XIENCE Skypoint™ 1804400-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08717648233494), received between Oct 26, 2021 and Jun 17, 2025 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. AFTER ROTABLATION AND PRE-DILATATION, THE 4X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM(SDS) WAS ADVANCED THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. AT THE TARGET LESION THE SDS BALLOON WAS INFLATED TO 6 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED. THEREFORE, THE SDS WITH THE STENT WERE REMOVED FROM THE PATIENT. ADDITIONAL BALLOON DILATATION, STENT IMPLANTATION AND POST-DILATATION WERE PERFORMED 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 22235283 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI), HAD ONE XIENCE SKYPOINT (4.0X23 MM) STENT IMPLANTED. ON (B)(6) 2025, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE (A PRE-EXISTING CONDITION) AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI). PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 21921311 ↗
• MalfunctionFeb 4, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER. THE 4.0X23MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE SDS WAS REMOVED WITH THE STENT STILL ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER SKYPOINT 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 21304160 ↗
• InjurySep 25, 2024Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE TIBIAL PERONEAL TRUNK. THE 4X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE TARGET LESION, WHEN THE STENT WAS NOTED TO HAVE PARTIALLY MOVED FROM THE MARKERS. THEREFORE, THE SDS WAS ATTEMPTED TO BE REMOVED WHEN THE STENT BECAME COMPLETELY DISLODGED FROM THE DELIVERY SYSTEM AND EMBOLIZED IN THE DISTAL VESSEL. A SNARE WAS USED TO ATTEMPT TO REMOVE THE STENT, BUT WAS UNSUCCESSFUL. A BALLOON WAS THEN ADVANCED AND USED TO EMBED THE STENT IN THE DISTAL VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA. NO PROCEDURE WAS THEN ABORTED AND NO STENT WAS IMPLANTED AT THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus

  MAUDE report 20303914 ↗
• InjuryAug 21, 2024Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY INTO THE DIAGONAL. THE .014 WHISPER GUIDE WIRE WAS PLACED FOLLOWED BY THE DEPLOYMENT OF THE 4.0X23MM XIENCE SKYPOINT STENT. WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE IT WAS NOTED TO BE JAILED BY THE STENT. WHEN SNARING OUT THE GUIDE WIRE THE STENT WAS CAME ALONG WITH IT. THEREFORE, A NEW UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020233 ↗
• InjuryMar 14, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A 50% STENOSED DE NOVO LESION IN THE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH HEAVY CALCIFICATION. THE 4MM XIENCE STENT WAS IMPLANTED. THE 4X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND THE STENT WAS NOTED TO BE INDENTED. A NON-ABBOTT BALLOON WAS USED FOR FURTHER POST-DILATION OF THE STENT INDENTATION. 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 18904306 ↗
• InjuryMar 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A LESION IN PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH HEAVY CALCIFICATION. THE 4X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCE TO THE TARGET LESION AND THE STENT WAS IMPLANTED. THE STENT WAS NOTED TO BE NARROWER IN THE CENTER. THEREFORE, A BALLOON WAS USED FOR POST DILATATION. AFTER BALLOON DILATATION A PERFORATION WAS NOTED. THEREFORE, A NC TREK BALLOON WAS USED TO ATTEMPTED TO TREAT THE PERFORATION; HOWEVER, WAS NOT SUCCESSFUL. THE PERFORATION WAS TREATED WITH IMPLANTATION OF A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 18859533 ↗
• MalfunctionNov 10, 2023Difficult 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 LESION IN THE MID RIGHT CORONARY ARTERY WITH 90% STENOSIS. THE 4.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO ANATOMY EVEN WITH THE AID OF AN UNSPECIFIED EXTENSION CATHETER. THERE WAS ALSO RESISTANCE FELT WITH THE ANATOMY DURING REMOVAL OF THE SDS. AN UNSPECIFIED DRUG COATED BALLOON 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 18113210 ↗
• MalfunctionOct 10, 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 4.0X23MM 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 BUT WAS REMOVED INDEPENDENTLY. 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 17908897 ↗
• MalfunctionAug 16, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 4.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TWICE AT 14 ATMOSPHERES TO DEPLOY THE STENT. DURING DEFLATION, THE BALLOON TOOK LONGER THAN USUAL DEFLATE; HOWEVER, WAS IT WAS ABLE TO BE COMPLETELY DEFLATED. THE SDS WAS REMOVED FROM THE PATIENT AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE STENT WAS IMPLANTED WITHOUT ISSUE. 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 17558020 ↗
