XIENCE Sierra™ 1550350-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08717648227448), received between Dec 18, 2018 and Dec 14, 2021 — classified as 4 deaths, 20 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• DeathDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 TWO XIENCE SIERRA STENTS WERE IMPLANTED WITHOUT ISSUE, A 3.0X8MM AND A 3.5X28MM. ON (B)(6) 2021 THE PATIENT WAS RE-HOSPITALIZED DUE TO CARDIAC DISTURBANCES. IN-STENT THROMBOSIS WAS SUSPECTED. THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND ULTIMATELY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 12992607 ↗
• MalfunctionOct 26, 2021Difficult to Remove; Failure to Advance; Material Deformation; Material Twisted/Bent; Difficult to Remove; Failure to Advance; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS MILDLY CALCIFIED AND HEAVILY TORTUOUS. THE XIENCE SIERRA STENT DELIVERY SYSTEM MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS. DURING REMOVAL, THERE WAS ALSO RESISTANCE WITH THE ANATOMY. THE PROXIMAL SHAFT BENT AND THE STENT STRUTS FLARED. A NEW XIENCE SIERRA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701595 ↗
• InjurySep 22, 2021Adverse 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) 2019, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, MODERATELY CALCIFIED LESION WITH IN-STENT RESTENOSIS (STENT NOT SPECIFIED). PRE-DILATATION WAS PERFORMED AND A 3.5X28MM XIENCE SIERRA STENT (1550350-28, 9052341) WAS IMPLANTED IN THE PROXIMAL LAD. FOLLOWING, AN INTRA-STENT PLAQUE PROTRUSION WAS OBSERVED, LEFT UNTREATED. A DISTAL STENT EDGE DISSECTION HAD ALSO OCCURRED WITH ADDITIONAL DILATATION PERFORMED FOLLOWING. 0% RESIDUAL STENOSIS WITH TIMI FLOW III WAS OBSERVED FOLLOWING. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH MIDSTERNAL PRESSURE ON EXERTION, ALONG WITH DYSPNEA. IMAGING WAS PERFORMED AND THE OSTIAL LAD HAD 90% STENOSIS WITH 95% MID IN-STENT RESTENOSIS. THE RIGHT CORONARY ARTERY (RCA) WAS OCCLUDED WITH COLLATERALS. THE 3.5X28MM XIENCE SIERRA STENT HAD REMAINED PATENT, WITHOUT RESTENOSIS. ON (B)(6) 2021, A CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED. A GRAFT WAS PLACED TO THE LAD AND POSTERIOR DESCENDING CORONARY ARTERY. PER PHYSICIAN, THE EVENT STARTING ON (B)(6) 2021 WAS UNRELATED TO THE XIENCE SIERRA STENT AND UNRELATED TO THE INDEX PRO

