XIENCE Skypoint™ 1804300-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08717648233258), received between Jan 29, 2021 and Mar 25, 2026 — classified as 1 death, 17 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.00X23MM XIENCE SKYPOINT DRUG-ELUTING STENT WAS DEPLOYED. AFTER DEPLOYMENT, STENT RECOIL WAS OBSERVED. THE STENT WAS POST-DILATED WITH A 4.5MM NC BALLOON; HOWEVER, THE STENT WAS STILL UNDER-EXPANDED. NO ADDITIONAL TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691419 ↗
• MalfunctionNov 19, 2025Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 99% STENOSED. THE 3.0X23MM XIENCE SKYPOINT WAS DEPLOYED SUCCESSFULLY; HOWEVER, UNDER FLUOROSCOPY THE STENT WAS NOT VISIBLE. INTRAVASCULAR ULTRASOUND (IVUS) VERIFIED THAT THE STENT LOOKED GOOD. 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 23599466 ↗
• 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, ON (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 23270418 ↗
• InjurySep 30, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT SHOULD BE NOTED THAT AFTER THE BALLOON COULD NOT BE READVANCED, IT WAS BALLED UP AND COULD NOT BE PULLED INTO THE GUIDING CATHETER FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23184675 ↗
• MalfunctionSep 12, 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 TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2.5X15MM NON-ABBOTT BALLOON. THE 3.0X23MM 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 STENT DELIVERY SYSTEM RUPTURED AT 6 ATMOSPHERES. AS THE STENT REMAINED MOUNTED ON THE DELIVERY SYSTEM THE DEVICE WAS SIMPLY REMOVED. THE LESION WAS PRE-DILATED AGAIN WITH ANOTHER 3.0X15MM NON-ABBOTT BALLOON AND A 2.75X23MM XIENCE SKYPOINT WAS DEPLOYED AND POST DILATATED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIOANL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043205 ↗
• MalfunctionMar 11, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO CALCIFICATION OR TORTUOSITY. THE 3.0X23 AND 2.5X28 MM XIENCE SKYPOINT STENTS WERE IMPLANTED. PLANNED ASPIRATION WAS THEN PERFORMED BUT THIS CAUSED THE STENTS TO BECOME DAMAGED AND THEY WERE UNEXPECTEDLY PULLED OUT WITH THE ASPIRATION CATHETER. TWO NON-ABBOTT STENTS WERE USED TO TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574927 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. ROTABLATION WAS PERFORMED USING A 1.25MM NON-ABBOTT ROTATIONAL ATHERECTOMY DEVICE, FOLLOWED BY PRE-DILATATION WITH A 2.5X10MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC). THE 3.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER INSTRUCTIONS FOR USE AND ADVANCED; HOWEVER, A PINHOLE RUPTURE OCCURRED WHEN THE BALLOON WAS INFLATED TO 6 ATMOSPHERES. THIS WAS ATTRIBUTED TO THE REMAINING CALCIFICATION POST ABLATION. THE STENT WAS RETRIEVED WITHOUT ISSUE. ADDITIONAL DILATATION WAS PERFORMED WITH A 2.75X10MM NON-ABBOTT BDC. A NEW 2.75X23MM XIENCE SKYPOINT STENT WAS ADVANCED AND SUCCESSFULLY IMPLANTED. POST-DILATION WAS PERFORMED USING A 3.0X12MM NC TREK NEO BDC, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUES. 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 20802628 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI), HAD ONE XIENCE SKYPOINT (3.0X23MM) STENT IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE AND STEMI. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED WITH HOME HEALTH ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 19924178 ↗
• MalfunctionDec 19, 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, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 3.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM BECAME STUCK WHEN ADVANCING THROUGH ANOTHER GUIDE EXTENSION CATHETER AND BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. ONCE REMOVED THE STENT STRUT WAS NOT TO BE FLARED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE 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 18360483 ↗
• MalfunctionSep 7, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. PRE-DILATATION WAS PERFORMED SEVERAL TIMES WITH A 2.75X15MM NON-ABBOTT BALLOON AND A 3.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE DELIVERY SYSTEM BALLOON RUPTURED AT 5 ATMOSPHERES AFTER 5 SECONDS. THE STENT DID NOT DEPLOY AND SDS WAS REMOVED WITH THE STENT FROM THE ANATOMY. IT WAS NOTED RESISTANCE WAS FELT WITH ANATOMY DURING ADVANCEMENT OF THE SDS. ADDITIONAL DILATATION WAS PREFORMED WITH A NON-ABBOTT BALLOON AND A 2.75X23MM XIENCE SKYPOINT WAS IMPLANTED. POST DILATATION WAS PERFORMED WITH A 3.0X15MM BALLOON TO 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 17705221 ↗
• MalfunctionMay 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION, A 3.00X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS REMOVED FROM THE PACKAGE WHEN IT WAS NOTED THAT IT WAS CRACKED AT THE HUB. THERE WAS NO DAMAGE TO THE PACKAGING OR CHIPBOARD BOX. ANOTHER XIENCE SKYPOINT DES WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT FOUND THAT THE RETURNED DEVICE HAD MULTIPLE LONGITUDINAL CRACKS AT THE PROXIMAL END OF THE HUB WHICH LEAKED FLUID WHEN TESTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844481 ↗
• DeathMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS STABLE PRIOR TO THE PROCEDURE AND WAS SCHEDULED FOR AN OUTPATIENT PROCEDURE DUE TO ANGINA. THE 3.0X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE LAD WITH MILD-MODERATE CALCIFICATION AND MILD TORTUOSITY AND THE 2.75X38 MM XIENCE SKYPOINT WAS IMPLANTED IN THE RCA WITH MILD TORTUOSITY. THE STENTS WERE IMPLANTED WITHOUT ISSUE. WHEN THE PATIENT WAS IN RECOVERY, THEY CODED AND WERE BROUGHT BACK TO THE CATH LAB. HOWEVER, THE PATIENT CONTINUED TO CODE IN THE LAB AND CPR WAS PERFORMED FOR 30-45 MINUTES AND THEN THE PATIENT EXPIRED. NO ANGIOGRAPHY WAS ABLE TO BE DONE TO CHECK FOR THROMBUS. THE CAUSE OF DEATH WAS COAGULOPATHY. IT WAS NOT DETERMINED IF THE XIENCE SKYPOINT STENTS CAUSED OR CONTRIBUTED TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16620370 ↗
• InjuryMar 24, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 1/31/2022, A 3.0X23MM XIENCE SKYPOINT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. A SECOND 3.0X12MM XIENCE SKYPOINT WAS IMPLANTED IN THE PROXIMAL DIAGONAL WITH NO ISSUES. DURING THE WINTER TIME THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN, SHORTNESS OF BREATH AND PAIN IN THE ARM. ON 2/28/2023, IT WAS CONFIRMED BOTH STENT'S HAD COLLAPSED AND A NEW UNSPECIFIED STENT WAS IMPLANTED FOLLOWED BY ADDITIONAL ANGIOPLASTY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Obstruction/Occlusion; Pain

