XIENCE Skypoint™ 1804300-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08717648233265), received between Aug 4, 2021 and Mar 19, 2026 — classified as 1 death, 9 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (17 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 3.00X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) THROUGH A NON-ABBOTT GUIDE CATHETER, THE SDS GOT STUCK. THE GUIDE CATHETER AND STENT WERE REMOVED AS ONE UNIT. IT WAS BELIEVED THAT THE ISSUE WAS WITH THE GUIDE CATHETER. A NEW XIENCE SKYPOINT DES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 24642771 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING LESION. A 3.00X28 MM XIENCE SKYPOINT STENT WAS IMPLANTED; HOWEVER, THROMBOSIS OCCURRED RESULTING IN ST ELEVATION. AN ADDITIONAL NON-ABBOTT STENT WAS USED TO TREAT THE THROMBOSIS. THROMBUS FORMATION REOCCURRED AND ASPIRATION WAS PERFORMED. THE PATIENT REQUIRED OVERNIGHT HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 24572042 ↗
• MalfunctionJan 14, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION BY THE TECH, THE STYLET WOULD NOT COME OUT OF THE 3.0X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS). THE TECH DID NOT WANT TO APPLY TOO MUCH FORCE, SO THIS SDS WAS NOT USED FOR THE PROCEDURE. NO PATIENT WAS INVOLVED WITH THIS DEVICE AND NO CLINICALLY SIGNIFICANT DELAY. ANOTHER SAME SIZE XIENCE SKYPOINT FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068744 ↗
• MalfunctionNov 5, 2025Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2.75X15MM NON-ABBOTT BALLOON. A 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FELT WITH ANATOMY. WHEN ATTEMPTING TO DEPLOY THE STENT THE BALLOON ON THE DELIVERY SYSTEM RUPTURED AT 6 ATMOSPHERES. THE STENT REMAINED MOUNTED ON DELIVERY SYSTEM; THEREFORE, SIMPLY WITHDRAWN. A 3.0X15MM WAS USED TO FURTHER DILATE AND A 2.75X28MM XIENCE SKYPOINT STENT WAS DEPLOYED WITHOUT ISSUE. POST-DILATATION WAS PERFORMED WITH A 3.0X15MM NON-ABBOTT BALLOON. 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 23480476 ↗
• InjuryOct 2, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY AND THE STENT WAS OBSERVED TO BECOME FLARED. A 3.0X23MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY AND WAS REMOVED. THE STENT WAS OBSERVED TO FLARED. THEREFORE, A 3.0X15MM XIENCE SKYPOINT STENT WAS ADVANCED AND IMPLANTED IN THE DISTAL LESION; HOWEVER, THE STENT MOVED FROM THE LESION SITE AND WAS REMOVED FROM THE ANATOMY WITH A BALLOON. A NEW UNSPECIFIED STENT WAS IMPLANTED SUCCESSFULLY. A 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED TO TREAT THE PROXIMAL PORTION OF THE LESION; HOWEVER, FAILED TO CROSS DUE TO ANATOMY AND THE STENT BECAME FLARED. THEREFORE, A NEW 3.0X28MM XIENCE SKYPOINT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY AND THE STENT DISLODGED. THE STENT TRAVELED TO THE AORTA OF THE PATIENT. A SNARE WAS USED TO REMOVE THE STENT AND THE LESION WAS LEFT UNTREATED. THERE WAS NO ADVERSE PATIENT SEQUELA AND CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23202925 ↗
• MalfunctionJun 30, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS MILD RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.0 X 28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION; HOWEVER, WHEN ATTEMPTING TO DEPLOY THE BALLOON OF THE DELIVERY SYSTEM WOULD NOT INFLATE. IT WAS NOTED TO HOLD PRESSURE; HOWEVER, NOT INFLATE. THE DEVICE WAS REMOVED FROM THE ANATOMY AND ATTEMPTED TO BE INFLATED OUTSIDE THE PATIENT HOWEVER, SAME ISSUE OCCURRED. A 4.0 X 23 MM XIENCE SKPOINT WAS USED 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 22366282 ↗
• InjuryNov 19, 2024Material Deformation; Material Deformation

  SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE 2.5X28 MM XIENCE SKYPOINT STENT WAS CRUSHED IN A DOUBLE KISSING TECHNIQUE PER STANDARD PROCEDURE. THE SMALL FILLING DEFECT SEEN IN THE 3.0X28 MM XIENCE SKYPOINT STENT WAS POSSIBLE SMALL THROMBUS AND THIS IS THE REASON AGGRASTAT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 20727305 ↗
• InjuryMay 16, 2024Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS DEPLOYED; HOWEVER, NOT FULLY OPPOSED TO THE VESSEL WALL AND HAD BECOME BENT. THEREFORE, AN UNSPECIFIED BALLOON CATHETER WAS USED TO REMOVE THE STENT. A NEW UNSPECIFIED STENT WAS USED AND IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335233 ↗
• InjuryMar 8, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  THIS EVENT WAS REPORTED THRU THE RECEIPT OF A MEDWATCH WHICH STATED: DESCRIBE THE EVENT OR PROBLEM: PER CARDIAC CATHETERIZATION NOTE - I ATTEMPTED TO CROSS THE BLOCKAGE WITH XIENCE SKYPOINT¿ STENT HOWEVER IT WOULD NOT CROSS. WHILE IT WAS BEING RETRIEVED, STENT CAME OFF THE BALLOON IN THE PROXIMAL CIRCUMFLEX. THERE WAS STILL THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 3 FLOW HOWEVER AT THIS POINT. I FOCUSED TO CROSS THE STENT STRUTS AGAINST THE VESSEL WALL. MULTIPLE WIRES, BALLOON AND SUPPORT CATHETERS WERE USED INCLUDING PILOT, FIELDER, RUN-THROUGH, WHISPER ALONG WITH TURNPIKE VERSUS SMALL SUPPORT BALLOONS BUT I COULD NOT CROSS BEYOND THIS SEGMENT. PATIENT WAS HAVING ACTIVE PAIN FOR WHICH I DECIDED TO STABILIZE LEFT MAIN INTO LEFT ANTERIOR DESCENDING ARTERY (LAD). 3.5 X 30 ONYX STENT WAS THEN DEPLOYED FROM MID LEFT MAIN INTO PROXIMAL LAD. SAME STENT BALLOON WAS USED FOR POST DILATION OF THIS STENTED SEGMENT. FURTHER POSTDILATION WAS DONE USING 4.0 NONCOMPLIANT BALLOON IN LEFT MAIN AND PROXIMAL LAD. I ATTEMPTED TO REWIRE THE CIRCUMFLEX WITH THE STENT STRUTS, AND I WAS ABLE TO GET THROUGH THE PROXIMAL STENT WHERE I HAD A 2.0 BALLOON TO OPEN UP STENT STRUTS. I COULD STILL NOT GO BEYO

  Patient problems: Angina; Foreign Body In Patient

  MAUDE report 18865876 ↗
• MalfunctionMar 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS, MILD CALCIFICATION AND NO TORTUOSITY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED WITHOUT RESISTANCE. THE SDS WAS DEPLOYED AFTER THE FIRST INFLATION AT NOMINAL PRESSURE; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATMS). THE XIENCE SKYPOINT STENT WAS SUCCESSFULLY DEPLOYED, SO ONLY THE SDS WAS REMOVED. ANOTHER BALLOON WAS USED FOR POST-DILATATION AND WAS PERFORMED PER STANDARD 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 18856321 ↗
• MalfunctionOct 9, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL AND ALL DEVICES WERE REMOVED AS A SINGLE UNIT. ANOTHER XIENCE SKYPOINT STENT 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 17894967 ↗
• MalfunctionJul 17, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO RESISTANCE MET WITH THE LESION. THEREFORE, THE SDS WAS REMOVED FROM THE ANATOMY AND RESISTANCE WAS ALSO MET DUE TO THE LESION. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. 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 17337765 ↗
• MalfunctionMay 17, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS; HOWEVER, ONCE REMOVED THE STENT WAS NOT MOUNTED PROPERLY ON THE DELIVERY SYSTEM. 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 16948117 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO CALCIFICATION, MILD TORTUOSITY AND 100% STENOSIS. THE 3.0X28M XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS IMPLANTED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT DEVELOPED SEVERE ANGINA AND STENOSIS WAS CONFIRMED DURING THE ANGIOGRAPHY. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TREAT THE STENOSIS AND THE PATIENT SYMPTOMS WERE RESOLVED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: Angina; Stenosis

