XIENCE Skypoint™ 1804350-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08717648233388), received between Jan 4, 2021 and Jun 1, 2026 — classified as 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 3.5X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE DURING REMOVAL AND THE STENT BECAME STRETCHED AND MANGLED. AN UNSPECIFIED DEVICE 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 25351371 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN OCTOBER 2022, ONCE 2.5X08MM XIENCE SKYPOINT WAS IMPLANTED IN THE PROXIMAL DIAGONAL, 3.5X23MM, 3.5X12MM, 3.5X15MM XIENCE SKYPOINTS IMPLANTED IN PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). ANOTHER 3.0X23, 3.0X12MM AND 3.5X08MM XIENCE SKYPOINTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITHOUT ISSUE. HOWEVER, IN (B)(6) 2025, THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN AND DIZZINESS. THEREFORE, A STRESS TEST AND ANGIOGRAM REVEALED THE MID RCA AND MID LAD ARE OCCLUDED. PATIENT IS AWAITING BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Obstruction/Occlusion

  MAUDE report 23270327 ↗
• MalfunctionSep 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AT MILDLY TORTUOUS, LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. WHEN LOADING A 3.50X12MM XIENCE SKYPOINT DRUG-ELUTING STENT ONTO AN UNSPECIFIED GUIDEWIRE, THE STENT FELL OFF. A NON-ABBOTT 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 23090667 ↗
• MalfunctionJul 28, 2025Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE LESION WAS PRE-DILATATED WITH A 3.0MM UNSPECIFIED CUTTING BALLOON. THE 3.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. THE STENT WAS REMOVED AND NOTED TO BE FRACTURED. ADDITIONAL PRE-DILATATION WAS PERFORMED AND A NEW XIENCE STENT OF THE SAME SIZE WAS SUCCESSFULLY DELIVERED ACROSS THE LESION AND DEPLOYED. THERE WAS 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 22637011 ↗
• MalfunctionApr 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AN UNKNOWN ISSUE OCCURRED WITH THE 3.50X12MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE GUIDE WIRE EXIT NOTCH WAS TORN. THE DEVICE WOULD NOT INFLATE, AND FLUID WAS LEAKING FROM THE NOTED TEAR IN THE GUIDE WIRE EXIT NOTCH.

  Patient problems: Insufficient Information

  MAUDE report 21738121 ↗
• MalfunctionMay 20, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY. DURING ADVANCEMENT OF THE 3.50X12MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) THROUGH THE 6F GUIDING CATHETER (GC) RESISTANCE WAS MET AND THE STENT BECAME DEFORMED DUE TO THE STENT BEING PUSHED AND PULLED AROUND THE GC. THE STENT WAS MISLOCATED ON THE BALLOON. THE SDS WAS WITHDRAWN FROM THE GC AND THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351953 ↗
• MalfunctionMar 19, 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 TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.5X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THEN THE GUIDING CATHETER BECAME UNSTABLE. THE SDS COLLIDED WITH THE EDGE OF THE GUIDING CATHETER AND THE STENT BECAME DEFORMED WHEN THE SDS WAS PUSHED AND PULLED BACK SEVERAL TIMES AROUND THE GUIDING CATHETER WITH RESISTANCE. THE STENT WAS THEN NOTED TO BE DISLODGED FROM THE BALLOON. THE SDS WAS REMOVED WITH THE STENT ON THE DELIVERY SYSTEM. THE PATIENT WAS TREATED WITH A 3.5×12 NON-ABBOTT STENT. 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 18936624 ↗
• MalfunctionDec 15, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOSED. THE 3.50 X 12MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT DID NOT CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS MET WITH THE LESION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340494 ↗
• MalfunctionNov 21, 2023Difficult or Delayed Positioning; Difficult to Remove; Difficult to Advance; Difficult or Delayed Positioning; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LAD ARTERY. A 3.5X12MM XIENCE SKYPINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT KEPT HEAVILY MOVING AND THE FIRST STENT WAS IMPLANTED A BIT TOO PROXIMAL BUT REMAINED IN THE TARGET LESION. A SECOND 3.5X12MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO CROSS THE FIRST IMPLANTED STENT BUT MET RESISTANCE WITH THE IMPLANTED STENT, AND FAILED TO CROSS. DURING THE ATTEMPT TO CROSS, THE SDS WAS PULLED BACK AND RESISTANCE WAS MET WITH THE IMPLANTED STENT, AND THE SECOND STENT DISLODGED. A THIRD 3.5X18MM XIENCE STENT WAS USED TO CRUSH THE DISLODGED XIENCE STENT INTO THE VESSEL AND A FOURTH STENT WAS USED TO SUCCESSFULLY TREAT THE REST THE OF THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184860 ↗
• InjuryNov 21, 2023Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LAD ARTERY. A 3.5X12MM XIENCE SKYPINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT KEPT HEAVILY MOVING AND THE FIRST STENT WAS IMPLANTED A BIT TOO PROXIMAL BUT REMAINED IN THE TARGET LESION. A SECOND 3.5X12MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO CROSS THE FIRST IMPLANTED STENT BUT MET RESISTANCE WITH THE IMPLANTED STENT, AND FAILED TO CROSS. DURING THE ATTEMPT TO CROSS, THE SDS WAS PULLED BACK AND RESISTANCE WAS MET WITH THE IMPLANTED STENT, AND THE SECOND STENT DISLODGED. A THIRD 3.5X18MM XIENCE STENT WAS USED TO CRUSH THE DISLODGED XIENCE STENT INTO THE VESSEL AND A FOURTH STENT WAS USED TO SUCCESSFULLY TREAT THE REST THE OF THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18184822 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED WITH A 3.0X10MM NON-ABBOTT BALLOON, THEN THE 3.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. THE SDS BALLOON RUPTURED DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 5 MINUTES. FLUOROSCOPY CONFIRMED THAT THE STENT WAS STILL ON THE BALLOON AND THE SDS WAS REMOVED FROM THE PATIENT. ADDITIONAL PRE-DILATATION WAS PERFORMED AND A NEW SAME SIZE XIENCE SKYPOINT STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321999 ↗
• MalfunctionApr 24, 2023Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.50X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS WAS REPORTED TO BE PREPPED (AIR ASPIRATION) INSIDE THE ANATOMY PRIOR TO USE. THEN, THE SDS WAS ADVANCED TO THE TARGET LESION WITH DIFFICULTY DUE TO THE ANATOMY. WHEN ATTEMPTING TO DEPLOY THE STENT THE BALLOON OF THE SDS RUPTURED AT 6 ATMOSPHERES (ATM) AFTER 5 SECONDS. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AN NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. AFTER ADDITIONAL PRE-DILATATION, ANOTHER SAME SIZE XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796249 ↗
• MalfunctionDec 22, 2022Defective Device; Defective Device

