XIENCE Skypoint™ 1804225-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648233029), received between Dec 31, 2020 and Mar 25, 2026 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY LESION. A 2.25X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS DIFFICULT TO DELIVER TO THE TARGET LESION AND WHEN PULLING BACK BEFORE DEPLOYMENT, RESISTANCE WAS NOTED. A SNARE WAS USED TO PREVENT THE STENT FROM DISLODGING FROM THE SDS DURING REMOVAL. AN ADDITIONAL NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691869 ↗
• MalfunctionDec 29, 2025Difficult to Remove; Material Rupture; Material Deformation; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON CATHETER AND THEN A 6FR GUIDE EXTENSION WAS INSERTED. THE 2.25X28MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 16 ATMOSPHERES (ATM) HOWEVER THE BALLOON DID NOT EXPAND. THE INDEFLATOR PRESSURE DROPPED AND CONTRAST MEDIA WAS NOTED TO BE LEAKING THEREFORE IT WAS THOUGHT THE BALLOON HAD RUPTURED. DURING RETRACTION OF THE SDS, THE STENT EDGE CAUGHT ON THE GUIDE CATHETER EXTENSION. THE SDS WAS THEN REMOVED TOGETHER WITH THE GUIDE CATHETER AND OUTSIDE THE BODY THE STENT EDGE WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER XIENCE. 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 23911650 ↗
• MalfunctionDec 20, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989521 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5X23MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE MID CIRCUMFLEX, FOLLOWED BY A 2.5X12MM XIENCE SKYPOINT IN THE OSTIAL CIRCUMFLEX AND CONCLUDING WITH A 2.75X28 XIENCE SKYPOINT IN THE LEFT MAIN. ALL THREE XIENCE SKYPOINT'S WERE IMPLANTED SUCCESSFULLY WITHOUT ISSUE. POST PROCEDURE THE PATIENT BECAME UNRESPONSIVE AND PULSELESS VENTRICULAR FIBRILLATION WAS NOTED. ANGIOGRAM CONFIRMED THROMBOSIS IN ALL THREE IMPLANTED STENTS. THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB AND CPR WAS PERFORMED BUT THE PATIENT EXPIRED. A CLINICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 20619870 ↗
• InjuryJul 10, 2024Difficult 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 PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. PRE-DILATION WAS PERFORMED WITH A 2.5X20 NC TREK NEO BALLOON DILATATION CATHETER (BDC). THE 2.75X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED YET FAILED TO CROSS THE LESION DUE TO PATIENT ANATOMY. THE 2.25 X28MM XIENCE SKYPOINT SDS WAS ADVANCED AND AGAIN FAILED TO CROSS DUE TO PATIENT ANATOMY. UPON WITHDRAWAL, RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT DISLODGED. THE STENT BECAME EMBEDDED IN A HEAVILY DISEASED AREA OF THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY EXTENDING INTO THE LEFT MAIN. UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE STENT WITH A SNARE. AN UNSPECIFIED ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO ANOTHER FACILITY FOR STENT RETRIEVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19712687 ↗
• InjuryJan 12, 2024Difficult 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 THE PROXIMAL TO MID CIRCUMFLEX CORONARY ARTERY WITH HEAVY CALCIFICATION. A DISSECTION WAS NOTED. THE 3.0X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION AND WAS NOT LONG ENOUGH FOR THE DISSECTION, THEREFORE THE SDS WAS REMOVED AND REPLACED WITH A 33 MM STENT. THE 2.25X28 MM XIENCE SKYPOINT SDS WAS THEN ADVANCED AND WAS INTENDED TO TREAT THE DISSECTION BUT THE PHYSICIAN DID NOT WANT TO CROSS THE BIFURCATION DUE TO THE DISSECTION. UPON ATTEMPTED REMOVAL FROM THE ANATOMY, A PROXIMAL STENT STRUT BECAME STUCK AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A GUIDEWIRE WAS ATTEMPTED TO BE USED TO REMOVE THE STENT BUT THIS WAS UNSUCCESSFUL. THE STENT REMAINS IN THE ANATOMY WITHIN THE TARGET LESION. THE DISSECTION WAS ULTIMATELY NOT TREATED BUT SEEMED TO HAVE RESOLVED BY THE END OF THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT AFTER THE 3.0X28 MM XIENCE SKYPOINT SDS FAILED TO CROSS THE LESION, A 33 MM XIENCE STENT WAS IMPLANTED. NEXT, THE 2.25X28 MM XIENCE SKYPOINT SDS REACHED THE LESION BUT WAS REMOVED AS IT WAS DEEMED A LONGER STENT WAS NEEDED. THERE WAS NO RESISTANCE DURING ADV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504532 ↗
• MalfunctionJan 8, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  USER FACILITY MEDWATCH REPORT ((B)(4)) RECEIVED STATING: DESCRIBE THE EVENT OR PROBLEM: STENT STRUTS SLID OFF BALLOON PRIOR TO DEPLOYMENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LEFT HEART CATHETERIZATION WITH CORONARY ANGIOGRAM PERCUTANEOUS INTERVENTION. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; ADDITIONAL INFORMATION WAS PROVIDED. THE VESSEL TREATED WAS THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH 100% STENOSIS AND CALCIFICATION. THE 2.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION AND THE STENT DISLODGED. THERE WAS NO RESISTANCE PRIOR TO THE DISLODGEMENT. THE STENT WAS RETRIEVED USING THE SAME BALLOON THAT CAME WITH THE STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469129 ↗
• MalfunctionDec 26, 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 LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THE SDS MET WITH RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND REMOVAL. 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 18394333 ↗
• InjuryNov 21, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE 2.25 X 28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED, BUT MET RESISTANCE WITH THE LESION AND THE STENT DISLODGED. THE DISLOGED STENT WAS RETRIEVED WITH A SNARE DEVICE. ANOTHER SAME SIZE XIENCE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184484 ↗
• MalfunctionApr 18, 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 RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND DIFFICULTLY WAS ALSO NOTED DUE TO THE ANATOMY. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY NOTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765712 ↗
• InjuryMar 18, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH CALCIFICATION. THE 2.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, DIFFICULTY WAS NOTED DUE TO THE ANATOMY. THE STENT BECAME DISLODGED IN THE ARTERY AND THE BALLOON OF THE SDS WAS USED TO CRUSH THE STENT INTO THE VESSEL WALL AT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. AN ADDITIONAL STENT WAS IMPLANTED AT THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16569776 ↗
• MalfunctionSep 20, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 2.25X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND THE STENT BECAME LOOSE ON THE BALLOON. THE DES WAS REMOVED AND ANOTHER XIENCE 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 15459837 ↗
• MalfunctionSep 12, 2022Difficult 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 HEAVILY TORTUOUS, HEAVILY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE 2.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL RESISTANCE WAS MET WITH ANATOMY AND THE STENT TIP WAS PARTIALLY FLARED. AFTER PRE-DILATATION WITH AN UNSPECIFIED ANOTHER 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 15406774 ↗
• InjuryApr 18, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY IN THE RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED SUCCESSFULLY. THE LESION WAS DISTAL TO A PREVIOUSLY IMPLANTED STENT. THE 2.25 X 28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS THE PREVIOUSLY IMPLANTED STENT AND THE XIENCE SKYPOINT STENT DISLODGED FROM THE BALLOON. THE STENT WAS COMPRESSED AGAINST THE VESSEL WITH ANOTHER XIENCE SKYPOINT STENT. ANOTHER XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14137349 ↗
• InjuryJan 19, 2022Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY(LAD) WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION A 2.0 X 8MM NON-ABBOTT STENT WAS PLACED IN THE DISTAL LAD. THEN A 2.25 X 28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE MID LAD, BUT THE STENT FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY. THE SDS WAS REMOVED FROM THE PATIENT. ADDITIONAL DILATATION WAS PERFORMED WITH A 2.25 AND 2.5 MM UNSPECIFIED BALLOONS. WHEN THE 2.5 UNSPECIFIED BALLOON WAS REMOVED, AN UNSPECIFIED WIRE THAT WAS PREVIOUSLY PLACED IN THE LAD AND DIAGONAL ARTERY CAME OUT. THEN THROMBOSIS WAS OBSERVED IN THE CIRCUMFLEX ARTERY. THE PATIENT DEVELOPED CHEST PAIN AND AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. IT IS UNKNOWN AT THIS TIME IF THE SDS CONTRIBUTED TO THE THROMBOSIS. THE CIRCUMFLEX ARTERY WAS TREATED WITH AN UNSPECIFIED STENT, BUT THE LAD WAS UNABLE TO BE REVASCULARIZED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 13293785 ↗
• InjuryNov 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). THE 2.25X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE BUT THE INDEFLATOR DID NOT HOLD PRESSURE AND CONTRAST WAS OBSERVED VIA IMAGING ON THE FIRST INFLATION ATTEMPT AT 1 ATMOSPHERE (ATM) INDICATING A BALLOON RUPTURE. THE CONTRAST LEAKED AND ENTERED THE ARTERY, AND THE PATIENT HAD A BRIEF EPISODE OF CHEST PAIN AND ST CHANGES. THE STENT REMAINED ON THE BALLOON AFTER THE RUPTURE AND THE DEVICE WAS REMOVED WITHOUT ISSUE. THE ANGINA AND ST CHANGES WERE TREATED WITH MORPHINE AND NITRILE GLYCERIN, WHICH RESOLVED QUICKLY, AFTER WHICH A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes

  MAUDE report 12816749 ↗
• MalfunctionOct 5, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) RESISTANCE WAS FELT WHEN REMOVING THE SHEATH. THE SDS WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY A NON-ABBOTT BALLOON. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577495 ↗
• MalfunctionSep 20, 2021Difficult 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 RIGHT POSTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOSED. A XIENCE SKYPOINT DEVICE WAS ATTEMPTED TO BE ADVANCED, HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE MET WITH THE LESION DURING REMOVAL. THE PATIENT WAS TREATED WITH A NON-ABBOTT DEVICE AND THE PROCEDURE WAS COMPLETED AFTER STENTING. THERE WAS NO REPORT OF 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 12503021 ↗
• MalfunctionJan 4, 2021Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED, DE NOVO, DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (DLAD) LESION. A 2.25X28 XIENCE SKYPOINT DRUG ELUTING STENT (DES), WAS ADVANCED AGAINST RESISTANCE AND FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS FLARED, AND THE STENT HAD SHIFTED ON THE BALLOON. 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 Consequences Or Impact To Patient

  MAUDE report 11113371 ↗
• MalfunctionDec 31, 2020Difficult 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 MILDLY TORTUOUS, HEAVILY CALCIFIED DISTAL RIGHT CORONARY ARTERY THAT WAS 99% STENOSED. A 2.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY AS THE STENT STRUTS WERE ALSO NOTED TO BE FLARED. THERE WAS RESISTANCE NOTED DURING REMOVAL OF THE SDS DUE TO ANATOMY. A 2.25X28MM 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 Consequences Or Impact To Patient

  MAUDE report 11102509 ↗