  MAUDE report 16810493 ↗
• MalfunctionOct 29, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT CIRCUMFLEX ARTERY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM BECAME STUCK WITH AN UNSPECIFIED HEMOSTATIC VALVE (RHV) WHEN ATTEMPTING TO ADVANCE. THE STENT DISLODGED IN THE UNSPECIFIED GUIDING CATHETER AND THE PHYSICIAN REMOVED GUIDE CATHETER, RHV AND THE GUIDE WIRE ALL AT THE SAME TIME TO MAKE SURE TO BE ABLE TO LOCATE THE STENT. A NEW UNSPECIFIED XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694661 ↗
• InjuryOct 19, 2022Adverse 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 (LAD) ARTERY THAT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION AND HYPOTENSION. THE FIRST (3X28MM) AND SECOND (3X18MM) SKYPOINT STENTS WERE IMPLANTED WITHOUT ISSUE. THE 3RD (2.5X18MM) SKYPOINT WAS ADVANCED TO THE DIAGONAL ARTERY (DX) AND IMPLANTED WITHOUT ISSUE. HOWEVER, AFTER IMPLANTING THE 3RD (2.5X18MM) SKYPOINT IN THE DX, IT WAS THEN NOTED THAT THERE WAS A PERFORATION CAUSED BY THE FIRST (3X28MM) SKYPOINT STENT IN THE LAD. A 2.8X26MM RX GRAFTMASTER (GM) STENT WAS DECIDED TO BE USED TO TREAT THE PERFORATION. THE GM STENT WAS ADVANCED BUT FAILED TO CROSS INITIALLY DUE TO THE FLARED STENT STRUTS OF THE IMPLANTED (2.5X18MM) SKYPOINT IN THE DX, BUT ULTIMATELY CROSSED IN A SECOND ATTEMPT (GM STENT WAS REMOVED AND REINSERTED). ONCE THE GM STENT WAS IMPLANTED, THE PERFORATION WAS SEALED SUCCESSFULLY. BUT THEN THERE WAS ACUTE THROMBUS THAT PRESENTED IN THE GM STENT. PATIENT EXPERIENCED CHEST PAIN. THE THROMBUS WAS TREATED WITH 2 ADDITIONAL (2.5X12MM AND 3X12MM) SKYPOINT STENTS AND MEDICATION FOR THE CHEST PAIN. PATIENT WAS FINE AFTERWARDS, THERE WERE NO OTHER ISSUES PRESENTED. NO ADDITIONAL INFORMATION WA

  Patient problems: Perforation of Vessels

  MAUDE report 15636394 ↗
• MalfunctionSep 30, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS NO RESISTANCE DURING REMOVAL. THERE WERE NO OTHER DEVICE ISSUES SUCH AS SHAFT SEPARATION OR STENT DISLODGEMENT. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED A STRETCHED SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519776 ↗
• MalfunctionSep 19, 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 PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER THE GUIDE WIRE CROSSED, A 3X28MM XIENCE SKYPOINT WAS ADVANCED BUT FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, THERE WAS RESISTANCE WITH ANATOMY AS WELL. A SAME SIZE NON-ABBOTT DEVICE 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 15451868 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2022, XIENCE SKYPOINT STENTS (3.0X28MM, 3.5X08MM, 4.0X18MM) WERE IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED FOR ELEVATED TROPONIN LEVELS. NO TREATMENT WAS PROVIDED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Enzyme Elevation

  MAUDE report 15418482 ↗
• MalfunctionAug 18, 2022Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE STYLET OF THE 3.0 X 28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM COULD NOT BE REMOVED. FORCE WAS APPLIED AND THE STYLET KINKED. THE DEVICE WAS NOT USED AND 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 15255376 ↗
• InjuryAug 17, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED DISTAL OBTUSE MARGINAL ARTERY. THE 3.0X28MM XIENCE SKYPOINT WAS IMPLANTED; HOWEVER, RESISTANCE WAS FELT WITH THE ANATOMY AND A PERFORATION WAS NOTED AT THE DISTAL END OF THE STENT IMPLANT. A 2.8X19MM GRAFTMASTER WAS ADVANCED WITH NO ISSUE AND IMPLANTED, SUCCESSFULLY SEALING THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDE.

  Patient problems: Perforation of Vessels

  MAUDE report 15242324 ↗
• MalfunctionJun 28, 2022Difficult 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 HEAVILY CALCIFIED AND TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 3.0X28MM XIENCE SKYPOINT WAS ADVANCED BUT FAILED TO REACH THE LESION. RESISTANCE WAS MET DURING REMOVAL OF THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED STENT CROSSED THE LESION AND WAS IMPLANTED EVEN THOUGH IT ALSO MET RESISTANCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847444 ↗
• MalfunctionJun 23, 2022Difficult 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 LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED AND 90% STENOSED. THE 3.0X28MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED BUT MET RESISTANCE AND FAILED TO REACH THE LESION DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS NOTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A DRUG COATED BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14793903 ↗
• MalfunctionApr 20, 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 MID RIGHT CORONARY ARTERY THAT WAS 100% STENOSED. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL OF THE SDS RESISTANCE WAS FELT WITH ANATOMY. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 14162244 ↗
• MalfunctionMar 17, 2022Difficult 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 LEFT ANTERIOR DESCENDING ARTERY THAT IS 85% STENOSED. THE 3.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL RESISTANCE WAS ALSO FELT WITH ANATOMY. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792167 ↗