SYNERGY™ XD H7493941816270Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729980889), received between Sep 1, 2021 and Oct 11, 2024 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED, AND STENT DISLODGEMENT RESULTING IN ADDITIONAL INTERVENTION. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.75 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS DISLODGED WHILE BEING PULLED BACK INTO THE GUIDE, TRYING TO RE-CROSS THE DEVICE BECOMING SNAGGED ON THE CA+ NODULE AND WAS STUCK AGAINST THE EDGE OF THE ROOFED GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20428678 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 2.75 X 16MM SYNERGY XD DRUG-ELUTING STENT, THE SHAFT WAS COMPLETELY BROKEN IN HALF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585954 ↗
• InjurySep 5, 2023Break; Difficult to Remove; Material Rupture; Difficult to Advance; Activation Failure; Break; Difficult to Remove; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT DEVICE ISSUES OCCURRED RESULTING IN REMOVAL DIFFICULTIES AND ADDITIONAL INTERVENTIONS. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). ATHERECTOMY WAS PERFORMED WITH A 1.25MM ROTA BURR WITHOUT COMPLICATION AND THE PHYSICIAN CHOSE TO CONTINUE INTERVENTION OVER THE ROTAWIRE. FOLLOWING PRE-DILATION USING AN EMERGE BALLOON, A 2.75X16 SYNERGY XD WAS INTRODUCED, BUT IT WAS UNABLE TO PASS THE PROXIMAL LESION AND WAS DEPLOYED IN THE PROXIMAL RCA LESION. POST DEPLOYMENT, THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED OUTSIDE THE PATIENT, BUT IT WAS DIFFICULT TO REMOVE FROM THE END OF THE ROTAWIRE. SIGNIFICANT FORCE WAS APPLIED AND THE STENT HYPOTUBE BROKE WITH THE HYPOTUBE REMAINING ON THE WIRE. THE ROTAWIRE WAS LEFT IN PLACE AND AN ATTEMPT WAS MADE TO BUDDY WIRE USING MULTIPLE LUGE GUIDEWIRES. THE LUGE WIRE KEPT GETTING STUCK ON OR BEHIND THE STENT STRUT, SO THE PHYSICIAN DECIDED TO CUT THE BACK OF THE ROTAWIRE AND CONTINUE INTERVENTION OVER THE PART OF THE WIRE ALREADY ACROSS THE LESION. A SECOND 2.75 X16 SYNERGY XD STENT WAS ADVANCED BUT IT WAS UNABLE TO CROSS THE LESION PAST THE FIRST DEPLOYED STENT. THE PHYSICIAN ATTEMPTED TO CROSS USING A 2.75 X 18

  Patient problems: Foreign Body In Patient

  MAUDE report 17686130 ↗
• InjurySep 5, 2023Break; Entrapment of Device; Failure to Advance; Break; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT DEVICE ISSUES OCCURRED RESULTING IN REMOVAL DIFFICULTIES AND ADDITIONAL INTERVENTIONS. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). ATHERECTOMY WAS PERFORMED WITH A 1.25MM ROTA BURR WITHOUT COMPLICATION AND THE PHYSICIAN CHOSE TO CONTINUE INTERVENTION OVER THE ROTAWIRE. FOLLOWING PRE-DILATION USING AN EMERGE BALLOON, A 2.75X16 SYNERGY XD WAS INTRODUCED, BUT IT WAS UNABLE TO PASS THE PROXIMAL LESION AND WAS DEPLOYED IN THE PROXIMAL RCA LESION. POST DEPLOYMENT, THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED OUTSIDE THE PATIENT, BUT IT WAS DIFFICULT TO REMOVE FROM THE END OF THE ROTAWIRE. SIGNIFICANT FORCE WAS APPLIED AND THE STENT HYPOTUBE BROKE WITH THE HYPOTUBE REMAINING ON THE WIRE. THE ROTAWIRE WAS LEFT IN PLACE AND AN ATTEMPT WAS MADE TO BUDDY WIRE USING MULTIPLE LUGE GUIDEWIRES. THE LUGE WIRE KEPT GETTING STUCK ON OR BEHIND THE STENT STRUT, SO THE PHYSICIAN DECIDED TO CUT THE BACK OF THE ROTAWIRE AND CONTINUE INTERVENTION OVER THE PART OF THE WIRE ALREADY ACROSS THE LESION. A SECOND 2.75 X16 SYNERGY XD STENT WAS ADVANCED BUT IT WAS UNABLE TO CROSS THE LESION PAST THE FIRST DEPLOYED STENT. THE PHYSICIAN ATTEMPTED TO CROSS USING A 2.75 X 18

