XIENCE Sierra™ 1550325-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648227356), received between Aug 23, 2018 and May 27, 2021 — classified as 1 death, 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 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 ST-ELEVATION MYOCARDIAL INFARCTION AND TWO (3.25X23MM AND 3.25X38MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11898862 ↗
• InjuryMar 12, 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 PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND A XIENCE SIERRA STENT WAS IMPLANTED. THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN ON (B)(6) 2020. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11475439 ↗
• MalfunctionDec 7, 2020Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN AN UNSPECIFIED ARTERY. THE 3.25 X 23 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, IT WAS NOTED THAT WHEN 8 ATMOSPHERES (ATM) OF PRESSURE WERE APPLIED, THE BALLOON DID NOT INFLATE. THE DEVICE WAS REMOVED, WITH THE STENT ON THE DELIVERY SYSTEM, AND IT WAS NOTED THAT THERE WAS A LEAK IN THE MIDDLE OF THE BALLOON. THE STENT REMAINED ON THE BALLOON, WITH NO MOVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10963150 ↗
• InjuryAug 17, 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 3.25X23 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RAMUS CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT WAS AT THE EMERGENCY ROOM WITH A NON ST ELEVATION MYOCARDIAL INFARCTION DUE TO IN-STENT RESTENOSIS OF THE XIENCE STENT. THE STENT WAS REVASCULARIZED ON (B)(6) 2020. THE CONDITION RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Stenosis

  MAUDE report 10414456 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020 VIA CHIBA VASCULAR INTERVENTION CONFERENCE, IN A PRESENTATION TITLED ¿STENT THROMBOSIS WHICH OCCURRED AFTER AN EMERGENT PCI FOR SEVERE NSTEMI PRESENTING CULPRIT SHOCK,¿ THAT THE FOLLOWING OCCURRED: A PATIENT WAS HOSPITALIZED ON (B)(6) 2019, AS THEY PRESENTED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION, HYPERTENSION, CARDIOGENIC SHOCK AND DIABETES. ADDITIONALLY, HEPATOPATHY AND NEPHROPATHY WERE ALSO NOTED. ANGIOGRAPHY WAS PERFORMED WHICH SHOWED 99% STENOSIS AT THE MID-DISTAL RIGHT CORONARY ARTERY (RCA), 90% STENOSIS AT THE PROXIMAL-DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 100% STENOSIS AT THE DISTAL CIRCUMFLEX (CX) WITH 20% EJECTION FRACTION (EF). THE RCA LESION WAS TREATED FIRST AND PREDILATATION WAS PERFORMED. A 2.25X38MM XIENCE SIERRA STENT WAS DEPLOYED AT 8 ATMOSPHERES (ATM) TO 16 ATM FROM THE POSTERIAL LATERAL TO THE DISTAL RCA. THEN THE SECOND STENT IMPLANTED AT 11 ATMOSPHERES WAS A 2.5X48MM XIENCE XPEDITION AT THE MID RCA. FINALLY A THIRD STENT (3.25X23MM XIENCE SIERRA) WAS IMPLANTED AT 12 ATM AT THE PROXIMAL RCA. POST-DILATATION WAS PERFORMED AND INTRAVASCULAR ULTRASOUND WAS CONDUCTED. ALTHOUGH BAD-FLOW WAS NOTED, THE LESION WAS OPENED

  Patient problems: Ischemia; Myocardial Infarction; Test Result; Thrombosis

  MAUDE report 9811941 ↗
• DeathJan 8, 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 XIENCE SIERRA 3.25X23 MM STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND THE XIENCE SIERRA 2.75X15 MM WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT HAD RIGHT SIDED PAIN RADIATING TO THE NECK AND JAW. THE CARDIAC ENZYMES INDICATED THAT THE PATIENT HAD A MYOCARDIAL INFARCTION MEDICATION WAS ADMINISTERED ON (B)(6)2019. DIAGNOSTIC IMAGING ONLY WAS PERFORMED ON (B)(6) 2019. THE ANGIOGRAM FOUND 90 TO 99% RESTENOSIS IN THE LAD AND LCX STENTS. THERE WAS ALSO RESTENOSIS IN THE OBTUSE MARGINAL AND THE RIGHT CORONARY ARTERIES. THE PATIENT WENT INTO CARDIAC ARREST ON (B)(6) 2019, BUT WAS SUCCESSFULLY RESUSCITATED. SUBSEQUENTLY, THE PATIENT STATUS WAS CHANGED TO DO NOT RESUSCITATE. CARDIAC ARREST OCCURRED AGAIN AND THE PATIENT EXPIRED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 9566876 ↗
• InjuryNov 15, 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) 2018, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED, TREATING THE RIGHT CORONARY ARTERY (RCA) LESION. A 3.25X23MM AND A 3.5X38MM XIENCE SIERRA STENT WERE IMPLANTED WITH STANDARD POST-DILATATION. REPORTEDLY, THERE WAS NO ISSUE WITH IMPLANTATION NOR STENT EXPANSION. PROCEDURAL RESULTS SHOWED TIMI FLOW 3 AND 0% DIAMETER STENOSIS. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR UNSTABLE CHEST PAIN. A REPEAT CARDIAC CATHETERIZATION WAS PERFORMED. THE MID LEFT ANTERIOR DESCENDING (LAD) HAD STENOSIS AND THE RCA WAS OBSERVED WITH MILD TO MODERATE IN-STENT RESTENOSIS (ISR) IN BOTH STENTS. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE HOSPITAL AGAIN FOR UNSTABLE ANGINA. ELEVATED CARDIAC ENZYMES WERE NOTED AND A MYOCARDIAL INFARCTION WAS DIAGNOSED. A REPEAT CORONARY ANGIOGRAM WAS PERFORMED WITH NO CHANGE NOTED FROM THE PREVIOUS ANGIOGRAM. THE PATIENT IS SCHEDULED FOR AN OUTPATIENT TARGET LESION REVASCULARIZATION. MEDICATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 9329381 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2018 THE PATIENT HAD A MYOCARDIAL INFARCTION THAT WAS TREATED WITH THREE XIENCE SIERRA STENTS (TWO WERE SIZES 3.25X23 AND ONE 3.25X33) IN THE PROXIMAL AND MID RIGHT CORONARY ARTERIES AND TWO NON-ABBOTT STENTS IN THE MID LEFT CIRCUMFLEX CORONARY ARTERY AND IN THE DIAGONAL ARTERY (SIZES 2.0X15 AND 2.0X18). AT THE ONE YEAR FOLLOW-UP VISIT ON (B)(6) 2019, THE ANGIOGRAM FOUND SEVERAL BLOCKAGES IN THE CORONARY ARTERY. A FIVE VESSEL CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT CONTINUED TO HAVE CHEST PAIN AFTER THE XIENCE STENTS WERE IMPLANTED IN 2018. THE PATIENT WAS REMOVED FROM THE VENTILATOR ON (B)(6) 2019. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2019.

