XIENCE Sierra™ 1550350-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648227400), received between Aug 1, 2018 and Apr 28, 2023 — classified as 1 death, 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2023Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND THE OSTIAL RCA WITHOUT CALCIFICATION OR TORTUOSITY. TWO XIENCE SIERRA STENTS, 2.25X23MM AND 3.5X12MM, WERE ADVANCED WITHOUT RESISTANCE AND IMPLANTED. HOWEVER, THE DISTAL END OF THE 3.5X12MM XIENCE SIERRA STENT DEPLOYED IN THE OSTIAL RCA WAS HARD TO VISUALIZE DURING CONTRAST INJECTIONS AND THE STENT PLACEMENT WAS A GEOGRAPHICAL MISS. THE DISTAL END OF THE STENT WAS BARELY ATTACHED TO THE VESSEL WALL AND ONCE THE STENT DELIVERY SYSTEM AND GUIDE WIRE WERE REMOVED WITHOUT RESISTANCE, THE STENT DISLODGED. SINCE THE STENT CANNOT BE VISUALIZED, THE DISLODGED STENT WAS UNABLE TO BE RETRIEVED AND NO ATTEMPTS WERE MADE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16834917 ↗
• InjuryApr 19, 2022Difficult 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 THE PROCEDURE WAS PERFORMED TO TREAT A SPONTANEOUS CORONARY ARTERY DISSECTION (SCAD) IN THE CIRCUMFLEX (CX) ARTERY. TWO UNKNOWN STENTS WERE IMPLANTED FIRST, A 3.0X38 MM STENT IN THE DISTAL CX AND A 3.5X38 IN THE PROXIMAL CX. THE 3.5X12 MM SIERRA STENT DELIVERY SYSTEM (SDS) WAS TO BE IMPLANTED IN THE GAP BETWEEN THE TWO STENTS. BUT THE SIERRA SDS FAILED TO CROSS THROUGH THE 3.5X38 STENT. RESISTANCE WAS FELT DURING REMOVAL AND THE STENT DISLODGED FROM THE BALLOON. ATTEMPTS TO RETRIEVE THE STENT WERE UNSUCCESSFUL. THE STENT IS FREE-FLOATING IN THE LEFT POSTERIOR DESCENDING ARTERY. THERE WAS NO INJURY AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THE PATIENT IS STABLE. THERE WAS NO DAMAGE TO THE PREVIOUSLY IMPLANTED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14142260 ↗
• MalfunctionAug 9, 2021Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. DURING ADVANCEMENT OF THE XIENCE SIERRA DES 3.50X12 RX US, RESISTANCE WAS FELT WITH THE GUIDING CATHETER, AND WHEN REMOVED THE STENT STRUTS WERE FLARED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE. DEVICE ANALYSIS REVEALED THE STENT IMPLANT WAS DISLOCATED ON THE BALLOON AS IT WAS MOVED DISTALLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298252 ↗
• MalfunctionJun 3, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS AND 90% STENOSED. AFTER PRE-DILATATION, A 3.5 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY AND THERE WAS RESISTANCE DURING REMOVAL. THE DEVICE WAS REPLACED WITH A DRUG COATED BALLOON TO COMPLETE PROCEDURE. THERE WERE NO REPORTED 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 11936302 ↗
• InjuryJan 13, 2021Patient-Device Incompatibility; Device Damaged by Another Device; Patient-Device Incompatibility; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE NON-CALCIFIED, NON-TORTUOUS RIGHT CORONARY ARTERY. A 3.5X12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT PRE-DILATATION, AND THE STENT WAS DEPLOYED WITHOUT ISSUE. AN UNSPECIFIED 4X12MM NC BALLOON WAS USED FOR POST-DILATATION AT 18 ATMOSPHERES WHEN THE BALLOON RUPTURED. AFTER THE BALLOON WAS REMOVED, THE IMPLANTED STENT APPEARED MALAPPOSED DUE TO THE BALLOON RUPTURE, SO A NEW GUIDE WIRE AND BALLOON WERE USED TO DILATE THE STENT AGAIN. AN UNSPECIFIED 4.0MM STENT WAS IMPLANTED ELSEWHERE IN THE ANATOMY. 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 11164057 ↗
• 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 HYPERTENSIVE HEART AND A 3.5X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND CANDIDAL SEPSIS. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10535132 ↗
• InjurySep 10, 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-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. TWO XIENCE SIERRA STENTS (3.50X12MM AND 3.50X18MM) WERE IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING INFECTION. THE PATIENT WAS TREATED WITH SURGERY AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10518151 ↗
• InjurySep 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 PATIENT HAD A 3.50X12 MM AND A 3.50X15 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED DUE TO NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND WAS TREATED WITH ANGIOPLASTY. FINAL PATIENT OUTCOME IS LISTED AS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 10504800 ↗
