XIENCE Sierra™ 1550350-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08717648227417), received between Jun 20, 2018 and Jan 29, 2021 — classified as 1 death, 18 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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.

• InjuryJan 29, 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) 2020, A 3.5 X 15 MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2020, THE PATIENT PRESENTED WITH COMPLAINTS OF CRESCENDO ANGINA. A REVASCULARIZATION PROCEDURE WAS PERFORMED, TREATING IN-STENT RESTENOSIS, RESOLVING THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 11251819 ↗
• MalfunctionDec 30, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE RIGHT CORONARY ARTERY (RCA). THE XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED OVER THE BALANCE MIDDLWEIGHT UNIVERSAL GUIDE WIRE. THE XIENCE SIERRA STENT WAS DEPLOYED AND NO ISSUES WERE NOTED. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, SLIGHT RESISTANCE WAS NOTED WITH THE GUIDE WIRE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11097781 ↗
• MalfunctionDec 29, 2020Activation, Positioning or Separation Problem; Material Twisted/Bent; Positioning Problem; Therapeutic or Diagnostic Output Failure

  THREE DEVICES FAILED. INCIDENT DESCRIPTION: OPENED, PREPPED, AND ADVANCED THREE STENT CATHETERS. UNABLE TO ADVANCE TO LESION SITE IN THE MID CIRCUMFLEX ARTERY. REMOVED OVER WIRE AND ALL THREE STENTS HAD DAMAGE TO THE STENT STRUTS. THERE WERE NO COMPLICATIONS. FROM THE PROCEDURAL NOTE: INTERVENTION: FOR PURPOSE OF INTERVENTION, I ULTIMATELY UPSIZED TO A 7-FRENCH SYSTEM FOR COMPLEX BIFURCATION INTERVENTION. I INITIALLY STARTED WITH A 6-FRENCH, AND CROSSED INTO THE FIRST MARGINAL AND INTO THE DISTAL AV CIRCUMFLEX, AFTER ACHIEVING AN ACT (ACTIVATED CLOTTING TIME) GREATER THAN 300 SECONDS WITH A ____ AND A PILOT WIRE. A PREDILATION WAS INITIALLY PERFORMED INTO THE MAIN AV GROOVE CIRCUMFLEX WITH A 3.0X12 MM BALLOON. INITIAL PLAN GIVEN THE ANATOMIC CONFIGURATION WAS TO PERFORM SIMULTANEOUS STENTING WITH A "PAIR OF PANTS" ANATOMIC CONFIGURATION. UNFORTUNATELY, GIVEN THAT THE 2 WIRES REPETITIVELY BECAME TWISTED AND ON TOP OF EACH OTHER, IT DID NOT ALLOW PASSAGE OF THE SECOND STENT DOWN THE VESSEL. I HAD TO UTILIZE SEVERAL DIFFERENT STENTS AND REPOSITIONED WIRES ON MULTIPLE OCCASIONS TO ATTEMPT TO ADDRESS THE ISSUE WITH SWITCHING OUT, WHICH THEN WE DELIVERED FIRST INTO THE AV GROOVE CIRCUMFL

  Patient problems: Perforation; Stenosis

  MAUDE report 11087020 ↗
• MalfunctionDec 23, 2020Difficult 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 HEAVILY CALCIFIED UNSPECIFIED LESION. A 3.50X15MM XIENCE SIERRA STENT FAILED TO CROSS DUE TO ANATOMY THEREFORE IT WAS REMOVED, AND RESISTANCE WITH ANATOMY WAS ALSO FELT. ONCE REMOVED, IT WAS NOTED THAT THE STENT STRUTS WERE FLARED. 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 Consequences Or Impact To Patient

