XIENCE Skypoint™ 1804400-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648233470), received between Feb 17, 2021 and May 8, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Break; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 4.0X15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION, SO ORBITAL ATHERECTOMY WAS ATTEMPTED; HOWEVER IT COULD NOT CROSS. THE TIP OF THE XIENCE SKYPOINT SDS BECAME FRAYED [BROKEN]. A 3.5X15 MM STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127034 ↗
• InjuryJan 12, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PRE-DILATED WITH A 3.0MM BALLOON, FOLLOWED BY IVUS TO CONFIRM CALCIFICATION. AFTER ATHERECTOMY WAS PERFORMED, THE 4.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED AT 11 ATMOSPHERES (ATM). A 4.0X15MM XIENCE SKYPOINT STENT WAS DEPLOYED; HOWEVER, THE STENT WAS NOT WELL APPOSED TO THE VESSEL WALL DUE TO THE CALCIFICATION. AN ADDITIONAL 4.0X15MM XIENCE STENT WAS INFLATED TO 15 ATM WITHOUT ISSUES, COMPLETING THE PROCEDURE. 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 24038891 ↗
• MalfunctionAug 26, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT HEAVILY CALCIFIED, MILDLY TORTUOUS CIRCUMFLEX CORONARY ARTERY. A 4.00X15MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) FAILED TO CROSS THE LESION DUE TO ANATOMY, AFTER MULTIPLE ATTEMPTS. UPON REMOVAL OF THE XIENCE SKYPOINT DES, THE STENT WAS OBSERVED TO BE MOVED BUT REMAINED TIGHTLY CRIMPED. THERE WAS NO OTHER DAMAGE NOTED. AN UNSPECIFIED STENT WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22900493 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE, UNDERWENT A CORONARY STENTING PROCEDURE WITH IMPLANT OF ONE 4.0X15MM XIENCE SKYPOINT STENT IN AN UNSPECIFIED VESSEL. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2024 WITH UNSTABLE ANGINA. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED IN AN UNSPECIFIED VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ALTHOUGH THE LOCATION OF THE TARGET VESSEL AND THE LOCATION OF THE CORONARY ANGIOPLASTY WERE UNSPECIFIED, THIS WILL BE CONSERVATIVELY REPORTED, AS WE CANNOT STATE FOR CERTAIN THAT THE ADVERSE PATIENT EFFECT IS RELATED TO THE IMPLANTED XIENCE SKYPOINT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 21068041 ↗
• MalfunctionJul 31, 2024

  ON (B)(6) 2023, I HAD A STENT PLACEMENT. IN 2021 I HAD A 6 WAY BYPASS HEART SURGERY, AND ONE OF THOSE ARTERIES COLLAPSED AND I HAD TO HAVE THIS STENT PROCEDURE DONE. TWO DAYS AFTER STENT PLACEMENT, (B)(6) 2023, I STARTED HAVING ITCHING, RASH, HIVES, LEFT ARM RESTRICTIONS AND NEEDLE SENSATIONS ALL ON MY SKIN. THE DOCTORS THOUGHT IT WAS A REACTION FROM THE BLOOD THINNERS. AFTER 3 DIFFERENT BLOOD THINNERS WERE CHANGED AND AFTER ABOUT 2 MONTHS AND THEN TOTALLY GETTING OFF OF BLOOD THINNERS, MY SYMPTOMS NEVER STOPPED. I WENT TO SEVERAL CARDIOLOGISTS, DERMATOLOGIST, RHEUMATOLOGIST, ALLERGIST, ONCOLOGIST AND NEUROLOGIST, NOTHING WAS FOUND TO HELP ME OR EVEN EXPLAIN WHAT WAS GOING ON. I TOLD THEM I THOUGHT I WAS ALLERGIC TO THE STENT, BUT THE DOCTORS SAID IT WAS RARE AND BLEW ME OFF. I ALSO HAD SEVERAL HOSPITAL STAYS THAT I THINK WERE A RESULT OF MY REACTIONS, BUT NOTHING WAS FOUND WRONG. I EVEN WENT TO SEVERAL ER'S BUT NOTHING. I INCREASINGLY HAVE GOTTEN WORSE OVER THE COURSE OF ALMOST A YEAR. MY SYMPTOMS HAVE STEADY GOTTEN WORSE AND NOW OVER THE LAST 3 MONTHS I HAVE DEVELOPED CHILLS, SWEATS, AND SHAKES, INTERNALLY AND OUTSIDE. I AND MY WIFE HAVE RESEARCHED ONLINE FOR MANY HOURS TRYING TO

  Patient problems: Chills; Hypersensitivity/Allergic reaction; Itching Sensation; Joint Contracture; Rash; Sleep Dysfunction

  MAUDE report 19885348 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE XIENCE SKYPOINT STENT WAS IMPLANTED; HOWEVER, PATIENT DEVELOPED AN ALLERGIC REACTION POSSIBLY TO THE IMPLANTED STENT 2 DAYS AFTER IMPLANTATION. CURRENTLY, SYMPTOMS ARE: ITCHING, NEEDLE SENSATION, WRINKLES, SHAKING, BACK OF EYES HURT, DRY MOUTH, TIGHTNESS STILL IN ARM AND CHEST, CHILLS, SWEATS, FATIGUE, ANXIETY/DEPRESSION, STRESS, AND MEMORY PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Fatigue; Headache; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 19763890 ↗
• MalfunctionJun 27, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED AND TORTUOUS 90% STENOSED CIRCUMFLEX ARTERY (CX). THE 4.0 X 15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED AND THE SDS WAS UNABLE TO CROSS. RESISTANCE WAS NOTED DURING REMOVAL, RELATED TO THE VESSEL AND LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837641 ↗
• MalfunctionMar 22, 2022Difficult 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, 90% STENOSED, DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA). A 4X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION TO BE TREATED. DURING REMOVAL, DIFFICULTY WAS MET WITH THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13848052 ↗
• MalfunctionDec 14, 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 PROXIMAL RIGHT CORONARY ARTERY (PRCA) THAT IS 99% STENOSED. THE 4.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE DURING REMOVAL WAS NOTED WITH ANATOMY. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003469 ↗
• MalfunctionDec 9, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THIS PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 4.0 X 15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) DID NOT CROSS THE LESION AND DURING REMOVAL THERE WAS RESISTANCE WITH THE LESION. WHEN THE SDS WAS REMOVED, THE TIP WAS NOTED TO BE FLARED. THE PATIENT WAS TREATED WITH A NEW XIENCE SKYPOINT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970502 ↗
• MalfunctionApr 24, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY. A 4X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND FACED RESISTANCE DURING REMOVAL DUE TO THE ANATOMY. AN UNSPECIFIED BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11721619 ↗
• MalfunctionFeb 17, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH MILD CALCIFICATION, MODERATE TORTUOSITY, AND 75% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY. A 4.0 X 15 MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) SYSTEM WAS ATTEMPTED TO ADVANCE BUT RESISTANCE DUE TO ANATOMY WAS FELT AND THE DES SYSTEM FAILED TO CROSS THE LESION. THE DES SYSTEM WAS REMOVED AND RESISTANCE WITH THE ANATOMY WAS FELT. THE EDGE OF THE STENT WAS NOTED TO BE FLARED. A NEW 4.0 X 28 MM XIENCE SKYPOINT STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 11338252 ↗