SYNERGY™ XD H7493941816350Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729981046), received between Jan 25, 2021 and Jan 13, 2026 — classified as 1 death, 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (14 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.

• MalfunctionJan 13, 2026Fracture; Device Damaged by Another Device

  IT WAS REPORTED VIA USER MEDWATCH MW5179553 THAT STENT DAMAGED POST-DEPLOYMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED, BUT A STENT STRUT FRACTURE WAS NOTED POST-DEPLOYMENT. A SECOND 3.50 X 16MM SYNERGY XD DES WAS THEN PLACED; HOWEVER, ANOTHER POST-DEPLOYMENT STENT STRUT FRACTURE OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055611 ↗
• MalfunctionJan 12, 2026Fracture; Device Damaged by Another Device

  IT WAS REPORTED VIA USER MEDWATCH MW5179553 THAT STENT DAMAGED POST-DEPLOYMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED, BUT A STENT STRUT FRACTURE WAS NOTED POST-DEPLOYMENT. A SECOND 3.50 X 16MM SYNERGY XD DES WAS THEN PLACED; HOWEVER, ANOTHER POST-DEPLOYMENT STENT STRUT FRACTURE OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048093 ↗
• MalfunctionDec 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 3.50 X 16MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT STRUT FRACTURED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745840 ↗
• MalfunctionJul 28, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE TORTUOUS TAKE-OFF FROM LEFT MAIN (LM) AND MODERATELY TO SEVERELY CALCIFIED LM. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED BUT HAD DIFFICULTY TRACKING. ANOTHER 3.50 X 16MM SYNERGY XD DES WAS ADVANCED BUT FAILED TO CROSS THE LESION. ADDITIONAL BALLOONING WAS PERFORMED, AND THE 3.50 X 16MM SYNERGY XD DES WAS RE-ADVANCED; HOWEVER, THE SHAFT BROKE IN THE GUIDE PROXIMAL TO THE LESION. THE DEVICE WAS REMOVED SUCCESSFULLY IN TWO PIECES. A 3.0 X12MM NON-BOSTON SCIENTIFIC STENT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631981 ↗
• MalfunctionMay 14, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 3.50 X 16MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT CROSS THE LESION. HOWEVER, IT WAS NOTICED THAT THE SHAFT WAS BROKEN ON THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020898 ↗
• InjuryJan 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VESSEL OCCLUSION, CARDIAC ARREST, REDUCED BLOOD FLOW, AND DISLODGEMENT, ALL OF WHICH REQUIRED ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A COMPLEX PROCEDURE ON THE PROXIMAL CIRCUMFLEX ARTERY, WHICH WAS 90% STENOSED AND HAD A 90-DEGREE BEND. IT WAS LOCATED IN A TORTUOUS AND SEVERELY CALCIFIED SEGMENT OF THE PROXIMAL CIRCUMFLEX ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. SHOCKWAVE THERAPY WAS USED TO PREPARE THE ARTERY, AND IMAGING WAS EMPLOYED TO ASSESS THE AREA. DURING THE PROCEDURE, THE STENT BECAME DISLODGED AND STAYED IN THE LEFT MAIN AREA OF THE ARTERY. AN ATTEMPT TO REMOVE IT WAS MADE USING A SNARE. HOWEVER, THE SNARING RESULTED IN CESSATION OF FLOW TO THE LEFT CORONARY SYSTEM, LEADING TO CARDIAC ARREST. THE PATIENT WAS RESUSCITATED, AND FLOW WAS RE-ESTABLISHED. THE DECISION WAS MADE TO STENT THE AREA WHERE THE DISLODGED STENT HAD ENDED UP, RESTORING FLOW AND STABILIZING THE PATIENT. THE PATIENT REMAINED ON IMPELLA SUPPORT POST-PROCEDURE, SUCCESSFULLY STENTED THE PROBLEM AREA, AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Cardiac Arrest; Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 21184447 ↗
• MalfunctionDec 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, WHILE CROSSING THE LESION, SEVERE CALCIUM PULLED UP THE STENT FROM THE BALLOON AT THE DISTAL EDGE OF THE STENT. THE STENT REMAINED ON THE BALLOON, AND THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032586 ↗
• InjuryNov 18, 2024Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DISLODGEMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION, WHICH WAS 90% STENOSED, WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. A NON-BOSTON SCIENTIFIC 6F GUIDE CATHETER AND A NON-BOSTON SCIENTIFIC 0.014-INCH GUIDEWIRE WERE ALSO USED. TWO ATTEMPTS WERE MADE TO DELIVER THE STENT INTO THE CIRCUMFLEX ARTERY; HOWEVER, THE PRESENCE OF MODERATE TORTUOSITY, SEVERE CALCIFICATION, AND A PRIOR STENT IN THE LEFT MAIN ARTERY CAUSED THESE ATTEMPTS TO FAIL. UPON REMOVAL OF THE STENT INFLATION DEVICE, FLUOROSCOPY REVEALED THAT THE STENT HAD INADVERTENTLY MOVED INTO THE LEFT MAIN ARTERY AFTER DETACHING FROM THE BALLOON BEFORE REACHING THE TARGET LESION. THIS CAUSED COMPLICATIONS, AS THE STENT WAS NO LONGER IN THE INTENDED POSITION. THE PHYSICIAN THEN ATTEMPTED TO PASS A BALLOON THROUGH THE UNDEPLOYED STENT, AIMING TO SLIGHTLY INFLATE THE BALLOON IN ORDER TO ENGAGE THE STENT AND PULL IT BACK INTO THE GUIDE CATHETER. HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. FLUOROSCOPY SHOWED THAT THE STENT HAD SHORTENED AND WAS NOW POSITIONED IN THE DISTAL LEFT MAIN A

