XIENCE Sierra™ 1550350-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08717648227462), received between Aug 8, 2018 and Sep 30, 2021 — classified as 2 deaths, 25 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2021Difficult 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 THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX CORONARY ARTERY. A 3.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS ADVANCED AGAINST RESISTANCE FURTHER, THEN THE SDS FELT RESISTANCE WITH THE ANATOMY DURING REMOVAL WHEN THE STENT DISLODGED WITHIN AN UNSPECIFIED GUIDING CATHETER. AN UNSPECIFIED 2X15MM BALLOON WAS ADVANCED TO INFLATE THE STENT AGAINST THE GUIDING CATHETER AND EVERYTHING WAS REMOVED TOGETHER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555378 ↗
• InjuryAug 26, 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 FIVE XIENCE SIERRA STENTS WERE IMPLANTED. ONE 3.5X38 STENT IN THE FIRST OBTUSE MARGINAL (OM1), ONE 3.5X18 IN THE RIGHT POSTERIOR ATRIO-VENTRICULAR (RPAV), AND THREE (2.5X38, TWO 3.0X38) IN THE RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2021 THE PATIENT HAD INCREASING FREQUENCY OF ANGINA AT REST AND HAD A POSITIVE STRESS TEST. CORONARY ANGIOGRAM SHOWED STENOSIS IN THE OM1, RCA, AND LEFT CIRCUMFLEX CORONARY ARTERY. THERE WAS NO STENOSIS IN THE RPAV. THE PATIENT WAS REFERRED FOR CORONARY ARTERY BYPASS GRAFT SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 12371732 ↗
• MalfunctionJul 20, 2021Deformation Due to Compressive Stress; Material Twisted/Bent; Activation Failure; Deformation Due to Compressive Stress; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID CIRCUMFLEX ARTERY THAT WAS HEAVILY CALCIFIED AND 75% STENOSED. THE XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND DURING ATTEMPTED DEPLOYMENT, THE BALLOON WOULD NOT INFLATE. UPON REMOVAL, WITHOUT ISSUE, IT WAS NOTED THAT THE SHAFT WAS BENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW XIENCE SIERRA STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197013 ↗
• MalfunctionJul 20, 2021Activation Failure; Activation Failure

  SUS VOLUNTARY EVENT REPORT (MW5101318) RECEIVED STATING: " PT [PATIENT] BROUGHT TO OPERATING ROOM (B)(6) FOR ANGIOGRAM WITH STENT PLACEMENT. CORONARY STENT BROUGHT FROM CATH LAB. STENT ALIGNED IN PATIENT BUT FAILED TO DEPLOY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196511 ↗
• InjuryJun 23, 2021Difficult 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 PERFORMED TO TREAT A 90% STENOSED, HEAVILY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 3.5X38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS BEING REMOVED BUT RESISTANCE WITH THE GUIDE LINER WAS FELT. THE SDS WAS REMOVED AND IT WAS NOTED THAT THE STENT HAD DISLODGED. THE GUIDE LINER WAS ALSO REMOVED AND IT WAS NOTED THAT THE ENTIRE DISTAL TIP WAS CRUSHED AND DEFORMED, POTENTIALLY CONTRIBUTING TO THE RESISTANCE DURING REMOVAL AND SUBSEQUENT STENT DISLODGMENT. THE STENT REMAINED ON THE GUIDE WIRE NEAR THE PROXIMAL RCA. THE PROXIMAL RCA WAS ALSO PLANNED TO BE STENTED; THEREFORE, MULTIPLE NC TREK BALLOON CATHETERS (GRADUALLY UPSIZING) WERE USED TO APPROPRIATELY EXPAND THE STENT AND DEPLOY IT AT THE INTENDED LOCATION IN THE PROXIMAL RCA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF FIVE XIENCE SIERRA STENTS IN THE RCA WITH NO RESIDUAL STENOSIS. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055131 ↗
• InjuryJun 1, 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 HAD A 3.50X38 MM XIENCE SIERRA STENT IMPLANTED. THE PATIENT HAS PRESENTED PRIOR WITH HYPERTENSIVE HEART DISEASE AND HEART FAILURE. ON (B)(6) 2021, THE PATIENT WAS READMITTED DUE TO HYPERTENSIVE HEART DISEASE AND HEART FAILURE. TREATMENT WAS NOT SPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 11915376 ↗
• MalfunctionMay 3, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ECCENTRIC DE NOVO LESION IN THE MID CIRCUMFLEX ARTERY. A 3.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS REMOVED AND RESISTANCE WITH THE ANATOMY WAS FELT. ONCE OUTSIDE THE PATIENT IT WAS NOTED THAT THE STENT STRUT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH PRE-DILATATION AND THE DEPLOYMENT OF A 3.5X33MM XIENCE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11766702 ↗
• MalfunctionJan 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKING OF A 3.50X38 XIENCE SIERRA, IT WAS NOTED THAT THE STENT IMPLANT HAD DISLODGED (WAS ONLY PARTIALLY ON THE BALLOON) STILL REMAINING ON THE STENT DELIVERY CATHETER. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER 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 11205388 ↗
• DeathNov 9, 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 ON (B)(6) 2020 WAS TO TREAT 90% STENOSED DE NOVO LESIONS IN THE DISTAL AND MID RIGHT CORONARY ARTERY (RCA). TWO XIENCE SIERRA STENTS (3.0X38 MM AND 3.50X38 MM) WERE SUCCESSFULLY IMPLANTED OVERLAPPING. PRE AND POST-DILATATION WERE PERFORMED. STENT APPOSITION WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS) WITH 0% STENOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2020; HOWEVER, IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2020 DUE TO AN UNKNOWN CAUSE. IN THIS STUDY, DEATH OF AN UNKNOWN CAUSE WITHIN 30 DAYS AFTER STENT DEPLOYMENT IS DEFINED AS PROBABLE STENT THROMBOSIS. CLOPIDOGREL AND RIVAROXABAN HAD BEEN ADMINISTERED TO PREVENT STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Thrombosis