  Patient problems: Prolapse; Vascular Dissection

  MAUDE report 12516801 ↗
• InjuryAug 31, 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THE 3.50X28MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND ACUTE STEMI. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 12392276 ↗
• MalfunctionAug 12, 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 RIGHT CORONARY ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE XIENCE SIERRA STENT SYSTEM WAS ADVANCED, BUT FAILED TO CROSS DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS NOTED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316006 ↗
• DeathAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THIS PATIENT WAS A PROHIBITIVE RISK FOR ANY SURGICAL INTERVENTION. AT THE BEGINNING OF THE CORONARY PROCEDURE, AN IMPELLA DEVICE WAS PLACED. ORBITAL ATHERECTOMY WAS PERFORMED IN THE LAD. THE 3.5X28 MM XIENCE SIERRA STENT WAS DEPLOYED AT NOMINAL PRESSURE. A NON-COMPLIANT 4.0 BALLOON DILATATION WAS INFLATED TO 16 ATMOSPHERES AND RESULTED IN A PERFORATION IN THE MID SEGMENT OF THE XIENCE STENT. BALLOON TAMPONADE AND EMERGENT PERICARDIOCENTESIS WERE PERFORMED TO STABILIZE THE PATIENT. EPINEPHRINE PUSHES WERE ADMINISTERED TO MAINTAIN BLOOD PRESSURE ALONG WITH AGGRESSIVE HYDRATION. THE PATIENT WAS MOVING AND WAS THUS PARALYZED AND INTUBATED FOR SAFETY REASONS. THE 3.5X19 MM GRAFTMASTER STENT WAS IMPLANTED IN THE DISTAL SEGMENT OF THE XIENCE STENT AND INFLATED TO 20 ATMOSPHERES. THERE WAS INADEQUATE WALL APPOSITION OF THE GRAFTMASTER WITH EVIDENCE OF CONTINUED PERFORATION AND EXTRAVASATION. A NON-COMPLIANT BALLOON WAS INSERTED, BUT WAS UNABLE TO BE DELIVERED. THE GUIDE CATHETER WAS REPLACED WITH ANOTHER GUIDE CATHETER. A GUIDE LINER WAS INCH-WORMED INTO THE MID LAD.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 12304613 ↗
• MalfunctionJun 28, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.5X28 MM XIENCE SIERRA STENT WAS ADVANCED TO THE LAD, BUT IT WAS UNABLE TO BE DEPLOYED. THE STENT DID NOT COME OFF THE BALLOON DELIVERY SYSTEM DURING DEPLOYMENT. THE UNDEPLOYED STENT WAS REMOVED WITH THE DELIVERY SYSTEM. ANOTHER 3.5X28 XIENCE SIERRA WAS USED WITHOUT INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED VIA AN USER FACILITY MEDWATCH. THE USER FACILITY MEDWATCH STATES: "SCRUB TECH PULLED YELLOW PROTECTANT COVER OFF DISTAL END OF STENT DELIVERY DEVICE AND FELT RESISTANCE. ASSUMED STENT WAS ATTACHED. DELIVERED DEVICE IN PATIENT AND INFLATED DEVICE. REMOVED DELIVERY DEVICE AND STENT NOT SEEN. STENT REMAINED STUCK IN YELLOW COVER AND PULLED OFF DELIVERY BALLOON DURING PREP. STENT DAMAGED (DEFORMED)." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076971 ↗
• MalfunctionDec 15, 2020Difficult to Remove; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 3.5X28MM XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY AND INTERACTION WITH THE GUIDELINER CATHETER. THE STENT IMPLANT SLID FROM THE BALLOON BUT REMAINED ON THE STENT DELIVERY SYSTEM (SDS), WHILE IT LOOKED CRIMPED. THE SYSTEM WAS REMOVED ALTOGETHER AS RESISTANCE WAS ALSO MET WITH THE GUIDELINER WHEN PULLING BACK ON THE SDS. A SAME SIZE 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 11011956 ↗
• MalfunctionDec 9, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH MODERATE CALCIFICATION, MILD TORTUOSITY, AND 75% STENOSIS IN THE RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT DEVICE. A 3.5 X 28 MM XIENCE SIERRA STENT WAS DEPLOYED TO THE TARGET LESION AT 12 ATMOSPHERES; HOWEVER, DESPITE FULLY DEFLATING, THE STENT DELIVERY SYSTEM BALLOON MET RESISTANCE WITH THE DEPLOYED STENT ON REMOVAL. THE BALLOON WAS SIMPLY REMOVED FROM THE ANATOMY AFTER INFLATING AND DEFLATING IT SEVERAL TIMES. THE STENT WAS CONFIRMED TO BE APPOSED TO THE VESSEL WALL. A NON-ABBOTT BALLOON WAS USED FOR POST-DILATATION AS PER STANDARD PROCEDURE 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 10980278 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY STENTING PROCEDURE, A 3.0 X 15 MM XIENCE SIERRA DRUG-ELUTING STENT WAS DEPLOYED ACROSS THE DISTAL STENOSIS AT 16 ATMOSPHERES. AT THAT TIME, THERE WAS A DISRUPTION OF THE PROXIMAL TO MID RIGHT CORONARY ARTERY STENOSIS AND THE DECISION WAS MADE TO COVER THIS AREA WITH A DRUG-ELUTING STENT. A 3.5 X 28 MM XIENCE SIERRA WAS THEN SUCCESSFULLY IMPLANTED AND POST-DILATED WITH A 3.5X20MM NC TREK. AFTER POST-DILATATION, A PERFORATION WAS NOTED. AT THAT TIME, A 3.5 X16 MM GRAFTMASTER COVERED STENT (9072241) WAS IMPLANTED ACROSS THE PERFORATION AT 20 ATMOSPHERES (ABOVE RATED BURSE PRESSURE), RESOLVING THE PERFORATION; HOWEVER, THE STENT WAS POST-DILATED WITH THE 3.5X20MM NC TREK AND THE PERFORATION WAS NOTED TO CONTINUE TO LEAK. TWO ADDITIONAL 3.5X19 GRAFTMASTER STENTS (9112841, 9032941) WERE IMPLANTED, ONE PROXIMAL AND ONE DISTAL TO THE IMPLANTED 3.5X16MM GRAFTMASTER STENT, BUT THE PERFORATION CONTINUED TO LEAK. AN ADDITIONAL XIENCE SIERRA 3.5 X 38 MM STENT WAS IMPLANTED BUT THE PERFORATION CONTINUED TO LEAK. A 2.8X19MM GRAFTMASTER STENT (8120641) WAS ADVANCED, BUT FAILED TO GET DISTAL TO THE LAST GRAFTMASTER STENT AND THE XIENCE SIERRA. ANO

