XIENCE Sierra™ 1550400-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648227479), received between Aug 27, 2019 and Nov 18, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2020Inflation Problem; Difficult or Delayed Activation; Migration; Inflation Problem; Difficult or Delayed Activation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND CHRONIC TOTAL OCCLUSION IN THE RIGHT CIRCUMFLEX CORONARY ARTERY. A 4.00 X 8 MM XIENCE SIERRA DRUG ELUTING STENT DELIVERY SYSTEM (SDS) WAS PREPPED OUTSIDE THE ANATOMY WITHOUT ANY ISSUES. THE SDS WAS ADVANCED AND THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DURING DEPLOYMENT, IT WAS SUSPECTED THAT THE BALLOON WAS NOT FULLY INFLATED. THIS CAUSED THE STENT TO NOT FULLY APPOSE TO THE ARTERIAL WALL RESULTING IN IT MOVING FREELY WITHIN THE VESSEL AS WITNESSED ON IVUS. AFTER THE GUIDE CATHETER [STENT DELIVERY SYSTEM] WAS PULLED BACK, THE STENT DETACHED, AND IT WAS OBSERVED ON IMAGING THAT THE STENT STARTED TO MOVE DISTALLY. IT WAS ALSO NOTED THAT A DISSECTION HAD OCCURRED. THE DISSECTION WAS NOT TREATED. SINCE THE STENT WAS MOBILE, IT WAS ATTEMPTED TO BE TRACKED. HOWEVER, THE STENT WAS UNABLE TO BE FOUND AND REMAINED IN THE PATIENT. IT WAS NOTED THAT THE PATIENT WAS STABLE AND DOING WELL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORTED DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Foreign Body In Patient; Intimal Dissection

  MAUDE report 10864887 ↗
• InjuryNov 16, 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) 2020, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI), ELEVATED CARDIAC ENZYMES, AND A PROXIMAL CIRCUMFLEX (CX), 95% STENOSED LESION. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED.PRE-DILATATION WAS PERFORMED ON THE CX LESION AND A 3.5X23MM XIENCE SIERRA STENT (1550350-23, 9120941) STENT WAS IMPLANTED WITH ACCEPTABLE RESULTS. POST-IMPLANTATION, A PROXIMAL EDGE DISSECTION WAS OBSERVED. AS TREATMENT, A 4.0X8MM XIENCE SIERRA STENT (1550400-08, 0051241) WAS IMPLANTED. POST IMPLANTATION, A PLAQUE PROTRUSION OCCURRED. ADDITIONAL DILATATION WAS PERFORMED AS TREATMENT. DURING THIS PROCEDURE, A 2.5X38MM XIENCE SIERRA STENT (1550250-38, 90100341) HAD ALSO BEEN IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN. ELEVATED CARDIAC ENZYMES WERE OBSERVED AND A NEW MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. MEDICATIONS HAD BEEN PROVIDED AND IMAGING WAS PERFORMED. THE PROXIMAL CX WAS 50% OCCLUDED WITH RESTENOSIS AND THROMBUS RIGHT WHERE THE 3.5 AND 4.0 XIENCE SIERRA STENTS OVERLAP. AS TREATMENT, ANOTHER PCI WAS PERFORMED. THE EVENT RESOLVED WITHOUT SEQUELA. REPORTEDLY, THERE WA

  Patient problems: Angina; Myocardial Infarction; Prolapse; Stenosis; Thrombosis

  MAUDE report 10844688 ↗
• InjuryJun 18, 2020Patient-Device Incompatibility; Device Damaged by Another Device; Material Deformation; Migration; Patient-Device Incompatibility; Device Damaged by Another Device; Material Deformation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC LESION IN THE LEFT MAIN (LM) ARTERY. A 4.0X8MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND DEPLOYED; HOWEVER, IT WAS NOTED UNDER INTRAVASCULAR ULTRASOUND (IVUS) THAT THE STENT EXPANSION WAS INSUFFICIENT. ADDITIONAL POST DILATATION WAS PERFORMED, BUT THE STENT BECAME DISLODGED AFTER INTERACTION WITH A GUIDE CATHETER AND ENDED UP IN THE AORTA. THE STENT WAS REMOVED WITH A SNARE AND WAS NOTED TO BE STRETCHED FROM THE REMOVAL PROCESS; HOWEVER, THE PHYSICIAN IS UNSURE IF ANY OF THE XIENCE SIERRA STENT REMAINS IN THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. AN UNSPECIFIED STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171573 ↗
• MalfunctionMar 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING REMOVAL OF THE STYLET, THE TIP OF THE 4.0X08 MM SIERRA STENT DELIVERY SYSTEM SEPARATED. THE DEVICE WAS NOT USED IN THE ANATOMY AND WAS REPLACED WITH ANOTHER SIERRA STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9813874 ↗
• InjuryJan 17, 2020Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS, NON-CALCIFIED LEFT MAIN LESION. THE 4.0X08MM XIENCE SIERRA STENT WAS DEPLOYED AT 20 ATMOSPHERES. POST-DILATATION WAS DONE WITH A 5.5X20MM NON-ABBOTT BALLOON AND WHEN THE BALLOON WAS RETRIEVED, THE STENT CAME BACK WITH IT AND BECAME LOOSE IN THE ANATOMY. THE STENT WAS RETRIEVED WITH A SNARE DEVICE. THERE WAS A 1 HOUR 10 MINUTES DELAY IN THE PROCEDURE. A NEW NON-ABBOTT STENT WAS USED TO TREAT THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9603727 ↗
• InjuryAug 27, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE XIENCE SIERRA STENT TO THE LESION, BUT THE STENT COULD NOT CROSS A PREVIOUSLY IMPLANTED STENT. DURING REMOVAL, THE STENT DISLODGED. UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE DISLODGED STENT, AS IT WAS ONLY ABLE TO BE MOVED TO THE ACCESS SITE IN THE RIGHT RADIAL ARTERY. CONTRAST WAS INJECTED, AND THE DISLODGED STENT WAS NOTED TO BE LODGED IN A BRANCH BETWEEN THE RADIAL AND ULNAR ARTERIES, SO IT WAS DECIDED TO LEAVE IT THERE AS IT DID NOT LIMIT THE FLOW IN THE SIDE BRANCH. THE FINAL PATIENT OUTCOME WAS GOOD WITH NO ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUS VOLUNTARY EVENT REPORT (MW5088723) RECEIVED REPORTING: STENT CAME OFF OF THE STENT CATHETER DELIVERY SYSTEM AND LEFT IN PT'S BODY. THE STENT WAS FOUND IN THE PT'S ARM IN THE .ARTERIAL SYSTEM. STENT WAS 4.0MM X 08MM.

  Patient problems: Foreign Body In Patient

  MAUDE report 8937679 ↗