRMED THAT THERE WAS A LITTLE PERFORATION. SUBSEQUENT ECHOCARDIOGRAM SHOWED NOTHING. THE PHYSICIAN THEN WORKED TO STENT THE VESSEL WITH A SYNERGY STENT AND WAS SUCCESSFUL. IT WAS NOT CERTAIN WHAT CAUSED THE DISSECTION AND PERFORATION. THE CIRCUMFLEX WAS ALSO STENTED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS SENT HOME OVER THE WEEKEND WITH NO FURTHER COMPLICATIONS AND FULLY RECOVERED.

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 15218079 ↗
• DeathJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT CAME IN FOR A PLANNED MULTI-VESSEL PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND CIRCUMFLEX ARTERY (CX). THE PHYSICIAN INITIALLY WIRED THE LAD AND DIAGONAL BRANCH. FOLLOWING USE OF A NON-BOSTON SCIENTIFIC (BSC) BALLOON, A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE MID LAD. POST-DILATATION WAS PERFORMED WITH A 3.25 NC QUANTUM APEX BALLOON CATHETER. THE PHYSICIAN THEN PROCEEDED TO WIRE THE CX AND INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH THE OPTICROSS 6 HD. AFTER IMAGING, THE PATIENT EXPERIENCED ST ELEVATION AND WHEN THE PHYSICIAN CHECKED THE LAD, IT SHOWED TIMI 0 FLOW. THE PHYSICIAN BELIEVED THE IVUS MAY HAVE BROKEN OFF A PIECE OF PLAQUE WHICH SHOWERED DOWN THE LAD. THE PHYSICIAN PROCEEDED TO STENT THE CX WITH A 2.75 X 20MM SYNERGY XD DES AND BALLOONED THE LAD STENT AGAIN. A 2.75 X 12MM SYNERGY XD DES WAS THEN PLACED DISTAL TO THE 3.0 IN THE LAD. THE PATIENT WAS CODED AND A NON BOSTON SCIENTIFIC VENTRICULAR ASSIST DEVICE WAS PLACED. DURING THE PROCEDURE THE PATIENT ALSO EXPERIENCED ARRHYTHMIA, THROMBOSIS, VENTRICULAR FIBRILLATION, AND VENTRICULAR TACHYCARDIA. TH

  Patient problems: Arrhythmia; Cardiac Arrest; Embolism/Embolus; Non specific EKG/ECG Changes; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 14937799 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN SEVERELY CALCIFIED CORONARY ARTERY. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER TRYING TO CROSS A CALCIFIED LESION, THE PROXIMAL SHAFT BROKE. THE DEVICE WAS REMOVED AND PULLED OUT FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565381 ↗
• MalfunctionMay 10, 2022Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE AND WHEN IT WAS DISCONNECTED, THE BLOOD FLOW RUSHED BACK AND IT WAS FOUND THAT THE MIDDLE SHAFT BROKE INTO 2 PIECES. THE ENTIRE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.50 X 20MM SYNERGY XD AND A 4.00 X 16MM SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347857 ↗
• InjuryMar 28, 2022Break; Material Rupture; Activation Failure; Break; Material Rupture; Activation Failure

  IT WAS REPORTED THAT BALLOON RUPTURE, PARTIAL DEPLOYMENT, AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL BRANCH. THE 3.00 X 24MM SYNERGY XD STENT WAS ADVANCED FOR TREATMENT. UPON INFLATION, THE STENT BALLOON RUPTURED LEAVING THE STENT PARTIALLY DEPLOYED. WHEN AN ATTEMPT WAS MADE TO REMOVE THE DEVICE, THE CATHETER BROKE LEAVING THE BALLOON AND ABOUT 20CM OF THE SHAFT INSIDE THE PATIENT. WIRE PLACEMENT WAS ALSO LOST. THE PATIENT WAS SENT FOR EMERGENCY CORONARY ARTERY BYPASS GRAFT AND THE DEVICE PORTION RETAINED IN THE PATIENT WAS PARTIALLY REMOVED DURING SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13933217 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 3.00 X 24MM SYNERGY XS DRUG ELUTING STENT WAS PREPARED FOR TREATMENT. HOWEVER, DURING PREPARATION, A SHAFT BREAK WAS OBSERVED NEAR THE DEVICE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN SIZE STENT. THERE WERE NO COMPLICATIONS NOR INJURIES REPORTED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894782 ↗
• MalfunctionJul 6, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, ONE OF THE STENT STRUTS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THE MIDDLE STRUTS WERE DAMAGED AND PROTRUDING OUT BUT ALL IN ONE PIECE. THE DEVICE WAS SAFELY REMOVED BY PULLING THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125923 ↗
• InjuryMay 27, 2021Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT MAIN (LM) AND CIRCUMFLEX ARTERY (CX). A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. WHILE THE LOCATION OF THE STENT WAS BEING ADJUSTED BEFORE DEPLOYING, THE STENT GOT STUCK IN THE LESION AND SLID OFF THE BALLOON. THE BALLOON CAME BACK INTO THE GUIDE CATHETER AND THE STENT WAS LEFT UNDEPLOYED IN THE LM AND CX. THE STENT WAS REMOVED BY SNARING AND THE PROCEDURE WAS COMPLETED WITH A 2.75 X 24 SYNERGY XD DES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895937 ↗
• MalfunctionApr 27, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED, THAT STENT DAMAGE OCCURRED. DURING THE INTENTION TO CROSS THE LESION, A GUIDE EXTENSION WAS PLACED. A 3.00 X 24MM SYNERGY XD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT BECAME STUCK INSIDE AND THE STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731162 ↗
• MalfunctionMar 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE BUT WAS FOUND TO HAVE A FRAYED STRUT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567254 ↗
• MalfunctionMar 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER THE STENT WAS LOADED ON THE WIRE AND ADVANCED, THE PHYSICIAN NOTICED THAT THE STENT DIDN'T LOOK FULLY CRIMPED ON THE BALLOON. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452267 ↗
• MalfunctionFeb 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT WAS STUCK IN THE CALCIUM. HOWEVER, WHEN THE DEVICE WAS REMOVED, THE PROXIMAL STENT STRUTS WERE DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355381 ↗