  Patient problems: Foreign Body In Patient

  MAUDE report 20709383 ↗
• InjuryMay 3, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT STENT FRACTURED WHICH RESULTED TO ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.50 X 16MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT IT WOULD NOT CROSS THE LESION. UPON REMOVAL, THE STENT DELIVERY SYSTEM (SDS) BROKE IN HALF LEAVING PART OF IT INSIDE THE PATIENT. A SNARE WAS USED TO REMOVE THE PORTION OF THE SDS OUT OF THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243586 ↗
• MalfunctionJan 16, 2024Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-JAN-2024. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION INTO THE 6FR NON-BOSTON SCIENTIFIC GUIDE-CATHETER, THE DEVICE SNAPPED AND BROKE APPROXIMATELY 4 INCHES FROM THE HUB. THE DETACHED PART WAS REMOVED INTACT BY GENTLE PULLING, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BREAK AT 20CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522066 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON ADVANCING OVER THE WIRE, THE SHAFT SNAPPED. THE PIECES WERE 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 18446933 ↗
• MalfunctionDec 21, 2023Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE, A RESISTANCE WAS FELT, AND THE MID SHAFT WAS KINKED AND BROKE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY. 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 18373155 ↗
• MalfunctionDec 18, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, STENT WOULD NOT PASS THROUGH THE GUIDE AND WAS FORCED TO ADVANCE BY THE PHYSICIAN UNTIL DELIVERY SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345857 ↗
• MalfunctionNov 17, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT CROSS THE LESION. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS MOVING UNDER THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162515 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A NEW SYNERGY XD DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012254 ↗
• DeathJul 25, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK AND DISSECTION OCCURRED, AND THE PATIENT DIED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AFTER RECEIVING NON-BOSTON SCIENTIFIC BALLOON LITHOTRIPSY THERAPY. DURING THE PROCEDURE, TWO NON-BOSTON SCIENTIFIC INDEFLATOR DEVICES LOCKED UP WHILE ATTEMPTING TO INFLATE THE STENT. EVENTUALLY, THE SECOND INFLATION DEVICE WAS ABLE TO INFLATE THE SYNERGY STENT BALLOON TO NOMINAL PRESSURE AND DEPLOYED THE STENT. DURING REMOVAL OF THE CATHETER AFTER STENT PLACEMENT, THE MID SHAFT WAS FOUND TO BE FRACTURED. THE PHYSICIAN CAREFULLY REMOVED THE WIRE AND THE GUIDE CATHETER SINCE HE NOTICED THAT THE DISTAL PART OF THE CATHETER WAS STILL ATTACHED TO THE WIRE ON THE MONORAIL SEGMENT. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS FOUND WHEN THE CATHETER WAS REMOVED, BUT THE PATIENT STARTED TO DEVELOP BRADYCARDIA AFTER THE FINAL ANGIOGRAM WAS PERFORMED. IT WAS NOTED THAT THE PATIENT FELT EXCRUCIATING PAIN WHEN THE LITHOTRIPSY BALLOON CROSSED THE LESION AND THE PAIN LEVEL INCREASED AS

