SYNERGY™ XD H7493941820300Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729980971), received between Nov 25, 2020 and Jun 18, 2026 — classified as 3 deaths, 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. DURING REMOVAL OF A 3.00 X 20MM SYNERGY? XD DRUG-ELUTING STENT FROM THE HOOP, THE STENT WAS FOUND NOT TO BE PROPERLY MOUNTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553602 ↗
• MalfunctionFeb 27, 2026Nonstandard Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLODGEMENT OCCURRED. A 3.00 X 20MM SYNERGY? XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, UPON UNPACKING, IT WAS NOTICED THAT THERE WAS NO STENT PRESENT ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24473955 ↗
• InjuryDec 18, 2025Nonstandard Device; Device Dislodged or Dislocated; Nonstandard Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGED REQUIRING ADDITIONAL INTERVENTION. A 3.00 X 20MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. WHILE CROSSING THE LESION, THE STENT CAME OFF OF THE DELIVERY SYSTEM BALLOON. THE PHYSICIAN OPTED TO DEPLOY AN ADDITIONAL STENT TO PIN THE DISLODGED STENT AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842373 ↗
• MalfunctionSep 5, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.00 X 20MM SYNERGY? XD DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. THE STENT BALLOON WAS INFLATED AT NOMINAL PRESSURE FOR 30 SECONDS. AFTER WAITING 15 SECONDS FOR BALLOON DEFLATION, DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO WITHDRAW THE STENT BALLOON FROM WITHIN THE DEPLOYED STENT. THE GUIDE ALSO BECAME DEEPLY INSERTED INTO THE LEFT MAIN. THE STENT BALLOON WAS EVENTUALLY REMOVED IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22987052 ↗
• MalfunctionJul 22, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT SHAFT LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, WHILE THE STENT WAS BEING PREPARED INSIDE THE PATIENT, BLOOD WAS OBSERVED BEING DRAWN BACK INTO THE INFLATION DEVICE WHICH SIGNIFIED SOME SORT OF LEAK IN THE SHAFT OF THE STENT. A KINKED WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565556 ↗
• MalfunctionMar 31, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS LIFTED OFF THE BALLOON UPON INSERTING INTO THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731040 ↗
• DeathJun 26, 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 LESION WAS LOCATED IN THE MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATION TO THE MID-LAD WITH A 2.5 X 15 NON-BOSTON SCIENTIFIC BALLOON, A 2.75 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THE TARGET LESION WAS FURTHER DILATED WITH A 3.0 X 15 NON-BSC BALLOON, ANOTHER 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED IN THE LAD AND 3.50 X 38MM SYNERGY XD STENT WAS IMPLANTED IN THE CIRCUMFLEX ARTERY. THE PHYSICIAN THEN USED TWO 2.5 X 15 BALLOON KISSING TECHNIQUE TO THE PROXIMAL PORTIONS OF THE STENT. THE PATIENT WAS STABLE AND WAS TAKEN BACK TO THE ROOM. AFTER A WHILE, THE PATIENT WAS CODED AND DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617219 ↗
• DeathApr 11, 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 LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT MAIN (LM) AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.25MM ROTAPRO WAS USED TO TREAT PATIENT WITH WORSENING HEART FAILURE ADMITTED POST PERCUTANEOUS OLD BALLOON ANGIOPLASTY (POBA) COMPLETED AT ANOTHER HOSPITAL. THE PATIENT WAS ADMITTED WITH CARDIOGENIC SHOCK AND ACUTE PULMONARY OEDEMA (APO). BALLOON AORTIC VALVULOPLASTY (BAV) WAS TO BE COMPLETED INITIALLY AND THEN TREATMENT TO THE LM AND LAD LESIONS WITH ROTABLATION. RIGHT CIRCUMFLEX FEMORAL ARTERY (RCFA) ACCESS WAS OBTAINED AS WELL AS RIGHT CIRCUMFLEX FEMORAL VEIN (RCFV). TEMPORARY PACING WIRE (TPW) WAS POSITIONED AT THE RIGHT VENTRICLE APEX AND PACING CAPTURE WAS CONFIRMED. BAV WAS PERFORMED WITH STABLE DIASTOLIC BLOOD PRESSURE AND RHYTHM AND THE TPW WAS WITHDRAWN. THE LAD LESION WAS THEN INITIALLY CROSSED WITH A NON-BOSTON SCIENTIFIC (BSC) WIRE AND EXCHANGED FOR A ROTAWIRE FLOPPY WITH AID OF A NON-BSC MICROCATHETER. ROTATIONAL ATHERECTOMY WAS PERFORMED WITH A 1.25MM ROTABURR BUT DURING THE RUN, THE BURR BECAME ENTRAPPED BETWEEN TWO HEAVILY CALCIFIED STENOSES. THE USER WAS UNABLE TO WITHDRAW THE BURR BY DIRECT RETRACTION UNDER HI