  Patient problems: Perforation

  MAUDE report 10700588 ↗
• InjurySep 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED VESSEL. ATHERECTOMY WAS PERFORMED USING A NON-ABBOTT DEVICE. THE 3.5 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS THEN ADVANCED. RESISTANCE WAS NOTED AT THE TARGET SITE AND FORCE WAS APPLIED. THE XIENCE SIERRA STENT DISLODGED AND EMBOLIZED TO THE LEFT ILIAC ARTERY. A BALLOON DILATATION CATHETER WAS ADVANCED TO THE DISLODGED STENT, AND INFLATED, CRUSHING THE STENT TO THE VESSEL WALL. ANGIOGRAPHY NOTED THAT THE STENT APPEARED TO BE WELL CRUSHED TO THE VESSEL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Foreign Body In Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 10582893 ↗
• MalfunctionSep 3, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING UNPACKING OF A 3.50X28MM XIENCE SIERRA, THE FOIL POUCH WAS NOTED WITHOUT ANY DAMAGES, HOWEVER, THE INSIDE CLEAR TYVEK POUCH WAS NOTED WITH A HOLE IN IT. THERE WERE NO DAMAGES NOTED TO THE CHIPBOARD BOX. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER 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 Patient Involvement

  MAUDE report 10489198 ↗
• MalfunctionJul 22, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS A MILDLY TORTUOUS, MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) THAT IS 90% STENOSED. A 3.5 X 28 MM XIENCE SIERRA DEVICE WAS ADVANCED BUT FAILED TO CROSS DUE TO PATIENT ANATOMY. RESISTANCE WAS NOTED WITH THE LESION DURING ADVANCEMENT AND REMOVAL. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10307706 ↗
• InjuryJul 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD) THAT WAS 100% STENOSED. A 3.5X28MM XIENCE SIERRA WAS IMPLANTED WITH NO ISSUES. AFTER SEVERAL MINUTES, INTRAVASCULAR ULTRASOUND CONFIRMED STRONG STENT RECOIL. ADDITIONAL DILATATION WITH A BALLOON WAS PERFORMED SEVERAL TIMES TO TREAT THE RECOIL, BUT FAILED TO TREAT IT. A NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE RECOIL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264354 ↗
• 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 10197629 ↗
• MalfunctionMay 4, 2020Difficult to Insert; Stretched; Difficult to Insert; Stretched

