XIENCE Sierra™ 1550250-23Recalls & reported problems
Abbott Vascular Inc. · XIENCE Sierra™ Everolimus Eluting Coronary Stent System 2.50 mm x 23 mm / Rapid-Exchange · Class 3 · Implant
All models of XIENCE Sierra (56)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648227110), received between Jul 30, 2018 and Nov 14, 2022 — classified as 20 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (2 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
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Failure to Advance2
- Material Rupture2
- Patient-Device Incompatibility2
- Activation Failure1
- Device Dislodged or Dislocated1
- Difficult or Delayed Activation1
- Difficult to Advance1
Patient problems
- Angina8
- Myocardial Infarction5
- Thrombosis4
- No Consequences Or Impact To Patient3
- Stenosis3
- High Blood Pressure/ Hypertension2
- Intimal Dissection2
- Prolapse2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THAT A 2.5X23 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY ON (B)(6) 2020. THE PATIENT EXPERIENCED ANGINA ON (B)(6) 2021. ON (B)(6) 2022, DURING A FOLLOW UP, 75% STENOSIS WAS NOTED IN THE PROXIMAL LAD; HOWEVER, NO IN-STENT RESTENOSIS WAS NOTED IN THE XIENCE SIERRA STENT IN THE MID LAD. ON (B)(6) 2022, ELECTIVE INTERVENTION WAS PERFORMED TO TREAT THE PROXIMAL LAD AND A 3.0X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. ACCORDING TO THE PHYSICIAN¿S OPINION, THE EVENT IS NOT RELATED TO THE STUDY AS IT IS A TREATMENT FOR DE NOVO LESION OCCURRING IN THE NATURAL HISTORY; HOWEVER, IT IS UNKNOWN IF THE RESTENOSIS WAS +/- 5 MM FROM THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Stenosis
MAUDE report 15789269 ↗InjuryJan 17, 2022Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). AFTER MULTIPLE PRE-DILATIONS WITH UNSPECIFIED BALLOON DILATION CATHETERS, A 2.5 X 23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE TARGET LESION DUE TO ANATOMICAL CHALLENGES. THE SDS WAS REMOVED AND A SMALL DISSECTION WAS OBSERVED WHICH WAS TREATED WITH A 2.5X15 MM MINI VISION STENT. A NON-ABBOTT STENT WAS USED TO TREAT THE TARGET LESION. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vascular Dissection
MAUDE report 13266209 ↗InjuryJun 25, 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 THE 2.5X23 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RAMUS CORONARY ARTERY. THE PATIENT WAS COMPLIANT WITH THE DUAL ANTIPLATELET DRUG THERAPY POST PROCEDURE. ON (B)(6) 2020 CARDIAC CATHETERIZATION WAS PERFORMED AS PART OF THE PATIENT'S WORK-UP FOR A NON-CARDIAC, SURGICAL PROCEDURE. THE CATHETERIZATION FOUND THAT THE PATIENT HAD ASYMPTOMATIC, STENT THROMBOSIS. THIS WAS TREATED WITH PERCUTANEOUS INTERVENTION USING ANGIOPLASTY AND AN ADDITIONAL STENT IN THE RAMUS ARTERY. THE CONDITION RESOLVED ON (B)(6) 2020. ON (B)(6) 2021 THE PATIENT HAD ANOTHER STENT THROMBOSIS IN THE RAMUS ARTERY FOUND ON CORONARY ANGIOGRAM. THIS WAS ALSO TREATED WITH PERCUTANEOUS INTERVENTION USING ANGIOPLASTY AND AN ADDITIONAL STENT IN THE RAMUS ARTERY. THE CONDITION RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Thrombosis/Thrombus
MAUDE report 12068101 ↗InjuryApr 6, 2021Adverse 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 TO TREAT A TARGET LESION IN THE DISTAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOUR XIENCE SIERRA STENTS WERE IMPLANTED: 2.5 X 23, 2.5 X 18, 3.0 X 38 AND 3.25 X 28. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2021 WITH COMPLAINTS OF CHEST PAIN. TROPONIN LEVELS WERE ELEVATED. MEDICATION WAS ADMINISTERED. A CORONARY ANGIOGRAM WAS PERFORMED ON (B)(6) 2021. THE DISTAL LAD WAS NOTED TO BE 95% OCCLUDED AND REVASCULARIZATION WAS PERFORMED, TREATING IN-STENT RESTENOSIS IN THE 2.5 X 23 MM XIENCE SIERRA STENT AND THE 2.5 X 18 MM XIENCE SIERRA STENT. THE EVENT RESOLVED ON 03/13/2021. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Cardiac Enzyme Elevation; Stenosis
MAUDE report 11623925 ↗MalfunctionJan 13, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. A 2.50X23MM XIENCE SIERRA WAS IMPLANTED WITH NO ISSUES; HOWEVER, IT WAS NOTED LATER THAT THE DEVICE WAS EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11158265 ↗InjuryDec 10, 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-ELEVATION MYOCARDIAL INFARCTION AND TWO (2.5X23MM AND 3.5X12MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND HYPERTENSIVE HEART. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 10984271 ↗InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020 A 2.50X23MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED WITH A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Myocardial Infarction
