SYNERGY™ XD H7493941838250Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729980858), received between Apr 5, 2021 and Sep 25, 2026 — classified as 1 death, 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Fracture; Difficult to Remove; Material Rupture; Activation Failure; Failure to Deflate

  It was reported that multiple device issue occurred requiring additional intervention.The target lesion was located in a non-tortuous vessel. The 2.50 x 38 mm Synergy XD drug eluting stent was selected for use. The technician noted resistance upon removing the balloon protector and stylet from the stent delivery system (SDS) and informed the physician. The physician did not notice any visible damage to the SDS balloon and decided to use the device. Upon advancing the stent to the lesion, the physician got the stent in the correct position and told the scrub technician to inflate/deploy the stent. During the attempt to deploy the stent at 12 atm, the inflation device kept spinning as if it was being inflated, but the balloon never completely inflated, and the stent seemed to only partially deploy around 2 atm. Upon trying to remove the device, the balloon appeared to not have deflated properly and became stuck. Another physician was consulted and the decision was made to remove everything as a whole, the guide catheter, guidewire, and SDS. When the system was pulled, the balloon snagged and caused the stent to fracture into two pieces. The SDS was removed as a whole, but the fractur

  Patient problems: Foreign Body In Patient

  MAUDE report 50893170 ↗
• InjuryMar 4, 2026Entrapment of Device; Material Deformation

