XIENCE Skypoint™ 1804350-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08717648233401), received between Jun 3, 2021 and Sep 29, 2026 — classified as 1 death, 10 injuries, 23 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Dislodged or Dislocated

  It was reported that the procedure was to treat the circumflex coronary artery. The 3.5x18 mm Xience Skypoint stent dislodged from the delivery system prior to reaching the target lesion. There was no resistance. The stent went down into the aorta and is undeployed. A snare was attempted but was unsuccessful. A non-Abbott stent was used to treat the target lesion and the patient was discharged as planned. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50935930 ↗
• MalfunctionJun 3, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY LESION WITH 90% STENOSIS. A NON-ABBOTT BDC WAS USED TO PRE-DILATE THE VESSEL WITHOUT ISSUE. THE 3.5X18 MM XIENCE SKYPOINT DRUG ELUDING STENT (DES) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. SLIGHT RESISTANCE WAS NOTED WHILE CROSSING THE LESION. DURING THE FIRST INFLATION AT 6 ATM, THE BALLOON RUPTURED. THE DES WAS REMOVED WITH THE STENT STILL MOUNTED ON THE BALLOON. A NEW 3.5X23 MM XIENCE SKYPOINT DES WAS IMPLANTED WITHOUT ISSUE. TWO NON-ABBOTT BALLOON DILATION CATHETERS WERE USED FOR POST-DILATION WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED. 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 25376975 ↗
• MalfunctionApr 14, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION AND THE STENT DISLODGED INTO THE GUIDE CATHETER EXTENSION. THE GUIDE CATHETER EXTENSION WAS REMOVED. ANOTHER GUIDE CATHETER EXTENSION AND A NON-ABBOTT SDS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875063 ↗
• MalfunctionSep 19, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.50X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET WITH RESISTANCE DURING ADVANCEMENT WITH THE GUIDE CATHETER. THE SDS WAS ATTEMPTED TO BE REMOVED FROM THE GC; HOWEVER, COULD NOT BE REMOVED; THEREFORE, THE SDS AND GC HAD TO BE REMOVED AS A SINGLE UNIT. ANOTHER GC AND XIENCE SKYPOINT STENT WERE USED TO CONTINUE 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 23097747 ↗
• InjuryJan 22, 2025Adverse 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 LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.5X18 MM XIENCE SKYPOINT STENT WAS IMPLANTED ON (B)(6) 2024 AND ON (B)(6) 2024 THE PATIENT EXPERIENCED MINOR SINUS PRESSURE, HEAVINESS IN THE CHEST WITH SLIGHT DIFFICULTY IN BREATHING, HOARSE OR STRAINED VOICE, CLEAR POST NASAL DRIP, AND DIZZINESS OR LIGHT HEADED FEELING. THE PATIENT WAS DISCHARGED WITHOUT FURTHER TREATMENT AND WAS INSTRUCTED TO WAIT AN ADDITIONAL 7 DAYS FOR SYMPTOMS TO RESOLVE. THE PATIENT WAS TAKING BRILINTA, AND ROSUVASTATIN 10 MG. THE BRILINTA GAVE HIM A RASH AND THEY STOPPED THE MEDICATION ON (B)(6) 2025, AND WAS SWITCHED TO PLAVIX ON (B)(6) 2025. ROSUVASTATIN WAS INCREASED FROM 10 MG TO 20 MG. THE PATIENT WENT TO URGENT CARE AROUND (B)(6) 2025 AND THEY DIAGNOSED HIM WITH SINUSITIS AND PRESCRIBED CLARITIN AND A NASAL SPRAY. THE PATIENT IS CONCERNED ABOUT AN ALLERGIC REACTION. THEY HAVE AN APPOINTMENT WITH THEIR CARDIOLOGIST IN 4 WEEKS AND PLAN TO SEE AN ALLERGIST. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Dyspnea; Hypersensitivity/Allergic reaction

  MAUDE report 21210602 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, AFTER THE SKYPOINT STENT DELIVERY SYSTEM WAS REMOVED FROM ITS PACKAGING WITHOUT ISSUE, A PIECE OF THE DEVICE MATERIAL WAS OBSERVED STICKING UP. IT LOOKED A BIT SEPARATED, BUT STILL INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT AS THE DEVICE NEVER ENTERED THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154077 ↗