  MAUDE report 10814106 ↗
• MalfunctionOct 15, 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 TO TREAT DE NOVO LESION WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY IN THE MID-RIGHT CORONARY ARTERY. AN ATTEMPT WAS MADE TO ADVANCE THE 3.5 X 38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FOR DIRECT STENTING, HOWEVER, THE SDS FAILED TO CROSS THE LESION DUE TO ANATOMY. DURING SDS REMOVAL, RESISTANCE WITH THE ANATOMY WAS ALSO NOTED. DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON, AND THE SDS WAS RE-INSERTED BUT FAILED TO CROSS THE LESION AGAIN. FINALLY, ATHERECTOMY WAS PERFORMED WITH A NON-ABBOTT DEVICE, AND A NON-ABBOTT DRUG-COATED BALLOON (DCB) 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 10685671 ↗
• InjurySep 11, 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 TWO XIENCE SIERRA STENTS (SIZES 3.5X33 AND 3.5X38) WERE IMPLANTED IN THE PROXIMAL AND MID RIGHT CORONARY (RCA) ARTERY. ON (B)(6) 2020 THE PATIENT HAD CHEST PAIN/HEAVINESS. ANGIOGRAM PERFORMED ON (B)(6) 2020 SHOWED IN-STENT RESTENOSIS IN BOTH THE RCA STUDY STENTS ALONG WITH STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE RAMUS ARTERY. A TRIPLE CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED ON (B)(6) 2020. THE PATIENT CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 10522133 ↗
• MalfunctionSep 4, 2020No Apparent Adverse Event; Activation Failure; No Apparent Adverse Event; Activation Failure

  IT WAS REPORTED THAT THE 3.5X38MM AND 2.50X38MM XIENCE SIERRA STENTS DELIVERY SYSTEM FAILED TO DEPLOY. BOTH DEVICES WERE REMOVED, AND ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED 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 10495262 ↗
• MalfunctionSep 3, 2020Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE 3.5X38MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS PREPARED PRIOR TO THE SHEATH REMOVAL. DURING REMOVAL OF THE PROTECTIVE SHEATH, WITHOUT RESISTANCE, THE STENT DISLODGED. 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 10491659 ↗
• MalfunctionAug 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE 3.5X38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), WAS REMOVED FROM THE HOOP, THE STENT DISLODGED FROM THE BALLOON ONTO THE STYLET WHEN THE STYLET WAS REMOVED. NO ATTEMPT HAD BEEN MADE TO REMOVE THE PROTECTIVE SHEATH; THE PROTECTIVE SHEATH, AND STENT DISLODGED FROM THE BALLOON UPON REMOVAL OF THE SDS FROM THE HOOP. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SIERRA SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10371169 ↗
• InjuryJul 30, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A XIENCE SIERRA STENT ON (B)(6) 2018.THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 WITH CHEST PAIN AND IT WAS NOTED THAT THE STENT HAD FRACTURED. THE PATIENT WAS TREATED WITH ANTI COAGULATION MEDICATION AND REMAINS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10347670 ↗
• InjuryJun 26, 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) AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. A 3.5X38MM XIENCE SIERRA STENT (1550350-38, 0033141) WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY LESION WITH ACCEPTABLE RESULTS. 0% DIAMETER STENOSIS AND TIMI FLOW 3 WAS OBSERVED. THAT SAME DAY POST-PROCEDURE, THE PATIENT FELT UNCOMFORTABLE, HAD ST CHANGES, ALONG WITH ELEVATED TROPONIN. THE PATIENT'S HEART RATE DROPPED TO 45 BEATS/MINUTE AND BLOOD PRESSURE DROPPED TO 74/59. ANESTHESIA WAS CALLED TO BEDSIDE AND THE PATIENT WAS BROUGHT AGAIN TO THE CATH LAB. PER ANGIOGRAM, THE MID RCA STENT WAS 100% OCCLUDED WITH THROMBUS. BALLOON ANGIOPLASTY WAS PERFORMED AND ANTICOAGULATION PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Bradycardia; Cardiac Enzyme Elevation; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Pain; Thrombosis

