XIENCE Sierra™ 1550300-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 08717648227301), received between Jun 22, 2018 and Jun 7, 2022 — classified as 7 deaths, 31 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 48 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 14627232 ↗
• InjuryMay 11, 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 TO TREAT IN-STENT RESTENOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 14366159 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED, INDICATING THAT THE ADVERSE EVENT RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12914143 ↗
• InjuryNov 6, 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, HEAVILY TORTUOUS, LESION IN THE CIRCUMFLEX (CX) ARTERY. A 3X38MM XIENCE SIERRA DRUG ELUTING STENT SYSTEM (DESS) WAS ADVANCED BUT COULD NOT CROSS THE DIFFICULT ANATOMY AND THE STENT DISLODGED FROM THE BALLOON UNBEKNOWNST TO THE PHYSICIAN. UPON REMOVAL OF THE DEVICE FROM THE ANATOMY, IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON OR IN THE TARGET LESION. THE STENT WAS LOCATED IN THE DISTAL AORTA. TWO SNARE DEVICES WERE USED TO PULL THE STENT OUT OF THE AORTA, INTO THE SHEATH, AND WAS REMOVED WITHOUT ISSUE. AN UNSPECIFIED BALLOON WAS USED TO DILATATE THE LESION TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755730 ↗
• InjuryOct 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CIRCUMFLEX ARTERY. TWO XIENCE SIERRA STENT DELIVERY SYSTEMS (SDS) (2.25X38 AND 3.0X38MM) WERE IMPLANTED WITHOUT ISSUE; HOWEVER, THE PHYSICIAN DID NOT LIKE THE APPOSITION OF WHERE BOTH STENTS OVER LAPPED IN THE MIDDLE. THEREFORE, THE 3.50X18MM XIENCE SIERRA SDS WAS ADVANCED WITH NO ISSUE, BUT THE BALLOON RUPTURED AT 2 ATMOSPHERES. THERE WAS DIFFICULTY REMOVING THE SDS DUE TO THE ANATOMY AND THE STENT BECAME DISLODGED. A 3.5X15MM NON-COMPLIANT BALLOON WAS ADVANCED AND USED TO TREAT THE MALPOSITION. THEN AN UNSPECIFIED TREK BALLOON WAS USED TO BRING THE DISLODGED STENT BACK INTO THE UNSPECIFIED GUIDE CATHETER AND REMOVE ALL OF THE DEVICES AS ONE UNIT. ONCE THE DEVICE WAS REMOVED IT WAS NOTED THE STENT WAS NOT IN THE GUIDE CATHETER AND REMAINED STUCK AT THE RIGHT GROIN. THE PATIENT WAS SENT TO SURGERY AND A CUT DOWN WAS PERFORMED TO SUCCESSFULLY REMOVE THE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12640035 ↗
• 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 12359250 ↗
• 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 12359202 ↗
• MalfunctionAug 5, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). THE 3X38MM XIENCE SIERRA DRUG ELUTING STENT (DES), WAS PREPARED PER THE IFU, ADVANCED AND DEPLOYED IN THE TARGET LESION WITHOUT ISSUE. AFTER BALLOON DEFLATION AND DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE BALLOON WOULD NOT RELEASE FROM THE STENT AND APPEARED TO BE PULLING THE STENT. TROUBLESHOOTING WAS PERFORMED AND ON THE FOURTH ATTEMPT TO REMOVE THE DELIVERY SYSTEM, THE BALLOON RELEASED AND THE DELIVERY SYSTEM REMOVED, LEAVING THE STENT IN PLACE AT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284573 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, TWO XIENCE SIERRA DRUG ELUTING STENTS (3X38MM; 3X28MM) WERE IMPLANTED, OVERLAPPING, IN A 90% STENOSED LESION IN THE MILDLY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2021, RESTENOSIS WAS CONFIRMED IN THE OVERLAPPED SECTION OF THE IMPLANTED STENTS AND REVASCULARIZATION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12240279 ↗
• InjuryJun 18, 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 PATIENT PRESENTED WITH IN-STENT RESTENOSIS OF THE MID CIRCUMFLEX (CX) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND A 3.0X38MM XIENCE SIERRA STENT (1550300-38, 9010442) WAS SUCCESSFULLY IMPLANTED IN THE MID CX WITH ACCEPTABLE RESULTS AND NO COMPLICATIONS. ON (B)(6) 2021, THE PATIENT NOTIFIED EMERGENCY PERSONNEL OF CHEST PAIN AND WAS HOSPITALIZED. A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. PER IMAGING, THE CX STENT WAS 95% RESTENOSED. MEDICATIONS WERE PROVIDED AND ANOTHER STENT WAS IMPLANTED IN THE CX AS TREATMENT. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 12027103 ↗
• DeathMay 25, 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-ELEVATION MYOCARDIAL INFARCTION. TWO XIENCE SIERRA STENTS (3.0X38MM AND 3.50X38MM) WERE IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ST-ELEVATION MYOCARDIAL INFARCTION. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME WAS DEATH (DEATH DATE WAS NOT SPECIFIED). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 11880988 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ATHEROSCLEROTIC HEART DISEASE AND UNSTABLE ANGINA. ON (B)(6) 2021 TWO XIENCE SIERRA STENTS WERE IMPLANTED (3.00X38MM AND A 3.50X38MM). THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2021 WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROTIC HEART DISEASE AND UNSTABLE ANGINA. TWO ADDITIONAL 4.00X15MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2021. THE PATIENT WAS RE-HOSPITALIZED AGAIN ON 03/28/2021 WITH CARDIOVASCULAR SYMPTOMS INCLUDING ACUTE KIDNEY FAILURE. UNSPECIFIED MEDICAL INTERVENTION WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11880628 ↗