MAUDE report 10972356 ↗InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 2.50X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION. ON (B)(6) 2020, THE PATIENT WAS READMITTED WITH CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina
MAUDE report 10959176 ↗InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 2.5X23MM XIENCE SIERRA STENT WAS IMPLANTED ON 2/24/2020. THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6)2020 AND (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH A STEMI AND NON-STEMI. UNSPECIFIED TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Myocardial Infarction
MAUDE report 10148870 ↗InjuryJun 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 MODERATELY CALCIFIED POSTERIOR DESCENDING ARTERY. A 2.5X18MM AND 3.5X38MM XIENCE SIERRA STENTS FAILED TO CROSS DUE TO THE ANATOMY. THEN A 2.5X18MM NON-ABBOTT STENT WAS ATTEMPTED BUT ALSO FAILED TO CROSS. THEN A 2.5X23MM XIENCE SIERRA STENT WAS BEING ADVANCED WHEN RESISTANCE WAS MET WITH THE ANATOMY AND THE STENT IMPLANT DISLODGED. THE DISLODGED STENT WAS EMBEDDED IN THE VESSEL BY DEPLOYING ANOTHER STENT. THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 10135682 ↗InjuryApr 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS FROM A PREVIOUS PERCUTANEOUS CORONARY INTERVENTION, LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A SIDE BRANCH OF THE LAD WAS OCCLUDED. PRE-DILATATION WAS PERFORMED AND A 2.5X23MM XIENCE SIERRA STENT (1550250-23, 9072241) WAS SUCCESSFULLY IMPLANTED FROM THE PROXIMAL-MID LAD INTO THE 1ST ANTEROLATERAL BRANCH. THE STENT WAS FULLY APPOSED TO THE VESSEL WALL EXCEPT MALPOSITION INVOLVING THE CONTINUATION OF THE MID LAD DISTAL TO THE TAKEOFF OF THE 1ST ANTEROLATERAL. THE SIDE BRANCH HAD BECOME JAILED AFTER 2.5X23MM XIENCE SIERRA STENT IMPLANTATION. POST-IMPLANTATION, INTRA-STENT MINIMAL PLAQUE PROTRUSION AND A MINOR, PROXIMAL LAD DISSECTION WERE OBSERVED, BOTH OF WHICH DID NOT REQUIRE TREATMENT. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ANGINA. ON (B)(6) 2020, ANOTHER PCI WAS PERFORMED AND IN-STENT RESTENOSIS (99%) WAS OBSERVED IN THE MID LAD. ANOTHER STENT WAS IMPLANTED AS TREATMENT AND THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Patient problems: Angina; Intimal Dissection; Occlusion; Prolapse; Stenosis
MAUDE report 9983066 ↗MalfunctionApr 1, 2020Activation Failure; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.5X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) CROSSED THE LESION BUT COMPLETELY FAILED TO DEPLOY. A NEW UNSPECIFIED XIENCE SIERRA SDS 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 9910416 ↗InjuryFeb 18, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. AFTER LESION PRE-DILATATION, A XIENCE SIERRA STENT WAS ADVANCED WITH RESISTANCE TO THE LESION AND DURING STENT DEPLOYMENT, THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE AND A PROXIMAL DISSECTION WAS OBSERVED. ANOTHER XIENCE STENT WAS IMPLANTED AS TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Intimal Dissection
MAUDE report 9723269 ↗InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
STUDY PATIENT (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE FIRST DIAGONAL CORONARY ARTERY AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5 X 23 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE FIRST DIAGONAL AND PLAQUE SHIFT OCCURRED. A 3.5 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD AS TREATMENT OF THE PLAQUE SHIFT. THE EVENT RESOLVED THE DAY OF PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Prolapse
MAUDE report 9454832 ↗InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 2.5X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CHRONIC OBSTRUCTIVE PULMONARY DISEASE. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 8960715 ↗InjurySep 3, 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 2.5X23 MM XIENCE SIERRA STENT AND A 2.25X38 MM XIENCE SIERRA STENT WERE IMPLANTED IN THE PATIENT. ON (B)(6) 2019 AND (B)(6) 2019 THE PATIENT WAS RE-ADMITTED FOR CHEST PAIN AND OTHER CARDIOVASCULAR SYMPTOMS AS WELL AS GASTRO REFLEX. SURGERY WAS PERFORMED AS TREATMENT. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina
MAUDE report 8958205 ↗InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN OF 7 DAYS AND DYSPNEA OF 4 DAYS. CORONARY ANGIOGRAPHY WAS PERFORMED, AND THROMBUS WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A MYOCARDIAL INFARCTION WAS DIAGNOSED. INTERVENTION WAS PERFORMED AND TWO XIENCE SIERRA STENTS (2.5X15 MM (8102442), 2.5X23MM (9011541) WERE IMPLANTED IN OVERLAPPING FASHION IN THE LAD. THE ACTIVATED CLOTTING TIME (ACT) WAS 260 ON A FIRST MEASUREMENT AND 400 ON A SECOND MEASUREMENT. THE PATIENT WAS ADMINISTERED ASPIRIN AND PLAVIX; HOWEVER, IT WAS NOTED THAT THE PATIENT WAS PLAVIX-RESISTANT. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN OF 1 DAY. THE LAD WAS NOTED TO BE OCCLUDED WITH THROMBUS IN THE STENTED SEGMENT. THE PATIENT WAS REFERRED FOR SURGICAL CONSULT AND UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE ON AN UNSPECIFIED DATE. POST-SURGICAL PROCEDURE, THE PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Thrombosis
MAUDE report 8562865 ↗InjuryFeb 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE STENTS WERE IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, (B)(6) 2019, AND (B)(6) 2019 THE PATIENT WAS READMITTED WITH HYPERTENSION, CHEST PAIN, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. TREATMENT WAS UNSPECIFIED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; High Blood Pressure/ Hypertension
MAUDE report 8364859 ↗InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE 2.5X15MM XIENCE SIERRA STENT AND 2.5X23MM XIENCE SIERRA STENT WERE BOTH IMPLANTED IN THE PATIENT ON (B)(6) 2018. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 PRESENTING WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND TEST RESULTS SHOWED ABNORMAL EKG/ECG. STEMI AND THROMBOTIC OCCLUSION OF PREVIOUSLY PLACED STENTS WAS CONFIRMED, AND THROMBECTOMY AND BALLOON ANGIOPLASTY WERE PERFORMED TO TREAT THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Myocardial Infarction; Non specific EKG/ECG Changes; Thrombosis
MAUDE report 8286198 ↗InjuryNov 9, 2018Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 75% STENOSED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH NO CALCIFICATION. FOLLOWING PRE-DILATATION, A 2.5X23MM XIENCE SIERRA STENT WAS BEING DEPLOYED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 9 ATMOSPHERES. POST-DILATATION WITH A 2.5X12MM NON-ABBOTT BALLOON CATHETER WAS PERFORMED TO SUCCESSFULLY DEPLOY THE STENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8057028 ↗InjuryAug 28, 2018Adverse 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 PROXIMAL RIGHT CORONARY ARTERY. PRIOR TO THE PROCEDURE, THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). A 2.5X23MM XIENCE SIERRA STENT WAS IMPLANTED AT THE LESION WITHOUT ISSUE. THE PATIENT WAS SENT TO THE RECOVERY ROOM. SOME TIME LATER THAT DAY, THE PATIENT EXPERIENCED STEMI AND WAS BROUGHT BACK TO THE PROCEDURE ROOM. ANGIOGRAPHY CONFIRMED IN-STENT THROMBOSIS. A 2.5X15 XIENCE SIERRA STENT WAS DEPLOYED WITHIN THE IMPLANTED STENT AND DILATED SUCCESSFULLY TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS FINE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Myocardial Infarction; Thrombosis
MAUDE report 7823840 ↗InjuryJul 30, 2018Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2018, DUAL ANTIPLATELET THERAPY (DAPT) WAS STARTED ON A PATIENT WHO PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (MI). A 2.5X23MM XIENCE SIERRA STENT WAS DEPLOYED TO TREAT THE MI. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED INSUFFICIENT DILATATION OF THE STENT DUE TO HEAVY CALCIFICATION. AT AN UNKNOWN DATE, DAPT WAS DISCONTINUED DUE TO MELENA AND ADMINISTRATION OF CLOPIDOGREL SULFATE WAS STARTED. AT AN UNKNOWN DATE, ALL ANTI-COAGULANT MEDICATION WAS DISCONTINUED FOR COLORECTAL CANCER SURGERY. ON (B)(6) 2018, THE PATIENT PRESENTED WITH CHEST PAIN, WHICH WAS DIAGNOSED AS MYOCARDIAL INFARCTION. IN-STENT SUBACUTE CORONARY THROMBOSIS WAS CONFIRMED BY ANGIOGRAPHY. AN INTRAAORTIC BALLOON PUMP (IABP) WAS INSERTED. THROMBUS WAS ASPIRATED WITH AN ASPIRATION CATHETER AND LONG-PERIOD DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER. FOLLOWING THROMBUS ASPIRATION, ADMINISTRATION OF ASPIRIN AND PRASUGREL HYDROCHLORIDE WAS RESUMED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND THE IABP IS AND WILL BE INSERTED TO SECURE BLOOD FLOW FOR TWO DAYS OR SO. THE PATIENT IS IN THE HOSPITAL DOING FINE AND IS SCHEDULED TO BE DISCHARGED WITHIN TWO WEEKS. THE PATIEN
Patient problems: Angina; Myocardial Infarction; Thrombosis
MAUDE report 7733512 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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