XIENCE Sierra™ 1550350-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08717648227431), received between Aug 2, 2018 and Jun 7, 2022 — classified as 1 death, 13 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (11 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2022Adverse 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 ON (B)(6) 2020, TREATING A TARGET LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). FOUR XIENCE SIERRA STENTS, TWO 3.0 X 38MM, A 2.75X38MM AND A 3.5X23MM, WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A STRESS TEST THAT WAS SUGGESTIVE OF INTERIOR/INFEROLATERAL ISCHEMIA. A SUBSEQUENT ANGIOGRAM PERFORMED ON(B)(6) 2021 REVEALED PATENT LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING (LAD), PATENT SAPHENOUS VEIN GRAFT (SVG) TO FIRST OBTUSE MARGINAL (OM1), PATENT SVG TO RAMUS ARTERY, BUT AN OCCLUDED SVG TO RCA. TARGET LESION REVASCULARIZATION WAS PERFORMED ON (B)(6) 2022, TREATING IN-STENT RESTENOSIS WITH IMPLANT OF AN ADDITIONAL DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 14627239 ↗
• MalfunctionJun 23, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION IN THE MODERATELY CALCIFIED, VERY TORTUOUS MID LEFT CIRCUMFLEX CORONARY ARTERY. THE 3.5X23 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT INCIDENT. DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS MET WITH THE GUIDE WIRE, SO THE WIRE AND SDS WERE REMOVED TOGETHER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054123 ↗
• MalfunctionMay 26, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH MILD CALCIFICATION AND SEVERE TORTUOSITY IN THE RIGHT CORONARY ARTERY (RCA). THE FIRST XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE SEVERE TORTUOSITY. WHEN THE SDS WAS REMOVED THERE WAS DIFFICULTY AND THE PROXIMAL END OF THE STENT BECAME FLARED. A SECOND XIENCE SIERRA WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE TORTUOSITY. THE SECOND SDS HAD THE SAME ISSUE DURING REMOVAL AND THE STENT PROXIMAL END OF THE STENT BECAME FLARED TOO. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AS NOTHING COULD CROSS THE LESION. THERE WAS NO 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 11886710 ↗
• MalfunctionMay 26, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH MILD CALCIFICATION AND SEVERE TORTUOSITY IN THE RIGHT CORONARY ARTERY (RCA). THE FIRST XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE SEVERE TORTUOSITY. WHEN THE SDS WAS REMOVED THERE WAS DIFFICULTY AND THE PROXIMAL END OF THE STENT BECAME FLARED. A SECOND XIENCE SIERRA WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE TORTUOSITY. THE SECOND SDS HAD THE SAME ISSUE DURING REMOVAL AND THE STENT PROXIMAL END OF THE STENT BECAME FLARED TOO. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AS NOTHING COULD CROSS THE LESION. THERE WAS NO 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 11886708 ↗
• InjuryApr 2, 2021Failure 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 AND TORTUOUS LESION IN THE CIRCUMFLEX (CX). OUTSIDE OF THE PATIENT THE 3.50X23MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED OVER THE NON-ABBOTT GUIDE WIRE WHEN RESISTANCE WAS MET AND THE SDS BECAME STUCK. HEMOSTATS WERE NEEDED TO REMOVE THE SDS FROM THE GUIDE WIRE. PER THE PHYSICIAN, THE GUIDE WIRE WAS NOT PROPERLY WETTED PRIOR TO ADVANCEMENT OF THE SDS. A SECOND 3.50X23MM RX XIENCE SIERRA SDS WAS ADVANCED INTO THE PATIENT HOWEVER MET RESISTANCE WHEN ATTEMPTING TO ADVANCE THROUGH THE OPEN CELL OF THE PREVIOUSLY IMPLANTED NON-ABBOTT STENT. THE SDS WAS PUSHED FORWARD HOWEVER THE STENT CAME OFF THE BALLOON. THE SDS WAS REMOVED AND A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT. THE PROCEDURE WAS ABORTED AT THIS TIME WITH NO FURTHER TREATMENT PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608175 ↗
• MalfunctionMar 18, 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 LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED, MODERATELY TORTUOUS AND 75% STENOSED. AFTER THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION, RESISTANCE WAS NOTED DURING REMOVAL. A FLARE AT THE EDGE OF THE STENT WAS NOTICED WHEN IT WAS REMOVED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE LESION WAS DILATED, AND A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Localized Skin Lesion

