SYNERGY™ XD H7493941812350Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729981039), received between Jan 13, 2021 and Jul 18, 2025 — classified as 1 death, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Break; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Break; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.50 X 12 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO THE LESION SITE FOR TREATMENT. THE STENT WAS INITIALLY ADVANCED AND THEN REMOVED INTACT. UPON RE-ADVANCEMENT, THE STENT FAILED TO INFLATE. DURING THE SECOND REMOVAL, THE STENT EXITED THE BODY WHILE STILL ON THE GUIDEWIRE AND BROKE AT THE STENT JUNCTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543404 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. DURING INSERTION, WHEN THE STENT WAS STILL INSIDE THE GUIDE CATHETER, THE SHAFT CATHETER BROKE. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE DEVICE DID NOT BREAK COMPLETELY IN TWO PIECES. ANOTHER 3.5X12MM SYNERGY DES WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812548 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE MID SHAFT FRACTURED INTO TWO INSIDE THE PATIENT. THE FRACTURED PORTION WAS PULLED BACK INTO THE GUIDE AND WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY TOGETHER WITH THE GUIDE. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278915 ↗
• MalfunctionFeb 27, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK CAUSED THE PROCEDURE'S CANCELLATION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT BROKE AND DUE TO THE SIGNIFICANT AMOUNT OF CONTRAST USED, THE PHYSICIAN ABORTED THE PROCEDURE. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793253 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. 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 18759051 ↗
• MalfunctionFeb 6, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE STENT GOT ENTRAPPED IN THE GUIDE EXTENSION. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE THE STENT GOT STUCK IN THE GUIDE EXTENSION. UPON TRYING TO PULL OUT THE DEVICE, THE STRUTS OF THE STENT WERE DAMAGED. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655503 ↗
• DeathAug 8, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT DIED. A 2.25 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED IN THE LEFT MAIN (LM); HOWEVER, THE STENT MIGRATED INTO THE PROXIMAL LEFT CIRCUMFLEX ARTERY AND WAS DEPLOYED WHERE IT WAS. DURING DEPLOYMENT, THE OSTIAL LM PART OF THE STENT HAD PROXIMAL STENT EDGE SHORTENING AND A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED AT THE ORIGINAL LESION, OVERLAPPING WITH THE FIRST STENT. A RECOMMENDATION WAS MADE FOR COMPLETION OF THE LEFT MAIN BIFURCATION STENTING DUE TO THE BUNCHING OF THE STENT WITHIN THE OSTIAL LEFT MAIN. SEVEN DAYS LATER, THE PATIENT RETURNED TO THE CATH LAB ON VASOPRESSIN AND PHENYLEPHRINE. DURING THIS PROCEDURE, A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY TO LM. DURING PROXIMAL OPTIMIZATION TECHNIQUE ON THE LEFT MAIN PORTION OF THE STENT, THERE WAS AGAIN STENT EDGE SHORTENING. TWO DAYS LATER THE PATIENT DIED. THE PRIMARY CAUSE OF DEATH WAS NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI).

  Patient problems: Myocardial Infarction

  MAUDE report 17484577 ↗
• MalfunctionJul 14, 2023Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF WHILE BEING INSERTED INTO THE GUIDEZILLA GUIDE-EXTENSION CATHETER AND BOTH DEVICES CAME OUT TOGETHER WITH THE STENT DEFORMED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329923 ↗
• InjuryJan 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS VESSEL BELOW THE KNEE. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. IN AN ATTEMPT TO IMPLANT THE STENT, THE SHAFT WAS BROKEN AND SNARING WAS USED TO REMOVE THE DEVICE. THE PHYSICIAN AGAIN ADVANCED ANOTHER 3.50 X 12MM SYNERGY XD DES AND WAS ABLE TO BE DELIVERED SUCCESSFULLY WHICH COMPLETED THE PROCEDURE. HOWEVER, UPON REMOVAL, THE SHAFT WAS BROKEN. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216197 ↗
• MalfunctionAug 16, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND UPON REMOVAL, THE HYPOTUBE SECTION OF THE SHAFT WAS FRACTURED. THE PHYSICIAN GRABBED THE REMAINING WIRE TO PULL OUT THE END WITH THE STENT. 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 15234731 ↗
• MalfunctionMar 21, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. FOLLOWING PRE-DILATATION, A 3.50 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, RESISTANCE WAS FELT DURING ADVANCING AND IT FAILED TO CROSS THE GUIDE CATHETER. UPON REMOVAL, IT WAS NOTED THAT A STRUT WAS STICKING UP AT THE DISTAL EDGE OF THE STENT. 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 13839160 ↗
• MalfunctionJan 14, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT COULD NOT CROSS THE LESION AND IT WAS FOUND THAT THE PROXIMAL PART OF THE STENT WAS DAMAGED. THE DEVICE WAS REMOVED 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 13258148 ↗
• MalfunctionDec 15, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN DISTAL RIGHT CORONARY ARTERY (RCA). A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS INSERTED THROUGH A PREVIOUS PLACED MID RCA STENT, BUT WOULD NOT CROSS THE DISTAL RCA LESION. HOWEVER, UPON REMOVAL, THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE LESION WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. THE STENT DID NOT CROSS DUE TO CALCIFICATION AND THE STENT STRUTS WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13008402 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE OUTSIDE THE PATIENT'S BODY, STENT DELIVERY SYSTEM BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393646 ↗
• MalfunctionMar 16, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, DURING THE PROCEDURE, IT GOT HUNG UP IN THE PROXIMAL CIRCUMFLEX ARTERY AND WOULD NOT TRACK DOWN TO THE TARGET LESION. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE STENT WAS MANGLED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497703 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE WHILE STILL OUTSIDE THE GUIDE, THE SHAFT FRACTURED. THE DEVICE WAS REMOVED 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 11399885 ↗
• MalfunctionJan 13, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS USED, HOWEVER; THE DEVICE BROKE AFTER REMOVING FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. PREVIOUSLY, IT WAS REPORTED THAT THE SHAFT BROKE. NOW, IT IS CONFIRMED THAT THE TIP OF THE HYPOTUBE WAS BENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 11164355 ↗