SYNERGY™ XD H7493941816250Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729980803), received between Dec 8, 2020 and May 5, 2026 — classified as 1 death, 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 34 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 80% IN-STENT RESTENOSIS AND NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2022, A 2.5 MM X 16 MM SYNERGY XD DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). IN (B)(6) 2026, THE PATIENT PRESENTED TO THE HOSPITAL AND WAS DIAGNOSED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). CORONARY ANGIOGRAPHY REVEALED 80% IN-STENT RESTENOSIS (ISR) IN THE PROXIMAL LCX AND REVASCULARIZATION WAS RECOMMENDED. THE 80% ISR IN THE PROXIMAL LCX WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY AND A DRUG-ELUTING STENT. POST REVASCULARIZATION, 0% RESIDUAL STENOSIS WAS NOTED WITH TIMI FLOW OF 3. THE PATIENT WAS DISCHARGED.

  Patient problems: Myocardial Infarction; Restenosis

  MAUDE report 25079684 ↗
• InjuryOct 29, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED RESULTING IN PATIENT IMPACT. A 2.50 X 16 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED IN AN ATTEMPT TO TREAT THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. SUBSEQUENTLY, THE PATIENT WAS OBSERVED TO HAVE BECOME HYPOTENSIVE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE EVENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23417261 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.50 X 16.00 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ADVANCING THE DEVICE INTO THE BODY, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390693 ↗
• MalfunctionSep 3, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. UPON WITHDRAWAL, THE FRICTION WITHIN THE STENT WERE ENCOUNTERED AND NOT COMING OUT WHICH CAUSED THE GUIDE CATHETER TO GET PULLED INWARD. THE BALLOON WAS INFLATED AT NOMINAL PRESSURE FOR 15 SECONDS AND WAITED FOR 10 SECONDS FOR THE BALLOON TO DEFLATE BEFORE PULLING BACK THE DEVICE IN ONE PIECE FULLY DEFLATED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957363 ↗
• MalfunctionJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT FELL OFF FROM THE BALLOON DELIVERY SYSTEM BEFORE GOING INTO THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22656612 ↗
• MalfunctionMar 28, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MIDDLE OF THE CIRCUMFLEX ARTERY. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT BALLOON DEPLOYMENT AT NOMINAL PRESSURE FOR 15 SECONDS, DIFFICULTY REMOVAL OF THE BALLOON WAS ENCOUNTERED UPON PULLING BACK. THE GUIDE WAS REPEATEDLY SUCKED IN FOR TWO MINUTES, AND NEGATIVE PRESSURE WAS APPLIED IN AN ATTEMPT TO REMOVE ALL AIR FROM THE BALLOON. THE DEVICE WAS REMOVED IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721767 ↗
• MalfunctionMar 14, 2025Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, PHYSICIAN EXPERIENCED DIFFICULTY AS IT SEEMED TO GET CAUGHT OR STUCK. WHEN THE DEVICE WAS PULLED BACK, A SNAG IN THE STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC STENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610259 ↗