  MAUDE report 10204120 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (3.5X38MM AND 4X38MM) WERE IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH UNSTABLE ANGINA BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10148806 ↗
• MalfunctionApr 28, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 75% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO RESISTANCE WITH THE ANATOMY. DURING REMOVAL OF THE SDS, RESISTANCE WAS FELT WITH THE ANATOMY. AFTER REMOVAL OF THE SDS IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS FLARED. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 10007825 ↗
• MalfunctionApr 8, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. IN-STENT RESTENOSIS WAS FOUND ON AN UNSPECIFIED STENT IMPLANTED ABOUT 15 YEARS AGO. PRE-DILATATION WAS DONE WITH AN UNSPECIFIED BALLOON. THE 3.50X38MM XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. DURING RETRIEVAL, RESISTANCE WAS NOTED WITH THE GUIDING CATHETER. IT WAS THEN NOTED THAT THE STENT HAD A BENT STRUT. A NEW SAME 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 Consequences Or Impact To Patient

  MAUDE report 9937708 ↗
• InjuryApr 8, 2020Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE IN THE VEIN GRAFT TO THE OBTUSE MARGINAL CORONARY ARTERY. THE PATIENT CAME IN EMERGENTLY AND WAS IN AN UNSTABLE CONDITION. BEFORE THE STENTING PROCEDURE BEGAN, THE PATIENT WAS DEFIBRILLATED TO RESOLVE AN ARRHYTHMIA THE PATIENT HAD. SEVERAL STENTS WERE IMPLANTED IN THE VEIN GRAFT AND THE LAST STENT WAS IN THE OSTIUM OF THE GRAFT, THE 3.5X38 MM XIENCE SIERRA. THE STENT WAS IMPLANTED WITHOUT ISSUE AND THE DELIVERY SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED AND THE GUIDE CATHETER WAS ATTEMPTED TO BE REMOVED BUT WAS STUCK. WHEN THE GUIDE CATHETER WAS REMOVED, DAMAGE TO THE IMPLANTED 3.5X38 SIERRA STENT WAS NOTED. IT WAS SUSPECTED THAT THE TIP OF THE GUIDE CATHETER SOMEHOW GOT UNDERNEATH THE STENT DURING DEPLOYMENT. ADDITIONAL BALLOON ANGIOPLASTY WAS PERFORMED IN THE DAMAGED STENT, BUT IT DID NOT IMPROVE THE FLOW. THEY DECIDED TO TREAT AN UNPLANNED ARTERY TO IMPROVE THE PATIENT'S BLOOD FLOW FROM OTHER VESSELS AS MUCH AS POSSIBLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 9936160 ↗
• MalfunctionMar 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF A 3.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), THE PROTECTIVE SHEATH WAS REMOVED, AND IT WAS NOTED THAT THE STENT WAS SHIFTED APPROXIMATELY 2.0MM FROM THE MARKER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9891801 ↗
• InjuryFeb 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE 3.50X38 MM XIENCE XPEDITION BALLOON SEPARATED FROM THE DELIVERY SYSTEM DURING DEPLOYMENT OF THE STENT. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PORTION WITH A SNARE. AS NO ADDITIONAL INFORMATION WAS PROVIDED BY THE ACCOUNT, IT COULD NOT BE CONFIRMED IF THE SEPARATED PORTION WAS RETRIEVED FROM THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9753046 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY PATIENT (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.0 X 38 MM XIENCE SIERRA AND A 3.5 X 38 MM XIENCE SIERRA STENT WERE IMPLANTED IN THE PROXIMAL RCA. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2019. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN. THE PATIENT REPORTED NON-COMPLIANCE WITH DUAL ANTI-PLATELET THERAPY (DAPT). THE PATIENT WAS THEN TAKEN TO THE CARDIAC CATHETERIZATION LAB AND IT WAS NOTED THAT THE RCA WAS 100% OCCLUDED DUE TO THROMBUS. A REVASCULARIZATION PROCEDURE WAS PERFORMED; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS THE TARGET VESSEL WITH THE UNSPECIFIED GUIDE WIRE AND NO INTERVENTION WAS PERFORMED. THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) TO EVALUATE FOR POSSIBLE CORONARY ARTERY BYPASS SURGERY. MRI NOTED SEVERE LEFT VENTRICULAR ENLARGEMENT; SMALL SUBENDOCARDIAL INFERIOR INFARCT, BUT ALL MYOCARDIAL SEGMENTS WERE VIABLE; NO SIGNIFICANT VALVE ABNORMALITIES; MILDLY DILATED ASCENDING AORTA; AND NORMAL APPEARING PERICARDIUM. BYPASS SURGERY HAS NOT BEEN SCHEDULED. ASPIRIN AND PLAVIX WERE PRESCRIBED. ON (B)(

