XIENCE Skypoint™ 1804300-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648233289), received between Jun 15, 2021 and Dec 18, 2024 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 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.

• InjuryDec 18, 2024Leak/Splash; Failure to Deflate; Leak/Splash; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND THEN ATHERECTOMY WAS PERFORMED WITH A DEVICE FROM ANOTHER MANUFACTURER. AFTER ATHERECTOMY WAS COMPLETED, ANOTHER OCT RUN WAS PERFORMED. A 2.75X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED FOR PRE-DILATATION AND THEN THE 3.0X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED SUCCESSFULLY. AFTER DEPLOYMENT, THE SDS BALLOON WAS PULLED BACK TO THE PROXIMAL LAD TO USE THE MARKERS TO GAUGE THE LENGTH FOR A SECOND STENT. THE BALLOON WAS THEN ADVANCED BACK INTO THE STENT AND POST DILATATION WAS PERFORMED. AFTER INFLATION, THE BALLOON WOULD NOT DEFLATE. A SECOND INDEFLATOR WAS USED BUT THIS ALSO DID NOT DEFLATE THE BALLOON. THE PATIENT BEGAN TO HAVE ST RHYTHM CHANGES. A BALLOON PUMP WAS INSERTED AND ATTEMPTS WERE MADE TO DEFLATE THE BALLOON. THE BALLOON WAS PARTIALLY INFLATED IN THE LAD FOR ABOUT 17 MINUTES. EVENTUALLY THE BALLOON CAME DOWN AND THE BALLOON WAS TESTED OUTSIDE THE ANATOMY. IT APPEARED THERE WAS A LEAK IN THE SHAFT OF THE DELIVE

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20964661 ↗
• MalfunctionJan 9, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED IT WAS NOTED THAT THE DISLODGED STENT REMAINED IN THE PROTECTIVE SHEATH. THE ACCOUNT REPORTED THAT THE SDS WAS PREPPED FOR USE AND ADVANCE TO THE TARGET LESION; HOWEVER, WHEN ANGIOGRAM WAS TAKEN THE STENT WAS NOTED TO HAVE DISLODGED AND WAS FOUND TO HAVE REMAINED IN THE PROTECTIVE SHEATH. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480252 ↗
• MalfunctionNov 2, 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 HEAVY CALCIFIED AND MODERATELY TORTUOUS AND 99% STENOSED. THE XIENCE SKYPOINT DID NOT CROSS THE LESION AND THERE WAS RESISTANCE DURING REMOVAL. 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 18060897 ↗
• MalfunctionOct 23, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, NO TORTUOSITY AND 80% STENOSIS. A 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED, HOWEVER, IT WAS NOTED AFTER USE THAT THE DEVICE IS EXPIRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990987 ↗
• MalfunctionJul 14, 2023Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.0X38MM XIENCE SKYPOINT STENT WAS DEPLOYED AND IMPLANTED. UPON POST DILATATION WITH A NON-COMPLIANT BALLOON PER STANDARD PROCEDURE, THE PHYSICIAN LOST WIRE AND EVERYTHING CAME OUT. THERE WAS DIFFICULTY RE-WIRING AND THERE WAS A POSSIBILITY THAT THE PHYSICIAN RE-WIRED THROUGH A STRUT OF THE STENT IMPLANTED. FURTHER POST DILATATION WAS PERFORMED AND IT WAS NOTED THAT THE STENT WAS POSSIBLY CRIMPED BY THE BALLOON. LOST WIRE AGAIN AFTER PUSHING ANOTHER BALLOON AND EVERYTHING CAME BACK OUT. RE-WIRED AGAIN AND A 3.5X15MM XIENCE SKYPOINT STENT WAS IMPLANTED PROXIMAL TO THE FIRST STENT IMPLANTED AS PLANNED. POST DILATATION WAS PERFORMED ON BOTH STENTS PER STANDARD PROCEDURE AND INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. GOOD FLOW SHOWED ON ANGIOGRAM. THERE WAS NO ADVERSE PATIENT SEQUELAE. ALTHOUGH THERE WERE REPORTED DELAYS IN THE PROCEDURE, IT WAS CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS; THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329456 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND NON-TORTUOUS. A 3.0X38MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE FOLLOWING DAY, THE PATIENT DEVELOPED EKG CHANGES AND CHEST PAIN. THE STENT HAD DEVELOPED THROMBOSIS AND A DISSECTION WAS OBSERVED AT THE DISTAL END OF THE IMPLANTED STENT. A 3.0X23MM XIENCE SKYPOINT STENT WAS IMPLANTED LATER IN THE DAY AS TREATMENT. THE PATIENT HAD A GOOD OUTCOME WITH NO ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 17221809 ↗
• MalfunctionMay 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS NON CALCIFIED AND NON TORTUOUS. REPORTEDLY, THE 3.0X38MM XIENCE SKYPOINT BALLOON BURST AT THE BEGINNING OF STENT DEPLOYMENT. A NEW 3.0X38MM XIENCE SKYPOINT STENT WAS SUCCESSFULLY DEPLOYED 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 17013643 ↗