  MAUDE report 16612470 ↗
• InjuryFeb 27, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE 3.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS SOAKED IN SALINE AND WAS PREPPED (AIR ASPIRATION) INSIDE THE ANATOMY PRIOR TO USE. NO RESISTANCE WAS MET WHEN THE PROTECTIVE SHEATH WAS REMOVED. THE SDS WAS ADVANCED WITHOUT RESISTANCE AND THE BALLOON INFLATED ONCE AT 8 ATMOSPHERES (ATMS) AND THEN DEFLATION OCCURRED DUE TO A PINHOLE RUPTURE. THE STENT WAS PARTIALLY DEPLOYED AND UNABLE TO BE REMOVED SO IT WAS FORCEDLY EXPANDED AND IMPLANTED. POST DILATATION WAS PERFORMED DUE TO THE RUPTURE AND INADEQUATE STENT DEPLOYMENT. THERE WAS NO RESISTANCE 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 16449034 ↗
• MalfunctionFeb 17, 2023Difficult to Remove; Failure to Advance; Material Split, Cut or Torn; Difficult to Remove; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT DISTAL CIRCUMFLEX CORONARY ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 3.0X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO RESISTANCE WITH THE ANATOMY. DURING REMOVAL, RESISTANCE WITH THE ANATOMY WAS ALSO NOTED. AFTER REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE SDS WAS TORN. 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 16398115 ↗
• InjuryDec 13, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH IN-STENT RESTENOSIS. ON (B)(6) 2021, A 3.0X23MM XIENCE SKYPOINT STENT WAS IMPLANTED AND POST DILATED TO 3.5 AT THAT TIME. THE PATIENT WAS MEDICALLY COMPLIANT AND ACCORDING TO THE NOTES IT WAS NOT STOPPED OR INTERRUPTED. THE PATIENT WAS TAKING ASPIRIN (81 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022, THE PATIENT CAME BACK WITH RESTENOSIS OF THE XIENCE SKYPOINT STENT WHICH WAS DISCOVERED BECAUSE THE PATIENT WAS SYMPTOMATIC WITH WORSENING ANGINA DURING ACTIVITY AND REST. ANGIOGRAPHY WAS DONE TO CONFIRM RESTENOSIS. ALSO, THERE WAS A DIAGONAL BRANCH WITH MILD CALCIFICATION AND MILD TORTUOSITY THAT WAS COVERED BY THE XIENCE SKYPOINT STENT WHEN IT WAS DEPLOYED ACROSS THE ENTIRE LAD IN 2021 THAT THE PHYSICIAN WANTED TO DILATE. THE 2.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT AS IT ENTERED THE VESSEL AND REACHED THE STENT, THE ENTIRE SYSTEM WAS KICKED OUT AND THE BDC WAS NOTED TO BE KINKED. AFTER REWIRING THE LAD, THE PROCEDURE FOR THE DIAGONAL BRANCH WAS ABORTED TO TREAT THE RESTENOSIS. THE RE-STENOSED AREA WAS BALLOONED AND A 3.5X18MM NON-ABBOTT STENT WAS

