XIENCE Skypoint™ 1804300-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648233234), received between Apr 5, 2021 and May 28, 2026 — classified as 9 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (9 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X15MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE PATIENT HOWEVER FAILED TO CROSS THE LESION DUE TO THE ANATOMY. WHEN THE SDS WAS REMOVED FROM THE PATIENT IT WAS NOTED THE STENT HAD MOVED ON THE BALLOON AND THE STENT STRUTS WERE BROKEN AND LIFTED. 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 25315249 ↗
• InjuryOct 2, 2025Migration; Migration

  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 23202924 ↗
• MalfunctionJul 28, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED IT SEEMS THE OUTER MEMBER WAS NOT EXTRUDED TO THE ENTIRE LENGTH OF THE CATHETER. THE STENT IS ON THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632337 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREPARED USING ABLATION AND BALLOON DILATATION. THE 3.0X15MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE CALCIFICATION. DURING INFLATION THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE SDS WAS REMOVED WITH THE STENT STILL MOUNTED ON THE BALLOON. THE LESION WAS PRE-DILATED AGAIN AND A 2.75X15MM SKYPOINT WAS IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358100 ↗
• MalfunctionApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) PROTECTIVE SHEATH WAS BEING REMOVED WHEN THE STENT DISLODGED DURING PREPARATION. THERE WAS NO FORCE APPLIED DURING THE REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED. ANOTHER SAME SIZE XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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 19160164 ↗
• MalfunctionMar 11, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. WHEN PULLING THE 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) OUT OF THE HOOP; RESISTANCE WAS MET. THE YELLOW PORTION OF STYLET WAS HELD; HOWEVER A 90-DEGREE ANGLE WAS NOTED AT THE END OF THE STYLET. RESISTANCE WAS NOTED WHEN REMOVING THE STYLET. THE SDS WAS INSERTED INTO THE BODY AND WHEN ATTEMPTING TO DEPLOY THE STENT, IT WAS NOT VISIBLE UNDER FLUOROSCOPY. THE STENT WAS LOCATED INSIDE THE YELLOW STYLET ON THE PREP TABLE. THE SDS WAS REMOVED WITHOUT ISSUE. ANOTHER SKYPOINT 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 18874111 ↗
• MalfunctionFeb 29, 2024Difficult 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

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE GUIDE LINER (GUIDE EXTENSION 5F) HOWEVER, THE DELIVERY SYSTEM BECAME STUCK. WHEN ATTEMPTING TO PULL OUT THE SDS, RESISTANCE WAS MET AND FORCE WAS APPLIED. THE SHAFT BROKE AND AT A POINT OUTSIDE OF THE Y-CONNECTOR; THEREFORE, EVERYTHING WAS REMOVED TOGETHER. ANOTHER 2.5X15MM SKYPOINT 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 18813321 ↗
• MalfunctionFeb 28, 2024Material Rupture; Material Deformation; Activation Failure; Material Rupture; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.0X15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) COULD NOT BE SUCCESSFULLY INFLATED TO DEPLOY THE STENT AND THE STENT WAS DEFORMED. A NEW UNSPECIFIED SDS WAS USED TO 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 18803670 ↗
• MalfunctionJan 19, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. A 6FRENCH (F) GUIDE LINER WAS USED TO AID IN THE DELIVERY OF THE 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) BUT HAD RESISTANCE DURING ADVANCEMENT INTO THE 6F GUIDE CATHETER AROUND THE AREA OF THE GUIDE LINER HALF PIPE CHANNEL ENTRY PORT. THE PHYSICIAN DECIDED TO WITHDRAW THE XIENCE SKYPOINT SDS AFTER SEVERAL ATTEMPTS, HOWEVER, IT WAS STUCK AND UNABLE TO BE REMOVED INDEPENDENTLY. ULTIMATELY EVERYTHING WAS REMOVED TOGETHER (GUIDE WIRE, GUIDE CATHETER AND STENT). THE STENT WAS REMOVED INTACT STILL ON THE SDS. A NEW GUIDE CATHETER, GUIDE WIRE AND ANOTHER 3.0X15MM XIENCE SKYPOINT STENT (NO GUIDE LINER USED THIS TIME) 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 18544774 ↗
• MalfunctionNov 29, 2023Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. THE 3.0X15MM RX XIENCE SKYPOINT DRUG ELUTING STENT SYSTEM (DES) WAS ADVANCED; HOWEVER, COULD NOT CROSS THE LESION. SEVERAL ATTEMPTS WERE MADE; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THE DES WAS REMOVED AND THE LESION PRE-DILATED AGAIN WITH A BALLOON CATHETER. THE DES WAS ADVANCED AGAIN WHEN RESISTANCE WAS MET AND THE PROXIMAL PORTION OF THE SHAFT OUTSIDE THE PATIENT SEPARATED. THE DISTAL PORTION OF THE DES WAS EASILY REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SKYPOINT OF THE SAME SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234863 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PROCEDURE WAS TO TREAT AN ECCENTRIC, LONGER THAN 20 MM LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD TORTUOSITY, AND MODERATE CALCIFICATION. THE LESION WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS) AND LESION MODIFICATION WAS PERFORMED WITH A CUTTING BALLOON. THEN A 2.5X33 MM AND 3.0X15 MM XIENCE SKYPOINT STENT WERE IMPLANTED. THE 3.0X15 MM XIENCE SKYPOINT STENT WAS IN THE MOST PROXIMAL POSITION. THE STENTS WERE POST DILATED AND THE PROCEDURE WAS SUCCESSFUL WITH NO COMPLICATIONS. AFTER THE INITIAL PROCEDURE, THERE WERE NO ABNORMALITIES AFTER THE 12 MONTH FOLLOW UP ON (B)(6) 2023. AFTER THE FOLLOW UP, THERE WAS A COMPLAINT OF CHEST PAIN. AFTER AN EXAMINATION ON (B)(6) 2023 THERE WAS A 75-90% STENOSIS IN THE AREA PROXIMAL TO THE TWO PREVIOUSLY IMPLANTED STENTS. REVASCULARIZATION WAS PERFORMED BY PRE-DILATING THE LESION AND THEN IMPLANTING A 3.0X23 MM XIENCE SKYPOINT STENT, FOLLOWED BY POST DILATATION. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY MEDICATIONS FOLLOWING THE INITIAL PROCEDURE, AND THEY WERE DISCONTINUED PER PROTOCOL AT THE 1 MONTH FOLLOW UP. FOLLOWING THE SECOND PROCEDURE, PRASUGREL AND AS