• MalfunctionFeb 5, 2025Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND REMOVAL DIFFICULTY OCCURRED. THE PHYSICIAN MENTIONED A FAILED ATTEMPT AT STENTING THE MID CIRCUMFLEX (CX) BIFURCATION DUE TO CHALLENGING ANATOMY AND DIFFICULTY CROSSING A PREVIOUSLY PLACED STENT IN THE RAMUS OSTIUM WHICH HAD STUCK OUT INTO THE LEFT MAIN ARTERY AND HAD PROTRUDED INTO THE CX OSTIUM. AFTER PLACING AN 8FR GUIDE CATHETER, A 7FR GUIDEZILLA CATHETER-GUIDE EXTENSION WAS USED TO DELIVER THE 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT BUT WAS UNABLE TO CROSS THE CX OSTIUM DUE TO A VERY ACUTE 90-DEGREE BEND ALONG WITH THE PROTRUSION OF THE PREVIOUSLY PLACED STENT. THE PHYSICIAN ATTEMPTED THE INCHWORM TECHNIQUE TO ADVANCE THE GUIDEZILLA OVER THE ACUTE BEND WITH VERY LITTLE SUCCESS. THE GUIDEZILLA HAD BARELY CROSSED OR HAD "VERY MINIMUM CROSSING" WHEN THE PHYSICIAN DECIDED TO DELIVER THE STENT AND, WHILE ADJUSTING THE STENT PLACEMENT, THE 2 NON-BOSTON SCIENTIFIC GUIDEWIRES MOVED FROM THEIR ORIGINAL POSITION AND SUPPORT WAS LOST. DURING REPOSITIONING, A BREAK WAS NOTED AND THE STENT DELIVERY SYSTEM WAS WITHDRAWN WITHOUT THE STENT ON THE BALLOON. THE GUIDEWIRES WERE REMOVED, BUT THE RADIOPAQUE MARKERS OF THE WIRES ALONG WITH THE DISLODGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313180 ↗
• MalfunctionFeb 4, 2025Difficult 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 LEFT CIRCUMFLEX CORONARY ARTERY (LCX) WHICH CONTAINED A 90-DEGREE BEND. A 2.50MM X 16MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS BEING ADVANCED THROUGH A NON-BOSTON SCIENTIFIC (NON-BSC) GUIDE CATHETER WITH TWO NON-BSC GUIDEWIRES AND A GUIDEZILLA GUIDE EXTENSION CATHETER. WHEN THE STENT WAS PULLED BACK FOR REPOSITIONING, THE STENT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) BALLOON, AND THE NON-BSC WIRES BROKE OFF AT THE RADIOPAQUE PORTIONS. THE DISLODGED STENT WAS CRUSHED AT THE OSTIAL/PROXIMAL LCX, AND ANOTHER STENT WAS ABLE TO CROSS AND BE DELIVERED AT THE OSTIAL/PROXIMAL SEGMENT. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305844 ↗
• MalfunctionDec 2, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT COULD NOT CROSS THE LESION DUE TO HIGHLY CALCIFIED LESION. HOWEVER, IT WAS FOUND THAT THE SHAFT BROKE DURING CROSSING THE LESION. THE DEVICE WAS SIMPLY REMOVED IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820968 ↗
• InjuryOct 24, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND HIGH-GRADE LESION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED; BUT FAILED TO CROSS THE LESION AND THROMBOSIS OCCURRED. MULTIPLE BALLOON INFLATIONS AND AN ATTEMPT TO PLACE THE STENT WERE PERFORMED. THE PATIENT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP TO BE SAFELY TRANSFERRED TO ANOTHER FACILITY. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20523534 ↗
• InjuryMay 9, 2024Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 2.50 X 16MM SYNERGY XD DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL RAMUS LESION. WHEN THE STENT DELIVERY SYSTEM WAS REMOVED, IT WAS FOUND THAT THE STENT HAD MIGRATED INTO THE DISTAL LEFT MAIN. A 5.0 MM BALLOON WAS THEN ADVANCED THROUGH THE STENT TO EXPAND IT IN THE LEFT MAIN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282727 ↗
• 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 18998062 ↗
• MalfunctionJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER TIP DETACHMENT OCCURRED. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT CORONARY ARTERY DISEASE. HOWEVER, DURING UNPACKING, THE TIP OF THE SHAFT WAS DISLODGED DURING REMOVAL OF STYLET. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545751 ↗
• MalfunctionDec 25, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION, THE MIDDLE OF THE HYPOTUBE BROKE INTO TWO PIECES. THE FRACTURED PORTION WAS OUTSIDE OF THE PATIENT AND WAS PULLED OUT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18390548 ↗
• InjuryMay 23, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A 2.50 X 16MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION AND ANGIOPLASTY WAS PERFORMED. FURTHER PRE-DILATION WAS DONE HOWEVER, THE STENT UNABLE TO CROSS THE LESION AND LOST WIRE PLACEMENT AND A DISSECTION WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 16989381 ↗