  Patient problems: Angina; Stenosis

  MAUDE report 15974310 ↗
• 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 15537682 ↗
• MalfunctionOct 3, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 90% STENOSIS. DURING ADVANCEMENT OF THE 3.0X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), THERE WAS RESISTANCE WITH THE ANATOMY. THE STENT WAS NOTED TO BE DISPLACED ON THE BALLOON; THEREFORE, THE SDS WAS REMOVED WITH THE STENT STILL ON THE DELIVERY SYSTEM. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 15533339 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT HAD A 3X23 MM XIENCE SKYPOINT STENT IMPLANTED. ON (B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED DUE TO CHEST PAIN AND HEART FAILURE. THERE WAS NO TREATMENT PERFORMED AND NO PATIENT EFFECTS. PATIENT WAS DISCHARGED ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Heart Failure/Congestive Heart Failure

  MAUDE report 15373752 ↗
• MalfunctionAug 26, 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 DISTAL RIGHT CORONARY ARTERY (DRCA) WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WERE NO OTHER DEVICE ISSUES SUCH AS SHAFT SEPARATION AND STENT DISLODGEMENT. THERE WAS RESISTANCE DURING REMOVAL BUT THE SDS WAS REMOVED INDEPENDENTLY. ANOTHER DEVICE 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 15306970 ↗
• 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 14982621 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL RESEARCH: (B)(6) STUDY PATIENT ID; (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY AND LEFT ATRIOVENTRICULAR (LAV) ARTERY. AFTER LESION PREPARATION WITH A SEMI-COMPLIANT BALLOON, THE LCX WAS THE FIRST TO BE STENTED. FIRST A 3X23MM XIENCE SKYPOINT WAS DEPLOYED AT 14 ATMOSPHERES IN THE LAV WITH STANDARD POST-DILATATION PERFORMED AFTERWARDS. PER THE PHYSICIAN, DISTAL EMBOLISM OF THE LAV WAS NOTED AND ASSOCIATED WITH POST-DILATATION AFTER THE STENT DEPLOYMENT AT THE TIME OF THE INITIAL PCI. THEN A 4X23MM XIENCE SKYPOINT WAS DEPLOYED AT 20 ATMOSPHERES IN THE LCX WITH STANDARD POST-DILATATION PERFORMED AFTERWARDS. THERE WERE NO COMPLICATIONS WHEN PCI WAS PERFORMED. MYOCARDIAL INFARCTION (MI) OCCURRED DUE TO SIDE BRANCH OCCLUSION OF THE LAV AT THE TIME OF THE PCI BUT WAS LATER IDENTIFIED POST PCI ON THE SAME DAY OF THE PROCEDURE. THE SITE OF ONSET OF MI IS IN THE LAV LESION, AND ST-ELEVATION WAS CONFIRMED. CK LEVEL ELEVATION WAS ALSO CONFIRMED. CONTINUOUS INFUSION OF NICORANDIL MEDICATION WAS STARTED. PATIENT WAS DISCHARGED ON (B)(6) 2022 (2 DAYS) AFTER PCI. NO ADDITIONAL IN

  Patient problems: Cardiac Enzyme Elevation; Embolism/Embolus; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 14610608 ↗
• MalfunctionMay 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 3X23MM XIENCE SKYPOINT WAS DELIVERED TO THE LESION, BUT DURING THE FIRST INFLATION THE STENT-BALLOON RUPTURED AT 8 ATMOSPHERES. THE STENT HAD BEEN ULTIMATELY IMPLANTED AND THERE WERE NO ISSUES NOTED WITH DEPLOYMENT. AFTERWARDS, STANDARD POST-DILATATION WAS PERFORMED WITH ANOTHER BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311926 ↗
• InjuryApr 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED WITH A NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND THE 3.0X23MM XIENCE SKYPOINT STENT WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED WITH UNSTABLE ANGINA AND NSTEMI. DILATATION OF THE STENT WAS PERFORMED [NOT OPPOSED TO THE VESSEL WALL]. THERE WERE NO ADVERSE SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 14193391 ↗
• MalfunctionApr 1, 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 MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. A 3.00 X 23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER THE STENT FAILED TO CROSS DUE TO ANATOMICAL CHALLENGES. THEREFORE, SDS WAS REMOVED AND RESISTANCE WAS NOTED DURING REMOVAL DUE TO ANATOMICAL CHALLENGES. A NON-ABBOTT STENT WAS USED TO 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 13982325 ↗