  MAUDE report 11521017 ↗
• MalfunctionFeb 1, 2021Improper 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 HEAVILY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.50X23MM XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL THE STENT DISLODGED IN THE GUIDELINER. THE DEVICE WAS REMOVED WITH THE GUIDELINER ALTOGETHER AS ONE UNIT; THEREFORE, THE DISLODGED STENT WAS SIMPLY REMOVED WITH NO ISSUES. IT WAS NOTED THE DEVICE WAS NOT PREPPED UNTIL IN THE BODY. THERE WAS NO ADDITIONAL TREATMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258692 ↗
• MalfunctionDec 16, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT OUT OF PACKAGING, IT WAS ATTEMPTED TO REMOVE THE STYLET FROM THE 3.50X23MM XIENCE SIERRA STENT DELIVERY SYSTEM BUT THE STYLET WAS STUCK. A NEW 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 Patient Involvement

  MAUDE report 11016164 ↗
• InjuryDec 2, 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 3.5X23 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10935146 ↗
• InjuryOct 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) 2020, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI), ELEVATED CARDIAC ENZYMES, AND A PROXIMAL CIRCUMFLEX (CX), 95% STENOSED LESION. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE CX LESION AND A 3.5X23MM XIENCE SIERRA STENT (1550350-23, 9120941) STENT WAS IMPLANTED WITH ACCEPTABLE RESULTS. POST-IMPLANTATION, A PROXIMAL EDGE DISSECTION WAS OBSERVED. AS TREATMENT, A 2.5X38MM XIENCE SIERRA STENT (1550250-38, 90100341) AND A 4.0X8MM XIENCE SIERRA STENT (1550400-08, 0051241) WERE IMPLANTED. POST-PROCEDURE IMAGING WAS PERFORMED WITH INTRA-STENT PLAQUE PROTRUSION OR THROMBUS, AND DISSECTION, UNKNOWN IF THIS WAS THE SAME PREVIOUS DISSECTION, WERE OBSERVED. THE STENT WAS NOT SPECIFIED IN THIS CASE. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN. ELEVATED CARDIAC ENZYMES WERE OBSERVED AND A NEW MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. AS TREATMENT, ANOTHER PCI WAS PERFORMED WITHIN THE 50% OCCLUDED, PROXIMAL CX. THE EVENT RESOLVED WITHOUT SEQUELA. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING

  Patient problems: Angina; Intimal Dissection; Myocardial Infarction; Occlusion; Prolapse; Stenosis; Thrombosis

