SYNERGY™ XD H7493941828300Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729980995), received between Mar 31, 2021 and Sep 30, 2026 — classified as 3 deaths, 6 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Advance; Device Dislodged or Dislocated

  Patient problems: Foreign Body In Patient

  MAUDE report 50946743 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT SHAFT BREAK OCCURRED. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT OF THE STENT BROKE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325880 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED VIA MEDSUN REPORT (B)(4) THAT SHAFT BREAK OCCURRED. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, THE STENT BROKE AT THE SHAFT DURING PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319704 ↗
• InjuryDec 2, 2025Break; Difficult to Remove; Break; Difficult to Remove

  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 A SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.00 X 28MM SYNERGY? XD DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. UPON RETRACTION OF THE STENT DELIVERY SYSTEM, THE BALLOON FRACTURED OFF, AND BOTH RADIOPAQUE MARKERS REMAINED INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO RETRIEVE THE DETACHED COMPONENT USING A SNARE, BUT THIS WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23698378 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION, LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, WAS PRE-DILATED USING A NON-COMPLIANT BALLOON. DURING THE PREPARATION, BLOOD RETURNED INTO THE INFLATOR. UPON REMOVAL OF THE DEVICE, BOTH COMPONENTS WERE RETRIEVED, BUT THE DEVICE WAS FOUND TO BE BROKEN AT THE MID-SHAFT. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW STENT. NO COMPLICATIONS WERE REPORTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684339 ↗
• InjuryJul 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON WHEN ATTEMPTING TO DELIVER DOWN THE VESSEL. THE DETACHED COMPONENT WAS SNARED AND REMOVED FROM THE PATIENT. 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 19829629 ↗
• DeathJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLICATIONS AND DEATH OCCURRED. THE PATIENT PRESENTED WITH TRIPLE VESSEL DISEASE AND HAD TURNED DOWN SURGERY. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE MID RCA WAS PREPARED USING AN NC BALLOON, AND A 3.50 LITHOTRIPSY BALLOON; THE PROXIMAL/OSTIUM RCA WAS TREATED WITH A SEMI-COMPLIANT BALLOON AND A 3.50 LITHOTRIPSY BALLOON. A 3.00 X 28 SYNERGY XD STENT WAS DEPLOYED, FOLLOWED BY A 4.00 X 20 SYNERGY XD STENT DEPLOYED IN THE RCA OSTIUM. REPOSITIONING WAS PERFORMED SEVERAL TIMES BEFORE THE 4.00 X 20 STENT WAS IMPLANTED. THE STENTS WERE DEPLOYED WITHOUT ISSUE AND ANGIOGRAPHY SHOWED THE STENTS APPEARED TO BE SUFFICIENTLY OVERLAPPED AND THE VESSEL LOOKED OPEN. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). SHORTLY AFTER, THE PATIENT COMPLAINED OF CHEST PAIN AND BECAME BRADYCARDIC. THE PATIENT WAS PUT UNDER ANESTHESIA AND INTUBATED AND WAS RETURNED TO THE CATH LAB. THE RCA WAS RE-ENGAGED WITH DIFFICULTY; THE GUIDE COULD NOT FULLY ENGAGE, LIKELY DUE TO THE STENT STRUTS AT THE OSTIUM. THE VESSEL WAS WIRED AND MECHANICAL THROMBECTOMY WAS ATTEMPTED BUT IT WAS UNSUCCESSFUL. IT

  Patient problems: Bradycardia; Cardiac Arrest; Chest Pain; Thrombosis/Thrombus

  MAUDE report 19595849 ↗
• MalfunctionApr 16, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. A 3.00 X 28MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, MORE RESISTANCE WAS FELT THAN USUAL DURING REMOVAL OF THE DEVICE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122701 ↗
• 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 18996660 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING AND LEFT MAIN ARTERIES. AFTER ROTABLATOR ATHERECTOMY AND SHOCKWAVE WAS PERFORMED, A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. A 2.0 BALLOON WAS USED IN THE RAMUS TO PROTECT THE VESSEL. THE PHYSICIAN PULLED THE STENT DELIVERY SYSTEM (SDS) BACK TO THE PROXIMAL PART OF THE STENT AND INFLATED THE STENT BALLOON TO DEPLOY THE STENT. HOWEVER, WHEN THE STENT BALLOON WAS PULLED OUT AFTER IT WAS DEFLATED, THE SHAFT BROKE. THE DEVICE WAS REMOVED WITH THE GUIDE ALL TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW GUIDE CATHETER, GUIDE WIRE, AND POST DILATED WITH A NEW BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888497 ↗
• InjuryMar 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE STENOSED TARGET LESION WAS ABOUT 60 TO 70%, LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON AND STAYED INSIDE THE HEART AT A CURVE BEFORE THE TREATMENT AREA. SUBSEQUENTLY, THE PATIENT WAS SENT FOR EMERGENCY CORONARY ARTERY BYPASS SURGERY. THE DEVICE STILL REMAINS IN THE PATIENT, AND NO ATTEMPTS WERE MADE TO RETRIEVE THE STENT. NO FURTHER ISSUES WERE REPORTED, AND THE PATIENT WAS WELL-CONDITIONED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18875951 ↗
• MalfunctionFeb 22, 2024

