XIENCE Sierra™ 1550275-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08717648227172), received between Jun 6, 2018 and Jun 7, 2022 — classified as 1 death, 19 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (5 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2020, TREATING A TARGET LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). FOUR XIENCE SIERRA STENTS, TWO 3.0 X 38MM, A 2.75X38MM AND A 3.5X23MM, WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A STRESS TEST THAT WAS SUGGESTIVE OF INTERIOR/INFEROLATERAL ISCHEMIA. A SUBSEQUENT ANGIOGRAM PERFORMED ON (B)(6) 2021 REVEALED PATENT LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING (LAD), PATENT SAPHENOUS VEIN GRAFT (SVG) TO FIRST OBTUSE MARGINAL (OM1), PATENT SVG TO RAMUS ARTERY, BUT AN OCCLUDED SVG TO RCA. TARGET LESION REVASCULARIZATION WAS PERFORMED ON (B)(6) 2022, TREATING IN-STENT RESTENOSIS WITH IMPLANT OF AN ADDITIONAL DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 14627245 ↗
• InjuryJun 18, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD). THE 2.75 X 15 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY; HOWEVER, DUE TO THE PATIENT ANATOMY, THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS TO THE TARGET LESION. THE STENT DELIVERY SYSTEM WAS PULLED BACK TO REMOVE AND THE STENT DISLODGED AND EMBOLIZED TO THE PROXIMAL LAD. A 1.0 DILATATION CATHETER WAS ADVANCED THROUGH THE STENT AND INFLATED TO MOVE THE STENT TO THE TARGET LESION. ONCE THE STENT WAS AT THE TARGET LESION, THE 1.0 DILATATION CATHETER WAS REMOVED AND A LARGER DILATATION CATHETER WAS ADVANCED THROUGH THE STENT AND INFLATED, FULLY APPOSING THE STENT TO THE VESSEL WALLS. NO ADDITIONAL INTERVENTION WAS REQUIRED TO TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 12028958 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 11917946 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND TWO (2.75X15MM AND 3.5X33MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND ATRIOVENTRICULAR BLOCK. SURGERY WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 11914742 ↗
• MalfunctionApr 13, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED, DISTAL POSTERIOR DESCENDING ARTERY (PDA) VIA FEMORAL ACCESS. A 2.75X15MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS ADVANCED TO THE LESION OVER A BMW GUIDE WIRE (GW). DURING DEPLOYMENT, THE DES BECAME CAUGHT WITH THE GW AND THE GW COILS UNRAVELED. THE GW AND THE STENT SYSTEM WERE REMOVED FROM THE ANATOMY TOGETHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. A WHISPER ES GW AND A NEW, SAME SIZE XIENCE SIERRA DES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661397 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THREE XIENCE SIERRA STENTS WERE IMPLANTED IN THE PATIENT [2.75 X 15, 4.00 X 12 AND 3.00 X 18 MM]. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED DUE TO AN UNSPECIFIED VASCULAR DISORDER. THE PATIENT UNDERWENT SURGERY AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 11438953 ↗
• InjuryMar 5, 2021Entrapment of Device; Unintended System Motion; Device Dislodged or Dislocated; Entrapment of Device; Unintended System Motion; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS DONE TO TREAT A DIAGONAL VESSEL WITH MILD CALCIFICATION AND NO TORTUOSITY. PRE-DILATATION WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BALLOON. A 2.75X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH NO ISSUES. HOWEVER, THE PHYSICIAN WAS ABOUT TO START DEPLOYING THE STENT WHEN THE SDS JUMPED BACK. THE PHYSICIAN WAS INFLATING AT 2 ATMS. THE INFLATION WAS INTENTIONALLY PERFORMED SLOW. WHEN THE SDS WAS BEING PULLED BACK INTO THE GUIDE, THE STENT DISLODGED OFF THE BALLOON (NO RESISTANCE WAS FELT WHEN PULLING BACK). THIS CAUSED A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN ATTEMPT WAS MADE TO SNARE THE STENT; HOWEVER, THE STENT COULD NOT BE SNARED THROUGH THE SHEATH. EVERYTHING WAS PULLED OUT, EXCEPT THE STENT, SNARE, AND WIRE. IT WAS NOTED THAT THE STENT WAS STUCK IN THE FEMORAL SCAR TISSUE. THEREFORE, A SURGEON WAS CALLED AND A CUT-DOWN WAS PERFORMED. THE STENT, SNARE, AND WIRE WERE RETRIEVED. THE PATIENT IS STABLE. THE TARGET LESION WAS NOT TREATED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423385 ↗