• MalfunctionFeb 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 3.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS REMOVED FROM PACKAGING, PREPPED; HOWEVER, UPON INSPECTING THE DEVICE IT WAS OBSERVED THE STENT WAS NOT ON THE BALLOON AND NOT IN THE SHEATH. ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18752915 ↗
• MalfunctionFeb 1, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) ARTERY WITH HEAVY CALCIFICATION. THE 3.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON COMPLETELY FAILED TO INFLATE. THE INFLATION DEVICE WAS SWITCHED TO A NEW INFLATION DEVICE; HOWEVER, THE BALLOON OF THE SDS STILL WOULD NOT INFLATE. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT. ANOTHER XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE REPORTED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628371 ↗
• MalfunctionJan 25, 2024Failure 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 AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY AND THE STENT SLIGHTLY SLIPPED OFF THE BALLOON. THE STENT STILL REMAINED ON THE BALLOON AND WAS REMOVED WITH THE DELIVERY SYSTEM. THE STENT WAS OBSERVED TO HAVE FLARED STRUTS. A 3.5X18MM XIENCE SKYPOINT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582643 ↗
• InjuryDec 5, 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 IN THE LEFT CORONARY CIRCUMFLEX (CX) ARTERY. A 3.50X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY AND DURING REMOVAL, THE STENT DISLODGED IN THE LEFT MAIN. ATTEMPTS TO RETRIEVE THE STENT WITH A SNARE WERE UNSUCCESSFUL; THEREFORE, A WIRE WAS ADVANCED AND PLACED THROUGH THE STENT AND THE STENT WAS DEPLOYED IN THE LEFT MAIN. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18269119 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT, WITH A HISTORY OF ACUTE MYOCARDIAL INFARCTION OF INFERIOR WALL / ST ELEVATION MYOCARDIAL INFARCTION (STEMI) HAD 1 XIENCE SKYPOINT (3.5X18 MM) STENT IMPLANTED. ON (B)(6), 2023, THE PATIENT WAS RE-ADMITTED WITH STEMI OF INFERIOR WALL AND THROMBOSED STENT. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND THROMBECTOMY WERE PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. PATIENT DISCHARGED TO HOME ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 17414814 ↗
• MalfunctionJul 11, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH CALCIFICATION AND 99% STENOSIS. THE 3.5X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THE DISTAL PART OF THE STENT STRUTS BROKE BUT DID NOT SEPARATE. THE DEVICE WAS SIMPLY WITHDRAWN. A NEW 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. SUBSEQUENT TO FIING THE INITIAL REPORT, AN ADDITIONAL 3.5X18 MM XIENCE SKYPOINT SDS WAS RECEIVED IN THE RETURNED GOODS LAB BUT IT WAS ONLY PREPPED AND HAD NOT BEEN USED IN THE PATIENT. THE STRUTS AT THE PROXIMAL END OF THE STENT IMPLANT WERE BENT AND STRETCHED DISTALLY. THERE WERE BENDS IN THE HYPOTUBE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299071 ↗
• MalfunctionJul 7, 2023Failure 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 90% STENOSED LESION IN CIRCUMFLEX ARTERY WITH CALCIFICATION AND TORTUOSITY. THE 3.50X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT MET WITH RESISTANCE WITH THE HEAVILY CALCIFIED LESION AND FAILED TO CROSS. WHEN THE SDS WAS REMOVED FROM ANATOMY AND THE STENT STRUTS WERE NOTED TO BE FLARED. ADDITIONAL PRE-DILATATION WAS PERFORMED AND A NEW XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED RETURN DEVICE ANALYSIS FOUND THE PROXIMAL END OF THE STENT IMPLANT WAS LOCATED 1MM DISTAL FROM ITS ORIGINAL CRIMPED POSITION AS THE STENT IMPLANT HAD MOVED DISTALLY ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278611 ↗
• MalfunctionJun 16, 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 HEAVILY CALCIFIED RIGHT CORONARY ARTERY. A 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO RESISTANCE WITH ANATOMY. A 3.5X18MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO CROSS; HOWEVER, ALSO FAILED DUE TO ANATOMY. DURING REMOVAL RESISTANCE WAS MET WITH THE GUIDE CATHETER AND THE STENT DISLODGED; HOWEVER, REMAINING ON THE GUIDE WIRE IN THE GUIDE CATHETER. THEREFORE, BOTH THE GUIDE CATHETER AND SDS WERE REMOVED AS A SINGLE UNIT. ADDITIONAL PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. ANOTHER 3.5X18MM XIENCE 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 17144840 ↗