  MAUDE report 10690943 ↗
• MalfunctionSep 22, 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 MILDLY CALCIFIED LESION IN THE MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX (PLCX) CORONARY ARTERY. THE 3.50X23 MM XIENCE SIERRA STENT WAS ATTEMPTED BUT COULD NOT CROSS THE LESION DUE TO THE TORTUOUS ANATOMY. THE DEVICE WAS STRONGLY PUSHED, CAUSING THE STENT EDGE TO FLARE. THERE WAS RESISTANCE MET WITH THE GUIDING CATHETER DURING REMOVAL. 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 10570909 ↗
• DeathAug 31, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, A 3.5 X 23MM XIENCE SIERRA STENT WAS ADVANCED BUT FAILED TO REACH THE LESION. ANGIOGRAPHY SHOWED A SIGNIFICANT PERFORATION. PATIENT BECAME HYPOTENSIVE AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND A TEMPORARY PACEMAKER WAS PLACED, SUCCESSFULLY REVIVING THE PATIENT. A 3.5X26MM GRAFTMASTER STENT SYSTEM WAS ADVANCED BUT FAILED TO REACH THE PERFORATION AND WAS REMOVED WITHOUT ISSUE. TWO ADDITIONAL GRAFTMASTER STENTS (3.5X19MM, 3.5X16MM) WERE ADVANCED AND SUCCESSFULLY SEALED THE PERFORATION; HOWEVER, A DISTAL EDGE DISSECTION WAS NOTED. A 3X12MM XIENCE SIERRA STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE DISSECTION. ADDITIONALLY, DURING THIS PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD SEVERE AORTIC STENOSIS AND WAS PLACED ON AN INTRA-ARTERIAL BALLOON PUMP. AORTIC BALLOON VALVOPLASTY WAS PERFORMED, WITH GOOD RESULTS. POST-PROCEDURE, THE PATIENT REMAINED IN CRITICAL CONDITION WITH A POOR PROGNOSIS. LATER THAT EVENING, THE PATIENT DIED FROM PULSELESS ELECTRICAL ACTIVITY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Bradycardia; Cardiac Arrest; Death; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 10474176 ↗
• MalfunctionJul 29, 2020Defective Device; Activation Failure; Defective Device; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING LESION. A 3.50X23MM XIENCE SIERRA CROSSED THE LESION AND WAS ATTEMPTED TO BE IMPLANTED. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT HAD SHORTENED AND DID NOT EXPAND AS EXPECTED. THE XIENCE SIERRA WAS SIMPLY REMOVED AND ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED SUBSEQUENT TO FILING THE INITIAL REPORT STATES THAT THE XIENCE SIERRA PARTIALLY DEPLOYED, REMAINING ON THE DELIVERY SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341269 ↗
• MalfunctionJul 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES STENT WAS NOT ON BALLOON AND PROPERLY SECURED TO THE STENT DELIVERY SYSTEM. RT CAUGHT THE ERROR PRIOR TO USING ON PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10309019 ↗
• MalfunctionJun 23, 2020Inflation Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure; Material Split, Cut or Torn; Inflation Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 3.5X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS NOT PREPPED (AIR ASPIRATED) PRIOR TO USE. THE SDS WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. ONCE AT THE TARGET LESION, AN ATTEMPT TO INFLATE THE SDS WAS MADE BUT IT WAS NOTED THAT THE SHAFT NEAR THE GUIDE WIRE PORT WAS TORN. NO LEAK WAS NOTED; HOWEVER, THIS RESULTED IN THE INABILITY TO INFLATE THE SDS AND DEPLOY THE STENT. THE SDS WITH STENT WERE REMOVED. AN ATTEMPT TO ADVANCE A 2.5X12MM XIENCE SIERRA SDS WAS MADE; HOWEVER, THE SDS COULD NOT CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS REMOVED AND IT WAS NOTED THAT THE STENT HAD DISLODGED AND WAS MISSING. THE STENT WAS FOUND OUTSIDE THE BODY ON THE GAUZE USED TO WIPE DOWN THE WIRE AFTER THE SDS WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH OTHER UNSPECIFIED STENTS. 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 10186611 ↗
• MalfunctionJun 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE PROTECTIVE SHEATH WAS REMOVED AND THE STENT DISLODGED, REMAINING IN THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED, THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10165982 ↗
• MalfunctionJun 2, 2020Difficult 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 MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A JAILED BALLOON TECHNIQUE WAS BEING USED AND A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS POSITIONED AT THE INFERIOR SEPTAL ARTERY. THE 3.50X23 MM XIENCE SIERRA STENT ATTEMPTED TO CROSS THE LESION AT THE MID LAD BUT FAILED DUE TO THE ANATOMY. WHEN THE BDC AND THE XIENCE SIERRA WERE PULLED BACK, THE STENT DISLODGED DUE TO INTERACTION WITH THE PROXIMAL SECTION OF THE NON-ABBOTT BALLOON. THE STENT WAS ABLE TO BE REMOVED WITH THE BDC. A NON-ABBOTT 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 10112807 ↗
• MalfunctionMay 6, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.5X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020, AND AFTER THE PROCEDURE, IT WAS NOTED THAT THE EXPIRATION DATE WAS 02/08/2020. 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 10030623 ↗
• InjuryMar 19, 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 WEAKNESS, NAUSEA, ELECTROCARDIOGRAM CHANGES, AND TWO BLOCKAGES, ONE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 80% STENOSED LESION. THAT DAY, A 3.5X23MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD WITHOUT REPORTED ISSUES. SINCE (B)(6) 2019, THE PATIENT STATED HER STOMACH AND ESOPHAGUS HAVE BEEN PAINFUL, AND SHE HAS SHORTNESS OF BREATH. SHE SUSPECTS AN ALLERGIC REACTION. SHE IS UNSURE IF THE REACTION IS DUE TO THE STENT OR THE ANTIPLATELET MEDICATIONS. THE PATIENT HAS BEEN TO MULTIPLE CARDIOLOGISTS AND HER ANTIPLATELET MEDICATION HAS BEEN CHANGED THREE TIMES WITHOUT ANY IMPROVEMENT. ONE PHYSICIAN HAD PLACED HER ON ANTI-ANXIETY MEDICATIONS BUT THAT HAS NOT HELPED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 9857635 ↗
• InjuryMar 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 (B)(6) 2019, A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION (PTCI) WAS PERFORMED ON THE PROXIMAL RIGHT CORONARY ARTERY (RCA), 95% STENOSED LESION. A 3.25X28MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL RCA. ON (B)(6) 2020, THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION, SEVERE IN-STENT RESTENOSIS AND IN-STENT THROMBOSIS. MEDICATIONS WERE ADMINISTERED. ON (B)(6) 2020 ASPIRATION THROMBECTOMY AND REVASCULARIZATION WAS PERFORMED AND A XIENCE SIERRA 3.5X23MM STENT WAS IMPLANTED WITHIN THE XIENCE SIERRA 3.25X28 STENT. THE ADVERSE PATIENT EVENT RESOLVED ON (B)(6) 2020. (THAT EVENT WAS PREVIOUSLY REPORTED ON ANOTHER MEDWATCH REPORT NUMBER.) ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH FATIGUE, HYPOTENSION, DYSPNEA AND ELEVATED TROPONIN. MYOCARDIAL INFARCTION WAS DIAGNOSED. A HEPARIN DRIP WAS INITIATED. PER IMAGING, IN-STENT STENOSIS WAS OBSERVED IN THE RCA AND THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY HAD A COMPLETE TOTAL OCCLUSION. ON (B)(6) 2020, ANOTHER PTCI WITH THROMBECTOMY/THROMBOLYSIS WAS PERFORMED IN THE PROXIMAL RCA. A NON-ABBOTT STENT WAS PLACED AS TREATMENT WITHIN THE XIENCE SIERRA STE

