XIENCE Sierra™ 1550250-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08717648227141), received between Jul 27, 2018 and Nov 15, 2021 — classified as 2 deaths, 20 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 99% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2021, A 2.5X38 MM AND A 2.75X18 MM XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT RETURNED DUE TO ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THEN OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED. THIS REVEALED THAT THE STENTS WERE UNDER EXPANDED AND MALPOSED AS THE PHYSICIAN DID NOT ADEQUATELY POST DILATE THE OVERLAP OF THE STENTS. ADDITIONALLY THERE WAS IN-STENT THROMBOSIS. THROMBECTOMY WAS PERFORMED AND POST DILATATION WAS PERFORMED WITH A 3.25X15 MM NC TREK BALLOON. OCT WAS AGAIN PERFORMED AND SHOWED 98% OF EXPANSION IN THE VESSEL AND WELL APPOSED STENT STRUTS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 12814854 ↗
• InjuryAug 31, 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, THE PATIENT PRESENTED IN WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT ANTERIOR DESCENDING (LAD), 80% STENOSED LESION. PRE-DILATATION WAS PERFORMED AND A 2.5X38MM XIENCE SIERRA AND A 2.5X12MM XIENCE SIERRA STENTS WERE SUCCESSFULLY IMPLANTED WITH ACCEPTABLE RESULTS. 0% RESIDUAL STENOSIS AND WITHOUT COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED WITH INTERMITTENT LEFT LOWER PARASTERNAL CHEST DISCOMFORT, UNSTABLE ANGINA, FOR APPROXIMATELY ONE WEEK. ELEVATED CARDIAC LABS WERE OBSERVED. THE PATIENTS VITAL SIGNS AND HEART FAILURE LAB PROBNP WERE WITHIN NORMAL RANGE. THE EKG REVEALED T WAVE INVERSION AND ST ELEVATION IN LEAD 4 AND A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. THE CHEST X-RAY REVEALED NO ACUTE ABNORMALITY. MEDICATION WAS PROVIDED. ON (B)(6) 2021, A TARGET VESSEL REVASCULARIZATION WAS PERFORMED, PLACING ANOTHER STENT IN THE 99% STENOSED LESION. REPORTEDLY, BOTH XIENCE SIERRA STENTS HAD RESTENOSED. THERE WAS NO DEVICE MALFUNCTION. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 12395861 ↗
• InjuryAug 24, 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 12359311 ↗
• MalfunctionAug 17, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 2.50X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. IT WAS NOTED DURING REMOVAL OF THE SDS RESISTANCE WAS ALSO MET WITH ANATOMY. THE PROCEDURE ENDED WITHOUT TREATMENT AS THE PATIENT HAD A RENAL ISSUE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331894 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2020, TREATING A TARGET LESION IN THE FIRST DIAGONAL ARTERY. A 2.5 X 38 MM XIENCE SIERRA STENT AND A 2.5 X 28 MM XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. CARDIAC CATHETERIZATION WAS PERFORMED AND IN-STENT RESTENOSIS OF THE FIRST DIAGONAL ARTERY WAS NOTED. ANGIOPLASTY WAS PERFORMED TO TREAT 70% OCCLUSION AND THE ADVERSE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 12181430 ↗
• MalfunctionJun 21, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION LOCATED IN AN UNSPECIFIED ARTERY. THE XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED BUT FAILED TO CROSS INTO THE LESION. RESISTANCE WAS NOTED, DURING REMOVAL FROM THE ANATOMY. 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 12037966 ↗
• MalfunctionJun 21, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION LOCATED IN AN UNSPECIFIED ARTERY. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED BUT FAILED TO CROSS INTO THE LESION. RESISTANCE WAS NOTED, DURING REMOVAL FROM THE ANATOMY. 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 12037886 ↗
• InjuryMar 16, 2021Adverse 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 2.25X38MM AND A 2.75X12MM XIENCE SIERRA STENTS IMPLANTED. THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS INCLUDING NON- ST ELEVATED MYOCARDIAL INFARCTION. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 11496564 ↗
• InjuryMar 11, 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 BEFORE THE INITIAL PROCEDURE. A 2.5X38MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSTABLE ANGINA. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11467846 ↗