  IT WAS REPORTED VIA MEDWATCH MW5182484 THAT STENTING ISSUES OCCURRED. THE PATIENT PRESENTED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS PLACED. ONE STENT WAS SUCCESSFULLY DELIVERED BUT WHEN ATTEMPTING TO PLACE A 2.50 X 38 MM SYNERGY XD STENT DISTAL TO THE FIRST STENT, THE 2.50 X 28 MM SYNERGY XD BECAME ENTRAPPED IN THE PROXIMAL VESSEL. IT COULD NOT BE REMOVED OR ADVANCED. AFTER MULTIPLE REMOVAL ATTEMPTS THE STENT WAS ABLE TO BE REMOVED FROM THE BODY. FURTHER IMAGING SHOWED THE RETAINED STENT AND/OR A WIRE FRAGMENT IN THE VESSEL AND AORTA. INSPECTION OF THE REMOVED EQUIPMENT SHOWED SIGNIFICANT DISTORTION OF THE STENT AND SHEARING OF THE WIRE. THE PART EXTENDING INTO THE AORTA WAS CUT AND REMOVED. NO WIRE WAS RETAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512009 ↗
• InjuryJan 22, 2026Fracture; Nonstandard Device; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE ISSUES OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 2.50 X 48 MM SYNERGY DRUG ELUTING STENT (DES) WAS PLACED SEMI-EMERGENTLY IN THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA) BUT DID NOT QUITE REACH THE BIFURCATION OF THE POSTERIOR DESCENDING ARTERY (PDA) AND THE POSTERIOR LATERAL BRANCH (PLB). THE STENT WAS POST-DILATED WITH 3.00 AND 3.50 NON-COMPLAINT BALLOONS CONSECUTIVELY. AN ATTEMPT WAS THEN MADE TO PLACE A 2.50 X 38 MM SYNERGY DES DISTAL AND INTO THE PDA. HOWEVER, THE STENT SEEMED TO GET STUCK WHEN IT REACHED THE PROXIMAL EDGE OF THE 48 MM SYNERGY DES. WHILE TRYING TO REMOVE THE 38 MM STENT, IT SEEMED TO GET HUNG UP RIGHT OUTSIDE THE GUIDE CATHETER IN THE OSTIAL/PROXIMAL RCA. EXTREME FORCE DID NOT MOVE THE STENT. A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER, A SNARE, AND FINALLY A TRAPPING BALLOON, WERE USED TO REMOVE EVERYTHING (STENT, WIRES, BALLOON) TOGETHER. THE STENT WAS SHREDDED AND THE WIRE WAS POSSIBLY SHEARED OFF BY THE 38 MM STENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO REMOVE THE PORTION OF THE 38 MM STENT THAT WAS STILL IN THE BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24150872 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.50 X 38MM SYNERGY? XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024239 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE STENT SHAFT WAS FRACTURED. EVERYTHING WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5 X 38 DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624259 ↗
• DeathFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED, AND THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY TO LEFT MAIN. A 2.5 X 32MM, 2.5 X 38MM, 3.5 X 28MM, 3.0 X 12MM SYNERGY XD DRUG ELUTING STENTS AND A 4.0 X 28MM SYNERGY MEGATRON STENT WERE IMPLANTED. THE PATIENT WAS HAVING SYMPTOMS DURING THE WHOLE PROCEDURE, AND THEY GOT EVEN WORSE AFTER THE CASE. IT WAS NOTED THAT THE ACTIVATED CLOTTING TIME (ACT) NUMBERS WERE FINE DURING THE PROCEDURE. HOWEVER, THE ASSUMPTION BY THE PHYSICIAN WAS THAT ONE OR MORE OF THE STENTS THROMBOSED. ANGIOGRAPHY WAS PERFORMED AND ACUTE THROMBOSIS WAS NOTED. ANTIPLATELET WAS GIVEN BEFORE AND DURING THE INITIAL PROCEDURE AND, ALSO, DURING RESCUE. SUBSEQUENTLY, THE PATIENT DIED ON THE SAME DAY AND THERE WAS NO AUTOPSY PERFORMED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18628281 ↗
• MalfunctionJan 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT A STENT FRACTURE OCCURRED. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE, THE PROXIMAL PART OF THE STENT CATHETER BROKE. THE DEVICE WAS REPLACED, AND 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 18454813 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE PROXIMAL PART OF THE CATHETER BROKE OFF. THE DEVICE WAS REMOVED, 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 17876771 ↗
• InjuryApr 21, 2023Break; Material Rupture; Failure to Deflate; Break; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE AND BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH ANGINA AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT BALLOON REACHED 4 ATMOSPHERES AND WOULD NOT INFLATE ANY FURTHER. THE PHYSICIAN SAW CONTRAST TRAVEL DISTAL TO THE STENT AND THE BLOOD CAME BACK INTO THE INFLATION DEVICE, SIGNALING A POSSIBLE BALLOON RUPTURE. BALLOON DEFLATION FAILED DESPITE MULTIPLE ATTEMPTS. THE PHYSICIAN THEN CUT THE HUB OF THE STENT CATHETER AND INSERTED A GUIDE EXTENSION CATHETER OVER IT, HOWEVER, THAT DID NOT WORK. THE PHYSICIAN DEEP SEEDED THE GUIDE AND WAS ABLE TO GET SOME MOVEMENT, WHICH ULTIMATELY RESULTED IN DEVICE REMOVAL. THE STENT FOUND ITS WAY TO THE SKIN TRACK ALONG THE FEMORAL ARTERY AND WAS CUT OUT WITH A SCALPEL. THE DEVICE WAS REMOVED IN PIECES AND IN DEFLATED STATE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791903 ↗
• InjuryFeb 23, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND IMPLANTED WITH NO ISSUES. HOWEVER, THREE HOURS POST-PROCEDURE, THE PATIENT WAS SENT BACK TO THE CARDIAC CATHETERIZATION LAB AND A STENT THROMBOSIS WAS DISCOVERED. THE PHYSICIAN RE-BALLOONED THE IMPLANTED STENT WITH NO ISSUES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16428640 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT ANGIOPLASTY WITH STENTING. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE STENT THROUGH A HEMOSTASIS VALVE, THE STENT BECAME LODGED AND APPEARED BROKEN. THE DEVICE WAS PULLED OUT FROM THE HEMOSTASIS VALVE AND THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575860 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND RESTENOSIS OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: III) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. NON-TARGET LESIONS IN THE MID LAD EXTENDING TO THE FIRST DIAGONAL WERE TREATED WITH PLACEMENT OF 2.50 MM X 16 MM, 2.50 MM X 38 MM, 2.50 MM X 38 MM AND 3.00 MM X 48 MM SYNERGY STENTS IN THE OVERLAPPING MANNER. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. ON (B)(6) 2022, THE SUBJECT PRESENTED AT THE EMERGENCY DEPARTMENT VIA EMERGENCY MEDICAL SERVICES (EMS) WITH COMPLAINTS OF SUDDEN ONSET OF MID CHEST PAIN RADIATING TO NECK AND JAW WITH ASSOCIATED SHORTNESS OF BREATH THAT BEGAN WHILE WALKING TO HIS TRUCK WHICH IMPROVED WITH A DOSE OF SUBLINGUAL NITROGLYCERINE. THE SUBJECT WAS ADMINISTERED ASPIRIN AND SUBLINGUAL NITROGLYCERINE BY E