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 9741968 ↗
• DeathFeb 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE PROXIMAL RIGHT CORONARY ARTERY (RCA), 70% STENOSED LESION. PRE-DILATATION AND ATHERECTOMY WAS PERFORMED ON THE RCA. FOLLOWING ROTABLATOR USE, A PROXIMAL RCA DISSECTION OCCURRED. REPORTEDLY, A 3.5X15MM XIENCE SIERRA STENT WAS IMPLANTED AT THE RCA OSTIUM DUE TO THIS DISSECTION. THERE WAS NO UNDEREXPANSION CONFIRMED OR REPORTED AND NO DEVICE MALFUNCTION. AS PLANNED, 3.0X38MM AND 3.5X38MM XIENCE SIERRA STENTS WERE IMPLANTED IN THE PROXIMAL RCA. POST-DILATATION WAS PERFORMED USING A NON-COMPLIANT BALLOON. THE DIAMETER STENOSIS WAS REDUCED TO 25% WITH TIMI FLOW III. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR SEVERE SUBSTERNAL CHEST PAIN. MEDICATIONS INCLUDING NITROGLYCERIN HAD BEEN PROVIDED. ELEVATED TROPONIN AND A ST ELEVATED MYOCARDIAL INFARCTION (STEMI) WAS DIAGNOSED. PER IMAGING, THE OSTIAL-PROXIMAL RCA WAS PATENT, HOWEVER, THE PROXIMAL RCA WITH THE 3.0X38MM AND 3.5X38MM XIENCE SIERRA STENTS, TO THE DISTAL RCA, WAS OCCLUDED WITH 100% THROMBUS. REPORTEDLY, BOTH THE 3.0X38MM AND 3.5X38MM XIENCE SIERRA STENTS WERE UNDEREXPANDED. HIGH PRESSURE BALLOON ANGIOPLASTY

  Patient problems: Angina; Myocardial Infarction; Respiratory Failure; Thrombosis

  MAUDE report 9714114 ↗
• InjuryJan 9, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE 3.50X38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS BEING ATTEMPTED TO BE PLACED DISTALLY; HOWEVER, IT COULD NOT CROSS THE MID PART OF THE VESSEL DUE TO CALCIFICATION. THE PHYSICIAN WANTED TO REMOVE THE SDS TO PRE-DILATE THE DISTAL PART OF THE VESSEL SO THE SDS WAS REMOVED. IT WAS NOT NOTED THAT THE STENT HAD DISLODGED UNTIL PRE-DILATATION WAS BEING PERFORMED WITH THE 3.50X20 MM TREK BALLOON DILATATION CATHETER (BDC) IN THE DISTAL VESSEL AND IT WAS SEEN ON ANGIOGRAPHY. NEGATIVE PRESSURE WAS HELD FOR 2 SECONDS; HOWEVER, THE BDC WOULD NOT COMPLETELY DEFLATE AND BECAME STUCK IN THE SAME AREA AS THE STENT IN THE CALCIFICATION. ADDITIONALLY, THE BALLOON SEPARATED FROM THE CATHETER. MULTIPLE WIRE ATTEMPTS WERE PERFORMED TO TRY TO REMOVE THE STENT AND BALLOON BUT WERE UNSUCCESSFUL. BOTH THE STENT AND BALLOON REMAIN STUCK IN CALCIFICATION IN THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9572158 ↗