  MAUDE report 11069705 ↗
• MalfunctionDec 8, 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 PERFORMED TO TREAT A DE NOVO LESION WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY, AND 99% STENOSIS IN THE RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND A 3.5 X 15 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WAS MET DUE TO ANATOMY AND THE SDS FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. THE SDS WAS REMOVED AND RESISTANCE WAS FELT WITH THE ANATOMY. ANOTHER PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT DEVICE AND THE SAME SDS WAS RE-INSERTED BUT FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. A NON-ABBOTT SDS WAS USED AND CROSSED THE LESION TO 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 10969791 ↗
• MalfunctionNov 16, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED DE NOVO DISTAL RIGHT CORONARY (DRCA) ARTERY THAT IS 90% STENOSED. AFTER PRE-DILATATION A 3.5X15MM XIENCE SIERRA STENT FAILED TO CROSS DUE TO ANATOMY. AFTER A NON-ABBOTT STENT EXPANSION WAS USED THE XIENCE SIERRA STENT FAILED TO CROSS AGAIN DUE TO ANATOMY. ANOTHER NON-ABBOT STENT EXPANSION WAS USED AND A NON-ABBOTT BALLOON WAS INFLATED UP TO 25 ATMOSPHERES; HOWEVER, WHEN THE XIENCE SIERRA WAS ADVANCED AGAIN THE PROXIMAL SHAFT BECAME BENT AND IT WAS DETERMINED THAT THE "PUSHES" COULD NOT BE APPLIED. IT WAS NOTED THERE WAS RESISTANCE MET DURING ADVANCEMENT AND REMOVAL OF THE XIENCE SIERRA. A DIFFERENT XIENCE SIERRA 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 10848760 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TO TREAT THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.5X15 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LAD. AFTER THE GUIDE WIRE WAS REMOVED, A PROXIMAL EDGE DISSECTION WAS NOTED IN THE PROXIMAL LAD. THE DISSECTION WAS RELATED TO THE STENT. ANOTHER STENT (3.5X8 MM) WAS IMPLANTED TO TREAT THE DISSECTION. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 10771797 ↗
• MalfunctionJul 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN RIGHT CORONARY ARTERY. A 3.5X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE STENT WAS SUCCESSFULLY DEPLOYED AT 12 ATMOSPHERES WITHOUT ANY ISSUES, THE SDS WAS MOVED TO POST DILATE THE EDGE OF THE STENT AS PER STANDARD PROCEDURE. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON OF THE SDS; HOWEVER, PRESSURE DID NOT INCREASE AND NO INFLATION WAS MADE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF AN UNSPECIFIED 4.0 MM STENT DUE TO THE LESION LENGTH AND POST-DILATATION OF BOTH STENTS WAS PERFORMED WITH THE SDS BALLOON OF THE SECOND 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 10261046 ↗
• DeathJun 16, 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 CALCIFIED DE NOVO LEFT MAIN (LM) ARTERY. THE RIGHT CORONARY ARTERY WAS ALSO TOTALLY OCCLUDED. PRE-DILATATION WAS DONE WITH A 3.0X15MM NON-ABBOTT BALLOON. A 3.50X15MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LM. POST-DILATATION WAS DONE WITH A 3.5X12MM NON-ABBOTT BALLOON. THE INTRA-AORTIC BALLOON PUMP WAS REMOVED. AFTER THE PATIENT WAS RETURNED TO THE WARD, THE PATIENT'S CONDITION DETERIORATED SUDDENLY AS THE PATIENT EXPERIENCED RESPIRATORY DISCOMFORT AND CARDIAC ARREST OCCURRED. IT WAS CONFIRMED VIA ANGIOGRAPHY THAT A THROMBOTIC OCCLUSION OCCURRED WHERE THE STENT WAS DEPLOYED. THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY WERE PERFORMED TO RECANALIZE. RESPIRATORY DISCOMFORT, VENTRICULAR FIBRILLATION, AND CARDIAC ARREST OCCURRED, THEN THE PATIENT DIED. PER THE PHYSICIAN, THE THROMBOSIS WAS NOT RELATED TO THE XIENCE SIERRA STENT NOR DID THE XIENCE SIERRA CAUSE OR CONTRIBUTE TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death; Dyspnea; Thrombosis; Ventricular Fibrillation