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686128 ↗
• InjuryJun 15, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED, SHAFT BREAK AND DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.75 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, DURING REMOVAL, THE DEVICE BECAME STUCK AND THE SHAFT BROKE. THE ENTIRE SYSTEM WAS REMOVED WITH THE BALLOON FULLY DEFLATED AND PULLED THROUGH A GUIDE CATHETER. HOWEVER, A SMALL DISSECTION WAS FOUND. A NON-BOSTON SCIENTIFIC STENT WAS DEPLOYED TO COVER THE DISSECTION. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS IN GOOD CONDITION AND FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 17134023 ↗
• InjuryDec 16, 2022Fracture; Migration; Fracture; Migration

  IT WAS REPORTED VIA MEDWATCH 5113583 THAT STENT FRACTURE AND MIGRATION OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN AND UPON EVALUATION WAS NOTED TO BE A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WITH ANGIOGRAM AND POSSIBLE STENT PLACEMENT. CARDIAC CATHETERIZATION WAS PERFORMED USING A 2.75 X 16 SYNERGY XD DRUG-ELUTING STENT. HOWEVER, DURING WITHDRAWAL, MULTIPLE STRANDS OF STENT MATERIAL CAME FREE AND REMAINED IN THE PATIENT, POSSIBLY IN THE AORTA. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE FRAYING OBJECT WITH A SNARE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15998960 ↗
• InjuryDec 8, 2022Difficult to Remove; Device Dislodged or Dislocated; Material Integrity Problem; Difficult to Remove; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN TRIED TO ADVANCE THE 2.75 X 16MM SYNERGY XD STENT THROUGH A PREVIOUSLY DEPLOYED STENT IN ORDER TO RESCUE A SIDE BRANCH WHICH HAD BEEN PINCHED. THE BALLOON WAS NEVER INFLATED BUT THE STENT MOVED ON THE BALLOON AND BECAME DISLODGED. AN ATTEMPT TO SNARE THE STENT WAS NOT SUCCESSFUL. THE STENT DELIVERY SYSTEM (SDS) WAS DIFFICULT TO REMOVE AND HAD TO BE REMOVED TOGETHER WITH THE GUIDEWIRE. ONCE OUTSIDE THE PATIENT, THE GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE SDS. THE SDS WAS NOTED TO BE STRETCHED. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. THE DISLODGED STENT IS SCHEDULED TO BE REMOVED ON (B)(6).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946007 ↗
• MalfunctionMay 30, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION AND THE STENT STRUT WAS STICKING UP. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14544786 ↗
• InjuryNov 12, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON AND WAS DIFFICULT TO REMOVE. THE PATIENT PRESENTED WITH 50% STENOSIS AND MODERATE CALCIFICATION AT THE BIFURCATION OF THE LEFT ANTERIOR ARTERY/DIAGONAL BRANCH AND 80% STENOSIS AND MODERATE CALCIFICATION AT THE MID DIAGONAL BRANCH. AFTER TREATMENT OF THE MID DIAGONAL WITH A 1.25 ROTAPRO BURR, THE 2.75 X 16MM SYNERGY DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT CROSS THE BIFURCATION. THE STENT WAS PULLED BACK AND A 6FR GUIDEZILLA GUIDE EXTENSION CATHETER WAS INSERTED TO HELP DELIVER THE DES. THE STENT WAS RE-INSERTED AND ADVANCED THROUGH THE GUIDEZILLA RIGHT UP TO THE BIFURCATION. THE DES CONTINUED TO BE ADVANCED BUT WAS UNABLE TO BE DELIVERED COMPLETELY TO THE MID DIAGONAL. AN ATTEMPT WAS MADE TO PULL THE DES BACK BUT IT GOT STUCK ON CALCIUM AND BEGAN TO DISLODGE FROM THE STENT BALLOON. THE STENT WAS PARTIALLY IN THE VESSEL AND PARTIALLY IN THE GUIDEZILLA. AN NC BALLOON WAS DELIVERED TO CRUSH THE STENT AGAINST THE GUIDEZILLA AND ALL DEVICES WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806885 ↗
• MalfunctionSep 1, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.75 X 16MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, STENT FOLD WHILE TRYING TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE LESION AND THE STENT STRUT WAS LIFTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405526 ↗