SYNERGY™ XD H7493941820350Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729981053), received between Dec 30, 2020 and Mar 2, 2026 — classified as 1 death, 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (13 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.

• MalfunctionMar 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. DURING UNPACKING OF A 3.50 X 20MM SYNERGY? XD DRUG-ELUTING STENT, IT WAS OBSERVED THAT THE STENT HAD SLIPPED DISTALLY, THOUGH NOT FULLY DETACHED, AND WAS NOT FULLY POSITIONED WITHIN THE BALLOON AREA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482935 ↗
• MalfunctionFeb 23, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED. DURING DEPLOYMENT, THE BALLOON WAS INITIALLY INFLATED AT LOW PRESSURE; HOWEVER, THE BALLOON RUPTURED. A NON-COMPLIANT BALLOON WAS THEN USED TO OPTIMIZE THE STENT. THE DEVICE WAS REMOVED SUCCESSFULLY WITH NO FRAGMENTS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412736 ↗
• InjuryDec 16, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, A BALLOON SHAFT AND A BROKEN WIRE WERE INADVERTENTLY RETAINED INTRAVASCULARLY, REQUIRING A SECOND PROCEDURE AT A DIFFERENT HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23823475 ↗
• MalfunctionJul 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED VIA MEDWATCH THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT ULTRASOUND-GUIDED RIGHT RADIAL ARTERIAL ACCESS, FOLLOWED BY LEFT SELECTIVE CORONARY ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) OF THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT MAIN CORONARY ARTERIES. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE OSTIAL, PROXIMAL, AND MID SEGMENTS OF THE MODERATELY CALCIFIED LAD WITH 90% STENOSIS. A 3.0 MM X 48 MM SYNERGY DRUG-ELUTING STENT (DES) WAS DEPLOYED AT NOMINAL PRESSURE AND OVERLAPPED PROXIMALLY WITH A 3.5 MM X 20 MM SYNERGY DES DEPLOYED SLIGHTLY ABOVE NOMINAL PRESSURE. DURING DEPLOYMENT, THE STENT BALLOON BURST DURING INITIAL INFLATION AT APPROXIMATELY 4 MMHG, BELOW ITS RATED BURST PRESSURE OF 16 MMHG, RESULTING IN THE PATIENT'S TEMPORARY ST ELEVATION AND A TEMPORARY SPIKE IN BLOOD PRESSURE. THE STENT DELIVERY SYSTEM WAS RETRIEVED INTACT, AND THE PATIENT SYMPTOMS RESOLVED WITHOUT FURTHER INTERVENTION. THE OVERLAPPING STENT SEGMENTS WERE SUBSEQUENTLY POST-DILATED USING THE BALLOON FROM THE PROXIMAL STENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: High Blood Pressure/ Hypertension; Non specific EKG/ECG Changes

  MAUDE report 22583779 ↗
• MalfunctionJun 30, 2025Material Rupture

  WHILE DEPLOYING A CORONARY STENT, THE STENT BALLOON BURST. THE BALLOON WAS INFLATED TO APPROXIMATELY 4MMHG WHEN IT BURST, RATED BURST FOR THIS BALLOON IS 16MMHG. THE PATIENT HAD A TEMPORARY ST ELEVATION AND TEMPORARY SPIKE IN BLOOD PRESSURE. PATIENT SYMPTOMS RESOLVED WITHOUT INTERVENTION. THE STENT WAS RETRIEVED FROM THE PATIENT INTACT.