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE 3.5X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) SYSTEM WAS ADVANCED TO THE LESION, BUT WAS NOTED TO BE SHORTER THAN THE LESION, SO THE COMPLETE DEVICE, WITH UNDEPLOYED STENT, WAS REMOVED FROM THE PATIENT ANATOMY, WITHOUT ISSUE. A 3.5X15MM XIENCE DES WAS THEN ADVANCED AND SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040207 ↗
• MalfunctionDec 20, 2022Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, 70% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION TO BE IMPLANTED DUE TO RESISTANCE WITH THE GUIDE WIRE. THE DES WAS ATTEMPTED TO BE REMOVED SO DILATATION COULD BE COMPLETED, HOWEVER, THE DES WAS DIFFICULT TO REMOVE FROM THE GUIDE WIRE (GW). ONCE THE DES WAS PULLED OFF OF THE GUIDE WIRE WITH FORCE, THE DISTAL TIP SEPARATED AND WAS LEFT BEHIND ON THE GUIDE WIRE. THE PROCEDURE WAS ABORTED, AND NO OTHER DEVICE WAS USED TO STENT THE LESION. 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 16019388 ↗
• InjuryJun 16, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE DISTAL LEFT MAIN (DLM) ARTERY. ATHERECTOMY WAS PERFORMED ON THE CALCIFIED LESION AND A 3X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED TWO TIMES TO 20 ATMOSPHERES (ATM). A 3X28MM SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE HEAVILY CALCIFIED ANATOMY AND WAS REMOVED. A 3.5X12MM TREK RX BDC WAS USED TO FURTHER DILATATE THE LESION AND A 3.5X12MM SKYPOINT DES WAS ADVANCED WITH RESISTANCE FROM THE CALCIUM AND AN UNSPECIFIED PREVIOUSLY IMPLANTED STENT IN THE DLM, CAUSING THE STENT TO DISLODGE FROM THE BALLOON INTO THE LEFT MAIN. AN ATTEMPT TO SNARE THE STENT WAS UNSUCCESSFUL SO THEY WENT IN WITH ANOTHER 3.5X12MM SKYPOINT AND USED IT TO CRUSH THE DISLODGED STENT IN THE LEFT MAIN WALL, AND ANOTHER 3X12MM SKYPOINT WAS USED TO COMPLETE STENTING IN THE TARGET LESION. A TREK BDC WAS THEN USED FOR POST DILATATION TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14722251 ↗
• MalfunctionJun 15, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE 3.5X12MM XIENCE SKYPOINT WAS ATTEMPTED TO BE ADVANCED HOWEVER, RESISTANCE WAS MET (UNKNOWN IF THE GUIDE CATHETER OR A GUIDE LINER THAT WAS ALSO IN THE GUIDE CATHETER WHEN THE XIENCE SKYPOINT WAS ADVANCING PER THE PHYSICIAN). THE STENT DISLODGED AND REMAINED IN THE GUIDE CATHETER; THEREFORE, THE GUIDE CATHETER WAS SIMPLY WITHDRAWN ALONG WITH THE STENT. ANOTHER SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14699759 ↗
• MalfunctionMay 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE MILDLY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 3.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED SUCCESSFULLY. HOWEVER, ON INFLATION, THE BALLOON OF THE SDS HAD SHOWN ELONGATION OF THE PROXIMAL SHOULDER AND INCREASED TAPERING. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14413411 ↗
• MalfunctionApr 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, 100% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3.5X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176963 ↗
• InjuryFeb 16, 2022Entrapment of Device; Difficult to Remove; Material Deformation; Entrapment of Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL LEFT DESCENDING ARTERY (PLAD) WITH HEAVY CALCIFICATION. PRE-DILATION WAS PERFORMED WITH A SEMI-COMPLIANT BALLOON AND A CUTTING BALLOON. THEN A 3.5 X 12 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER THE STENT BECAME STUCK IN THE LESION WHILE ATTEMPTING TO POSITION THE STENT. THE STENT WAS REMOVED WITH THE SDS FROM THE PATIENT WITH A SNARE DEVICE. AFTER THE STENT WAS REMOVED FROM THE PATIENT, THE STRUTS WERE OBSERVED TO BE FLARED. A NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542450 ↗
• InjuryJan 28, 2022Migration; Migration