• MalfunctionMay 10, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION. THE 3.00X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE AND THE STENT STRUTS WERE NOTED TO BE FLARED. THEREFORE, THE SDS WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE SDS COULD NOT BE INSERTED INTO THE GUIDE CATHETER. THE SDS HAD TO BE REMOVED WITH THE GUIDEWIRE AND GUIDE CATHETER AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE STENT WAS DEPLOYED AFTER REMOVAL TO EVALUATE THE STENT DAMAGE POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16905667 ↗
• MalfunctionApr 3, 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 99% STENOSED OBTUSE MARGINAL ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS. THE 3.0X38MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED AGAINST RESISTANCE, AND FAILED TO CROSS THE LESION. RESISTANCE WAS NOTED DURING DEVICE REMOVAL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16670943 ↗
• MalfunctionFeb 27, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS NOTED DURING REMOVAL OF THE SDS. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448515 ↗
• MalfunctionFeb 14, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CIRCUMFLEX (CX) ARTERY INTO THE LEFT MAIN WITH HEAVY CALCIFICATION AND SEVERE TORTUOSITY. THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE BALLOON CATHETER CAUGHT ON SOME CALCIUM IN THE VESSEL AND THE PHYSICIAN HAD TO PULL ON IT TO GET IT OUT AND IT SEPARATED. THE NC TREK WAS REMOVED INDEPENDENTLY BUT THE PHYSICIAN WAS AGGRESSIVE AND THE SHAFT SEPARATED. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE USED AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE DURING REMOVAL AND FORCE WAS APPLIED. THE STENT WAS NOTED TO HAVE FLARED STRUTS ON THE PROXIMAL END AND NOT FRAYED. ANOTHER NC TREK BDC AND XIENCE SKYPOINT SDS WERE 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 16374308 ↗
• MalfunctionFeb 3, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS DEPLOYED; HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED. DURING REMOVAL RESISTANCE WAS MET WITH THE UNSPECIFIED GUIDING CATHETER. NO OTHER DEVICE WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293811 ↗
• MalfunctionDec 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.00X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, SDS WAS REMOVED FROM THE PATIENT AND DIFFICULTY WAS ALSO NOTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030027 ↗
• MalfunctionDec 13, 2022Device Dislodged or Dislocated; Component Misassembled; Device Dislodged or Dislocated; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED CIRCUMFLEX CX ARTERY. THE 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT ISSUE AND WHEN POSITIONING TO DEPLOY PHYSICIAN NOTICED A LARGER GAP BETWEEN THE MARKER AND THE STENT. HOWEVER, DEPLOYED THE STENT IN TARGET LESION WITHOUT ISSUE AND DID POST IMAGING WITH INTRAVASCULAR ULTRASOUND (IVUS) AND FOUND NO ISSUES. THE PHYSICIAN COULD NOT CONFIRM, IF THE MARKER WAS IN THE INCORRECT PLACE OR IF THE STENT WAS LOOSE. THERE WAS 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 15970743 ↗
• MalfunctionDec 2, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS OBTUSE MARGINAL BRANCH. THE 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS MET DURING REMOVAL WITH ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906410 ↗
• MalfunctionNov 7, 2022Difficult to Remove; Failure to Advance; Material Too Soft/Flexible; Difficult to Remove; Failure to Advance; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE VESSEL WAS PRE-DILATED WITH A 3.0X20MM TRAVELER. A 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY; HOWEVER, THE PHYSICIAN ALSO STATED FAILURE TO CROSS WAS DUE TO THE DEVICE NOT PROVIDING ENOUGH SUPPORT TO CROSS. DURING REMOVAL THE SDS MET RESISTANCE WITH ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749773 ↗
• InjuryAug 17, 2022Material Rupture; Device Dislodged or Dislocated; Activation Failure; Material Rupture; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 3.0 X 38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION. AN ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE PRESSURE DID NOT INCREASE AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY, AND A NON-ABBOTT BALLOON CATHETER WAS ADVANCED TO FULLY OPEN AND IMPLANT THE STENT. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15244989 ↗
