XIENCE Skypoint™ 1804250-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648233111), received between Jan 5, 2021 and Mar 30, 2026 — classified as 1 death, 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE DIAGONAL ARTERY. THE 2.50X33MM RX XIENCE SKYPOINT STENT WAS IMPLANTED AND THEN POST DILATED WITH A 2.75MM NC BALLOON. INTRAVASCULAR ULTRASOUND (IVUS) POST IMPLANT NOTED THE STENT WAS UNDER EXPANDED. 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 24712993 ↗
• MalfunctionJan 6, 2026Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 90% STENOSED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A XIENCE SKYPOINT 2.50X33 DRUG ELUTING STENT (DES) WAS INSERTED AND ADVANCED BUT WAS DIFFICULT TO CROSS THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BALLOON RUPTURED AT 6ATM. THEREFORE, THE DEVICE WAS REMOVED. UPON REMOVAL, IT WAS OBSERVED THE STENT DID NOT DEPLOY. A NON-ABBOTT DEVICE WAS THEN 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 23975428 ↗
• DeathMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2024 WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH NO CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS), PRE-DILATED WITH A NON-COMPLIANT BALLOON AND THE 3.0 X 38 MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE STENT WAS POST-DILATED AND THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. ON (B)(6) 2024 THE PATIENT RETURNED FOR A PLANNED PROCEDURE TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS CONFIRMED WITH FRACTIONAL FLOW RESERVE (FFR) AND OPTICAL COHERENCE TOMOGRAPHY (OCT). INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED DUE TO THE MODERATE CALCIFICATION AND THE 2.5 X 33 MM XIENCE SKYPOINT STENT WAS IMPLANTED AND POST-DILATED. THE PROCEDURE WAS SUCCESSFUL WITH NO COMPLICATIONS. THE PATIENT DID NOT VISIT THE OUTPATIENT CLINIC FOR THE 1 YEAR FOLLOW UP AND IT WAS FOUND THAT THE PATIENT EXPIRED ON (B)(6) 2024 DUE TO AN UNKNOWN CAUSE. THE MEDICAL INSTITUTION'S OPINION IS THAT THE EVENT IS UNRELATED TO THE STUDY; HOWEVER, THE DEATH IS POTENTIALLY RELATED TO THE STENTS, PER THE PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROV

  Patient problems: Unspecified Heart Problem

  MAUDE report 21730934 ↗
• MalfunctionMay 8, 2024Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED YET FAILED TO REACH THE LESION DUE TO RESISTANCE WITH THE GUIDING CATHETER. DURING REMOVAL THE SDS, THE STENT BECAME CAUGHT ON THE GUIDING CATHETER CAUSING THE STENT TO BECOME DEFORMED AND MOVE ON THE BALLOON. THE SDS WITH THE STENT WAS REMOVED FROM THE FEMORAL ACCESS SITE. A 2.5X33MM NON-ABBOTT SDS 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 19269588 ↗
• MalfunctionApr 23, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, THE STENT WAS ONLY PARTIALLY DEPLOYED AND MATERIAL DEFORMATION [MANGLED] WAS NOTED. THE XIENCE SKYPOINT STENT AND DELIVERY SYSTEM WERE REMOVED. A BALLOON DILATATION CATHETER (BDC) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169258 ↗
• MalfunctionApr 2, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS 75% STENOSED. REPORTEDLY, THE 2.5X33MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THE PROXIMAL SHAFT SEPARATED IN TWO OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE SAME SIZE STENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19020827 ↗
• MalfunctionJan 4, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE DEVICE WAS REMOVED INDEPENDENTLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445238 ↗
• InjuryDec 14, 2023Adverse 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 LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. A 2.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED MID-DISTAL AND THEN A 3.0X28MM XIENCE SKYPOINT WAS IMPLANTED PROXIMAL-MID WITH A SLIGHT OVERLAP. THE STENTS WERE POST-DILATED. THERE WAS SIGNIFICANT TISSUE PROTRUSION [PROLPASE] AT THE PROXIMAL PORTION OF THE 2.5X33MM XIENCE SKYPOINT STENT JUST DISTAL TO THE OVERLAP. IT WAS STENTED OVER WITH 2.5X15MM XIENCE SKYPOINT STENT. THE PROCEDURE WAS FINISHED AT WHICH POINT THE PATIENT STARTED HAVING CHEST PAIN. THE PATIENT WAS RE-ACCESSED AND IT WAS NOTED THAT THE 2.5X15MM STENT THROMBOSED AT THE POINT OF TISSUE PROTRUSION. STENTS WERE POST-DILATED AGAIN. ADDITIONALLY, PROXIMAL CALCIUM AT THE OSTIAL LAD WAS TREATED WITH SHOCKWAVE AND THEN STENTED OVER WITH A 3.5X18MM XIENCE SKYPOINT STENT. PROCEDURE WAS FINISHED. PATIENT WAS REMOVED OFF THE TABLE AND STARTED HAVING CHEST PAINS AGAIN AND WENT INTO VENTRICULAR FIBRILLATION, WHICH WAS TREATED WITH DEFIBRILLATION. PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE HE HAD TWO MORE EPISODES OF CHEST PAIN AND DEFIBRILLATION. PATIENT WAS ULTIMATELY SUCCESSFULLY DISCHARGED.