  Patient problems: Cardiac Tamponade; Perforation of Vessels; Pericardial Effusion; Vascular Dissection

  MAUDE report 19093620 ↗
• MalfunctionApr 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NOT TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 20MM SYNERGY XD BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE THE STENT WAS STUCK AND FRACTURED INSIDE A NON BOSTON SCIENTIFIC DEVICE. THE DEVICE WAS REMOVED INTACT OUTSIDE THE PATIENT BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059896 ↗
• DeathFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACURATE IDE STUDY: IT WAS REPORTED THAT THE PATIENT DIED. ON (B)(6) 2023, THE SUBJECT WAS BROUGHT TO THE EMERGENCY DEPARTMENT WITH CHIEF COMPLAINTS OF ACUTE CHEST PRESSURE, CONFUSION WITH ALTERED MENTAL STATUS, DIZZINESS, AND NAUSEA/EMESIS. THE SUBJECT WAS DIAGNOSED WITH INFERIOR ST ELEVATION MYOCARDIAL INFARCTION. THE SUBJECT RECEIVED 324 MG ASPIRIN AS WELL AS HEPARIN BOLUS AND WAS REFERRED FOR IMMEDIATE PERCUTANEOUS CORONARY INTERVENTION (PCI). CORONARY ANGIOGRAPHY REVEALED A 99% STENOSED OSTIUM TO PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION. OWING TO THE NEED FOR RCA INTERVENTION, DUE TO BRADYCARDIA, HYPOTENSION AND HEART BLOCK, THE SUBJECT WAS IMPLANTED WITH A TEMPORARY PACER. THE VESSEL WAS PRE-DILATED WITH A 1.50 MM NON-BOSTON SCIENTIFIC (BSC), 2.00 MM EMERGE, 2.50 MM EMERGE, 2.50 MM NC EMERGE, AND 3.00 MM NC EMERGE BALLOONS. HOWEVER, THERE WAS EXTENSIVE RECOIL OF THE BALLOONS. WITH EACH BALLOONING, THE SUBJECT BECAME PROFOUNDLY HYPOTENSIVE RESULTING IN CARDIOGENIC SHOCK WHICH REQUIRED IV EPINEPHRINE, LEVODOPA. THE SUBJECT ALSO BECAME PROFOUNDLY HYPOXIC AND UNRESPONSIVE WHICH REQUIRED TRANSIENT CHEST COMPRESSION. THE SUBJECT WAS INTUBATED IN THE CATH LAB, AND A NON-BSC HEART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695923 ↗
• MalfunctionSep 25, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND NOTED TO BE FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17809654 ↗
• MalfunctionJul 21, 2023Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. IT WAS NOTED THAT THE PRODUCT WAS PROPERLY SEALED IN THE BOX, BUT THE STERILE PACKAGING ON THE INSIDE THE BOX WAS OPENED AND SEEMED TO BE UNSTERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373902 ↗
• MalfunctionJun 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE, AND BLOOD WAS NOTED IN THE INFLATION DEVICE. IT WAS NOTED THAT THE BALLOON WAS BURST. 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 17057183 ↗
• MalfunctionMay 15, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED OVER WIRE. HOWEVER, DURING INTRODUCTION, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT BROKE IN HALF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935401 ↗
• MalfunctionApr 21, 2023Break; Defective Device

  AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS BROUGHT INTO THE CARDIAC CATHETERIZATION LABORATORY AND PREPPED AND DRAPED IN THE USUAL STERILE FASHION. CORONARY ANGIOGRAPHY WAS INITIALLY PERFORMED. FINDINGS INCLUDE A TYPE III LAD. THERE IS WHAT APPEARS TO BE A 60-70% LESION IN THE LAD WITH DPR SHOWING THAT THIS WAS SIGNIFICANT. THE TEAM DECIDED TO PROCEED WITH INTERVENTION OF THE MID LAD. WHEN IT WAS TIME FOR THE SYNERGY XD TO BE USED, DEVICE WAS REMOVED FROM THE PACKAGING AND IT WAS FOUND TO BE DEFECTIVE WITH THE END OF SHAFT BROKEN. THE DEVICE WAS NEVER INSIDE THE PATIENT. THIS WAS REPLACED BY ANOTHER SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY¿ XD (PER SITE REPORTER.) DEVICE GIVEN TO FIELD REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785070 ↗