• InjuryMay 1, 2023Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED AND CROSSED THE DISTAL RCA. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN ADVANCED TO THE VESSEL AND THE FILLING DEFECT IN THE DISTAL RCA WAS NOTED TO BE ULCERATED PLAQUE WITH DISSECTION. THE 3.5X18MM XIENCE SKYPOINT STENT WAS DEPLOYED, HOWEVER, THE BALLOON DRAGGED THE STENT BACK TO THE PROXIMAL RCA. A 5.5X15MM COMPLIANT BALLOON WAS ADVANCED THROUGH THE STENT TO DEPLOY IT AGAINST THE WALL OF THE PROXIMAL RCA. HOWEVER, THE COMPLIANT BALLOON PUSHED THE STENT DOWN TO THE DISTAL RCA. THE STENT WAS POST-DILATED; HOWEVER, UPON PULLING THE BALLOON BACK AGAIN, THE STENT WENT BACK TO THE PROXIMAL RCA. POST DILATATION WAS PERFORMED AGAIN AND DEPLOYED THE STENT IN THE PROXIMAL RCA. A 3.5 MM X 23 MM XIENCE SKYPOINT STENT WAS THEN DEPLOYED IN THE DISTAL RCA AND WAS POST DILATED WITH A 4.0MM NON-COMPLIANT BALLOON. IVUS CONFIRMED EXCELLENT EXPANSION AND WALL APPOSITION OF BOTH STENTS. POST-INTERVENTION TIMI FLOW WAS 3. THERE WAS A 0% RESIDUAL STENOSIS POST INTERVENTION. THERE WAS NO ADVERSE PATIENT SEQUALAE AND THERE WAS NO CLINICALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843850 ↗
• MalfunctionApr 19, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A GUIDE WIRE WAS ADVANCED AND INTRAVASCULAR ULTRASOUND (IVUS) PERFORMED BEFORE THE 3.5X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED FOR DIRECT STENTING. THE SDS COULD NOT CROSS THE TORTUOSITY. THERE WAS RESISTANCE WITH THE LESION DURING REMOVAL. ANOTHER UNSPECIFIED DEVICE ALSO COULD NOT CROSS SO THE PROCEDURE WAS DISCONTINUED. 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 16773524 ↗
• MalfunctionApr 13, 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 3.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WERE NO OTHER DEVICE ISSUES NOTED. THERE WAS RESISTANCE DUE TO THE ANATOMY DURING REMOVAL, HOWEVER, THE DEVICE WAS REMOVED INDEPENDENTLY. A NON-ABBOTT 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 16735260 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2023, A 2.0X30MM NON-ABBOTT STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. PATIENT WAS PLACED ON AN ANTI-PLATELET MEDICATION. ON (B)(6) 2023, THE PATIENT WAS REHOSPITALIZED AND THROMBUS WAS NOTED IN THE NON-ABBOTT STENT. A 3.5X18MM XIENCE SKYPOINT STENT WAS IMPLANTED AS TREATMENT, AND THE ANTI-PLATELET MEDICATION WAS CHANGED. ON (B)(6) 2023, THE PATIENT WAS REHOSPITALIZED WITH CHEST PAIN. THROMBOSIS WAS NOTED IN THE XIENCE SKYPOINT STENT. BALLOON ANGIOPLASTY WAS PERFORMED AND THE ANITPLATELET MEDICATION WAS CHANGED AGAIN. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT WAS NON-COMPLIANT WITH THE ANTIPLATELET MEDICATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 16585020 ↗
• MalfunctionFeb 27, 2023Difficult 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 MODERATELY CALCIFIED DE NOVO PROXIMAL RIGHT CORONARY ARTERY (PRCA). THE 3.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE GUIDE EXTENSION TELESCOPE; THEREFORE, FAILING TO CROSS THE LESION. WHEN ATTEMPTING TO REMOVE THE SDS IT WAS NOTED TO BE STUCK IN THE GUIDE EXTENSION AND BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THE DISTAL EDGE OF THE STENT WAS NOTED TO BE FLARED. THE PROCEDURE WAS CONTINUED WITH A NEW GUIDE EXTENSION TELESCOPE AND A NEW SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS 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 16449685 ↗