  Patient problems: Prolapse

  MAUDE report 18328676 ↗
• MalfunctionDec 8, 2023Difficult 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 LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, MODERATELY TORTUOUS AND 75% STENOSED. THE XIENCE SKYPOINT DID NOT CROSS THE LESION AND THE STENT STRUT WAS NOTED TO BE FLARED. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL, HOWEVER, THERE WERE NO REPORTED 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 18297279 ↗
• MalfunctionNov 29, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY TO THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. THE XIENCE SKYPOINT STENT BALLOON HAD DIFFICULTY INFLATING AT THE LESION AND THE STENT GOT BENT. A NEW STENT WAS USED AND IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS 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 18233135 ↗
• MalfunctionJun 8, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 2.5X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING INDEPENDENT REMOVAL. A 2.25X33 MM XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087566 ↗
• InjuryDec 29, 2022Material Rupture; Activation Failure; Material Rupture; Activation Failure

  N/A.

  Patient problems: Perforation of Vessels

  MAUDE report 16073415 ↗
• InjuryOct 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND A MYOCARDIAL INFARCTION WAS DIAGNOSED. THE PROCEDURE WAS TO TREAT A 90% STENOSED, DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. ON 9/12/2022, A 2.5X33MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED WITHOUT ISSUE AND THE STENT WAS NOTED TO BE FIRMLY APPOSED TO THE VESSEL WALL. ON 9/17/2022, THE PATIENT REPORTED CHEST PAIN. ELECTROCARDIOGRAM CONFIRMED AN ST ELEVATION, SO AN EMERGENCY CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED. IN-STENT THROMBOSIS (OCCLUSION) WAS CONFIRMED. THROMBECTOMY WAS PERFORMED, AND A NON-ABBOTT BALLOON DILATED THE LESION TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 15656709 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE LEFT MAIN (LM) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. TWO XIENCE SKYPOINTS WERE IMPLANTED IN THE LAD AND LM ARTERIES. THE NC TREK BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS USED FOR POST DILATATION PER STANDARD PROCEDURE, HOWEVER, A PERFORATION OCCURRED IN THE LAD. AN ADDITIONAL NON-ABBOTT STENT WAS USED TO TREAT THE PERFORATION. THE BALLOON WAS USED AGAIN FOR POST-DILATATION AND WAS FULLY DEFLATED (CONFIRMED BY X-RAY). HOWEVER, THE BALLOON WOULD NOT COME OUT OF THE GUIDE CATHETER. FORCE WAS APPLIED. ALL DEVICES WERE REMOVED TOGETHER AS A UNIT, HOWEVER, THE BALLOON SEPARATED FROM THE SHAFT AND GOT STUCK IN THE LM ARTERY. INTERVENTION WAS ATTEMPTED TO EMBED THE BALLOON BUT COULD NOT GET A GUIDEWIRE PAST THE BALLOON. THE PATIENT DIED. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED AND THERE WAS NO THROMBUS. IN THE PHYSICIAN'S OPINION, THE NC TREK WAS PART OF THE REASON THAT CAUSED AND CONTRIBUTED TO THE DEATH, HOWEVER, THE 2 XIENCE SKYPOINT STENTS DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. NO ADDITIONAL INFORM