• MalfunctionJun 24, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY. AFTER PRE-DILATATION, A 3X38MM XIENCE SKYPOINT FAILED TO CROSS THE LESION DUE TO ANATOMY. THERE WAS RESISTANCE DURING REMOVAL OF THE DEVICE. THEN A 2.5X38MM XIENCE SKYPOINT WAS ALSO ATTEMPTED BUT ALSO FAILED TO CROSS DUE TO ANATOMY. THERE WAS RESISTANCE DURING REMOVAL OF THE DEVICE. IT WAS ALSO NOTED THAT THE DISTAL PART OF THE STENT WAS NOTED TO BE FLARED. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITHOUT ANY TREATMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808574 ↗
• MalfunctionMay 6, 2022Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MILDLY CALCIFIED VESSEL IN THE OBTUSE MARGINAL (OM) ARTERY. DURING USE OF THE 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) IT GOT STUCK WITH THE GUIDE WIRE DUE TO THE CONTRAST AND BLOOD THAT WAS ON THE WIRE AND WAS NOT WIPED. IT WAS NOTED THAT THE TIP WAS FLARED UPON REMOVAL WITH FORCE. THE SDS WAS REMOVED INDIVIDUALLY. ANOTHER XIENCE SKYPOINT 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 14307284 ↗
• MalfunctionJan 2, 2022Leak/Splash; Difficult to Advance; Leak/Splash; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED VESSEL IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND ADVANCED TO THE GUIDE WIRE, HOWEVER, BLOOD WAS NOTICED IN THE STENT CATHETER SYSTEM WHEN THE TECHNICIAN PULLED NEGATIVE PRIOR TO INFLATION ATTEMPT. THERE WAS RESISTANCE DURING ADVANCEMENT DUE TO HEAVY CALCIFICATION. THE SDS WAS REMOVED FROM THE BODY INTACT. 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 13139117 ↗
• InjuryDec 7, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT HAD A NON-ABBOTT STENT IMPLANTED IN (B)(6) OF 2008 IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ADDITIONALLY, A 2.5X23 MM XIENCE SIERRA STENT PLACED IN THE CIRCUMFLEX (CX) AND 3.5X23 MM XIENCE SIERRA STENT PLACED IN THE LEFT MAIN (LM) TO THE CX ON (B)(6) 2021 AFTER A ROTO BURR WAS USED. THE STENTS WERE POST DILATED UP TO 4.25 MM AND INTRAVASCULAR ULTRASOUND (IVUS) WAS USED POST PROCEDURE. THERE WERE NO ISSUES DURING DEPLOYMENT OF THE XIENCE SIERRA STENTS AND THE POST DILATATION WAS PERFORMED PER STANDARD PROCEDURE. ON (B)(6) 2021 THE PATIENT HAD AN ANGIOGRAPHY WHICH SHOWED THAT THE LAD WAS SUBTOTALLY OCCLUDED IN THE MID VESSEL BUT WAS DETERMINED TO BE NONVIABLE TERRITORY. THE OCCLUSION WAS NOTED TO BE IN THE LAD IN THE NON-ABBOT STENT DUE TO RESTENOSIS. ON (B)(6) 2021 THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND ELEVATED TROPONIN AND IT WAS DECLARED THE PATIENT WAS HAVING A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). THERE WAS NO OCCLUSION IN EITHER OF THE XIENCE SIERRA STENTS. THE PATIENT WAS STILL ON DUAL ANTIPLATELET THERAPY. THE PATIENT WAS SENT TO THE CATH LAB AND THE RIGHT RADIAL ARTERY WAS ACCESSED FOR ANGIOGRAPHY. A GUIDE WIRE WAS

  Patient problems: Vascular Dissection

  MAUDE report 12952963 ↗
• MalfunctionOct 29, 2021Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A NON-ABBOTT GUIDE WIRE (GW) WAS ADVANCED TO THE LESION AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS COMPLETED WITH AN UNSPECIFIED 2.5MM BALLOON. A 3X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS THEN ADVANCED WITH RESISTANCE FROM THE ANATOMY AND COULD NOT REACH THE TARGET LESION. UPON REMOVAL OF THE DES, RESISTANCE WAS NOTED WITH THE ANATOMY AND A KINK IN THE SHAFT WAS OBSERVED. THE PROCEDURE WAS COMPLETED, AS IS. 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 12721314 ↗
• MalfunctionSep 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0X38MM RX XIENCE SKYPOINT, STENT DELIVERY SYSTEM (SDS), THE STENT FELT LOOSE ON THE BALLOON. THE SDS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY TO THE INTENDED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519639 ↗
• MalfunctionJun 15, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. THE 3.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. A NEW NON-ABBOTT STENT 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 12005281 ↗