XIENCE Sierra™ 1550400-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648227516), received between Jun 26, 2018 and Nov 9, 2022 — classified as 3 deaths, 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THROUGH THE TACTICS REGISTRY THAT A 4X23MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2020. DUAL ANTIPLATELET TREATMENT WAS GIVEN AFTER STENT IMPLANTATION ON (B)(6) 2021 THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND 100% STENOSIS WAS NOTED PROXIMAL TO THE XIENCE SIERRA STENT. A NON-ABBOTT STENT WAS IMPLANTED FROM THE NEW LESION OVERLAPPING INTO THE IMPLANTED XIENCE SIERRA STENT, AND A DRUG COATED BALLOON WAS USED AS WELL. ON (B)(6) 2021, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. IT IS THE PHYSICIAN¿S OPINION THAT THE EVENT WAS NOT RELATED TO THE STUDY AS IT WAS PROGRESSION OF DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Stenosis

  MAUDE report 15765117 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. POST STENT IMPLANTATION OF A XIENCE STENT, WORSENING HEART FAILURE WAS NOTED. THIS WAS RESOLVED IN AN UNSPECIFIED MANNER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838255 ↗
• MalfunctionJan 5, 2022Difficult 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 RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 4.0X23 MM XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. A GUIDE CATHETER EXTENSION WAS APPLIED BUT AGAIN THE XIENCE SIERRA SDS FAILED TO CROSS AND DUE TO FRICTION IN THE GUIDE CATHETER EXTENSION DURING ADVANCEMENT AND REMOVAL, IT ALMOST BECAME STUCK SO THE SDS AND GUIDE CATHETER EXTENSION WERE REMOVED. AN 18 MM XIENCE SIERRA SDS WAS USED WITH A DIFFERENT GUIDE CATHETER EXTENSION 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13168482 ↗
• InjurySep 27, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 4.0X23 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS INSERTED TO TREAT THE RIGHT CORONARY ARTERY, BUT IT WAS UNABLE TO CROSS DUE TO INADEQUATE SUPPORT FROM THE GUIDE CATHETER. THE GUIDE CATHETER WAS REPOSITIONED SEVERAL TIMES, BUT THE SDS WAS UNABLE TO CROSS. THE SDS WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE XIENCE SIERRA, WHICH WAS SUCCESSFULLY IMPLANTED AT THE TARGET. AFTER REMOVAL OF THE FIRST SDS, IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE SDS. THE PATIENT WAS CHECKED, BUT THE STENT WAS UNABLE TO BE FOUND ON ANGIOGRAM. THE STENT WAS ALSO NOT FOUND ON THE BACK PREP TABLE. DURING DEVICE PREP, THERE WAS NO RESISTANCE REMOVING THE PROTECTIVE SHEATH. THE PATIENT DID NOT HAVE ANY ADVERSE SYMPTOMS RELATED TO THE MISSING STENT. THE STENT IS THOUGHT TO BE INSIDE THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12532751 ↗
• DeathJul 19, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN IN-STENT RESTENOSIS IN THE LEFT ANTERIOR DESCENDING (LAD). A 3.0 X 23 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED. HOWEVER, IT WAS NOTED THAT PLAQUE SHIFT HAD OCCURRED WHICH CAUSED AN OBSTRUCTION TO THE SEPTAL AND DIAGONAL BRANCHES. THE PHYSICIAN WAS ABLE TO USE A GUIDE WIRE TO OPEN UP THE BRANCHES. THE PROCEDURE WAS COMPLETED. WHEN THE PATIENT WAS TAKEN OFF THE TABLE, THE PATIENT CODED (CARDIOPULMONARY ARREST). CARDIOPULMONARY RESUSCITATION (CPR) DEFIBRILLATOR AND INTRA-AORTIC BALLOON PUMP THERAPY WERE USED THE PATIENT WAS PUT BACK ON THE TABLE AND STENT THROMBOSIS WAS NOTED. ASPIRATION WAS PERFORMED TO TREAT THE THROMBUS. ADDITIONALLY, A 4.0 X 23 MM XIENCE SIERRA STENT WAS IMPLANTED IN LAD TO THE LEFT MAIN ARTERY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM AND DIED SHORTLY AFTER ON (B)(6) 2021 DUE TO ACUTE THROMBOSIS. IN THE PHYSICIAN'S OPINION, THE XIENCE SIERRA STENTS DID NOT CAUSE OR CONTRIBUTE TO THE DEATH, BUT THE STENTS WERE SUSPECTED TO BE NOT FULLY EXPANDED. ADDITIONALLY, THE PATIENT HAD A HISTORY OF BEING NOT COMPLIANT WITH THE DUAL ANTIPLATELET DRU