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND 90% STENOSED OSTIAL LEFT MAIN ARTERY. A XIENCE SKYPOINT 3.5 X 12 DRUG ELUTING STENT (DES) WAS INSERTED AND DEPLOYED WITHOUT ISSUES. WHILE ATTEMPTING POST DILATATION, IT WAS OBSERVED THE STENT WAS NO LONGER IN THE LOCATION WHERE IT HAD BEEN DEPLOYED. THE PHYSICIAN LOOKED FOR THE STENT BUT WAS UNABLE TO LOCATE IT. AN ADDITIONAL XIENCE WAS INSERTED AND DEPLOYED AT THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13388746 ↗
• InjuryDec 17, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. A 3.5X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION DUE TO THE SEVERE CALCIFICATION. DURING REMOVAL FROM THE ANATOMY, THE STENT DISLODGED INTO THE LEFT MAIN ARTERY. A SNARE WAS ATTEMPTED BUT WAS UNSUCCESSFUL IN REMOVING THE DISLODGED STENT. AN UNSPECIFIED STENT WAS ADVANCED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL AND 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: Device Embedded In Tissue or Plaque

  MAUDE report 13031152 ↗
• MalfunctionNov 17, 2021Difficult to Remove; Difficult to Remove

  DURING PREPARATION OF THE 3.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) RESISTANCE WAS FELT WHEN REMOVING THE STYLET. ANOTHER NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832577 ↗
• MalfunctionNov 7, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756381 ↗
• MalfunctionAug 6, 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 75% STENOSED, MILDLY TORTUOUS, AND HEAVILY CALCIFIED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. AFTER DEPLOYMENT OF AN UNSPECIFIED 38MM STENT, A 3.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE SKYPOINT STENT GOT CAUGHT ON THE DEPLOYED STENT AND THE STENT BECAME DEFORMED. 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 12291566 ↗
• MalfunctionAug 5, 2021Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, THE 3.5X12MM XIENCE SKYPOINT STENT WAS SUCCESSFULLY IMPLANTED TO TREAT THE OSTIUM OF THE CIRCUMFLEX ARTERY. ON (B)(6) 2021, THE PATIENT RETURNED FOR A PROCEDURE TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING THE ADVANCEMENT OF AN UNSPECIFIED GUIDEWIRE TO THE TARGET LESION, THE GUIDE WIRE BECAME STUCK UNDERNEATH THE SKYPOINT STENT. WHEN ATTEMPTING TO PULL OUT THE GUIDE WIRE WITHOUT EXCESSIVE FORCE, THE STENT WAS REMOVED [EXPLANTED] FROM THE ANATOMY WITH THE GUIDE WIRE. THE PROCEDURE FOR THE LAD CONTINUED. THERE WAS NO FURTHER TREATMENT FOR THE CIRCUMFLEX ARTERY. 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 12280228 ↗