XIENCE Sierra™ 1550300-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08717648227257), received between Aug 29, 2018 and Mar 24, 2022 — classified as 28 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE RADIO FREQUENCY IDENTIFICATION (RFID) CONSIGNMENT TRACKING TAG FOR THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) IS SHOWING THE WRONG EXPIRATION YEAR, THE MONTH AND DATE ARE CORRECT. THE EXPIRATION DATE ON THE RFID TAG IS SHOWING 12/22/2008. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13894341 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPTIMA-AF STUDY. IT WAS REPORTED THAT THE INDEX PROCEDURE ON (B)(6) 2020, WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0X15MM XIENCE SIERRA WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2021, THE PATIENT SHOWED SYMPTOMS OF MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS WAS CONFIRMED. REVASCULARIZATION WAS PERFORMED WITH A DCB [DRUG COATED BALLOON] DUE TO IN-STENT RESTENOSIS. TIMI 3 FLOW WAS ACHIEVED. A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Stenosis

  MAUDE report 12813490 ↗
• MalfunctionOct 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A 3X15MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS UNPACKAGED AND IT WAS NOTED THAT THE STENT STRUTS MAY HAVE BEEN SEPARATED, IN TWO PIECES. THE DEVICE WAS NOT USED IN THE PROCEDURE AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12676998 ↗
• MalfunctionOct 5, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, WHEN THE BOX WAS OPENED AND THE PACKAGE CONTAINING THE STENT WAS PULLED OUT OF THE BOX, THE STICKER ON THE FOIL WRAPPER WAS NOTED TO BE RIPPED. THE DEVICE WAS NO LONGER STERILE. IT LOOKED LIKE THE PACKAGE MAY HAVE PREVIOUSLY BEEN OPENED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12578397 ↗
• MalfunctionJun 14, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY. A 3X15MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS INSERTED AND ATTEMPTED TO BE ADVANCED. HOWEVER, DUE TO PATIENT ANATOMY, THE STENT WAS UNABLE TO CROSS THE LESION. THEREFORE, IT WAS ATTEMPTED TO BE REMOVED. HOWEVER, DURING REMOVAL, IT WAS OBSERVED THE STENT BECAME DISLODGED. ALL DEVICES WERE THEN REMOVED FROM THE ANATOMY AND IT WAS OBSERVED THE DISLODGED STENT REMAINED INSIDE THE CATHETER. THE VESSEL WAS RE-PREPPED AND A NON-ABBOTT DEVICE WAS SUCCESSFULLY IMPLANTED. 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 11995908 ↗
• InjuryJun 2, 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 PRESENTED WITH SHORTNESS OF BREATH AND TWO (3.0X15MM AND 3.5X15MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 11922686 ↗
• InjuryJun 2, 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 PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND TWO (3.0X15MM AND 3.5X12MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND SHORTNESS OF BREATH. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 11921594 ↗
• MalfunctionMar 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE RIGHT CORONARY ARTERY. THE XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY; HOWEVER, AFTER THE PROCEDURE WAS COMPLETED, IT WAS NOTED THAT THE STENT WAS EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11499495 ↗
• MalfunctionMar 15, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER IMPLANTING A XIENCE SIERRA STENT ON (B)(6) 2021, IT WAS NOTED TO BE EXPIRED (EXPIRED (B)(6) 2021). THE PATIENT IS DOING WELL. 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 11490389 ↗
• 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 3.0X15MM XIENCE SIERRA STENT WAS IMPLANTED IN A CORONARY ARTERY. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR CHEST PAIN AND HYPERTENSIVE HEART DISEASE. UNSPECIFIED TREATMENT WAS PROVIDED. A DEVICE RELATIONSHIP TO THE EVENT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; High Blood Pressure/ Hypertension

  MAUDE report 10969891 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY STENTING PROCEDURE, A 3.0 X 15 MM XIENCE SIERRA DRUG-ELUTING STENT WAS DEPLOYED ACROSS THE DISTAL STENOSIS AT 16 ATMOSPHERES. AT THAT TIME, THERE WAS A DISRUPTION OF THE PROXIMAL TO MID RIGHT CORONARY ARTERY STENOSIS AND THE DECISION WAS MADE TO COVER THIS AREA WITH A DRUG-ELUTING STENT. A 3.5 X 28 MM XIENCE SIERRA WAS THEN SUCCESSFULLY IMPLANTED AND POST-DILATED WITH A 3.5X20MM NC TREK. AFTER POST-DILATATION, A PERFORATION WAS NOTED. AT THAT TIME, A 3.5 X16 MM GRAFTMASTER COVERED STENT (9072241) WAS IMPLANTED ACROSS THE PERFORATION AT 20 ATMOSPHERES (ABOVE RATED BURSE PRESSURE), RESOLVING THE PERFORATION; HOWEVER, THE STENT WAS POST-DILATED WITH THE 3.5X20MM NC TREK AND THE PERFORATION WAS NOTED TO CONTINUE TO LEAK. TWO ADDITIONAL 3.5X19 GRAFTMASTER STENTS (9112841, 9032941) WERE IMPLANTED, ONE PROXIMAL AND ONE DISTAL TO THE IMPLANTED 3.5X16MM GRAFTMASTER STENT, BUT THE PERFORATION CONTINUED TO LEAK. AN ADDITIONAL XIENCE SIERRA 3.5 X 38 MM STENT WAS IMPLANTED BUT THE PERFORATION CONTINUED TO LEAK. A 2.8X19MM GRAFTMASTER STENT (8120641) WAS ADVANCED, BUT FAILED TO GET DISTAL TO THE LAST GRAFTMASTER STENT AND THE XIENCE SIERRA. ANO