• InjuryNov 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X38MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS PREPARED AND ADVANCED WITHOUT ISSUE. DURING INFLATION, THE BALLOON RUPTURED AT 4ATM. THE PHYSICIAN REALIZED THAT THE PROXIMAL END OF THE STENT HAD PARTIALLY OPENED SO HE ADVANCED A 1.5 NON-ABBOTT BALLOON TO FULLY OPEN THE STENT THEN WENT BACK IN WITH AN NC BALLOON TO FULLY DEPLOY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10916340 ↗
• MalfunctionOct 13, 2020Leak/Splash; Off-Label Use; Activation Failure; Leak/Splash; Off-Label Use; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TIBIAL ARTERY. A 2.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS PREPPED (AIR ASPIRATED) PRIOR TO USE WITHOUT ISSUES. THE SDS WAS ADVANCED; HOWEVER, ONCE AT THE LESION SITE THE BALLOON COULDN'T INFLATE AND THE DEVICE WAS SLOWLY LEAKING PRESSURE. THE LEAK LOCATION WAS UNKNOWN. THE SDS WAS REMOVED WITH THE STENT ON THE SDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 2.5X38MM 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 10674300 ↗
• MalfunctionSep 24, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS PROCEDURE TO TREAT A CORONARY ARTERY. THE XIENCE SIERRA WAS INSERTED, BUT WAS UNABLE TO CROSS THE VESSEL DUE TO THE MODERATELY CALCIFIED PATIENT ANATOMY. AFTER REMOVAL OF THE XIENCE SIERRA DELIVERY SYSTEM, THE STENT WAS NO LONGER ON THE BALLOON, BUT REMAINED ON THE DELIVERY SYSTEM. ANOTHER SAME SIZE XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583830 ↗
• MalfunctionSep 4, 2020No Apparent Adverse Event; Activation Failure; No Apparent Adverse Event; Activation Failure

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE DEVICES WERE NOT DEPLOYED AS IT WAS NOTED THAT THE INCORRECT SIZE STENTS WERE CHOSEN AND THEY WERE UNDERSIZED FOR THE LESION. THE STENTS WERE NOT IMPLANTED AND THERE WAS NO ISSUE NOTED WITH THE STENTS OR DELIVERY SYSTEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10495299 ↗
• InjuryAug 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) 2019, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION AND A 70% STENOSED LESION WITHIN THE MID RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED WITHIN THE MID RCA AND A 2.5X38MM (1550250-38, 9020841) AND A 2.75X23MM (1550275-23, 8091141) XIENCE SIERRA STENT WERE IMPLANTED. POST-DILATATION WAS PERFORMED. 0% RESIDUAL STENOSIS WAS NOTED WITHOUT A DEVICE ISSUE REPORTED. ON (B)(6) 2020, DURING A FOLLOW-UP, THE PATIENT REPORTED EXPERIENCING ONGOING, INTERMITTENT CHEST PAIN THAT WAS RELIEVED WITH REST. AS TREATMENT, THE PATIENT'S MEDICATION (NITROGLYCERINE) WAS PROVIDED/ADJUSTED. ON (B)(6) 2020, DURING A FOLLOW-UP, THE PATIENT PRESENTED WITH WORSENING CHEST PAIN. PER NUCLEAR STRESS TEST, ST SEGMENT DEPRESSION WAS OBSERVED. ON (B)(6) 2020, THE PATIENT CONTINUED TO HAVE CHEST PAIN. THE PATIENT WAS HOSPITALIZED AND IN-STENT RESTENOSIS WAS OBSERVED IN BOTH RCA, XIENCE SIERRA STENTS. AS TREATMENT, ANGIOPLASTY WAS PERFORMED ON THE 99% OCCLUDED LESION WITHIN THE RCA. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis; Test Result

  MAUDE report 10454673 ↗
• MalfunctionAug 24, 2020Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5X38MM XIENCE SIERRA WAS ADVANCING WHEN RESISTANCE WAS MET WITH AN UNSPECIFIED GUIDING CATHETER. RESISTANCE WAS ALSO FELT WITH THE UNSPECIFIED GUIDING CATHETER DURING REMOVAL AND ONCE THE DEVICE WAS REMOVED IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS NOT CRIMPED ON PROPERLY TO THE BALLOON. ANOTHER SAME SIZE STENT WAS USED TO 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 10442250 ↗
• InjuryJun 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, A 2.5X38MM XIENCE SIERRA STENT AND A NON-ABBOTT STENT WERE IMPLANTED WITHOUT AN ISSUE NOTED. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HYPERTENSION AND HEART FAILURE. THE PATIENT WAS DISCHARGED TO AN EXTENDED CARE FACILITY. THE DEVICE RELATIONSHIP TO THE EVENT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 10150894 ↗
• MalfunctionJun 1, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X38 MM XIENCE SIERRA STENT WAS IMPLANTED AFTER THE EXPIRATION DATE. 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 10105881 ↗