  Patient problems: Angina; Stenosis

  MAUDE report 9272206 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2018 THE PATIENT HAD A MYOCARDIAL INFARCTION THAT WAS TREATED WITH THREE XIENCE SIERRA STENTS (TWO WERE SIZES 3.25X23 AND ONE 3.25X33) IN THE PROXIMAL AND MID RIGHT CORONARY ARTERIES AND TWO NON-ABBOTT STENTS IN THE MID LEFT CIRCUMFLEX CORONARY ARTERY AND IN THE DIAGONAL ARTERY (SIZES 2.0X15 AND 2.0X18). AT THE ONE YEAR FOLLOW-UP VISIT ON (B)(6) 2019, THE ANGIOGRAM FOUND SEVERAL BLOCKAGES IN THE CORONARY ARTERY. A FIVE VESSEL CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT CONTINUED TO HAVE CHEST PAIN AFTER THE XIENCE STENTS WERE IMPLANTED IN 2018. THE PATIENT WAS REMOVED FROM THE VENTILATOR ON (B)(6) 2019. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2019.

  Patient problems: Angina; Stenosis

  MAUDE report 9272128 ↗
• InjuryOct 8, 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 3.25X23 XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH RADIATING CHEST PAIN TO THE SHOULDERS ON EXERTION. THE PATIENT EXPERIENCED RELIEF FROM THE PAIN WITH REST. A DIAGNOSTIC ANGIOGRAM ON (B)(6) 2019 REVEALED TRIPLE VESSEL DISEASE WITH 90% DISEASE IN THE PROXIMAL LCX, LEFT ANTERIOR DESCENDING, AND RAMUS ARTERIES. FOUR CORONARY ARTERIES, THE RAMUS, DIAGONAL, FIRST OBTUSE MARGINAL, AND LEFT POSTEROLATERAL, WERE SURGICALLY BYPASSED ON (B)(6) 2019. ALTHOUGH THERE WAS NO RESTENOSIS INSIDE THE XIENCE STENT, THERE WAS STENOSIS WITHIN 5 MM OF THE STENT. THE CONDITION RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 9169016 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 23 MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. ON(B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN, AN INFECTION, 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: Angina; Unspecified Infection

  MAUDE report 8701950 ↗
• MalfunctionJun 3, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.25X23MM XIENCE SIERRA STENT WAS DEPLOYED AT AN UNKNOWN PRESSURE IN THE PROXIMAL END OF THE RCA INTO THE OSTIUM. POST DILATATION WAS PERFORMED WITH A 3.50X12MM NC TREK BALLOON DILATATION CATHETER AT THE PROXIMAL END OF THE STENT IN AN ATTEMPT TO FLARE THE STENT OUT INTO THE OSTIUM. THE BALLOON WAS INFLATED TO 18 AND THEN 20 ATMOSPHERES. ON THE THIRD INFLATION AT 16 ATM, THE BALLOON RUPTURED AND A DISSECTION WAS NOTED. ANOTHER SIERRA STENT WAS DEPLOYED OVERLAPPING THE FIRST STENT AS TREATMENT. IN THE PHYSICIANS OPINION, THE BALLOON MATERIAL CAUGHT ON THE STENT STRUT DURING INFLATION, CAUSING THE RUPTURE AND SUBSEQUENT DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663006 ↗
• InjuryJan 8, 2019Adverse 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 LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING THE PROCEDURE, THREE XIENCE SIERRA STENTS (2.5 X 38MM 3.0 X 15MM, AND 3.25 X 23MM), WERE DEPLOYED; HOWEVER, THROMBOSIS WAS NOTED ON ALL THREE STENTS. THERE WERE NO DEVICE ISSUES AND THE STENTS WERE WELL-APPOSED TO THE VESSEL WALL. ASPIRATION WAS PERFORMED TO REMOVE THE CLOTS AND THE PATIENT WAS GIVEN MEDICATION. THE PROCEDURE WENT WELL. THE PATIENT REMAINED ON MEDICATION AND WAS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 8226619 ↗
• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.25X23 XIENCE SIERRA STENT WAS IMPLANTED WITH NO ISSUE. ON (B)(6) 2018, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. ANGIOGRAPHY WAS PERFORMED WHICH NOTED THROMBOSIS IN THE SIERRA STENT. THE THROMBUS WAS TREATED WITH BALLOON ANGIOPLASTY AND IMPLANTATION OF TWO STENTS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Angina; Thrombosis

  MAUDE report 7810296 ↗