SYNERGY™ XD H7493941828250Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729980834), received between Oct 7, 2020 and Feb 16, 2026 — classified as 1 death, 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 28 reports, in the reporter's own words as published by the FDA.

• DeathFeb 16, 2026Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED VIA MEDWATCH MW5182566 THAT THE PATIENT DIED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE WITH UNSTABLE ANGINA ADMITTED FOR ELECTIVE LEFT HEART CATHETERIZATION. A 2.50 X 28MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT USING A NON-BOSTON SCIENTIFIC (NON-BSC) GUIDE EXTENSION CATHETER. HOWEVER, DURING THE INFLATION AT SIX ATMOSPHERES THE STENT DELIVERY SYSTEM BALLOON RUPTURED. THE STENT AND BALLOON COULD NOT BE WITHDRAWN THROUGH AN OLDER PROXIMAL STENT. THE PROXIMAL PORTION OF THE BALLOON WAS RETRACTED OUT OF THE NEWLY UNDER-DEPLOYED STENT. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE RETAINED EQUIPMENT USING WIRE ESCALATION AND A MICROCATHETER. THE PATIENT SUBSEQUENTLY EXPERIENCED CARDIAC ARREST, AFTER WHICH A NON-BSC HEART PUMP AND TEMPORARY PACING WIRE WERE PLACED. THE PHYSICIAN MADE SEVERAL UNSUCCESSFUL SNARE ATTEMPTS TO RETRIEVE THE RETAINED BALLOON FRAGMENT FROM THE ASCENDING AORTA. THE PATIENT WAS THEN ADMITTED TO THE ICU. CARDIOTHORACIC SURGERY WAS CONSULTED, AND NO SURGICAL INTERVENTION FOR THE RETAINED FRAGMENT WAS RECOMMENDED DUE TO THE PATIENT BEING CONSIDERED A VERY POOR CANDIDATE. THREE DAYS LATER, THE NON-BSC HEART PUMP WAS REMOVED D

  Patient problems: Anemia; Cardiac Arrest; Foreign Body In Patient; Ventilator Dependent

  MAUDE report 24344397 ↗
• InjuryJan 28, 2026Break; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY (CX). A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED WITH GUIDEZILLA SUPPORT TO OVERLAP A PREVIOUSLY PLACED PROXIMAL STENT. DURING INITIAL DEPLOYMENT, THE BALLOON RUPTURED AT 6 ATMOSPHERES. FOLLOWING THE RUPTURE, THE STENT BALLOON COULD NOT BE REMOVED, AND THE STENT BECAME DISLODGED ON THE PREVIOUSLY PLACED STENT, WITH BOTH THE STENT AND BALLOON WERE FIXED IN THE CX. AN ATTEMPT WAS THEN MADE TO RETRIEVE THE SYSTEM, BUT THE STENT DELIVERY SHAFT SUBSEQUENTLY SNAPPED. A SECOND WIRE WAS PLACED; HOWEVER, NOTHING WOULD CROSS. MULTIPLE ATTEMPTS TO SNARE THE REMAINING DEVICE WERE MADE BUT WERE UNSUCCESSFUL. AS A RESULT, THE ENTIRE STENT, THE STENT BALLOON, AND A PORTION OF THE DELIVERY SHAFT REMAINED IN THE VESSEL, AND THE BALLOON COULD NOT BE REMOVED. SHORTLY AFTER, A NON-BOSTON SCIENTIFIC HEART PUMP WAS PLACED, AND THE PATIENT STABILIZED. DESPITE STABILIZATION, THE PATIENT EXPERIENCED ARRHYTHMIA, DISCOMFORT/PAIN, ST-SEGMENT ELEVATION, THROMBOSIS, AND CARDIAC ARREST. THE BALLOON AND STENT

  Patient problems: Arrhythmia; Cardiac Arrest; Discomfort; Foreign Body In Patient; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 24199055 ↗
• MalfunctionOct 6, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT STENT BALLOON DAMAGE OCCURRED. A 2.50 X 28MM SYNERGY? XD WAS ADVANCED BUT UNABLE TO PASS THROUGH THE GUIDE CATHETER. UPON INSPECTION, A SLIGHT BULGE WAS NOTICED ON THE BALLOON BEYOND THE TIP OF THE STENT AND WAS BELIEVED TO BE THE CAUSE OF DIFFICULTY PASSING THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222226 ↗
• MalfunctionSep 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 28 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS OBSERVED THAT THE STENT CAME ENTIRELY OFF THE BALLOON AFTER UNPACKING. THE OPENED ANOTHER STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953343 ↗
• MalfunctionSep 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SHAFT LEAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS INITIALLY TREATED WITH MULTIPLE BALLOON INFLATIONS AND THE SHOCKWAVE DEVICE, FOLLOWED BY PRE-DILATION USING A 2.5MM BALLOON. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DELIVERED; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO FULLY INFLATE THE BALLOON, ONLY ABOUT A 1MM SEGMENT AT THE PROXIMAL END OF THE STENT. THE STENT WAS REMOVED FROM THE GUIDE CATHETER AND REMAINED INTACT ON THE BALLOON CATHETER. FURTHER INSPECTION WAS PERFORMED, AND A LEAK WAS NOTED AT THE CONNECTION OF THE FLEXIBLE AND STIFF SHAFTS, WITH A HOLE IN THE CATHETER. THE DEVICE WAS REMOVED FROM THE STERILE FIELD, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED EXCEPT FOR JUST A SHORT DELAY IN STENT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952549 ↗
• MalfunctionMay 5, 2025Difficult to Remove; Device Damaged by Another Device; Migration; Difficult to Remove; Device Damaged by Another Device; Migration

