SYNERGY™ XD H7493941848350Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08714729985235), received between Oct 30, 2020 and Mar 12, 2026 — classified as 2 deaths, 9 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 48MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION, AND THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24585899 ↗
• MalfunctionOct 30, 2025Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE SHAFT WAS BROKEN AND THE PROCEDURE WAS CANCELED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL AND 3.50 X 48MM SYNERGY XD MONORAIL US WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT DUE TO VERY HEAVY CALCIUM BURDEN IN PROXIMAL VESSEL, DEVICES COULD NOT ADVANCED UNDER EXERTION AND SHAFTS WERE KINKED/BROKEN WHILE ATTEMPTING TO ADVANCE. THE PROCEDURE WAS CANCELED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423190 ↗
• InjuryOct 27, 2025Break; Nonstandard Device; Failure to Advance; Break; Nonstandard Device; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED WHICH RESULTED TO ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT NOT EASILY PASS FURTHER. THE PHYSICIAN DECIDED TO REMOVE THE STENT AND NOT DEPLOY. ANOTHER MANUFACTURER WAS SELECTED AS THE SECOND STENT. UPON REMOVAL, THE STENT AND DELIVERY BALLOON WERE CAUGHT, AND THE SHAFT APPEARED TO BREAK PROXIMAL TO THE STENT AND BALLOON. THE STENT AND BALLOON REMAINED LODGED IN THE OSTIAL PORTION OF THE LESION. THE REMAINDER OF THE CATHETER WAS REMOVED, AND THE PHYSICIAN ATTEMPTED TO RETRIEVE IT WITH SEVERAL TECHNIQUES, INCLUDING SNARE, BALLOON, AND GUIDEWIRE RETRIEVAL. RETRIEVAL WAS UNSUCCESSFUL, AND SURGERY WAS RECOMMENDED FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23391567 ↗
• DeathSep 5, 2025Break; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Break; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A TARGET LESION LOCATED IN THE CORONARY ARTERY. INITIALLY, A SHOCKWAVE BALLOON WAS ADVANCED BUT FAILED TO CROSS THE LESION. SUBSEQUENTLY, A 3.0MM EMERGE BALLOON CATHETER WAS SUCCESSFULLY ADVANCED AND INFLATED WITH MINIMAL WASTE. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS THEN SELECTED FOR TREATMENT, BUT IT ALSO FAILED TO CROSS. HOWEVER, DURING REMOVAL OF THE DES SYSTEM, A STRUT BECAME STUCK AND BEGAN TO COME OFF OF THE DISTAL END OF THE CATHETER. AFTER ADDITIONAL ATTEMPTS TO REMOVE THE DES SYSTEM, THE SHAFT BROKE. A SNARE WAS THEN USED IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DEVICE FRAGMENT. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, BUT UNFORTUNATELY, THE PATIENT DIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22987140 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST AND MYOCARDIAL INFARCTION. A SYNERGY XD MR US 3.50 X 48MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, THE PATIENT CODED FOR 30 SECONDS AND NEEDED TO BE REVIVED. APPROXIMATELY TWO MONTHS AFTER THE USE OF THE SYNERGY STENT, THE PATIENT EXPERIENCED A HEART ATTACK.