  MAUDE report 10158294 ↗
• InjuryJun 5, 2020Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO A LESION IN THE HEAVILY TORTUOUS CIRCUMFLEX CORONARY ARTERY. THE 3.5X15 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY. RESISTANCE WAS MET WITH THE ANATOMY DURING REMOVAL AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A SNARE DEVICE SUCCESSFULLY RETRIEVED THE STENT AND IT WAS NOTED THAT THE DISTAL STENT STRUTS WERE MANGLED. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO 3.0X8MM SIERRA STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10126177 ↗
• 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 3.5X15MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9803904 ↗
• InjuryFeb 21, 2020Deflation Problem; Inflation Problem; Patient-Device Incompatibility; Deflation Problem; Inflation Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS NON-CALCIFIED, NON-TORTUOUS AND 90% STENOSED. THE XIENCE SIERRA STENT SYSTEM WAS ADVANCED TO THE LESION WITHOUT ISSUES AND INFLATED TWICE TO 12 ATMOSPHERES FOR 10 SECONDS. IT WAS NOTED THAT THE WALL APPOSITION OF THE PROXIMAL PART OF THE STENT WAS NOT SUFFICIENT, DUE TO HOW THE BALLOON WAS INFLATING, SO THE DELIVERY SYSTEM WAS PULLED BACK ABOUT 1 MM AND INFLATED TO 14 ATMOSPHERES. ATTEMPTS TO DEFLATE THE BALLOON WERE MADE, BUT IT FAILED TO DEFLATE. THE PATIENT CONDITION WAS GETTING WORSE AND VENTRICULAR FIBRILLATION WAS OBSERVED, SO THE XIENCE SIERRA STENT DELIVERY SYSTEM WAS REMOVED SLOWLY. AT THIS POINT IT WAS NOTED THAT THE BALLOON WAS APPEARING TO DEFLATE. THE SYSTEM WAS SUCCESSFULLY REMOVED AND POST DILATATION WAS PERFORMED FOR COMPLETE WALL APPOSITION OF THE STENT. NO OTHER TREATMENT WAS GIVEN TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 9741618 ↗
• MalfunctionFeb 11, 2020Break; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Break; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 3.50X15MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND PREPARATION WAS PERFORMED INSIDE THE ANATOMY. WHEN APPLYING NEGATIVE PRESSURE, A LEAK AND CRACK IN THE HUB WERE NOTICED AND THE BALLOON FAILED TO INFLATE. THE STENT WAS REMOVED AND REPLACED. 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 9694434 ↗
• InjuryJan 24, 2020Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.5X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, NOT DEPLOYED. THE SDS WAS REMOVED FROM THE PATIENT AND RE-INSERTED OVER THE WIRE. AT THIS POINT, FLARING WAS NOTED BEFORE THE STENT WAS INSERTED BACK INTO THE PATIENT ANATOMY. AT SOME POINT DURING THIS PROCESS, A BEND IN THE ARTERY WAS NOTED AND THE UNDEPLOYED STENT DISLODGED AND REMAINED IN THE PROXIMAL RCA. THE PATIENT WAS SENT TO ANOTHER HOSPITAL FOR ANOTHER CARDIAC CATHETER PROCEDURE. THE STENT WAS CRUSHED IN PLACE WITH ANOTHER STENT AND BALLOON. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9630016 ↗
• InjuryDec 19, 2019Adverse 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, THE PATIENT PRESENTED WITH PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD), SEVERE IN-STENT RESTENOSIS. PRE-DILATATION WAS PERFORMED AND A 3.0X23MM (1550300-23, 8091041) XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LAD. FOLLOWING, A PLAQUE SHIFT OCCURRED INTO THE DIAGONAL CORONARY ARTERY, TREATED WITH BALLOON ANGIOPLASTY. THERE WERE NO FURTHER COMPLICATIONS REPORTED. A 3.5X15MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD. REPORTEDLY, BOTH STENTS WERE IMPLANTED WITH ACCEPTABLE RESULTS, TIMI FLOW III AND 0% DIAMETER STENOSIS. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR WORSENING CHEST PAIN WITH ACTIVITY. PER IMAGING, THE MID LAD WAS SEVERELY RESTENOSED AND CORONARY ARTERY DISEASE WAS NOTED IN THE FIRST DIAGONAL. REPORTEDLY, THE PROXIMAL LAD, 3.5X15MM XIENCE SIERRA STENT REMAINED PATENT. AS TREATMENT, ANOTHER PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE MID LAD AND DIAGONAL CORONARY ARTERIES, PLACING ADDITIONAL STENTS. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Prolapse; Stenosis