• MalfunctionMay 9, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 2.50 X 16-MM SYNERGY DRUG-ELUTING SYSTEM WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE SHAFT OF THE STENT SNAPPED. THE DETACHED PORTION OF THE DEVICE WAS REMOVED BY PULLING IT OUT OF THE CATHETER. NO FRAGMENTS LEFT INSIDE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899768 ↗
• MalfunctionApr 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5116438 THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED THIRD OBTUSE MARGINAL BRANCH CORONARY ARTERY. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INFLATION AT 11 ATMOSPHERES, THE STENT BALLOON WAS UNABLE TO MAINTAIN PRESSURE. MULTIPLE ATTEMPTS WERE PERFORMED IN REINFLATING THE BALLOON AND IT WAS FULLY DEFLATED AFTER APPROXIMATELY 20 SECONDS AND WAS SLOWLY REMOVED FROM THE PATIENT. SINCE THE DISTAL EDGES OF THE STENT WERE ALREADY DEPLOYED, A 2.5MM X 143CM X 8MM BALLOON CATHETER WAS USED TO POST DILATE THE STENT. THE PROCEDURE WAS COMPLETED; HOWEVER, IT CAUSED SOME DELAY IN THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795509 ↗
• MalfunctionApr 6, 2023Difficult or Delayed Positioning; Inflation Problem

  CORONARY STENT BEING PLACED WITH DIFFICULTY INFLATING THE ATTACHED DEVICE BALLOON. UNABLE TO FULLY INFLATE BALLOON, AND HAD BLOOD RETURN NOTED IN THE CATHETER INDICATING POSSIBLE HOLE OR RUPTURE TO BALLOON. STENT WAS DEPLOYED WITHOUT INCIDENT, DEVICE BALLOON WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701418 ↗
• MalfunctionFeb 28, 2023Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. AFTER A GUIDEZILLA WAS ADVANCED FOR SUPPORT, A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT DISLODGED INSIDE THE BALLOON DELIVERY SYSTEM AND WAS REMAINED INSIDE THE GUIDEZILLA ON THE STENT DELIVERY SYSTEM SHAFT. THE PHYSICIAN REMOVED THE GUIDEWIRE, GUIDEZILLA AND THE DEVICE WITH THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455437 ↗
• MalfunctionFeb 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ENTERING THE STENT THROUGH THE GUIDING CATHETER, IT WAS OBSERVED THAT THE STENT WAS NO LONGER ON THE DELIVERY BALLOON. THE STENT WAS ON THE TABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409196 ↗
• MalfunctionFeb 16, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. FOLLOWING PRE-DILATATION WITH A WOLVERINE CUTTING BALLOON, A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. DURING REMOVAL, THE STENT STRUTS WERE DAMAGED AND THE PROCEDURE WAS NOT COMPLETED DUE TO UNSPECIFIED REASON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392269 ↗
• MalfunctionNov 18, 2022Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. A 2.50 X 16MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT STARTED TO SLIP OFF THE BALLOON WHEN IT WAS TANGLED WITH ANOTHER WIRE AND TRYING TO CROSS THROUGH STENT STRUTS. THE STENT WAS STILL ON THE BALLOON, ALBEIT IN A DIFFERENT LOCATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825898 ↗
• MalfunctionSep 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THERE WAS DEBRIS NOTED ON THE STENT AFTER TAKING OUT OF PACKAGE SO THE DEVICE WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420370 ↗
• MalfunctionAug 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. A 2.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY (RCA). HOWEVER, DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS PARTIALLY OFF BALLOON AND THE BALLOON MARKER WAS 3-4MM BELOW THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180580 ↗