• MalfunctionDec 14, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, HEAVILY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.75X15 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION DUE TO THE ANATOMY. ADVANCEMENT WAS ATTEMPTED AGAIN WITH A GUIDELINER; HOWEVER, THE SDS STILL FAILED TO ADVANCE. THE SDS WAS REMOVED WITH RESISTANCE NOTED WITH THE ANATOMY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11004133 ↗
• MalfunctionDec 10, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 2.75X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS INFLATED TO 12ATMS. THE PROXIMAL EDGE OF THIS STENT WAS THE ONLY PORTION THAT OPENED AND REMAINED FLARED. A LEAK WAS NOT NOTED. THE SDS WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. A NEW UNSPECIFIED STENT 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 Consequences Or Impact To Patient

  MAUDE report 10984537 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION BEFORE THE INITIAL PROCEDURE. A 2.75X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSTABLE ANGINA. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10970950 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT, WITH A HISTORY OF NON-ST ELEVATION MYOCARDIAL INFARCTION, UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 2.75 X 15 MM XIENCE SIERRA STENT. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH HYPOTENSION AND HEART FAILURE. MEDICATION WAS ADMINISTERED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 10953823 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH ELEVATED CARDIAC ENZYMES AND A PROXIMAL CIRCUMFLEX (CX), 99% STENOSED LESION AND 1ST OBTUSE MARGINAL (OM), 80% STENOSED LESION. PRE-DILATATION WAS PERFORMED ON THE PROXIMAL CX, AND A 2.5X12MM XIENCE SIERRA STENT AND A 2.75X15MM STENT WERE IMPLANTED. A 2.25X8MM AND A 2.5X12MM XIENCE SIERRA STENT WERE IMPLANTED IN THE 1ST OM. POST-DILATATION HAD BEEN PERFORMED WITH TIMI FLOW III AND 0% RESIDUAL STENOSIS. THERE WAS NO DEVICE MALFUNCTION REPORTED. ON (B)(6) 2020, THE PATIENT PRESENTED WITH CHEST PAIN. AN ELECTIVE CARDIO-ANGIOGRAM WAS PERFORMED DISPLAYING PROXIMAL CX 70% RESTENOSIS, 1ST OM, 90% RESTENOSIS, RIGHT CORONARY ARTERY 50% RESTENOSIS. REPORTEDLY, ONLY THE PROXIMAL CX 2.75X15MM XIENCE SIERRA STENT RESTENOSED. THE 2.5X12MM, 2.25X8MM, AND 2.5X12MM XIENCE SIERRA STENTS HAD REMAINED PATENT, WITHOUT RESTENOSIS. AS TREATMENT, ANOTHER PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE 1ST OM AND A STENT WAS IMPLANTED IN THE PROXIMAL CX. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 10564061 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND A 2.75X15MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND HYPERTENSIVE HEART FAILURE DISEASE. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 10535925 ↗
• InjuryJul 6, 2020Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE NON-TORTUOUS MID LEFT ANTERIOR LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED AND 90% STENOSED. FOLLOWING PRE-DILATATION, THE XIENCE SIERRA STENT SYSTEM WAS INTRODUCED INTO THE ANATOMY, PREPARED FOR USE AND ADVANCED TO THE LESION. DURING STENT DEPLOYMENT, THE BALLOON RUPTURED AT 14 ATMOSPHERES. ANGIOGRAPHY INDICATED THAT THE STENT WAS NOT FULLY EXPANDED; THUS, POST DILATATION WAS PERFORMED WITH AN NC TRAVELER BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237694 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 2.75X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED DUE TO CHEST PAIN, AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10169429 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND THREE (2.75X15MM, 2.75X38MM, AND 3.5X23MM) XIENCE SIERRA STENTS AND ONE UNSPECIFIED ALPINE RX STENT WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND HYPOTENSIVE HEART FAILURE. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 10155184 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION BEFORE THE PROCEDURE. ON (B)(6)2020, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROSIS. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10154112 ↗
• MalfunctionJun 3, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION. AFTER MULTIPLE ATTEMPTS, THE 2.75X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE HEAVILY CALCIFIED LESION. DURING REMOVAL, RESISTANCE WAS MET WITH THE ANATOMY, BUT THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DIFFERENT SIZED SDS, IN CONJUNCTION WITH A GUIDELINER, WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117014 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.75X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 AND (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROTIC HEART DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Stenosis

  MAUDE report 9788004 ↗
• DeathJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(64) 2019 THE XIENCE SIERRA 3.25X23 MM STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND THE XIENCE SIERRA 2.75X15 MM WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT HAD RIGHT SIDED PAIN RADIATING TO THE NECK AND JAW. THE CARDIAC ENZYMES INDICATED THAT THE PATIENT HAD A MYOCARDIAL INFARCTION MEDICATION WAS ADMINISTERED ON (B)(6)2019. DIAGNOSTIC IMAGING ONLY WAS PERFORMED ON (B)(6) 2019. THE ANGIOGRAM FOUND 90 TO 99% RESTENOSIS IN THE LAD AND LCX STENTS. THERE WAS ALSO RESTENOSIS IN THE OBTUSE MARGINAL AND THE RIGHT CORONARY ARTERIES. THE PATIENT WENT INTO CARDIAC ARREST ON (B)(6) 2019, BUT WAS SUCCESSFULLY RESUSCITATED. SUBSEQUENTLY, THE PATIENT STATUS WAS CHANGED TO DO NOT RESUSCITATE. CARDIAC ARREST OCCURRED AGAIN AND THE PATIENT EXPIRED ON 11/14/2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 9566931 ↗
• MalfunctionNov 18, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH MILD CALCIFICATION AND MILD TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING ADVANCEMENT OF THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) THROUGH THE GUIDING CATHETER, THERE WAS RESISTANCE AND THE PROXIMAL SHAFT SEPARATED IN TWO PIECES. THE DISTAL SHAFT REMAINED IN THE GUIDING CATHETER; THEREFORE, THE COMPLETE SDS WAS REMOVED FROM THE PATIENT ANATOMY. A NEW SDS WAS ADVANCED THROUGH THE GUIDING CATHETER WITH NO ISSUE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335808 ↗
• MalfunctionNov 14, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 2.75X15MM XIENCE SIERRA STENT WAS DEPLOYED WITHOUT ISSUES; HOWEVER, IT WAS NOTED THAT IT WAS DEPLOYED AFTER EXPIRATION. THE PROCEDURE WAS SUCCESSFULLY CONCLUDED AFTER THE DEPLOYMENT OF THE EXPIRED 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 9324942 ↗
• MalfunctionNov 12, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. A 2.75X15MM XIENCE SIERRA STENT WAS IMPLANTED AT THE LESION WITHOUT ISSUE. AFTERWARDS, IT WAS NOTED THAT THE STENT EXPIRED ON 10/8/2019. THE PATIENT IS FINE. 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 9310014 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED FOR AN INFECTION. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 8725206 ↗
• MalfunctionMay 7, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-COMPLEX LESION LOCATED IN THE MID CIRCUMFLEX CORONARY ARTERY. THE XIENCE SIERRA STENT WAS IMPLANTED ONE DAY PAST ITS EXPIRATION DATE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586340 ↗