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY INTO LEFT MAIN. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO PULLED BACK THE STENT INTO THE LEFT MAIN ARTERY BY ANOTHER DEVICE AFTER DEPLOYMENT. THE TARGET LESION WAS TREATED BY OPEN-HEART SURGERY AFTER FAILED RETRIEVAL OF THE STENT. ADDITIONALLY, THE DEVICE BECAME UNRAVELED AFTER DEPLOYMENT BY ANOTHER PRODUCT THAT ENTERED AFTERWARD, CAUSING MIGRATION. THE PROCEDURE WAS COMPLETED BY LEAVING THE STENT WHERE IT WAS. PATIENT WAS STABLE AT THE TIME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960755 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 65-70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE CROSSING OF THE LESION, THE PROXIMAL SHAFT OF THE STENT WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870478 ↗
• InjuryAug 28, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED OBTUSE MARGINAL CORONARY ARTERY. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WOULD NOT CROSS THE LESION. UPON REMOVAL OF THE DEVICE, THE STENT FELL OFF OF THE BALLOON IN THE LEFT MAIN/PROXIMAL CIRCUMFLEX ARTERY. THE DETACHED STENT WAS LEFT INSIDE THE PATIENT AND AN ADDITIONAL STENT WAS IMPLANTED TO COVER THE DISLODGED STENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092272 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RE-OCCLUSION OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS DIAGONAL ARTERY. ON (B)(6) 2023, A 2.50 X 28MM SYNERGY XD DRUG ELUTING STENT WAS PLACED IN THE DIAGONAL ARTERY AND A 3.00 X 48MM SYNERGY XD DRUG ELUTING STENT WAS PLACED IN THE LAD USING A CULOTTE BIFURCATION TECHNIQUE. THE STENTS WERE POST DILATED INDIVIDUALLY AND USING A KISSING BALLOON TECHNIQUE. ON NOVEMBER 8, 2023, THE PATIENT PRESENTED WITH CHEST PAIN AND ELEVATED TROPONINS. CARDIAC CATHETERIZATION SHOWED THAT THE 3.00 X 48MM SYNERGY XD WAS OCCLUDED. THE STENTS HAD TO BE BALLOONED TO OPEN FOR FLOW AND THE PATIENT WAS DISCHARGED TO CARDIAC REHABILITATION.

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Obstruction/Occlusion

  MAUDE report 18193510 ↗
• MalfunctionAug 25, 2023Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT HAD MOVED ON THE BALLOON. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT IN A PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE STENT BECAME STUCK AND WAS UNABLE TO BE ADVANCED INTO A GUIDEZILLA. WHEN THE SYNERGY WAS REMOVED, THE STENT CAME OFF 90% FROM THE BALLOON AND GOTTEN STRETCHED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623627 ↗
• MalfunctionJul 12, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 2.50 X 28MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVAL OF THE WHITE PACKAGE WHICH CONTAINED STENT FROM THE BOX, IT WAS NOTICED THAT THE PACKAGE WAS NOT SEALED, AND THE STERILITY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309023 ↗
• MalfunctionMay 9, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A PERIPHERAL ARTERIAL VESSEL. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, IT WAS NOTICED THAT THE SHAFT WAS KINKED AND IT EVENTUALLY SNAPPED. THE DEVICE WAS PULLED OUT FROM THE SHEATH WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895758 ↗
• InjuryOct 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 2.50 X 28MM SYNERGY XD BALLOON EXPANDABLE STENT WAS SELECTED FOR TREATMENT FOR A LESION IN A CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE SYNERGY XD STENT CAME OFF THE BALLOON AS IT WAS BEING REMOVED FROM THE CALCIFIED LAD. THE SYNERGY XD STENT WAS SNARED IN THE ILIAC ARTERY. THE PROCEDURE COMPLETED WITH ANOTHER 2.50 X 28MM SYNERGY XD BALLOON EXPANDABLE STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659249 ↗
• InjuryJul 21, 2022Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT AND STENT DAMAGE OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED THROUGH A PREVIOUSLY IMPLANTED 2.50X28 SYNERGY STENT FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS CAUGHT ON THE IMPLANTED STENT AND DISLODGED FROM THE BALLOON. THE STENT BECAME LODGED INTO THE OSTIAL RCA AND BOTH STENTS WERE NOTED TO BE DAMAGED. THE STENT WAS SNARED AND REMOVED FROM THE PATIENT SUCCESSFULLY. 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 15080366 ↗
• MalfunctionJun 28, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE >90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DIAGONAL BRANCH. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 20 BALLOON CATHETER. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, RESISTANCE WAS FELT DURING ADVANCEMENT AND THE DEVICE WOULD NOT CROSS THE LESION. THE STENT WAS REMOVED IN ORDER TO INSERT A GUIDE EXTENSION CATHETER FOR EXTRA SUPPORT. AT THAT TIME, THE STENT WAS NOTED TO HAVE STRUTS RAISED OFF BALLOON. IT WAS CAUSED BY AGGRESSIVE PUSHING AND NOT A PRODUCT DEFECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846881 ↗
• MalfunctionNov 30, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND AN ADVERSE DELAY OCCURRED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE COMPLAINT WAS FURTHER EVALUATED, AND ANOTHER DEVICE WAS ABLE TO CROSS THE LESION TO COMPLETE THE PROCEDURE. THE REPORTED INFORMATION DOES NOT MEET CRITERIA OF A SERIOUS INJURY