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12189182 ↗
• InjuryMay 26, 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 (STEMI) BEFORE THE INITIAL PROCEDURE. TWO XIENCE SIERRA STENTS (4X23MM AND 4X38MM) WERE IMPLANTED ON (B)(6) 2021. ON( B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11890509 ↗
• MalfunctionSep 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN ARTERY. TWO GUIDE WIRES WERE ALREADY PLACED IN THE ANATOMY. AS THE 4X23MM XIENCE SIERRA WAS BEING ADVANCED AND REACHED THE GUIDING CATHETER, THE PHYSICIAN NOTED THAT THE PROXIMAL PORTION OF THE DEVICE FELT LOOSE. IT WAS DECIDED TO REMOVE THE DEVICE. ONCE REMOVED COMPLETELY THE PROXIMAL SHAFT SEPARATED. NO FORCE OR RESISTANCE WAS NOTED AT ANY TIME. ANOTHER SAME SIZE XIENCE SIERRA WAS USED TO SUCCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10555372 ↗
• InjurySep 12, 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 ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 4X23MM AND 4X18MM XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH VENTRICULAR TACHYCARDIA AND OTHER CARDIOVASCULAR SYMPTOMS. RESTORATION OF CARDIAC RHYTHM PROCEDURE WAS PERFORMED; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Tachycardia

  MAUDE report 10526028 ↗
• MalfunctionSep 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO USE IN THE PATIENT AND DURING DEVICE PREPARATION, THE XIENCE SIERRA STENT DISLODGED FROM THE BALLOON. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH/STYLET AND NO DAMAGE TO THE OUTER OR INNER PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10500296 ↗
• InjuryAug 10, 2020Material Rupture; Improper or Incorrect Procedure or Method; Activation Failure; Material Rupture; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED DE NOVO LESION IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND PRE-DILATATION WAS PERFORMED. TWO UNSPECIFIED STENTS WERE IMPLANTED FROM PERIPHERAL. FOLLOWING, A 4.0X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. THE SDS WAS PREPPED (AIR ASPIRATED), WHILE INSIDE THE PATIENT ANATOMY. THE BALLOON OF THE SDS WAS INFLATED; HOWEVER, PRESSURE GRADUALLY DECREASED AT 12 ATMOSPHERES. A PINHOLE RUPTURE WAS SUSPECTED. THE SDS WAS REMOVED AND AN UNSPECIFIED NON-COMPLIANT BALLOON CATHETER WAS USED TO POST DILATE THE STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388769 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING HYPERTENSIVE HEART. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10168900 ↗
• MalfunctionMay 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN ATTEMPT TO INSERT A 4.0X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) ONTO A GUIDE WIRE WAS MADE; HOWEVER, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS SHIFTED ABOUT 1MM TOWARD THE TIP FROM ITS USUAL POSITION ON THE MARKER. THE SDS WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4.0X23MM 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 Consequences Or Impact To Patient

  MAUDE report 10071681 ↗
• MalfunctionApr 6, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, RESISTANCE WAS FELT WHEN REMOVING THE STYLET AND PROTECTIVE SHEATH FROM A 4.0X23MM XIENCE SIERRA STENT DELIVERY SYSTEM. AFTER REMOVAL OF THE PROTECTIVE SHEATH, IT WAS NOTED THAT THE STENT HAD MOVED BUT REMAINED ON THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 4.0X23MM XIENCE SIERRA STENT. THERE WAS NO REPORT OF DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9929216 ↗
• DeathJan 22, 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 HAD CARDIAC ARREST TWICE WHILE BEING TRANSPORTED TO THE HOSPITAL. ONCE AT THE HOSPITAL, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED THAT DAY. A 4.0X23MM XIENCE SIERRA STENT WAS IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY, WITHOUT REPORTED ISSUES. REPORTEDLY, POST-PROCEDURE, THE PATIENT WAS DOING FINE. ON (B)(6) 2019, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH PRESCRIBED BRILINTA. REPORTEDLY, THE PHYSICIAN STATED DYSPNEA WAS PART OF THE MEDICATION (BRILINTA) SIDE EFFECTS. THE PATIENT HAD DYSPNEA AFTER DISCHARGE BUT ASSUMED IT WAS A MEDICATION SIDE EFFECT. HOURS AFTER RETURNING HOME, THE PATIENT HAD A MYOCARDIAL INFARCTION AND WENT INTO CARDIOPULMONARY ARREST THREE TIMES. EMERGENCY PERSONNEL WERE CALLED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND MEDICATIONS PROVIDED. THE PATIENT EXPIRED THAT DAY. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Arrest; Death; Dyspnea; Myocardial Infarction