  Patient problems: Dyspnea; Fatigue; Low Blood Pressure/ Hypotension; Myocardial Infarction; Stenosis; Thrombosis

  MAUDE report 9789111 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50X23MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY IN 2017. TEN DAYS POST STENT IMPLANT, THE PATIENT RETURNED WITH IN-STENT THROMBOSIS. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. ON (B)(6) 2020, THE PATIENT RETURNED AGAIN WITH IN-STENT THROMBOSIS. ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS THEN REFERRED FOR SURGERY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9607221 ↗
• MalfunctionNov 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE XIENCE SIERRA STENT DELIVERY SYSTEM WAS OPENED AND WHEN THE PROTECTIVE SHEATH WAS REMOVED, THE STENT IMPLANT WAS NOT OBSERVED. THE STENT WAS NOTED TO BE DISLODGED FROM THE BALLOON AND REMAINED INSIDE THE PROTECTIVE SHEATH. THERE WAS NO REPORTED RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS REPLACED WITH A NON-ABBOTT STENT TO COMPLETE THE PROCEDURE. 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 Patient Involvement

  MAUDE report 9331399 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A XIENCE SIERRA STENT WAS SUCCESSFULLY DEPLOYED AT 12 ATMOSPHERES. THE STENT WAS POST-DILATED WITH A 4.0 NON-ABBOTT BALLOON AND A PROXIMAL PERFORATION WAS NOTED. A NON-ABBOTT COVERED STENT WAS USED AS TREATMENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 9234946 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS CIRCUMFLEX CORONARY ARTERY. BEFORE THE PROCEDURE, A MINI TREK BDC WAS OPENED DURING PREP AND IT WAS NOTED THAT THE BALLOON WAS SEPARATED FROM THE SHAFT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A 3.5 X 23 MM XIENCE SIERRA WAS IMPLANTED WITHOUT ISSUE; HOWEVER, WIRE POSITION WAS LOST AS THE VESSEL CLOSED FOR AN UNKNOWN REASON. A NEW BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED AS WELL AS A WHISPER GUIDE WIRE AND THE WHISPER WAS THOUGHT TO BE IN THE TRUE LUMEN OF THE VESSEL. THE BMW WENT UNDER AND AROUND A COUPLE STRUTS OF THE PREVIOUSLY IMPLANTED XIENCE SIERRA STENT AND OVER THE WHISPER GUIDE WIRE. THE BMW WAS THEN JAILED WITH A 2.25 X 18 MM XIENCE SIERRA STENT. THE BMW WAS STUCK AND WAS NOT ABLE TO BE REMOVED. BALLOON ANGIOPLASTY WAS ATTEMPTED IN ORDER TO FREE THE GUIDE WIRE BUT IT WAS UNSUCCESSFUL. THE BMW THEN SEPARATED AND COILED INTO A BALL. THE TIP OF THE WHISPER GUIDE WIRE ALSO SEPARATED DUE TO THE BMW GUIDE WIRE WRAPPING AROUND IT. THE SEPARATED PORTIONS OF THE GUIDE WIRES BOTH REMAIN IN THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 9130975 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2019, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROSIS OF CORONARY BYPASS GRAFT. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8957783 ↗