XIENCE Sierra™ 1550350-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08717648227424), received between Jun 13, 2018 and Jun 28, 2023 — classified as 1 death, 30 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HYPOGLYCEMIC EVENT AND CHEST PAINS. THE PROCEDURE WAS TO TREAT A RESTENOSIS IN AN UNSPECIFIED ARTERY. THE 3.5X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020, HOWEVER, THE PATIENT WENT BACK TO THE HOSPITAL ON (B)(6) 2023 DUE TO THE STENT BEING BLOCKED BY SCAR TISSUE. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY (DAPT) AFTER THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED TO CONFIRM RESTENOSIS. A BALLOON WAS USED TO OPEN UP THE IMPLANTED STENT. THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELAE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 17218138 ↗
• InjuryOct 18, 2021Difficult to Remove; Material Rupture; Device Dislodged or Dislocated; Difficult to Remove; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CIRCUMFLEX ARTERY. TWO XIENCE SIERRA STENT DELIVERY SYSTEMS (SDS) (2.25X38 AND 3.0X38MM) WERE IMPLANTED WITHOUT ISSUE; HOWEVER, THE PHYSICIAN DID NOT LIKE THE APPOSITION OF WHERE BOTH STENTS OVER LAPPED IN THE MIDDLE. THEREFORE, THE 3.50X18MM XIENCE SIERRA SDS WAS ADVANCED WITH NO ISSUE, BUT THE BALLOON RUPTURED AT 2 ATMOSPHERES. THERE WAS DIFFICULTY REMOVING THE SDS DUE TO THE ANATOMY AND THE STENT BECAME DISLODGED. A 3.5X15MM NON-COMPLIANT BALLOON WAS ADVANCED AND USED TO TREAT THE MALPOSITION. THEN AN UNSPECIFIED TREK BALLOON WAS USED TO BRING THE DISLODGED STENT BACK INTO THE UNSPECIFIED GUIDE CATHETER AND REMOVE ALL OF THE DEVICES AS ONE UNIT. ONCE THE DEVICE WAS REMOVED IT WAS NOTED THE STENT WAS NOT IN THE GUIDE CATHETER AND REMAINED STUCK AT THE RIGHT GROIN. THE PATIENT WAS SENT TO SURGERY AND A CUT DOWN WAS PERFORMED TO SUCCESSFULLY REMOVE THE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647264 ↗
• InjuryAug 31, 2021Adverse 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. TWO XIENCE SIERRA STENTS (3.5X18MM AND 3.0X12MM) WERE IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS ADMITTED WITH CHEST PAIN (ANGINA). UNSPECIFIED TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 12398544 ↗
• MalfunctionJul 19, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (DRCA). DURING THE PROCEDURE, THE 3.5X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS ADVANCED TOWARDS THE TARGET LESION BUT COULD NOT CROSS THE CALCIFIED ANATOMY. DURING WITHDRAWAL OF THE DES FROM THE ANATOMY, THE STENT WAS DIFFICULT TO REMOVE FROM THE COPILOT AND WAS NOTED TO BE CRUSHED UPON REMOVAL, POSSIBLY FROM THE INTERACTION WITH THE ANATOMY. ANOTHER SAME SIZE XIENCE SIERRA 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 12189326 ↗
• InjuryMay 27, 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI); THEREFORE, THE 3.50X18MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED WITH HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11897658 ↗
• MalfunctionApr 27, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE DIAGONAL ARTERY. A 3.5X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR USE; HOWEVER, A NEGATIVE WAS NOT PULLED PRIOR TO USE OF THE STENT DURING PREPARATION. FOLLOWING PRE-DILATATION, THE SDS FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS BEING REMOVED, BUT RESISTANCE WITH THE GUIDE CATHETER WAS FELT AND THE STENT DISLODGED OFF THE BALLOON WHILE IN THE GUIDE CATHETER. THE DISLODGED STENT, SDS, AND GUIDE CATHETER WERE ALL SIMPLY REMOVED AS A UNIT. A SECOND 3.5X18MM XIENCE SIERRA SDS WAS ADVANCED BUT FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. ALL EQUIPMENT WAS REMOVED AND IT WAS NOTED THAT THE STENT STRUT WAS FLARED. A NEW GUIDE WIRE WAS INSERTED. A 3.5X08MM XIENCE SIERRA SDS WAS ADVANCED, BUT THIS TOO FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.5X12MM 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11734835 ↗
• InjuryMar 30, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND NO TORTUOSITY. DURING USE OF THE 3.50X18 MM XIENCE SIERRA STENT DELIVERY SYSTEM, RESISTANCE WAS NOTED DURING ADVANCEMENT AND THE SDS COULD NOT REACH THE LESION. THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE BALLOON OF THE DELIVERY SYSTEM WAS USED TO BRING THE STENT TO THE ACCESS SITE BUT IT WAS STUCK IN THE ARTERIOTOMY AND REQUIRED SURGERY TO BE REMOVED. FINAL PATIENT OUTCOME IS OK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593104 ↗