• MalfunctionJul 20, 2020Defective Device; Material Deformation; Defective Device; Material Deformation

  (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE FIRST 3.5 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, ON ANGIOGRAPHY, THE STENT DELIVERY SYSTEM BALLOON APPEARED SLIGHTLY INFLATED, AS IF THE STENT WAS SLIGHTLY EXPANDED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THE STENT REMAINED ON THE DELIVERY SYSTEM BALLOON. THE SECOND 3.5 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE TARGET LESION. NO DIFFICULTY WAS NOTED; HOWEVER, THIS STENT DELIVERY SYSTEM BALLOON ALSO APPEARED SLIGHTLY INFLATED, AS IF THE STENT WAS SLIGHTLY EXPANDED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THE STENT REMAINED ON THE DELIVERY SYSTEM BALLOON. THE PROCEDURE CONTINUED WITH IMPLANTATION OF A 3.5 X 15 MM XIENCE SIERRA STENT. 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 10299454 ↗
• MalfunctionJul 20, 2020Defective Device; Material Deformation; Defective Device; Material Deformation

  (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE FIRST 3.5 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, ON ANGIOGRAPHY, THE STENT DELIVERY SYSTEM BALLOON APPEARED SLIGHTLY INFLATED, AS IF THE STENT WAS SLIGHTLY EXPANDED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THE STENT REMAINED ON THE DELIVERY SYSTEM BALLOON. THE SECOND 3.5 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE TARGET LESION. NO DIFFICULTY WAS NOTED; HOWEVER, THIS STENT DELIVERY SYSTEM BALLOON ALSO APPEARED SLIGHTLY INFLATED, AS IF THE STENT WAS SLIGHTLY EXPANDED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THE STENT REMAINED ON THE DELIVERY SYSTEM BALLOON. THE PROCEDURE CONTINUED WITH IMPLANTATION OF A 3.5 X 15 MM XIENCE SIERRA STENT. 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 10299449 ↗
• MalfunctionMay 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT OF A 3.5X12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS NOTED TO NOT BE MOUNTED ON THE PROPER POSITION ON THE BALLOON DURING PREPARATION OF THE DEVICE. THE SDS WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED XIENCE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10089816 ↗
• InjuryApr 8, 2020Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS SEVERELY CALCIFIED. FOLLOWING PRE-DILATATION WITH A 3.0 MM BALLOON, A XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AGAINST SLIGHT RESISTANCE. WHEN THE SDS WAS PULLED BACK TO CONFIRM THE POSITION TO IMPLANT, DUE TO THE CALCIFICATION IN THE LESION, THE STENT DISLODGED. THE DISLODGED STENT WAS RETRIEVED WITH A SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER XIENCE SIERRA WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9936405 ↗
• InjuryFeb 27, 2020Adverse 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 TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED AND PLAQUE SHIFT OCCURRED. A SECOND UNSPECIFIED STENT WAS IMPLANTED. OPTICAL COHERENCE TOMOGRAPHY WAS PERFORMED AND A DISSECTION WAS NOTED, RELATED TO THE PLAQUE SHIFT OCCURRING AFTER DEPLOYMENT OF THE 3.5 X 12 MM XIENCE SIERRA STENT. A THIRD STENT WAS IMPLANTED IN THE RAMUS ARTERY VIA KISSING TECHNIQUE, SUCCESSFULLY TREATING THE DISSECTION. THE EVENT RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection; Prolapse

  MAUDE report 9766169 ↗
• DeathFeb 4, 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 3/4/2019 THE 3.5X12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT HAD CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AND TREATED WITH MEDICATION. THE CONDITION WAS DEALT WITH AS SECONDARY TO HYPERTENSIVE URGENCY. A CORONARY ANGIOGRAM WAS NOT PERFORMED BECAUSE OF THE PATIENT'S HISTORY OF ADVANCED CHRONIC KIDNEY DISEASE. THE CONDITION RESOLVED ON (B)(6) 2020. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTING AGAIN WITH SHORTNESS OF BREATH AND CHEST PAIN. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2020 THE PATIENT HAD UNSTABLE ANGINA. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON (B)(6) 2020. ON (B)(6) 2020 THE PATIENT WENT INTO VENTRICULAR FIBRILLATION/CARDIAC ARREST. CARDIO-PULMONARY RESUSCITATION WAS PERFORMED AND MEDICATION WAS ADMINISTERED. THE PATIENT WAS PRONOUNCED DEAD IN THE EMERGENCY ROOM. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Angina; Cardiac Arrest; Cardiac Enzyme Elevation; Death; Dyspnea; High Blood Pressure/ Hypertension; Ventricular Fibrillation