  STENT DISLODGED FROM BALLOON IN CORONARY ARTERY BEFORE BEING DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767685 ↗
• MalfunctionFeb 21, 2024Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED CORONARY ARTERY. A 3.00 X 28MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT STRUGGLED TO DELIVER THE STENT. HOWEVER, IT WAS FOUND THAT THE STENT WAS MANGLED AND BROKEN WHEN IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748431 ↗
• InjuryFeb 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 3.00 X 28 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT DISLODGED IN THE ARM OF THE PATIENT AND WAS LEFT BEHIND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18628796 ↗
• InjuryDec 27, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DISTAL TIP SEPARATION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. AFTER ROTATIONAL ATHERECTOMY WITH ROTABLATOR AND PRE-DILATATION WITH A BALLOON WAS PERFORMED, A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE STENT WAS REMOVED, AND THE LESION WAS BALLOONED AGAIN. WHEN ATTEMPTED TO ADVANCE THE STENT AGAIN, IT FAILED TO DELIVER, AND IT WAS NOTED TO BE FRACTURED CLOSE TO THE TIP OF THE STENT. IT BECAME STUCK IN THE GUIDE AND PARTIALLY IN THE LEFT MAIN DUE TO THE FRACTURE/BREAK. THE DETACHED DEVICE WAS REMOVED BY USING ANOTHER GUIDEWIRE AND BALLOON TO TRAP THE DETACHED DEVICE IN THE GUIDE AND PULL THE DEVICES OUT AS A WHOLE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405014 ↗
• MalfunctionApr 21, 2023Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION, ONE OF THE STENT STRUTS WAS OBSERVED TO BE BROKEN/FLARED UNDER FLUOROSCOPY. THE DEVICE WAS REMOVED INTACT WITH THE DELIVERY CATHETER, AND A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788920 ↗
• MalfunctionJan 23, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ANGINA AND WAS BEING TREATED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS MODERATELY CALCIFIED VESSEL. A 3.00 X 28MM SYNERGY XD AND A 3.50 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENTS WERE ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF BOTH STENTS THROUGH GUIDELINER, THE MID SHAFT OF BOTH SYNERGY MEGATRON STENT BROKE. THE WHOLE DEVICES WERE PULLED AND REMOVED FROM THE PATIENT. A NON-BSC DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225634 ↗
• MalfunctionDec 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVEMENT FROM THE BALLOON OCCURRED. A 3.00 X 28MM SYNERGY XD BALLOON EXPANDABLE STENT WAS SELECTED FOR TREATMENT. THE SYNERGY XD ADVANCED THROUGH THE COPILOT AND A 6F GUIDEZILLA GUIDE EXTENSION CATHETER. THE SYNERGY XD BALLOON WAS INFLATED WITHIN THE VESSEL AND REMOVED. AFTER REMOVAL, IT WAS OBSERVED THAT THE SYNERGY XD STENT WAS ON THE PROXIMAL PART OF THE BALLOON. A NEW STENT AND NEW GUIDEZILLA GUIDE EXTENSION CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951571 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY BLOCKAGE. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE HYPOTUBE BROKE WHILE TRYING TO CROSS THE LESION. THE DEVICE WAS PULLED OUT INTACT AND THE PROCEDURE WAS COMPLETED WITH A 3X22MM NON-BOSTON SCIENTIFIC CORONARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324654 ↗
• MalfunctionMar 29, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DISTAL END OF THE STENT NEAR THE TIP WAS DAMAGED OUT OF THE PACKAGE, AND THE DEVICE COULD NOT EVEN BE LOADED ON THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945604 ↗
• MalfunctionMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DELIVERY, THE STENT CAME OF THE DELIVERY SYSTEM AND WAS SUBSEQUENTLY FOUND IN THE GUIDE CATHETER WHEN IT WAS REMOVED. 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 13937638 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO DELIVER THE STENT, THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13429655 ↗
• MalfunctionJan 13, 2022Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE BODY AND THE PHYSICIAN NOTICED A FRACTURE AT THE PROXIMAL END OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253349 ↗
• InjuryDec 27, 2021Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY REMOVING A BALLOON, ELEVATED ST CHANGES IN AN EKG OCCURRED, AND FAILURE TO DEFLATE A BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 28MM SYNERGY XD WAS ADVANCED, THE BALLOON WAS INFLATED FOR 11 SECONDS, AND THE STENT DEPLOYED IN THE LESION. IT WAS NOTED THAT THE BALLOON WAS INITIALLY SLOW TO INFLATE. UPON DEFLATION, THE PROXIMAL END OF THE BALLOON WOULD NOT COME DOWN. THE INDEFLATOR WAS PULLED NEGATIVE, BUT THE PROXIMAL END OF THE BALLOON REMAINED INFLATED, WHICH CAUSED ST CHANGES IN AN EKG. AN EMPTY 20CC SYRINGE WAS THEN ATTACHED TO THE STOPCOCK, AND WAS PULLED NEGATIVE, WHICH ALLOWED THE BALLOON TO DEFLATE ENOUGH TO REMOVE IT. IT WAS NOTED THAT 30 SECONDS WERE ATTEMPTED TO DEFLATE THE BALLOON, AND VACUUM WAS HELD DURING WITHDRAWAL. AFTER THE BALLOON WAS REMOVED, THE DEVICE WAS INSPECTED FOR KINKS AND DEFECTS. IT WAS NOTICED THAT THE HUB WAS BENT. IT WAS NOTED THAT THERE WERE SOME MILD BENDS IN THE DELIVERY PLATFORM, BUT NO KINKS NOTED PRIOR TO REMOVAL. IT WAS ADDITIONALLY NOTED THAT THE BALLOON WAS PARTIALLY INFLATED, AS IT DID NOT FULLY DEFLATE, EVEN WITH

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 13087706 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. WHEN THE 3.00 X 28MM SYNERGY STENT DELIVERY SYSTEM WAS BEING REMOVED FROM PACKAGING DURING PREPARATION, THE SHAFT BROKE. NO PACKAGING DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805735 ↗