  MAUDE report 9496541 ↗
• InjuryDec 5, 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 A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND A 3.5X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9420430 ↗
• MalfunctionOct 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 TORTUOUS CIRCUMFLEX CORONARY ARTERY WITH TWO 90 DEGREE TURNS. DURING ADVANCEMENT, A 3.50X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS RAMMED/JAMMED BACK AND FORTH IN THE ATTEMPT TO CROSS THE LESION. THE SDS WAS PULLED OUT AND IT WAS NOTED THAT THE STENT HAD SNAGGED ON THE USERS GLOVES. AT THIS POINT, WHEN OUTSIDE THE PATIENT ANATOMY, THE STENT WAS COMPLETELY FREE AND DETACHED FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X15MM XIENCE SIERRA STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234498 ↗
• MalfunctionOct 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) OF THE 3.5X15 MM XIENCE SIERRA STENT WAS REMOVED FROM THE PLASTIC COIL WITHOUT ISSUE. WHEN THEY WENT TO LOAD THE SDS ON TO THE GUIDE WIRE, THAT IS WHEN THEY NOTICED THAT THERE WAS NO STENT ON THE SDS. THEY CHECKED THE HOOP AND FOUND THE STENT WAS ON THE MANDREL IN THE HOOP. THERE WAS NO PATIENT INVOLVEMENT WITH THIS DEVICE. ANOTHER SAME SIZE XIENCE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9216372 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6)2019. THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH CORONARY ARTERY DISSECTION. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED AS TREATMENT, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8967717 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2019 DURING WHICH A 3.5 X 15 MM XIENCE SIERRA STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2019 FOR SYNCOPE, COLLAPSE AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope

  MAUDE report 8966723 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) 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 8961542 ↗
• MalfunctionAug 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE XIENCE SIERRA STENT WAS SUCCESSFULLY DEPLOYED, HOWEVER, AS THE DEVICE BEING REMOVED FROM THE GUIDE CATHETER, THE PROXIMAL PART OF THE SHAFT BROKE. IT WAS SIMPLY REMOVED WITHOUT ISSUE THROUGH THE GUIDE CATHETER WITH NO RESISTANCE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8952767 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2019, AFTER 3 DAYS OF EXPERIENCING CHEST DISCOMFORT, DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION (MI). TWO XIENCE SIERRA STENTS (3.0 X 38 MM, 3.5 X 15 MM) WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, IN AN OVERLAPPING FASHION. THE ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE 331 ON THE FIRST MEASUREMENT, AND 303 ON THE SECOND. POST PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL CHEST PAIN, DIAGNOSED AS DRESSLER'S SYNDROME, AS A RESULT OF THE MI. ONE DAY POST PROCEDURE, THE PATIENT HAD COMPLAINTS OF CONTINUED CHEST PAIN. AN INTEGRILIN BOLUS WAS ADMINISTERED AND CORONARY ANGIOGRAPHY WAS PERFORMED, NOTING THROMBUS IN THE LAD, STENTED SEGMENT, WHICH WAS 100% OCCLUDED. AN EDGE DISSECTION WAS NOTED AT THE DISTAL EDGE OF THE LAD STENTED SEGMENT. A 3.0 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED TO TREAT THE DISSECTION. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8575906 ↗
• InjuryMar 26, 2019Adverse 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 PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5 X 15 MM XIENCE SIERRA STENT WAS IMPLANTED. SIX DAYS POST PROCEDURE, ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED WITH A MYOCARDIAL INFARCTION. IN-STENT RESTENOSIS WAS NOTED. A REVASCULARIZATION PROCEDURE WAS PERFORMED, AND A 3.0 X 15 MM XIENCE SIERRA STENT WAS IMPLANTED. THE EVENT RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Stenosis

  MAUDE report 8454341 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 3.5 X 15 MM XIENCE SIERRA STENT. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH MYOCARDIAL INFARCTION AND WAS TREATED WITH BALLOON ANGIOPLASTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8149459 ↗