  Patient problems: Stenosis

  MAUDE report 17991293 ↗
• InjuryApr 12, 2023Leak/Splash; Difficult or Delayed Activation; Device Dislodged or Dislocated; Leak/Splash; Difficult or Delayed Activation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE 3.00X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, WHEN ATTEMPTING TO DEPLOY THE STENT THE BALLOON WAS THOUGHT TO HAVE LEAK AND MAY HAVE RUPTURED. PRESSURE WAS INCREASED; HOWEVER, NO ATMOSPHERES (ATM) WERE REACHED TO INFLATE THE BALLOON AND BLOOD WAS NOTED TO COME BACK INTO THE INDEFLATOR. THE SDS WAS REMOVED FROM THE PATIENT; HOWEVER, THE STENT WAS NOTED TO NOT BE THE BALLOON. THE GUIDE CATHETER AND GUIDEWIRE WERE THEN REMOVED FROM THE PATIENT. THE STENT WAS NOT IN THE GUIDE CATHETER. CINE AND FLUOROSCOPY WERE PERFORMED UP AND DOWN THE RADIAL ACCESS SITE TO LOOK FOR THE DISLODGED STENT AND THE XIENCE STENT WAS FOUND TO BE PARTIALLY DEPLOYED AS BOTH ENDS OF THE STENT WERE NOTED TO HAVE EXPANDED SLIGHTLY IN THE SMALL BRANCH OF THE ULNAR ARTERY. NO INTERVENTION WAS PERFORMED IN THE REMOVE THE DISLODGED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16727386 ↗
• MalfunctionFeb 22, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 99% STENOSED. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED DEVICE. THE 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO RESISTANCE WITH ANATOMY. DURING REMOVAL, RESISTANCE WAS ALSO MET WITH THE ANATOMY. THE PROCEDURE WAS COMPLETED WITHOUT TREATMENT. 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 16418758 ↗
• InjuryFeb 14, 2023Adverse 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 DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH MILD CALCIFICATION, AND MILD TORTUOSITY. ON (B)(6) 2023, THE 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS IMPLANTED AFTER A 7FRENCH (FR) GUIDE CATHETER WAS INSERTED AND PRE-DILATED WITH A SEMI-COMPLIANT BALLOON. POST-DILATATION WAS PERFORMED. ADDITIONALLY, THE KISSING BALLOON TECHNIQUE WAS PERFORMED IN THE PLAD AND FIRST DIAGONAL ARTERY. THE PROCEDURE WAS COMPLETED. THERE WERE NO ISSUES DURING THE PROCEDURE UNTIL DISCHARGED. ATRIAL FIBRILLATION (AF) WAS OBSERVED ON ECHOCARDIOGRAM (ECG) ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT COMPLAINED OF CHEST PAIN AND THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL. THE PATIENT WAS ADMINISTERED DRUG BUT CHEST PAIN PERSISTED. ECG WAS PERFORMED AND AF AND COMPLETE RIGHT BUNDLE BRANCH BLOCK (CRBBB) WERE NOTED SO THE PATIENT WAS ADMINISTERED SUNRYTHM. ADDITIONALLY A DIRECT CURRECT DEFIBRILLATOR WAS USED ON THE PATIENT. CORONARY ANGIOGRAM (CAG) WAS PERFORMED AND THEN PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE SAME DAY. STENT THROMBOSIS IN PLAD WAS SUSPECTED ON CAG AND MYOCARDIAL INFARCTION W