  Patient problems: Arrhythmia; High Blood Pressure/ Hypertension

  MAUDE report 22352599 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CATHETER SNAPPED INSIDE THE PATIENT'S BODY. THE DEVICE WAS COMPLETELY REMOVED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895201 ↗
• InjuryOct 28, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED RESULTING IN VESSEL OCCLUSION. THE PATIENT PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). A 3.50 X 20 MM SYNERGY XD DRUG-ELUTING STENT WAS TO BE DEPLOYED IN THE PROXIMAL CIRCUMFLEX. DURING THE PROCEDURE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VFIB) AND WAS BROUGHT BACK TO SINUS RHYTHM WHILE THE BALLOON WAS DEFLATED. UPON RETURNING TO FLUOROSCOPY, THE PHYSICIAN COULD STILL SEE THE MARKER BANDS OF THE BALLOON. HOWEVER, THE BALLOON CAME OFF THE SHAFT WHEN IT WAS PULLED OUT. THE PHYSICIAN THEN WAS UNABLE TO SNARE IT OR CROSS ANOTHER DEVICE, WHICH CAUSED THE VESSEL TO OCCLUDE. THE CIRCUMFLEX SHUT DOWN, RESULTING IN NO FLOW. THE PATIENT HAS BEEN INTUBATED AND IS IN THE INTENSIVE CARE UNIT (ICU). NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Arrhythmia; Foreign Body Embolism; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 20545256 ↗
• MalfunctionAug 27, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING WITHDRAWAL, THE BALLOON SHAFT WAS BENT INSIDE THE BODY AFTER BEING PUSHED ON AND WHEN THE PHYSICIAN PULLED BACK, THE SHAFT BROKE INTO 2 PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075670 ↗
• MalfunctionAug 15, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED UPON RETRACTION OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996233 ↗
• MalfunctionMar 14, 2024Positioning Failure; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Failure; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILD TO MODERATELY CALCIFIED LEFT MAIN ARTERY. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING WAS ADVANCED TO TREAT THE LESION. THE STENT BALLOON WAS INFLATED AND DEFLATED AND RE-INFLATED AGAIN. UPON REMOVAL OF THE STENT DEPLOYMENT BALLOON, RESISTANCE WAS FELT AS THE DEPLOYMENT DEVICE WAS ABOUT TO EXIT THE GUIDE CATHETER. THE DEVICE WAS REMOVED WITH SOME FORCE, AND UPON REMOVAL, IT WAS NOTED THAT THE STENT DID NOT DEPLOY IN THE LEFT MAIN ARTERY. IT WAS OBSERVED THAT THE STENT HAD MOVED ON THE BALLOON AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY XD DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907884 ↗
• MalfunctionNov 29, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN THE STENT DELIVERY WAS PULLED OUT, THE PROXIMAL SHAFT BROKE AT 8 INCHES ABOVE THE HUB. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225177 ↗
• MalfunctionAug 14, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, DURING PREPARATION, THE STENT GOT STUCK ON THE INDEFLATOR AND BROKE WHEN ATTEMPTED TO BE REMOVED. THE STENT WAS NOT INSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541430 ↗
• DeathJul 26, 2023Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED WHICH RESULTED IN MYOCARDIAL INFARCTION AND PATIENT DEATH. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED MID CIRCUMFLEX ARTERY. AFTER THE LESION WAS PREPARED USING A 1.5 ROTA BURR, THE 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED AT 16 ATMOSPHERES. HOWEVER, THERE WAS AN UNDER EXPANDED STENT AREA AND THE DISTAL END OF THE STENT DELIVERY SYSTEM (SDS) BALLOON APPEARED TO BE STUCK IN CALCIFICATION. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON OVER THE COURSE OF 30-40 MINUTES. REINFLATION AND DEFLATION COULD NOT BE PERFORMED BECAUSE THE BALLOON WOULD NOT INFLATE. AN ATTEMPT WAS MADE TO WIRE NEXT TO THE BALLOON TO RELEASE IT FROM WHEREVER IT WAS STUCK, AND A SURGEON WAS ALSO CONSULTED TO PROVIDE HELP IN REMOVING THE SDS. IN A FINAL ATTEMPT TO REMOVE THE BALLOON, THE SDS CATHETER BROKE, AND THE BALLOON REMAINED INSIDE THE PATIENT. THE LEFT CIRCUMFLEX SHUT DOWN AND MYOCARDIAL INFARCTION OCCURRED. THE PATIENT DIED ON THE TABLE.