  Patient problems: Prolapse

  MAUDE report 10693794 ↗
• InjurySep 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 A 3.0X15MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND ACUTE RENAL FAILURE. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Renal Failure

  MAUDE report 10516257 ↗
• InjuryJul 10, 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 CORONARY INTERVENTION WAS PERFORMED ON THE RIGHT CORONARY ARTERY (RCA), 95% STENOSED LESION. A 3.0X15MM XIENCE SIERRA STENT (1550300-15, 9011441) WAS IMPLANTED IN THE DISTAL RCA WITHOUT COMPLICATION. FOLLOWING, A 3.0X18 AND A 3.5X18MM XIENCE SIERRA STENT WERE IMPLANTED IN THE MID RCA WITHOUT COMPLICATION. ACCEPTABLE RESULTS WERE NOTED AS THE RCA WAS OBSERVED WITH TIMI FLOW III AND 0% DIAMETER STENOSIS FOLLOWING STENT IMPLANTATION. ON (B)(6) 2019, THE PATIENT EXPERIENCED WORSENING JAW PAIN AND A POSITIVE NON-STRESS TEST WAS NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CORONARY ARTERY DISEASE. ANOTHER CARDIAC CATHERITIZATION WAS PERFORMED AND TARGET VESSEL DISEASE WAS OBSERVED. 80% PROXIMAL LAD STENOSIS, 99% DISTAL LCX STENOSIS, 99% PROXIMAL RCA STENOSIS, WIDELY PATENT STENT (STENT NOT SPECIFIED), AND 70% DISTAL RCA STENOSIS. ON (B)(6) 2020, A CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED IN THE LAD, OM AND PDA. ELEVATED TROPONIN WAS NOTED FOLLOWING. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Cardiac Enzyme Elevation; Stenosis; Test Result

  MAUDE report 10261450 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROSIS. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10148379 ↗
• InjuryMar 8, 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 3.0X15MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9803956 ↗
• InjuryMar 8, 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). TWO (3.0X15MM, 3.50X12MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH DRESSLER SYNDROME. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation

  MAUDE report 9803942 ↗
• MalfunctionJan 20, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS NON-TORTUOUS, MODERATELY CALCIFIED AND 70% STENOSED. THE XIENCE SIERRA STENT WAS SUCCESSFULLY DEPLOYED AT 16 ATMOSPHERES FOR 20 SECONDS; HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE PROXIMAL SEGMENT OF THE BALLOON APPEARED ELONGATED BEYOND THE PROXIMAL MARKER. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9608590 ↗
• InjuryDec 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  STUDY PATIENT (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2019, TREATING A TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0 X 15 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2019, THE PATIENT WAS WORKING AT HOME AND DEVELOPED DIFFICULTY BREATHING AND SHIVERING, WITH CLAMMINESS. EMERGENCY MEDICAL SERVICES WAS CALLED AND ADMINISTERED ASPIRIN. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT AND HOSPITALIZED. THE PATIENT WAS HEMODYNAMICALLY STABLE. TROPONIN LEVELS WERE ELEVATED AND NON-ST ELEVATION MYOCARDIAL INFARCTION WAS DIAGNOSED. THE PATIENT WAS TAKEN TO THE CATH LAB AND CORONARY ANGIOGRAPHY NOTED THAT THE STENT WAS UNDERDEPLOYED. BALLOON ANGIOPLASTY WAS PERFORMED. ANTIPLATELET MEDICATIONS WERE ADMINISTERED. THE PATIENT WAS OBSERVED FOR TWO DAYS. THE EVENT RESOLVED ON 11/16/2019 AND THE PATIENT WAS DISCHARGED TO HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Dyskinesia; Dyspnea; Myocardial Infarction

  MAUDE report 9454870 ↗
• InjuryDec 9, 2019Adverse 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 ATHEROSCLEROTIC HEART DISEASE THEREFORE TWO 3.0X15MM AND ONE 3.0X18MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH A GASTRIC ULCER WITH HEMORRHAGE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9441014 ↗
• InjuryDec 9, 2019Adverse 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 3.0X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH AORTIC VALVE STENOSIS. SURGERY WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9440207 ↗
• InjuryDec 9, 2019Adverse 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 3.0X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9438225 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH HYPOTENSION AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 9434334 ↗
• InjuryAug 29, 2019Adverse 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 A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 3.0X15MM XIENCE SIERRA AND 4.0X18MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH VENTRICULAR TACHYCARDIA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Tachycardia

  MAUDE report 8946398 ↗
• MalfunctionJul 18, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT A 3.0X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE. THE SDS BECAME STUCK WITH THE GUIDE WIRE, AND THE SDS SHAFT BECAME SEPARATED DURING REMOVAL. A LARGER QUANTITY OF CONTRAST WAS USED THAN USUAL AMOUNT. ANOTHER NON-ABBOTT GUIDE WIRE 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 8804931 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THREE XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED FOR CHEST PAIN. TREATMENT WAS PROVIDED, BUT NOT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina

  MAUDE report 8725222 ↗