  MAUDE report 9666695 ↗
• InjuryDec 9, 2019Adverse 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 3.50X12MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9438566 ↗
• MalfunctionSep 10, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY DE NOVO ARTERY THAT WAS 75% STENOSED. A 3.50X12MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO AN INTERACTION WITH AN INTRAVASCULAR ULTRASOUND (IVUS) DEVICE. THERE WAS RESISTANCE NOTED WITH THE IVUS DEVICE DURING REMOVAL. A NEW NON-ABBOTT STENT WAS USED TO SUCCESSFUL 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 8984461 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH HYPERTENSIVE HEART AND OTHER CARDIOVASCULAR SYMPTOMS ANGINA. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 8958552 ↗
• InjuryJun 24, 2019Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT MAIN CORONARY ARTERY. AN UNSPECIFIED STENT WAS DEPLOYED IN THE PROXIMAL LEFT MAIN. THEN, A STENT WAS NEED TO BE PLACED DISTAL TO THE IMPLANTED STENT BUT IT BECAME STUCK WITH THE IMPLANTED STENT. THE STENT DISLODGED FROM THE BALLOON SO IT WAS DECIDED TO EMBED THE STENT IN THE VESSEL WALL. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8728583 ↗
• InjuryJun 14, 2019Adverse 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-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND 4 XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE AND OTHER CARDIOVASCULAR SYMPTOMS. THE TYPE OF INTERVENTION HAS NOT BEEN REPORTED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8702044 ↗
• InjuryJun 14, 2019Adverse 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-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND A 2.50 X 12 MM AND 3.50 X 12 MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH THROMBOSIS OF THE STENT AND OTHER CARDIOVASCULAR SYMPTOMS. A 2.50 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED AS TREATMENT. FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 8702001 ↗
• InjuryMar 6, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID CIRCUMFLEX (CX) ARTERY. A 3.5 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS USED; HOWEVER, THE SDS MET RESISTANCE WITH THE ANATOMY AND FAILED TO CROSS THE LESION. ADDITIONALLY, THE STENT DISLODGED FROM THE STENT DELIVERY BALLOON AND REMAINED IN THE PROXIMAL CX ARTERY. THEREFORE, AN UNSPECIFIED TREK BALLOON CATHETER WAS USED TO FULLY APPOSE THE STENT TO THE VESSEL WALL. TWO ADDITIONAL UNSPECIFIED STENTS WERE THEN ADVANCED THROUGH THE XIENCE SIERRA STENT TO TREAT THE TARGET LESION IN THE MID CX ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8395399 ↗
• InjuryOct 9, 2018Difficult 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 IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, RIGHT CORONARY ARTERY. THE 3.5X12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE PATIENT ANATOMY; HOWEVER THE SDS FAILED TO CROSS THE TARGET LESION DUE TO RESISTANCE FELT WITH A PREVIOUSLY IMPLANTED STENT. RESISTANCE WAS FELT WITH THE PREVIOUSLY IMPLANTED STENT DURING REMOVAL, AND THE SIERRA STENT DISLODGED IN THE IMPLANTED STENT. AN UNSPECIFIED BALLOON WAS USED TO DEPLOY THE SIERRA STENT INSIDE THE IMPLANTED STENT. THE LESION WAS TREATED WITH A 4.0MM BALLOON. THE PATIENT IS STABLE. THERE WAS CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7948593 ↗
• InjuryAug 1, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX. DURING ADVANCEMENT OF THE 3.50X12MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS MET AND THE STENT DISLODGED FROM THE BALLOON. A 2.0MM RX TREK BALLOON WAS USED TO DEPLOY THE DISLODGED STENT PROXIMAL TO THE TARGET LESION. A 3.0X12MM NC TREK BALLOON WAS USED TO POST DILATE THE STENT. A 3.50X8MM SIERRA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7739443 ↗