  Patient problems: Heart Failure/Congestive Heart Failure; Myocardial Infarction; Restenosis

  MAUDE report 15052898 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND RESTENOSIS OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: III) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. NON-TARGET LESIONS IN THE MID LAD EXTENDING TO THE FIRST DIAGONAL WERE TREATED WITH PLACEMENT OF 2.50 MM X 16 MM, 2.50 MM X 38 MM, 2.50 MM X 38 MM AND 3.00 MM X 48 MM SYNERGY STENTS IN THE OVERLAPPING MANNER. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. ON (B)(6) 2022, THE SUBJECT PRESENTED AT THE EMERGENCY DEPARTMENT VIA EMERGENCY MEDICAL SERVICES (EMS) WITH COMPLAINTS OF SUDDEN ONSET OF MID CHEST PAIN RADIATING TO NECK AND JAW WITH ASSOCIATED SHORTNESS OF BREATH THAT BEGAN WHILE WALKING TO HIS TRUCK WHICH IMPROVED WITH A DOSE OF SUBLINGUAL NITROGLYCERINE. THE SUBJECT WAS ADMINISTERED ASPIRIN AND SUBLINGUAL NITROGLYCERINE BY E

  Patient problems: Heart Failure/Congestive Heart Failure; Myocardial Infarction; Restenosis

  MAUDE report 15052886 ↗
• InjuryNov 16, 2021Failure to Advance; Defective Device; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INCORRECT STENT SIZE WAS USED. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTICED THAT THE DEVICE HAS A WRONG SIZE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE COMPLAINT HAS NOTHING TO DO WITH PACKAGING. THE PHYSICIAN HAS CHOSEN THE WRONG SIZE AND JUST WANTED A LONGER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821059 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN TO CIRCUMFLEX ARTERY. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USED. HOWEVER, THE SHAFT BROKE APPROXIMATELY 30-40CM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577007 ↗
• MalfunctionOct 4, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE DELIVERY WIRE BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569736 ↗
• MalfunctionJun 21, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.50 X 32MM SYNERGY XD DRUG-LUTING STENT (DES) WAS ADVANCED BUT FAILED TO BE DELIVERED. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE PROXIMAL END OF THE STENT WAS DEFORMED. ANOTHER 2.50 X 38MM SYNERGY XD DES WAS ADVANCED; HOWEVER, THE DEVICE ALSO FAILED TO BE DELIVERED AND UPON REMOVAL, IT WAS DETERMINED THAT THE PROXIMAL END OF STENT GOT DEFORMED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032397 ↗
• MalfunctionApr 5, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SECOND OBTUSE MARGINAL ARTERY. A 2.50 X 38MM 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. IT WAS FURTHER REPORTED THAT A 6F GUIDE CATHETER WAS USED AND THAT 6 SECONDS WERE WAITED FOR BALLOON DEFLATION BEFORE PULLING BACK THE DEVICE. ABSENCE OF CONTRAST WITHIN THE BALLOON WAS CONFIRMED UNDER FLUOROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614687 ↗