  Patient problems: Perforation of Vessels

  MAUDE report 15551526 ↗
• InjuryJul 8, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Malposition of Device; Deformation Due to Compressive Stress; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Malposition of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. A 2.75X18MM XIENCE STENT WAS IMPLANTED MID LAD, FOLLOWED BY A 3.00X28MM XIENCE STENT IMPLANTED PROXIMAL MID LAD AND THEN A 3.00X12MM XIENCE STENT WAS DEPLOYED TO OVERLAP THE 2 IMPLANTED STENTS. THE 2.50X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCE TO THE TARGET LESION; HOWEVER THE SDS GOT STUCK AND COULD NOT ADVANCE OR BE REMOVED FROM THE IMPLANTED 3.00X28MM XIENCE STENT; THEREFORE, THE STENT WAS DEPLOYED AT THE PROXIMAL/MID LAD, WHICH WAS NOT THE INTENDED LOCATION. ADDITIONALLY, THE SDS CATHETER BECAME KINKED. AFTER THE STENT WAS DEPLOYED, THE SDS WAS REMOVED FROM THE PATIENT. AT AN UNKNOWN POINT DURING THE PROCEDURE A 2.25X18MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO BE ADVANCED IN THE GUIDE CATHETER, BUT THE SHAFT BROKE WHILE ADVANCING THROUGH THE GUIDE CATHETER. THE 2.25X18MM XIENCE SKYPOINT SDS WAS SIMPLY REMOVED FROM THE PATIENT, WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF 2 NO

  Patient problems: Foreign Body In Patient

  MAUDE report 14964405 ↗
• MalfunctionJun 29, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. ROTOBLADE WAS USED AND A 2.50X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH SOME RESISTANCE WITH ANATOMY. DURING INFLATION AT 14 ATMOSPHERES THE BALLOON RUPTURED. THE SDS WAS REMOVED WITHOUT ISSUE AND ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852453 ↗
• MalfunctionJun 1, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, THERE WAS RESISTANCE FELT WHEN REMOVING THE STYLET FROM THE XIENCE SKYPOINT STENT DELIVERY SYSTEM. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570078 ↗
• MalfunctionMar 15, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS PROXIMAL TO DISTAL LEFT CIRCUMFLEX ARTERY. A GUIDE WIRE CROSSED WITHOUT ISSUE. A 2.5MM BALLOON WAS USED TO PREDILATE THE LESION. THEN A 2.5X33MM XIENCE SKYPOINT STENT WAS ATTEMPTED TO BE DELIVERED BUT FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WAS MET WITH ANATOMY AS WELL. DILATATION WAS PERFORMED AGAIN WITH THE SAME BALLOON. THEN A NEW 2.5X33MM XIENCE SKYPOINT WAS ABLE TO BE DELIVERED TO THE LESION WITHOUT ISSUE AND 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 13771405 ↗
• MalfunctionDec 27, 2021Difficult to Remove; Failure to Advance; Difficult to Advance; Difficult to Remove; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A XIENCE SKYPOINT 2.5 X 33 DRUG ELUTING STENT (DES) WAS INSERTED, BUT RESISTANCE WAS FELT DURING ADVANCEMENT. THE STENT WAS UNABLE TO CROSS; THEREFORE, THE DEVICE WAS REMOVED. HOWEVER, RESISTANCE WAS NOTED DURING REMOVAL. A NON-ABBOTT DEVICE WAS THEN USED TO PERFORM 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 13087867 ↗
• MalfunctionDec 20, 2021Difficult to Remove; Failure to Advance; Difficult to Advance; Difficult to Remove; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS AND 99% STENOSED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A XIENCE SKYPOINT 2.5 X 33 DRUG ELUTING STENT (DES) WAS INSERTED, BUT RESISTANCE WAS FELT DURING ADVANCEMENT. THE STENT WAS ABLE TO BE ADVANCED TO THE TARGET LESION, BUT WAS UNABLE TO CROSS; THEREFORE, THE DEVICE WAS REMOVED. HOWEVER, RESISTANCE WAS NOTED DURING REMOVAL. A NON-ABBOTT DEVICE WAS THEN USED TO PERFORM 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 13044164 ↗
• MalfunctionSep 21, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 2.5X33MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE ANATOMY AND THE DES DID NOT REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED 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 12509450 ↗
• MalfunctionSep 2, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT UPON OPENING OF THE 2.50X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) THERE WAS RESISTANCE REMOVING THE SDS FROM THE DISPENSER COIL. ADDITIONALLY, THERE WAS RESISTANCE WHEN REMOVING THE STYLET/PROTECTIVE SHEATH AND THE STENT WAS DISLOCATED ON THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418075 ↗
• MalfunctionJul 20, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AT 12 ATMOSPHERES (ATM). THE 2.5X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE SDS FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. IT WAS NOTED THAT DURING REMOVAL OF THE SDS, RESISTANCE WAS ALSO MET WITH THE ANATOMY. THE DEVICE WAS REMOVED INDEPENDENTLY. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197437 ↗
• MalfunctionJan 5, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED AND 99% STENOSED. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS AND THERE WAS RESISTANCE DURING REMOVAL WITH THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 11121127 ↗