  Patient problems: Myocardial Infarction; Reduced Blood Flow

  MAUDE report 17399106 ↗
• MalfunctionFeb 20, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE TIP OF THE PLASTIC CATHETER BROKE OFF WITHIN THE HUB OF THE DEVICE AND WAS FAILED TO UTILIZE. ANOTHER 3.50 X 20MM SYNERGY XD DES WAS THEN DELIVERED INTO THE GUIDE CATHETER, BUT IT WAS STUCK HALFWAY UP THE CATHETER. WHEN ATTEMPTED TO REMOVED, THE SHAFT BROKE IN HALF AT ABOUT 40 TO 50 CM FROM THE TIP OF THE STENT CATHETER. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A 3.5X22MM NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403518 ↗
• MalfunctionJan 9, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE DEVICE BECAME STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. ATTEMPTS WERE MADE TO FLUSH THE STENT AND GUIDEWIRE, BUT THE DEVICE STILL FAILED TO ADVANCE. THE STENT AND GUIDEWIRE WERE REMOVED INTACT AND AS A UNIT. THE TARGET LESION WAS REWIRED, AND ANOTHER 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125124 ↗
• InjuryNov 8, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS TRACKING THROUGH THE GUIDE CATHETER, RESISTANCE WAS NOTED AND THE PHYSICIAN FELT THE MONORAIL SHAFT SHIFT. FLUOROSCOPY WAS PERFORMED AND IT WAS NOTED THAT THE SHAFT HAD BROKEN INSIDE THE GUIDE CATHETER. A BALLOON WAS INSERTED INTO THE GUIDE CATHETER PAST THE STENT AND WAS INFLATED; EVENTUALLY, THE DEVICE AND GUIDE WERE REMOVED FROM THE PATIENT'S BODY SUCCESSFULLY. THE PHYSICIAN THEN RE-WIRED THE LAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752643 ↗
• MalfunctionNov 1, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM DID NOT BREAK, ONLY THE STENT ITSELF THAT WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707500 ↗
• MalfunctionOct 15, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE TARGET LESION WAS SEVERELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT HOWEVER, DURING DELIVERY OF THE DEVICE TO THE LESION, THE PHYSICIAN WAS PUSHING WITH A LOT OF FORCE AND THE SHAFT OF THE STENT BROKE NEAR THE HUB. THE PHYSICIAN PULLED THE STENT SHAFT OUT 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 15612391 ↗
• MalfunctionOct 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USED. DURING PREPARATION OUTSIDE THE PATIENT, WHEN THE PLASTIC COVER REMOVED FROM THE DEVICE, THE STENT WAS DETACHED FROM THE BALLOON OF THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539698 ↗
• MalfunctionAug 8, 2022Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR USE. HOWEVER, DURING INTRODUCTION, THE PROXIMAL SHAFT WAS KINKED AND FRACTURED. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188151 ↗
• MalfunctionMay 27, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE THE DEVICE WAS FAILED TO CROSS THE LESION AND THE STENT WAS NOTED TO BE FRAYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522067 ↗
• MalfunctionMar 23, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT BALLOON COULD NOT BE RETRACTED NORMALLY INSIDE THE GUIDE CATHETER AND IT WAS DIFFICULT TO DEFLATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870718 ↗
• MalfunctionSep 8, 2021Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND IT WAS NOTICED THAT THE STENT STRUTS BROKE. 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 12440545 ↗
• MalfunctionMay 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE WHILE ATTEMPTING TO PASS INTO OVERLAPPING STENTS, IT WAS NOTED THAT THE STENT DISTAL END WAS DAMAGED. 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 11785690 ↗
• MalfunctionApr 29, 2021Break; Break

  CASE REPORTED VIA A USER FACILITY MAUDE REPORT #MW51000079. IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE STENT SYSTEM BROKE INSIDE THE PATIENT. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750932 ↗