  Patient problems: Angina; Atrial Fibrillation; Cardiac Enzyme Elevation; Myocardial Infarction; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 16372906 ↗
• InjuryNov 14, 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 MINIMALLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT IS 95% STENOSED. ON (B)(6) 2022, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND THE 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED AS ANGIOGRAM CONFIRMED THROMBOSIS HAD OCCURRED AND THE PATIENT SUFFERED A HEART ATTACK. THE PATIENT WAS GIVEN MEDICATION AND A NON-COMPLIANT BALLOON WAS USED FOR TREATMENT. THE PHYSICIAN STATED THROMBUS OCCURRED DUE TO THE PATIENT NOT TAKING THE MEDICATION PRESCRIBED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 15790111 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HISTORY OF NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2022, A 3.00X15MM AND 4.00X23MM XIENCE SKYPOINT STENTS WERE IMPLANTED . ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED EXPERIENCING VENTRICULAR FIBRILLATION AND GOING INTO CARDIAC ARREST. ON (B)(6) 2022, PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED. A 2.25X33MM XIENCE SKYPOINT STENT AND A NON-ABBOTT STENT WERE IMPLANTED. THERE WAS NO ADVERSE PATIENT SEQUELA. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 15782420 ↗
• InjuryOct 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 A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). MEDICATIONS WERE PROVIDED AND A 2.5X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS PLACED IN THE MRCA, AND A 3X15MM SKYPOINT DES WAS PLACED PROXIMAL TO THAT STENT. A 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION AND THE PATIENT WAS TRANSFERRED TO THEIR ROOM FOR RECOVERY. APPROXIMATELY 2 MINUTES AFTER THE PATIENT WAS TRANSFERRED TO THEIR ROOM, AND EXPERIENCED CHEST PAIN. AN ELECTROCARDIOGRAM (EKG) WAS PERFORMED WHICH INDICATED AN ST-ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS IMMEDIATELY PLACED BACK IN THE CATH LAB FOR THE SECOND TIME THAT DAY. UPON ENGAGING THE RCA WITH A GUIDE CATHETER (GC) IT WAS DISCOVERED THERE WAS A HEAVY THROMBUS THROUGHOUT THE LENGTH OF THE VESSEL, INSIDE AND OUTSIDE OF THE RECENTLY IMPLANTED STENTS. MEDICATIONS WERE PROVIDED AND A 3.5X15MM SKYPOINT DES AND A 3.0X15MM SKYPOINT DES WERE IMPLANTED PROXIMAL TO THE INITIAL 2 STENTS IN THE MRCA. POST-DILATATION WAS PERFORMED. AFTER THE PROCEDURE WAS COMPLETED, THE ACT RESULTED AT 248 SECONDS. THE PATIENT WAS STABLE WITHOUT CHEST

  Patient problems: Angina; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 15655873 ↗
• MalfunctionOct 18, 2022Inflation Problem; Activation Failure; Inflation Problem; Activation Failure