• InjuryMay 6, 2021Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). RESISTANCE WAS FELT WITH THE ANATOMY, DURING ADVANCEMENT OF THE 3.0X38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION. THE STENT DISLODGED FROM THE BALLOON AT THE TARGET LESION. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. A NEW BALLOON WAS USED TO EXPAND THE DISLODGED STENT TO THE VESSEL WALL AT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788105 ↗
• InjuryMar 9, 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-ELEVATION MYOCARDIAL INFARCTION. A 3.0X38MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING A COMPLETE ATRIOVENTRICULAR BLOCK. SURGERY WAS PERFORMED AS TREATMENT; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 11448401 ↗
• 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 SEPSIS. THREE XIENCE SIERRA STENTS (3.0X38MM, 3.25X38MM, AND 2.25X38MM) WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND ATRIAL FIBRILLATION. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 10985994 ↗
• InjuryDec 9, 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 3.00X38 MM, 3.25X38 MM AND 2.25X38 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED DUE TO ST ELEVATED MYOCARDIAL INFARCTION (STEMI). THE METHOD OF TREATMENT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 10979849 ↗
• DeathDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED ON THE FIRST XIENCE STENT DEPLOYED. IT WAS REPORTED THAT THE XIENCE 3.0X38 WAS DEPLOYED FIRST IN THE MID RIGHT CORONARY ARTERY (RCA) AND OVERLAPPED THE 4.0X18 XIENCE THAT WAS IMPLANTED IN THE PROXIMAL RCA SECOND. A 4.0 NC (NON-COMPLIANT) BDC (BALLOON DILATATION CATHETER) WAS USED TO POST DILATE AND THEN A 4.0X15 NC BDC AT 18 ATMOSPHERES. PATIENT THEN HAD CHEST PAIN AND A PERFORATION IN THE MID RCA WAS NOTED, LIKELY FROM POST DILATATION. THE 3.5X19 MM GRAFTMASTER STENT WAS INSERTED TO TREAT THE PERFORATION, BUT IT WAS UNABLE TO CROSS THROUGH THE STENTS DUE TO THE TORTUOSITY. THE PATIENT WENT INTO CARDIAC ARREST AS SHE BECAME HYPOTENSIVE AND BRADYCARDIC. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED WITH ADMINISTRATION OF EPINEPHRINE, ATROPINE, BICARBONATE. TRANSTHORACIC ECHOCARDIOGRAM SHOWED A LARGE PERICARDIAL EFFUSION. PERICARDIOCENTESIS DRAINED 1.1 LITERS OF BLOOD. THE GRAFTMASTER WAS ATTEMPTED AGAIN WITH ANOTHER GUIDE WIRE, BUT IT WAS STILL UNABLE TO CROSS. CPR WAS DISCONTINUED AFTER A LONG TIME OF PERFORMING IT AND IN VIEW OF UNLIKELY RECOVERY. THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 10977841 ↗
• MalfunctionDec 7, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN AN UNSPECIFIED CORONARY VESSEL THAT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. AFTER THE XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS, THERE WAS RESISTANCE DURING REMOVAL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE 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 10963372 ↗
• MalfunctionNov 25, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A 3.0X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE CHIPBOARD BOX AND IT WAS NOTED THAT THE INTERNAL POUCH WAS OPEN, AND THE DEVICE WAS NOT STERILE. THERE WAS NO DAMAGE NOTED TO THE CHIPBOARD BOX. THE SDS WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.0X38MM XIENCE SIERRA STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10905727 ↗
• 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 10814109 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE FINAL MDR, ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT WAS RE-HOSPITALIZED WITH ELEVATED RIGHT HEART PRESSURE WITH SIGNIFICANT VOLUME OVERLOAD [HEART FAILURE]. THE PATIENT WAS PLACED ON BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP), AND THE PATIENT¿S CONDITION IMPROVED WITH OXYGENATION, AND LATER WEANED TO ROOM AIR. INTERVENTION WAS PERFORMED TO TREAT RESTENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE PATIENT CONDITION RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Hypoxia; Myocardial Infarction; Neurological Deficit/Dysfunction; Stenosis; Tachycardia

  MAUDE report 10744358 ↗
• MalfunctionOct 21, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION WITH MILD CALCIFICATION AND MILD TORTUOSITY IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0 X 38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THE SDS WAS REMOVED AND RESISTANCE DUE TO ANATOMY WAS ALSO NOTED. A 3.0 X 23 MM 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 Consequences Or Impact To Patient

  MAUDE report 10715453 ↗
• MalfunctionSep 17, 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 HEAVILY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X38MM XIENCE SIERRA WAS ATTEMPTED TO CROSS BUT FAILED DUE TO ANATOMY. THE STENT MET RESISTANCE DURING ADVANCEMENT AND REMOVAL WITH ANATOMY. IT WAS NOTED THAT THE STENT WAS FLARED. ANOTHER DIFFERENT SIZE STENT WAS USED TO SUCCESSFULLY 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 10547305 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA BEFORE THE PROCEDURE. THREE XIENCE SIERRA STENTS (3X38MM, 3.25X18MM, AND 4X28MM) WERE IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH NON-RHEUMATIC AORTIC VALVE STENOSIS AND OTHER CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10517929 ↗
• InjurySep 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 THE PATIENT HAD A 2.5X38 MM, 3.00X38 MM AND A 3.50X12 MM XIENCE SIERRA STENT IMPLANTED. THE PATIENT WAS DISCHARGED AND RETURNED ON (B)(6) 2020 FOR PARAXYSMAL ATRIAL FIBRILLATION. TREATMENT WAS NOT SPECIFIED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 10505413 ↗