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 17393725 ↗
• InjuryJul 19, 2023Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED AND ADDITIONAL SURGERY WAS REQUIRED. DURING INSERTION OF A 3.50 X 16 SYNERGY XD, THE STENT GOT CAUGHT ON A PREVIOUSLY PLACED STENT. WHEN THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE BODY, IT WAS NOTED THAT THE STENT HAD BECOME DISLODGED FROM THE BALLOON AND RETAINED IN CORONARY. THE STENT WAS "PINNED" WITH A STENT PREVIOUSLY IMPLANTED IN THE LEFT MAIN. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE DISLODGED STENT WITH NO SUCCESS. THE PATIENT WAS SENT FOR OPEN HEART SURGERY, BUT THE STENT WAS NOT RETRIEVED AND WILL PERMANENTLY REMAIN IN THE LEFT MAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17352548 ↗
• MalfunctionFeb 24, 2023Failure to Advance; Device Dislodged or Dislocated; Material Integrity Problem; Failure to Advance; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 16MM SYNERGY XD DRUG ELUTING STENT WAS USED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. ADDITIONALLY, THE BALLOON TIP WAS DAMAGED AND THE STENT CAME APART FROM THE BALLOON OF THE STENT DELIVERY SYSTEM. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440397 ↗
• MalfunctionSep 16, 2022Break; Physical Resistance/Sticking

  LATE 60¿S MALE WITH HISTORY OF HYPERTENSION AND SEVERE MULTIVESSEL CORONARY ARTERY DISEASE BEING WORKED UP FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). PROCEDURE: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY ROTABLATOR AND STENT. THE SYNERGY MONORAIL WAS DAMAGED, IT GOT STUCK IN THE GUIDZILLA. REMOVED FROM PATIENT WITHOUT KNOWN HARM, ANOTHER DEVICE USED WITHOUT PROBLEMS. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY¿ XD (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437489 ↗
• MalfunctionAug 12, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE AND THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218198 ↗
• MalfunctionMay 11, 2022Contamination; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Contamination; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. DURING PREPARATION, A 3.50 X 16MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THERE WAS DIFFICULTY OPENING THE PACKAGE AND IT WAS NOTED IT RIPPED INCONSISTENTLY WITH HOW IT TYPICALLY OPENS. THE FOIL PACKAGING RIPPED INCONSISTENTLY IN THE MIDDLE OF THE PACKAGE WHEN IT WAS OPENED IN THE PROPER MANNER. THE STENT FELL OUT OF THE FOIL PACKAGING AND STERILITY WAS COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360565 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING THE PREPARATION PRIOR TO INSERTION, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081708 ↗
• MalfunctionMay 21, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. THE PHYSICIAN KINKED THE STENT BEFORE ADVANCING, HOWEVER, DURING EXTRACTION, IT WAS NOTED THAT THE SHAFT HAD CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866566 ↗
• MalfunctionMay 10, 2021Inflation Problem; Device Dislodged or Dislocated; Material Deformation; Inflation Problem; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED AND THEN A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE BALLOON FAILED TO INFLATE AND THE STENT WAS DISLODGED AND TRAVELED ONTO THE SHAFT OF THE CATHETER. THE STENT WAS TOTALLY DISFIGURED. THE DEVICE WAS COMPLETELY REMOVED AND 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 11801439 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CATHETER BROKE. THE BROKEN PART WAS REMOVED MANUALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787456 ↗