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12902246 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED VESSEL. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN APPLIED HEAVY FORCE AND TORQUE TO THE STENT DELIVERY CATHETER AND THE CATHETER FRACTURED. THE SHAFT BROKE OUTSIDE THE PATIENT, PROXIMAL TO THE TUOHY, SO EVERYTHING WAS REMOVED SAFELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857819 ↗
• MalfunctionOct 26, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22OCT2021 IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION. A SYNERGY XD MR US 2.50 X 28MM STENT BALLOON EXPANDABLE DEVICE COULD NOT CROSS THE HIGHLY CALCIFIED ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697849 ↗
• MalfunctionOct 12, 2021Device Dislodged or Dislocated; Material Deformation; Packaging Problem; Device Dislodged or Dislocated; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT STENT MOVED ON BALLOON WAS ENCOUNTERED. A 2.50 X 28MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR PREPARATION. HOWEVER THERE WAS BEND RIGHT BEHIND THE BALLOON AND THE STENT MOVED ON THE BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE WAS NOT USED FOR THIS PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE STENT WAS DAMAGED AND NOT FULLY ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617391 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 28MM SYNERGY XD DRUG ELUTING STENT WAS USED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE STENT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590729 ↗
• InjuryOct 5, 2021Difficult to Insert; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Insert; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED CIRCUMFLEX ARTERY AND OBTUSE MARGINAL ARTERY. PREDILATION WAS PERFORMED WITH A 2.5X12MM EMERGE BALLOON CATHETER. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED IN THE PROXIMAL CIRCUMFLEX ARTERY FOR 14 SECONDS AT 11 ATM. HOWEVER, DURING PROCEDURE, THE STENT DISLODGED AND MIGRATED TO THE AORTA. THE STENT WAS REMOVED VIA SNARE. AN EMERGE 1.5X12MM BALLOON CATHETER WAS INFLATED FOR 29 SECONDS AT 14 ATM IN THE FIRST OBTUSE MARGINAL. SUBSEQUENTLY, A 2.50X28MM A SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WAS DISLODGED. THE STENT WAS REMOVED VIA SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577008 ↗
• MalfunctionSep 21, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING REMOVAL, THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE FELT DURING INSERTION ON WHICH THE STENT STRUT WAS NOTED TO BE DAMAGED, AND THE DEVICE WAS REMOVED COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510680 ↗
• MalfunctionJun 3, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION INTO THE GUIDE, THE DELIVERY SYSTEM WAS KINKED. WHEN THE PHYSICIAN STRAIGHTENED OUT THE KINK, THE DELIVERY SYSTEM BROKE. THE WHOLE SYSTEM WAS REMOVED FROM THE GUIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936000 ↗
• MalfunctionApr 5, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED FIRST OBTUSE MARGINAL ARTERY. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. INFLATION WAS PERFORMED AT 16 ATMOSPHERES FOR 15 SECONDS. HOWEVER, DURING WITHDRAWAL, IT WAS NOTICED THAT THE BALLOON FELT LIKE IT WAS STICKING TO THE INSIDE OF THE STENT AND WAS DIFFICULT TO REMOVE. THE BALLOON WAS FULLY DEFLATED AND WAS ABLE TO BE REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614875 ↗
• MalfunctionMar 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT STENT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS POSTERIOR DESCENDING ARTERY. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452477 ↗