• InjuryFeb 8, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH NO CALCIFICATION AD NO TORTUOSITY. THE XIENCE SIERRA 3.5X18 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUES. TO DEPLOY THE STENT, THE BALLOON WAS INFLATED THREE SEPARATE TIMES AT THREE SEPARATE ATMOSPHERES (1ST AT 15ATMS, 2ND AT 17 ATMS AND 3RD AT 19ATMS). HOWEVER, WHEN ATTEMPTING TO RETRACT THE DELIVERY SYSTEM, IT WAS OBSERVED THAT THE STENT DID NOT FULLY DEPLOY. THE STENT WAS STILL ATTACHED TO THE DELIVERY SYSTEM AND WAS NOW IN THE MID RCA. THE PHYSICIAN WAS THEN ABLE TO BE DETACH THE STENT FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUES, BUT THE STENT REMAINED IN THE MID RCA. THE PATIENT WAS THEN IMMEDIATELY TRANSPORTED TO A DIFFERENT HOSPITAL WHERE THE STENT WAS ATTEMPTED TO BE RETRIEVED. HOWEVER, THE RETRIEVAL OF THE STENT WAS UNSUCCESSFUL, AND THE STENT WAS LEFT STUCK IN THE MID RCA. IT WAS NOTED THAT THE TARGET LESION WAS NEVER TREATED. THE PATIENT IS NOW IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11294001 ↗
• InjuryDec 8, 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 3.5X18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THIS PATIENT WHO HAD A NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AGAIN WITH A NSTEMI. TREATMENT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 10969241 ↗
• MalfunctionDec 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A 3.5X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS RETURNED TO THE RETURNS GOOD LAB (RG) WITH A HAND WRITTEN ¿STENT BROKE¿ ON A YELLOW POST-IT NOTE. A QUICK VISUAL INSPECTION NOTED THAT THE PROXIMAL PORTION OF THE HYPOTUBE WAS SEPARATED, INCLUDING THE HUB. BLOOD WAS NOTED ON AND INSIDE OF THE DEVICE AND THE BALLOON HAD BEEN PARTIALLY INFLATED. THE STENT WAS DEPLOYED BUT NOT RETURNED WITH THE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 10968983 ↗
• MalfunctionNov 25, 2020Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION AND MILD TORTUOSITY IN THE LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING ATHERECTOMY, A 3.50 X 18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) PROTECTIVE SHEATH WAS REMOVED WITHOUT RESISTANCE AND THE SDS WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS NOTED WITH THE GUIDING CATHETER. ON ATTEMPTING TO DEPLOY THE STENT OF THE SDS, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 4 ATMOSPHERES AND THE STENT FAILED TO EXPAND. THE SDS [AND STENT] WAS SIMPLY REMOVED WITHOUT ANY RESISTANCE. ANOTHER XIENCE SIERRA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS SUSPECTED THAT THE RESISTANCE INSIDE THE GUIDING CATHETER WAS THE REASON WHY THE BALLOON RUPTURE OCCURRED. THERE WERE NO REPORTED 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 10901089 ↗
• InjuryAug 12, 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 3.5X18MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITHOUT INCIDENT. ON (B)(6) 2020 THE PATIENT HAD RECURRENT LEFT SIDED CHEST PAIN (PRECORDIAL CHEST PAIN/PRESSURE) WHILE HE WAS PLAYING CARDS WITH HIS WIFE. THE ELECTROCARDIOGRAM SHOWED SINUS RHYTHM, BUT THERE WAS AN INCREASE IN TROPONIN I TO 0.72. A CORONARY ANGIOGRAM PERFORMED ON (B)(6) 2020 SHOWED A SMALL NON ST ELEVATION MYOCARDIAL INFARCTION MOST LIKELY DUE TO THE APICAL LAD, TRANSIENT STENT THROMBUS, OR OTHER SMALL VESSEL DISEASE. THE LAD IS NOT AMENABLE TO PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT WILL BE TREATED WITH OPTIMAL MEDICAL THERAPY, INCLUDING ONE YEAR OF PLAVIX. THE CONDITION RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 10396190 ↗
• MalfunctionJul 28, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A 3.5X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) CROSSED; HOWEVER, FAILED TO EXPAND PROPERLY AND ONLY PARTIALLY INFLATED. THE SDS WAS REMOVED WITH THE STENT ON IT WITHOUT ANY ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNSPECIFIED DEVICE. 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 10333313 ↗
• MalfunctionJul 22, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE 3.5X18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) EXPERIENCED RESISTANCE DURING ADVANCEMENT WITH THE GUIDING CATHETER. THE SDS SEPARATED AT THE MID SHAFT AND WAS ABLE TO BE RETRIEVED WITH THE GUIDE WIRE ALREADY IN THE ANATOMY. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND 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 10309670 ↗