• InjuryDec 21, 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 THE COMPLETE OCCLUSION OF THE LEFT ANTERIOR TIBIAL AND PERONEAL ARTERIES. A 6FR 45 CM SHEATH WAS USED AS WELL AS THROMBECTOMY AND A 3.5X18 MM XIENCE SKYPOINT STENT WAS DEPLOYED SUCCESSFULLY IN THE DISTAL POPLITEAL ARTERY; HOWEVER, THE ANTERIOR TIBIAL ARTERY (ATA) HAD DECREASED FLOW AND WAS JAILED OFF AFTER DEPLOYMENT. A TWIN PASS CATHETER WAS USED TO AID IN WIRING THE ATA. A 3.0X20 MM TREK BALLOON WAS USED FOR PRE-DILATATION TO 18 ATMOSPHERES AND A 3.5X15 MM XIENCE SKYPOINT STENT WAS DEPLOYED TO THE OSTIAL TO PROXIMAL ATA. A SMALL PERFORATION WAS NOTED IN THE MID ATA SO A 3.5X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED WITHOUT ISSUE AND FINAL ANGIOGRAM SHOWED EXCELLENT FLOW WITH VESSEL RUNOFF TO THE ANKLE. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16024263 ↗
• MalfunctionDec 9, 2022Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED THROUGH A NON-ABBOTT EXTENSION CATHETER WITH RESISTANCE BETWEEN THE DEVICES. THE DES WAS THEN REMOVED FROM THE ANATOMY WITH THE EXTENSION CATHETER AND WHEN THE EXTENSION CATHETER WAS REMOVED, RESISTANCE WAS MET WITH THE DES A SECOND TIME AND THE STENT WAS NOTED TO BE COMPLETELY OFF OF THE DELIVERY SYSTEM BALLOON INSIDE OF THE EXTENSION CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW XIENCE DES AND A GUIDE LINER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955592 ↗
• MalfunctionOct 4, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 90% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED USING A CUTTING BALLOON. THE 3.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND UPON REMOVAL (PRIOR TO ADDITIONAL PRE-DILATATION ATTEMPT), THE STENT WAS NOTED TO BE DISLOCATED BUT REMAINED ON THE BALLOON. THE STENT MOVED 1.5MM SO THAT THE PROXIMAL MARKER BECAME UNSEEN. THEREFORE, ANOTHER 3.5X18MM XIENCE SKYPOINT SDS WAS ADVANCED BUT DID NOT CROSS THE LESION AFTER PRE-DILATATION WITH A CUTTING BALLOON. UPON REMOVAL (IN ORDER TO USE THE BACK-UP CATHETER), THE STENT WAS AGAIN NOTED TO BE DISLOCATED BUT REMAINED ON THE BALLOON, SO THE BACK-UP CATHETER WAS INSERTED AND ANOTHER XIENCE SKYPOINT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537726 ↗
• InjuryJul 11, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA) AND HEAVILY CALCIFIED CIRCUMFLEX ARTERY. THE 3.50X18MM AND 4.0X18MM SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION IN THE MID RCA, DUE TO THE ANATOMY. BOTH SDS WERE REMOVED WITHOUT ISSUE, HOWEVER AFTER THE 4.0X18MM SKYPOINT WAS REMOVED A DISSECTION WAS OBSERVED. IT IS UNKNOWN WHICH OF THE TWO SDS CAUSED THE DISSECTION. THE DISSECTION WAS TREATED WITH BALLOONING AND AN UNSPECIFIED STENT. A 3.0X23MM SKYPOINT WAS ADVANCED IN THE CIRCUMFLEX ARTERY, HOWEVER IT FAILED TO CROSS TO THE TARGET LESION DUE TO THE CALCIFICATION. THE SDS WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT SDS WAS ABLE TO CROSS. A DISSECTION WAS OBSERVED, IT IS UNKNOWN WHICH SDS CAUSED THE DISSECTION, THE ABBOTT SDS OR THE NON-ABBOTT STENT. THE DISSECTION WAS TREATED WITH THE NON-ABBOTT STENT THAT CROSSED. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14982668 ↗
• MalfunctionJun 23, 2022Difficult to Remove; Material Too Rigid or Stiff; Failure to Advance; Difficult to Remove; Material Too Rigid or Stiff; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT THE 3.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH ANATOMY AS WELL AS DURING REMOVAL OF THE SDS. IN THE PHYSICIAN'S OPINION THE NO CROSS WAS DUE TO STENT DELIVERABILITY AS THE STENT COULD NOT FOLLOW WITH VESSEL TORTUOSITY AND BEND. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789572 ↗
• MalfunctionMay 11, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 90% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE LEFT CIRCUMFLEX (LCX). THE 3.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE LESION DURING ADVANCEMENT AND FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE SDS WAS REMOVED INDEPENDENTLY. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL. 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 14360033 ↗