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 22751064 ↗
• MalfunctionJun 17, 2025Difficult to Advance; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE STENT SEEMED PARTIALLY DEPLOYED IN THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237222 ↗
• InjuryMay 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 80 TO 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 3.50X48 MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED, AND POST-DILATED WITH A 3.5X15MM NON-BOSTON SCIENTIFIC (BSC) NON-COMPLIANT (NC) BALLOON. A 4.0X38 MM SYNERGY XD DES WAS OVERLAPPED AND POST-DILATED USING A 4.0 NON-BSC NC BALLOON. A 3.5 NC BALLOON WAS THEN PLACED TO POST-DILATE IN BETWEEN STENTS BUT IT FAILED TO PASS. THE NON-BSC GUIDE CATHETER, GUIDELINER, AND GUIDEWIRE ALL CAME BACK AND UNKNOWINGLY, THE GUIDEWIRE WENT SUBINTIMAL AT SOME POINT. AN ATTEMPT TO CROSS THE 3.5 NC BALLOON AGAIN, BUT IT STILL FAILED. THE STENT WAS FOUND TO BE DEFORMED, AND DISTAL RCA STAINING WAS NOTED DISTAL TO THE ORIGINAL 3.5X48MM SYNERGY XD DES. THE PATIENT EXPERIENCED PAIN AND ST ELEVATION ON THE ELECTROCARDIOGRAM AFTER THE FLOW LIMITING DISSECTION. ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THAT THE STENT WAS FRACTURED INTO TWO PIECES. THE NON-BSC WIRE WAS REPLACED, AND ANOTHER ATTEMPT WAS MADE TO CROSS WITH THE 3.5 NC BALLOON, ALONG WITH A 2.75X24MM SYNERGY XD DES WHICH WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952362 ↗
• MalfunctionMar 11, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT COULD NOT CROSS THE LESION. HOWEVER, THE SHAFT BROKE IN TWO WHEN TRYING TO REINSERT THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576082 ↗
• MalfunctionJan 21, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NEW SYNERGY DES WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200797 ↗
• MalfunctionSep 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 3.50 X 48MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. WHEN THE DEVICE WAS HANDED TO THE PHYSICIAN, THE STENT DISLODGED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170598 ↗
• InjuryJun 18, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE STENT AND A SHAFT BREAK OCCURRED, NECESSITATING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VEIN GRAFT. PRE-DILATION WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC BALLOON. DURING THE PROCEDURE, A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, WHEN THE STENT DELIVERY SYSTEM WAS DEFLATED, DIFFICULTY WAS ENCOUNTERED IN REMOVING THE STENT. SUBSEQUENTLY, DURING ATTEMPTS TO PULL OUT THE STENT, THE SHAFT WAS BROKEN, LEAVING A PORTION OF THE STENT INSIDE THE PATIENT'S BODY AND THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING. A SNARE WAS ATTEMPTED, AND THE DEVICE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT REMAINED STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556771 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MINIMALLY TORTUOUS AND NON-CALCIFIED MID LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING PRE-DILATATION, A 3.5 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND DEPLOYED. THE ANGIOGRAM FOLLOWING STENT IMPLANTATION INDICATED THAT THE VESSEL WAS SHUT DOWN, IT WAS NOTED THAT THIS WAS DUE TO PLAQUE PROTRUSION. A BALLOON WAS USED TO REGAIN FLOW TO THE LCX WITH SUB-OPTIMAL RESULTS. A NON-BOSTON SCIENTIFIC ASPIRATION DEVICE WAS THEN USED WHICH RESTORED VESSEL FLOW. THE PROCEDURE WAS COMPLETED UNDER LOCAL ANESTHESIA. A SECOND LESION WAS PRESENT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY; HOWEVER, IT WAS LEFT UNTREATED DUE TO THE LCX COMPLICATION. THE PATIENT RETURNED ON A LATER DATE TO HAVE THE LAD TREATED SUCCESSFULLY WITH A PROMUS ELITE STENT. AT THAT TIME, THE LCX STENT WAS PATENT WITH NORMAL FLOW. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19370393 ↗
• DeathMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. SIX SYNERGY XD DRUG ELUTING STENTS WERE IMPLANTED, A 2.25MM X 12MM, A 2.75MM X 12MM, A 3.00 X 16MM, A 3.00MM X 38MM, A 3.5MM X 28MM AND A 3.5MM X 48MM, WITH NO VISIBLE EDGE DISSECTIONS. TWENTY MINUTES AFTER ARRIVING IN THE RECOVERY UNIT, THE PATIENT COMPLAINED ABOUT CHEST PAIN AND DEVELOPED ST SEGMENT ELEVATION. THE PATIENT WAS BROUGHT BACK TO THE CARDIAC CATHETERIZATION LABORATORY AND THE STENTS IN BOTH THE LAD AND LCX WERE THROMBOSED. THROMBECTOMY WAS PERFORMED IN AN ATTEMPT TO RE-OPEN THE ARTERIES. THE PATIENT CODED FOR SIXTY MINUTES AND EXPIRED.