  MAUDE report 9616369 ↗
• 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 A 4.0X23MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH A HEMORRHAGE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9440027 ↗
• DeathFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A 4.0X23MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH HEMOTHORAX AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. THE PATIENT ULTIMATELY DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8376198 ↗
• MalfunctionNov 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-PROXIMAL RIGHT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS 90% STENOSED. WHEN A 4.0 X 23 MM XIENCE SIERRA STENT DEPLOYMENT WAS ATTEMPTED, THE PRESSURE OF THE INDEFLATOR WOULD NOT INCREASE. HOWEVER, THE STENT WAS DEPLOYED AT THE INTENDED SITE. WHILE PRESSURE ESCAPED, INFLATION WAS PERFORMED AGAIN AND AGAIN FOR SUCCESSFUL DEPLOYMENT. POST-DILATATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON TO COMPLETE THE PROCEDURE AND AN INTRAVASCULAR ULTRASOUND WAS PERFORMED. WHEN THE STENT DELIVERY SYSTEM WAS INVESTIGATED OUTSIDE THE ANATOMY, A PINHOLE RUPTURE WAS CONFIRMED AT THE CENTER PART OF THE BALLOON. 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 8116563 ↗
• InjuryNov 19, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH ANGINA. THE PROCEDURE WAS TO TREAT A LESION LOCATED IN A MODERATELY TORTUOUS, MODERATELY CALCIFIED CONCENTRIC MID TO DISTAL RIGHT CORONARY ARTERY (RCA) A 4.0X23MM XIENCE SIERRA STENT AND A 4.0X38MM XIENCE SIERRA STENT WERE DEPLOYED IN AN OVERLAPPED MANNER. TIMI FLOW CHANGED FROM 2 TO 3. INTRAVASCULAR ULTRASOUND (IVUS) WAS CONFIRMED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY AFTER THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED DUE TO CHEST PAIN. IN-STENT THROMBUS WAS CONFIRMED VIA ANGIOGRAPHY. THE STENT WAS RECOILED. BALLOON ANGIOPLASTY WAS PERFORMED WITH A 4.0X12MM UNSPECIFIED BALLOON. ON (B)(6) 2018, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8086925 ↗
• MalfunctionNov 12, 2018Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED, NON TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. AN ATTEMPT TO ADVANCE A 4.0X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) AND BUDDY GUIDE WIRE THROUGH A 7F GUIDE CATHETER WAS MADE; HOWEVER, THE SDS MET RESISTANCE WITH THE GUIDE CATHETER AND THE THE TIP OF THE SDS WAS MANGLED. THE SDS DID NOT EXIT THE GUIDE CATHETER. EVERYTHING WAS PULLED OUT AS A UNIT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4.0X23MM XIENCE ALPINE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURN DEVICE ANALYSIS IDENTIFIED THE DISTAL TIP HAD TWO SPLITS GOING PROXIMALLY FOR A LENGTH OF 2MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8062097 ↗
• InjurySep 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. THE XIENCE SIERRA 4.0 X 23 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS SUCCESSFULLY DEPLOYED, HOWEVER, THE SDS BALLOON RUPTURED DURING THE FIRST INFLATION BELOW NOMINAL PRESSURE AT 10-11 ATMOSPHERES. A POST DILATATION BALLOON WAS USED TO OPEN THE STENT TO ITS FULL DIAMETER. 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 7864843 ↗
• MalfunctionJun 26, 2018Partial Blockage; Difficult To Position; Torn Material

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED, 100% STENOSED LESION IN THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA). RESISTANCE ADVANCING A 4.0X23 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) ONTO A NON-ABBOTT GUIDE WIRE WAS FELT. THE NON-ABBOTT GUIDE WIRE WAS WIPED WITH SALINE AND A SECOND ATTEMPT TO ADVANCE WAS MADE, BUT THE SDS COULD NOT ADVANCE. THE SDS NEVER ADVANCED INTO THE PATIENT ANATOMY AND WAS REMOVED INDEPENDENTLY WITHOUT RESISTANCE. THERE WAS NO DAMAGE NOTED TO THE SDS. IT WAS SUSPECTED THAT THERE WAS SOME KIND OF BLOCKAGE IN THE GUIDE WIRE LUMEN. A NEW SAME SIZE XIENCE SIERRA STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE INNER MEMBER WAS TORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7639207 ↗