XIENCE Sierra™ 1550325-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648227370), received between Aug 12, 2019 and May 4, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2021Inflation Problem; Difficult to Remove; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Inflation Problem; Difficult to Remove; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, LEFT CIRCUMFLEX (CX) ARTERY. A 3.25X33MM XIENCE SIERRA DRUG ELUTING STENT (DES) SYSTEM WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING INFLATION, THE INDEFLATOR WENT UP TO 12 ATMOSPHERES (ATM) BUT THE BALLOON OF THE DES WOULD NOT INFLATE. SUSPECTING THE ISSUE TO BE WITH THE INDEFLATOR, A NEW INDEFLATOR WAS USED, BUT THE BALLOON WOULD STILL NOT INFLATE. IT WAS DECIDED TO REMOVE THE DES TO EXCHANGE IT FOR A NEW ONE. DURING REMOVAL OF THE DEVICE, RESISTANCE WAS FELT WITH WHAT THEY SUSPECT WAS THE CATHETER, AND THE STENT WAS MANGLED, STICKING UP AND SLIGHTLY DISLODGED ON THE BALLOON WITH A SLIGHT KINK IN THE SHAFT. ANOTHER SAME SIZE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773552 ↗
• MalfunctionJun 25, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT TWO EXPIRED XIENCE SIERRA STENTS WERE IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197642 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X33MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED DUE TO ATHEROSCLEROTIC HEART AND ANGINA. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10155832 ↗
• MalfunctionJun 1, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 3.25X33MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE PATIENT ANATOMY; HOWEVER, IT WAS NOTED THAT THE PRODUCT WAS EXPIRED THEREFORE THE SDS WAS REMOVED AND THE STENT WAS NOT DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.25X33MM XIENCE SIERRA STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106938 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS DE NOVO DIAGONAL BRANCH. A 3.25X33MM XIENCE SIERRA STENT WAS DEPLOYED IN THE LEFT ANTERIOR DESCENDING ARTERY WHICH CAUSED THE BRANCH TO BECOME OCCLUDED. AN ATTEMPT WAS MADE TO ADVANCE A VERSATURN F GUIDEWIRE THROUGH THE STENT STRUTS TO THE DIAGONAL BRANCH BUT FAILED AS RESISTANCE WAS MET WITH THE STENT. THE GUIDEWIRE WAS REPLACED WITH A NON-ABBOTT GUIDE WIRE AND THE STENT STRUT CELLS WERE EXPANDED WITH AN UNSPECIFIED BALLOON TO SUCCESSFULLY CROSS AND COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 9929408 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2018 THE PATIENT HAD A MYOCARDIAL INFARCTION THAT WAS TREATED WITH THREE XIENCE SIERRA STENTS (TWO WERE SIZES 3.25X23 AND ONE 3.25X33) IN THE PROXIMAL AND MID RIGHT CORONARY ARTERIES AND TWO NON-ABBOTT STENTS IN THE MID LEFT CIRCUMFLEX CORONARY ARTERY AND IN THE DIAGONAL ARTERY (SIZES 2.0X15 AND 2.0X18). AT THE ONE YEAR FOLLOW-UP VISIT ON (B)(6) 2019, THE ANGIOGRAM FOUND SEVERAL BLOCKAGES IN THE CORONARY ARTERY. A FIVE VESSEL CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT CONTINUED TO HAVE CHEST PAIN AFTER THE XIENCE STENTS WERE IMPLANTED IN 2018. THE PATIENT WAS REMOVED FROM THE VENTILATOR ON (B)(6) 2019. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2019.

  Patient problems: Angina; Stenosis

  MAUDE report 9272174 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, NON-CALCIFIED DIAGONAL BRANCH. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON IN THE BIFURCATED LESION OF THE LEFT ANTERIOR DESCENDING ARTERY AND THE DIAGONAL. OPTICAL COHERENCE TOMOGRAPHY WAS PERFORMED AND THEN A 3.25X33MM XIENCE SIERRA STENT WAS IMPLANTED IN THE BIFURCATED LESION OF THE LEFT ANTERIOR DESCENDING ARTERY AND THE DIAGONAL. NO FLOW WAS CONFIRMED IN THE DIAGONAL WHICH PER THE PHYSICIAN THE STENT CAUSED OR CONTRIBUTED TO THE OCCLUSION. THEREFORE, AN UNSPECIFIED GUIDE WIRE WAS RE-CROSSED THROUGH THE STENT. DURING ADVANCEMENT OF A 2.0X8MM NC TRAVELER BALLOON DILATATION CATHETER (BDC), SLIGHT RESISTANCE WAS MET WITH EITHER THE GUIDING CATHETER OR GUIDE WIRE. IT WAS THEN NOTED THAT THE PROXIMAL SHAFT BECAME SEPARATED. A 2.0X12MM NC TRAVELER BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. BLOOD FLOW WAS RECOVERED AT THE DIAGONAL. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 8885742 ↗