  Patient problems: Cardiac Arrest; Chest Pain; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 19368003 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT (DES), 3.50 X 38MM SYNERGY XD DES, AND A 3.50 X 48MM SYNERGY XD DES WERE ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE THREE DEVICES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949372 ↗
• MalfunctionMar 8, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY VESSEL. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE INSERTION OF THE STENT THROUGH THE GUIDE CATHETER, THE MIDDLE OF THE DELIVERY SYSTEM BROKE IN HALF. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866693 ↗
• MalfunctionFeb 20, 2024Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS PLACED ON THE WIRE AND ADVANCED INTO A BOSTON SCIENTIFIC HEMOSTASIS VALVE OR GUIDE CATHETER. DURING ADVANCEMENT, RESISTANCE WAS FELT, AND THE SHAFT OF THE STENT WAS BENT OUTSIDE OF THE BODY AND AT THE LEVEL OF THE HEMOSTASIS VALVE. HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE WIRE, THE SHAFT COMPLETELY BROKE AND BOTH PIECES WERE RETRIEVED. A NEW 3.5 X 48 DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743693 ↗
• InjuryJan 5, 2024Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND BALLOON DETACHMENT OCCURRED. THE 100% STENOSED CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. THERE WAS A 90-DEGREE BEND PROXIMALLY. AN 8F GUIDE WITH 8F GUIDEZILLA WERE USED DURING THE PROCEDURE. THE CTO WAS OPENED AND BALLOONED WITH MULTIPLE SIZE BALLOONS. A 3.50 X 48MM SYNERGY XD WAS ADVANCED FOR TREATMENT AND DEPLOYED. THE BALLOON WAS INFLATED AT 17 ATMOSPHERES FOR 15 SECONDS AND WAS DEFLATED. HOWEVER, DURING THE PROCEDURE, EVEN THOUGH THE BALLOON WAS FULLY DEFLATED, THE PHYSICIAN HAD DIFFICULTY REMOVING THE BALLOON. WHEN THE BALLOON WAS PULLED BACK, THE BALLOON DETACHED FROM THE SHAFT. THE SHAFT WAS REMOVED BUT THE BALLOON REMAINED ON THE WIRE. AFTER MULTIPLE ATTEMPTS TO REMOVE THE STENT BALLOON, INCLUDING BLOWING UP A BALLOON AGAINST THE STENT BALLOON AND ATTEMPTING TO PULL BACK, THE PHYSICIAN WAS FINALLY ABLE TO GET THE WIRE AND BALLOON OUT AS ONE UNIT. IT WAS FURTHER REPORTED THAT MULTIPLE DEFLATION ATTEMPTS WERE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18457148 ↗
• MalfunctionNov 7, 2023Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ENTRAPMENT ON THE GUIDEWIRE OCCURRED. A 3.50 X 48MM SYNERGY STENT WAS ADVANCED FOR A PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, THE DEVICE WAS JOINT TOGETHER WITH THE WIRE AND WOULD NOT COME OFF, THEREFORE WAS STUCK. NO FURTHER INFORMATION ON THE OUTCOME OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089405 ↗
• MalfunctionOct 10, 2023Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50 X 48MM SYNERGY DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. THE PHYSICIAN DEPLOYED THE STENT AND INFLATED FOR 20 SECONDS BEFORE DEFLATION. POST-DILATATION WAS NOT PERFORMED. WHEN PULLING THE NON-BOSTON SCIENTIFIC (BSC) WIRE BACK, THE STENT DETACHED FROM THE VESSEL AND THE ENTIRE STENT CAME BACK ON THE WIRE. THE SYNERGY STENT WAS COMPLETELY REMOVED FROM THE PATIENT. NO OTHER ADDITIONAL EQUIPMENT WAS PRESENT IN THE VESSEL AND NO ACCIDENTAL MOVEMENT OCCURRED WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908572 ↗
• MalfunctionMar 16, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT BROKE AT THE PROXIMAL END. THE DEVICE WAS COMPLETELY REMOVED WITHOUT ANY ISSUE NOTED AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553998 ↗
• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ANGINA. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN ATTEMPTING TO CROSS THE DEVICE TO THE LESION, IT WAS NOTICED THAT THE SHAFT WAS FRACTURED AT 8 INCHES FROM THE HUB. THE DEVICE WAS PULLED AND WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551966 ↗
• MalfunctionNov 8, 2022Wrong Label; Wrong Label

  IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN OPENING THE PACKAGED, IT WAS NOTICED THAT THE STENT SIZE WAS DIFFERENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754337 ↗
• MalfunctionJun 24, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON 21JUNE2022. IT WAS REPORTED THAT TIP DAMAGED OCCURRED. A 3.50 X 48MM SYNERGY XD DEVICE TIP WAS OBSERVED DAMAGED DURING PREPARATION. THE DEVICE WAS NOT USED IN THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802006 ↗
• MalfunctionJun 2, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14583800 ↗
• MalfunctionMay 19, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, THE STENT WAS DISLODGED OUT OF THE PACKAGE DURING PREPARATION. 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 14438113 ↗