• MalfunctionJun 22, 2020Patient-Device Incompatibility; Device Damaged by Another Device; Difficult to Advance; Material Deformation; Patient-Device Incompatibility; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY VIA RIGHT RADIAL ACCESS. THE 3.5X18 MM XIENCE SIERRA STENT WAS FIRST IMPLANTED IN THE PROXIMAL LAD (PLAD) AND WAS POSSIBLY UNDER EXPANDED. NEXT, THE PHYSICIAN WENT THROUGH THE STENT IN THE PLAD TO PLACE A 3.0X18 MM XIENCE SIERRA STENT IN THE MLAD WITH NO ISSUES REPORTED. NEXT, THE CIRCUMFLEX (CX) CORONARY ARTERY WAS WIRED THROUGH A STRUT OF THE 3.5X18 XIENCE SIERRA STENT AND IT WAS ATTEMPTED TO PLACE A 3.5X12MM XIENCE SIERRA STENT IN THE CX BUT THE STENT WOULD NOT CROSS THE PREVIOUSLY IMPLANTED STENT. THE STENT WAS REMOVED WITHOUT ISSUE AND THERE WERE NO OTHER ISSUES NOTED. THE PHYSICIAN REMOVED BOTH GUIDE WIRES AND THE GUIDE CATHETER AND WHEN THEY WERE REMOVED, THE 3.5X18 MM XIENCE SIERRA STENT WAS FOUND ON THE END OF THE GUIDE CATHETER UNRAVELED. THE PROCEDURE WAS COMPLETED. THE PATIENT IS STABLE AND BEING DISCHARGED AND PLANS TO RETURN IN 1 WEEK TO HAVE ANOTHER ANGIOGRAPHY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179695 ↗
• InjuryJun 16, 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) 2018, A 3.5 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. THE PATIENT WAS DISCHARGED TO HOME THE DAY OF THE PROCEDURE. ON (B)(6) 2020, THE PATIENT HAD COMPLAINTS OF DYSPNEA ON EXERTION, DIZZINESS AND NON-RADIATING LEFT SIDED CHEST PAIN, OCCURRING DURING EXERTION AND RESOLVING WITH REST. CORONARY ANGIOGRAM WAS PERFORMED IN-STENT RESTENOSIS WAS NOTED IN THE CIRCUMFLEX (CX) ARTERY. AN ADDITIONAL DRUG ELUTING STENT WAS IMPLANTED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Dyspnea; Stenosis

  MAUDE report 10160886 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION AND MYOPATHY BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH MYOPATHY. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10153118 ↗
• MalfunctionMar 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A 3.5X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), THE DEVICE WAS REMOVED FROM THE DISPENSER COIL AND THE PROTECTIVE SHEATH WAS REMOVED; HOWEVER, IT WAS NOTED THAT THE STENT WAS OFF CENTER. THE DEVICE WAS NOT USED IN THE PATIENT AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9901467 ↗
• InjuryMar 14, 2020Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AT THE DIAGONAL BIFURCATION, THAT WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. THE PATIENT HAD TORTUOSITY HIS IN LEGS ALSO. DURING ADVANCEMENT OF THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), AFTER EXITING THE GUIDE CATHETER, ACCESS WAS LOST, SO THE SDS WAS RETRACTED, AND REMOVED FROM THE ANATOMY. UPON REMOVAL, THE STENT WAS NOTED TO BE DISLODGED AND WAS FOUND LODGED IN THE RIGHT POSTERIOR TIBIAL ARTERY. THE DISLODGED STENT WAS SNARED AND SUCCESSFULLY REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A SAME SIZE XIENCE SIERRA WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832916 ↗
• InjuryMar 8, 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 ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). TWO (3.5X18MM, 3.25X38MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED DUE TO COMPLICATIONS OF THE ARTERY. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803960 ↗
• InjuryMar 8, 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). A 3.50X18MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803946 ↗
• InjuryFeb 27, 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 LESION IN THE NON-CALCIFIED, NON-TORTUOUS RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION, SO A 3.5X18MM XIENCE SIERRA STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. ON THE SAME DAY, THE PATIENT EXPERIENCED CHEST PAIN AND CARDIAC ARREST. A DEFIBRILLATOR WAS USED AND CPR WAS GIVEN AS TREATMENT. IN-STENT THROMBOSIS WAS CONFIRMED VIA ANGIOGRAPHY, SO AN UNSPECIFIED BALLOON WAS USED FOR DILATATION. TWO UNSPECIFIED STENTS WERE IMPLANTED, AND THE PATIENT WAS DISCHARGED THREE DAYS LATER. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Arrest; Thrombosis

  MAUDE report 9765773 ↗
• MalfunctionFeb 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, AND BEFORE USE IN THE PATIENT, WHEN THE STYLET WAS REMOVED, THE STENT WAS PULLED OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9674079 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.50X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH AN ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9418992 ↗
• InjuryNov 2, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCE IN THE PATIENT, BUT FAILED TO CROSS DUE TO THE HEAVILY CALCIFIED ANATOMY. DURING REMOVAL, THERE WAS RESISTANCE WITH THE ANATOMY, AND THE STENT DISLODGED FROM THE BALLOON. A NON-ABBOTT STENT WAS DEPLOYED AND CRUSHED THE STENT TO THE VESSEL WALL TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9270314 ↗