• MalfunctionMay 27, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 2.50X38MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE IT WAS NOTED THAT THE STENT WAS EXPIRED ON 5/2/2020, BUT IT WAS USED BECAUSE IT WAS READ OUT LOUD AS 5/20/20 WHICH WAS INCORRECT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093158 ↗
• MalfunctionMar 12, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X38MM XIENCE SIERRA STENT WAS IMPLANTED AFTER THE EXPIRATION DATE. 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 9826542 ↗
• MalfunctionFeb 12, 2020Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT ON 01/17/2020 A 2.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LEFT ANTERIOR DESCENDING (LAD), HEAVILY CALCIFIED AND 90% OCCLUDED LESION DUE TO ANATOMY. DURING ADVANCEMENT ATTEMPTS, A FLARED STENT WAS OBSERVED. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUES AND ANOTHER XIENCE SIERRA SDS WAS USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE. SUBSEQUENTLY, ON (B)(6) 2020, ABBOTT VASCULAR'S PRELIMINARY ANALYSIS OF THE RETURNED DEVICE FOUND THE INNER AND OUTER MEMBER (SHAFT) WERE STRETCHED AND THE PROXIMAL BALLOON MARKER APPEARED TO HAVE MOVED APPROXIMATELY 2CM DISTAL TO THE PROXIMAL SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701855 ↗
• MalfunctionDec 4, 2019Defective Device; Component Misassembled; Defective Device; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, NON-TORTUOUS DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY. ALTHOUGH THE 2.5X38MM XIENCE SIERRA STENT WAS DEPLOYED IN THE TARGET LESION, THE PLACEMENT OF THE BALLOON MARKERS WAS OFF IN RELATION TO THE BALLOON SHOULDER. PER THE PHYSICIAN, THE DISTANCE BETWEEN THE PROXIMAL END OF THE BALLOON SHOULDER AND THE PROXIMAL MARKER WAS TOO LONG. THE PHYSICIAN SUSPECTED THAT THE BALLOON HAD BEEN ASSEMBLED INCORRECTLY DURING THE MANUFACTURING PROCESS. 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 9411083 ↗
• InjuryOct 9, 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) 2019, THE PATIENT UNDERWENT A CORONARY PROCEDURE, PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, WITH 90% STENOSIS. A 2.5 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED ON THE LAD: HOWEVER, IT BLOCKED THE 1ST DIAGONAL ARTERY, CAUSING A 90% OCCLUSION. ADDITIONAL BALLOON DILATATION WAS REQUIRED AND THE EVENT RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 9173475 ↗
• InjuryOct 8, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. TWO XIENCE SIERRA STENTS WERE IMPLANTED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2019, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND A MYOCARDIAL INFARCTION WAS DIAGNOSED. ANGIOGRAPHY WAS PERFORMED AND CONFIRMED THROMBOSIS IN BOTH STENTS. THROMBECTOMY WAS PERFORMED WITH GOOD RESULTS. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND SUB-OPTIMAL STENT DEPLOYMENT WAS NOTED AND TREATED WITH ADDITIONAL BALLOON DILATATION. IT WAS CONFIRMED THAT PATIENT HAD BEEN COMPLIANT WITH DUAL ANTI-PLATELET THERAPY POST IMPLANT OF THE TWO XIENCE STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 9169019 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (2) 2.5X38 MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. THE PATIENT STOPPED DUAL ANTIPLATELET THERAPY (DAPT) ON (B)(6) 2019 DUE TO UNRELATED UPCOMING SURGERY. THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION ON (B)(6) 2019 AND THROMBOSIS WAS CONFIRMED IN BOTH STENTS VIA ANGIOGRAPHY. THE AREA WAS TREATED WITH BALLOON ANGIOPLASTY AND INTRAVASCULAR ULTRASOUND (IVUS) WITH GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 9162583 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (2) 2.5X38 MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. THE PATIENT STOPPED DUAL ANTIPLATELET THERAPY (DAPT) ON (B)(6) 2019 DUE TO UNRELATED UPCOMING SURGERY. THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION ON (B)(6) 2019 AND THROMBOSIS WAS CONFIRMED IN BOTH STENTS VIA ANGIOGRAPHY. THE AREA WAS TREATED WITH BALLOON ANGIOPLASTY AND INTRAVASCULAR ULTRASOUND (IVUS) WITH GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 9162486 ↗