• MalfunctionDec 8, 2022Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT A NO CROSS OCCURRED. A 3.00 X 20MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED BUT COULD NOT CROSS THE LESION. HOWEVER, A PHOTO WAS PROVIDED, AND IT WAS OBSERVED THAT THE STENT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940981 ↗
• InjuryNov 18, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 70% STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, A RESISTANCE WAS FELT WHEN ATTEMPTING TO PASS THE STENT THROUGH LESION, THE STENT WAS DISLODGED FROM THE BALLOON AT THE PROXIMAL VESSEL. THE PHYSICIAN DID NOT ATTEMPT TO REMOVE THE DISLODGED STENT. THE DETACHED COMPONENT WAS LEFT IN THE PATIENT TO AVOID THE RISK OF EMBOLIZATION OF THE DEVICE. THE STENT WAS THEN DILATED WITH SMALL BALLOONS TO DEPLOY THE STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826498 ↗
• MalfunctionJul 8, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN ADVANCING THE STENT TO THE LESION. THE DEVICE WAS REMOVED AND THE MID PORTION OF THE STENT WAS FOUND TO BE FRAYED WITH STENT STRUTS STICKING UP. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957589 ↗
• InjuryJun 24, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE PATIENT EVENT OCCURRED. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE INABILITY TO CROSS THE LESION CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE THAT RESULTED IN AN ADVERSE PATIENT EVENT. DESPITE MULTIPLE EFFORTS, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 14799455 ↗
• MalfunctionApr 11, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED, HOWEVER, FAILED TO CROSS THE LESION AND DEFECTIVE STENT BALLOON. THERE WERE NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079295 ↗
• MalfunctionNov 19, 2021Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18NOV2021. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE WAS BEING PERFORMED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY . A 3.00 X 20MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS IDENTIFIED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846189 ↗
• InjuryOct 12, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTICED THAT THE STENT DISLODGED FROM THE BALLOON. SNARING WAS ATTEMPTED BUT THE STENT WAS UNABLE TO BE RETRIEVED. THE PHYSICIAN THEN DEPLOYED ANOTHER 3.00 X 20MM SYNERGY XD STENT AND PUSHED THE DISLODGED STENT UP AGAINST THE VESSEL. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12620559 ↗
• InjuryAug 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE POST DEPLOYMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, POST DEPLOYMENT, A STENT FRACTURE IN THE MID PORTION OF THE DEVICE WAS NOTED. A SECOND STENT WAS PLACED AND ADDITIONAL BALLOONS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288921 ↗
• MalfunctionJun 23, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN DISTAL RIGHT CORONARY ARTERY. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT COULD NOT CROSS THE LESION AND WHEN PULLED BACK TO REPOSITION, THE PROXIMAL END OF THE STENT STRUTS WERE KINKED. 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 12048306 ↗
• MalfunctionMar 12, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. A KINK WAS NOTICED ON THE DEVICE AS IT WAS REMOVED FROM THE CARRIER TUBE. IN ATTEMPTS TO STRAIGHTEN THE DEVICE THE SHAFT BROKE 20CM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474569 ↗