  IT WAS REPORTED THAT THE MID RIGHT CORONARY ARTERY LESION WAS PRE-DILATED WITH A 3.0X12 TREK BALLOON CATHETER. A 3.0X15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION, HOWEVER THE BALLOON FAILED TO INFLATE, AND THE STENT DID NOT DEPLOY. THE SDS WAS REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SAME SIZE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621743 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED AFTER EXPERIENCING AN ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). TWO XIENCE SKYPOINT STENTS (3.0X15MM , 3.0X28MM) WERE IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022 THE PATIENT WAS READMITTED WITH CHEST PAIN. NO TREATMENT WAS REPORTED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. THERE WAS NO REPORTED ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 15033268 ↗
• MalfunctionMay 7, 2022Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, REPEAT ANGIOGRAPHY REVEALED HEAVY BURDEN OF THROMBUS. ASPIRATION CATHETER WAS INTRODUCED AND MANUAL ASPIRATION THROMBECTOMY PERFORMED. REPEAT ANGIOGRAPHY REVEAL SIGNIFICANT IMPROVEMENT IN THROMBUS BURDEN. A 2.5X23MM XIENCE STENT WAS POSITIONED AND DEPLOYED WITHOUT DIFFICULTY. ANGIOGRAPHY REVEALED REMAINING WAIST AS WELL AS REMAINING STENOSIS IN THE MORE PROXIMAL VESSEL. DURING AN ATTEMPT TO PLACE A 3.00X15MM XIENCE SKYPOINT IN A SLIGHT OVERLAPPING FASHION WITH THE PREVIOUSLY PLACED STENT, RESISTANCE WITH THE ANATOMY WAS FELT DURING ADVANCEMENT. ONCE POSITIONED ADEQUATELY AT THE TARGET LESION, AN ATTEMPT TO DEPLOY THE STENT WAS UNSUCCESSFUL AS PRESSURE WOULD NOT HOLD WHEN ATTEMPTING TO INFLATE THE BALLOON. IT WAS SUSPECTED THAT THE STENT DELIVERY BALLOON WAS RUPTURED; THEREFORE, THE ENTIRE SYSTEM WAS REMOVED WITHOUT DEPLOYING THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH DEPLOYMENT OF A 3.0X18MM XIENCE STENT. 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 14318100 ↗
• MalfunctionMar 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 DISTAL RIGHT CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. A XIENCE SKYPOINT WAS ADVANCED BUT RESISTANCE WAS MET AND THE DEVICE DID NOT REACH THE LESION. DURING REMOVAL, RESISTANCE WAS MET, BUT THE DEVICE WAS REMOVED WITHOUT FURTHER ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER STENT SYSTEM FAILED TO CROSS, SO BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865625 ↗
• MalfunctionFeb 22, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 85% STENOSED. THE 3.0X15MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY. IT WAS NOTED RESISTANCE DURING REMOVAL WITH ANATOMY WAS FELT. A NON-ABBOTT DEVICE 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 13581603 ↗
• MalfunctionJan 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE XIENCE SKYPOINT STENT DELIVERY SYSTEM BOX WAS LABELED 3.0X15MM (PART#1804300-15, LOT#1060941) BUT WHEN THE BOX WAS OPENED, THE POUCH WAS LABELED 3.0X28MM (ON THE POUCH: PART# 1804300-28, LOT#1032241); THEREFORE, THE DEVICE WAS NOT USED. THERE WAS NO EVIDENCE OF TAMPERING WITH THE BOX AND THE POUCH WAS SEALED. A NEW 3.0X15MM SKYPOINT WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389575 ↗
• MalfunctionJan 24, 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 75% STENOSED DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX(DLCX) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED WITH A 2.5X15 MM NON-ABBOTT BALLOON CATHETER AND A 2.75 X 16MM NON-ABBOTT STENT WAS IMPLANTED DISTAL TO THE TARGET LESION. THEN A 3.00 X 15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCING TO THE TARGET LESION. AN ATTEMPT WAS MADE TO PLACE THE STENT PROXIMAL TO THE TARGET LESION TO OVERLAP THE PREVIOUSLY IMPLANTED STENT. HOWEVER, THE SDS BECAME STUCK WITH THE PREVIOUSLY IMPLANTED STENT. DESPITE SEVERAL ATTEMPTS TO ADVANCE AND RETRACT THE SDS, THE STENT COULD NOT CROSS THE TARGET LESION. THE SDS WAS REMOVED FROM THE PATIENT AND ADDITIONAL DILATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AT THE PROXIMAL PART OF THE PREVIOUSLY IMPLANTED STENT. A DECISION WAS MADE NOT TO RE-INSERT THE XIENCE SKY POINT STENT DUE TO THE DISTAL END OF THE STENT WAS OBSERVED TO BE FLARED. THEREFORE, A 3.0 X 18MM XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. 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 13337910 ↗
• InjuryJan 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LIPIDIC LESION PER OPTICAL COHERENCE TOMOGRAPHY (OCT) WITH NO CALCIFICATION OR TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THE STENT WAS DEPLOYED AT THE INTENDED SITE. UPON INFLATION AT NOMINAL PRESSURE, A SPURT OF CONTRAST CAME OUT OF THE BALLOON CAUSING A PERICARDIAL PERFORATION AND CARDIAC TAMPONADE. THE BALLOON AND THE DELIVERY SYSTEM WERE IMMEDIATELY REMOVED AND BALLOON TAMPONADE WAS PERFORMED TO TREAT THE PERFORATION. THERE WAS A DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 13307514 ↗