  IT WAS REPORTED THAT THE 3.5X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS PREPARED FOR USE BUT WAS UNABLE TO LOAD ONTO THE 0.014 INCH GUIDEWIRE; THEREFORE, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN ANALYSIS NOTED THE SHAFT WAS STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020661 ↗
• InjuryApr 8, 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 HEAVILY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED, DE NOVO LESION IN THE MID TO RIGHT CORONARY ARTERY (RCA). A 3.5X28MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS INFLATED TO 16 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED, CAUSING A DISSECTION IN THE PERIPHERAL VESSEL. A 3.5X12MM XIENCE SIERRA WAS USED TO TREAT THE DISSECTION. IT WAS NOTED THAT THE DEVICE WAS PREPARED INSIDE THE ANATOMY. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 9938762 ↗
• DeathApr 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)(6) 2020, THE PATIENT PRESENTED WITH A SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY LESION. PRE-DILATATION AND ATHERECTOMY WAS PERFORMED. A 3.5X28MM XIENCE SIERRA STENT (1550350-28, 9110641) WAS IMPLANTED WITHOUT COMPLICATIONS. STENT PLACEMENT WAS REPORTEDLY ACCEPTABLE WITH 0% DIAMETER STENOSIS AND TIMI FLOW III. ON (B)(6) 2020, THE PATIENT PASSED AWAY DUE TO A MYOCARDIAL INFARCTION (MI). NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 9935499 ↗
• InjuryMar 25, 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 LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.5X28MM XIENCE SIERRA STENT WAS IMPLANTED, AND POST-DILATATION WAS PERFORMED. LATER THAT DAY, THE PATIENT RETURNED WITH CHEST PAIN. THROMBOSIS WAS CONFIRMED, AND A NON-ABBOTT STENT WAS USED AS TREATMENT. THE PATIENT IS FINE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 9879865 ↗
• InjuryMar 11, 2020Failure to Advance; Failure to Advance

  NO NEW INFORMATION.

  Patient problems: Embolism

  MAUDE report 9821175 ↗
• 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 3.50X28MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE. SURGICAL TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Stenosis

  MAUDE report 9788059 ↗
• InjuryJan 29, 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 3.5X28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THIS WAS A BIFURCATION WITH THE FIRST DIAGONAL BRANCH. AFTER THE LAD WAS STENTED, THE FIRST DIAGONAL BECAME SUBTOTALLY OCCLUDED. BALLOON ANGIOPLASTY AND KISSING BALLOON ANGIOPLASTY WERE PERFORMED AS TREATMENT FOR THE OCCLUSION. THE PATIENT HAD GOOD RESULTS. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 9643824 ↗
• MalfunctionJan 28, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATATION, A 3.5X28MM XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO STRONG RESISTANCE WITH THE LESION. RESISTANCE WAS NOTED DURING REMOVAL DUE TO THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.5X28MM UNSPECIFIED DRUG ELUTING STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639813 ↗
• MalfunctionNov 5, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE 3.5 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS REMOVED FROM THE DEVICE PACKAGING WITHOUT ISSUE. THE PROTECTIVE SHEATH WAS REMOVED FROM THE DEVICE WITHOUT RESISTANCE AND IT WAS NOTED THAT THE STENT WAS FLARED AND LOOSE ON THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS REPLACED WITH A SECOND SAME SIZE XIENCE SIERRA. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9282829 ↗
• InjuryNov 2, 2019Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 3.5X28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION TO EIGHT ATMOSPHERES. THE STENT DISLODGED AND WAS SUCCESSFULLY CRUSHED TO THE VESSEL WALL WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9270004 ↗