• InjuryJul 28, 2023Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE OSTIAL RIGHT CORONARY ARTERY (RCA). POST- DEPLOYMENT OF THE 4.0X23MM XIENCE SKYPOINT STENT, THERE WAS SLIGHT RESISTANCE REMOVING THE STENT DELIVERY SYSTEM. THE STENT WAS PULLED HALF WAY INTO THE AORTA AND ONLY A PORTION WAS STILL IN THE PROXIMAL RCA. THIS WAS ONLY OBSERVED ON POST IMAGING AND WAS NOT REALIZED DURING REMOVAL OF THE DELIVERY SYSTEM. THE PATIENT'S HEART RATE WAS ELEVATED AND A BALLOON PUMP WAS PUT IN AND MEDICATIONS WERE ADMINISTERED [DOPAMINE] AS TREATMENT. THE PATIENT WAS EMERGENTLY TRANSFERRED TO THE CATH LAB ACROSS THE STREET. [ST. JOSEPH ATLANTA]. ADDITIONAL FOLLOW-UP INDICATED TREATMENT INCLUDED EMBEDDING THE STENT WITH A FLARE BALLOON AND IMPLANTING AN ADDITIONAL STENT WITH GREAT RESULTS. THE PATIENT DID WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Device Embedded In Tissue or Plaque; Low Blood Pressure/ Hypotension

  MAUDE report 17419965 ↗
• MalfunctionJul 17, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 4.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION DUE TO RESISTANCE. THERE WAS ALSO RESISTANCE WITH THE LESION DURING REMOVAL OF THE SDS. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NOT 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 17337587 ↗
• MalfunctionMay 17, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE DURING DEPLOYMENT OF THE 4.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) IT WAS NOTED THE BALLOON MATERIAL INFLATED MORE THAN USUAL BEYOND THE STENT MARKER. THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948113 ↗
• MalfunctionOct 20, 2022Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT THE LEFT MAIN ARTERY. THE 4.0X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPARED WITHOUT ISSUES AND INSERTED INTO THE ANATOMY AND ADVANCED WITHOUT RESISTANCE. ONCE THE TARGET VESSEL WAS REACHED, THE BALLOON WAS INFLATED. HOWEVER, WHEN 2 ATMOSPHERES (ATM) WAS REACHED, IT WAS OBSERVED THE BALLOON STOPPED INFLATING. THEREFORE, NEGATIVE PRESSURE WAS PULLED AND BLOOD WAS OBSERVED TO BE ENTERING THE BALLOON. THEREFORE, THE SDS WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE DEVICE. 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 15640635 ↗
• InjuryOct 3, 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 WAS HOSPITALIZED WITH A HISTORY OF CHRONIC ISCHEMIC HEART DISEASE AND A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). A 4.0X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. NO TREATMENT WAS PROVIDED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 15534111 ↗
• MalfunctionJun 27, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED AND TORTUOUS 100% STENOSED RIGHT CORONARY ARTERY (RCA). THE 4.0 X 23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED AND THE SDS WAS UNABLE TO CROSS. RESISTANCE WAS NOTED DURING REMOVAL, RELATED TO THE VESSEL AND LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837270 ↗
• MalfunctionMay 9, 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. THE 4.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. IT WAS NOTED THAT RESISTANCE WAS FELT WITH ANATOMY DURING REMOVAL. A 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14338655 ↗
• InjuryApr 7, 2022Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated; Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH A 3.00 X 15MM TREK BALLOON. THEN A 4.00 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. THE SDS WAS BEING REMOVED FROM THE PATIENT WHEN THE STENT BECAME STUCK IN THE CALCIUM AND DISLODGED FROM THE DELIVERY SYSTEM; THEREFORE, THE STENT WAS SNARED TO THE WRIST, BUT THE STENT WAS UNABLE TO BE RETRIEVED AND WAS LEFT STUCK IN THE WRIST. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ADDITIONAL PRE-DILATATION WAS PERFORMED WITH A CUTTING BALLOON AND THEN A NEW 4.00 X 23 XIENCE SKYPOINT STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION TO TREAT THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14047934 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A SAPHENOUS VEIN GRAFT IN THE CIRCUMFLEX ARTERY. A XIENCE SKYPOINT 4.0X23MM WAS INSERTED AND DEPLOYED AT THE INDENTED LOCATION. HOWEVER, AFTER DEPLOYMENT, A DISSECTION WAS OBSERVED AT THE PROXIMAL END OF THE STENT. FOR TREATMENT, AN ADDITIONAL STENT WAS IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 13803514 ↗
• MalfunctionJan 12, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PRE-DILATATION, THE 4.0X23MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS ALSO MET. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 13235834 ↗
• MalfunctionDec 16, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, HEAVILY CALCIFIED AND TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY. THE 4.0 X 23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION BUT COULD NOT CROSS THE LESION AND DURING REMOVAL OF THE SDS THERE WAS RESISTANCE WITH THE LESION. A NEW NON-ABBOTT SDS 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 13019828 ↗
• MalfunctionDec 13, 2021Difficult 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 LEFT ANTERIOR DESCENDING ARTERY THAT IS 99% STENOSED. THE 4.0X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS NOTED DURING REMOVAL WITH ANATOMY. A NON-ABBOTT STENT 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 12987119 ↗
• MalfunctionDec 10, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 4.0X23MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. THE SDS WAS REMOVED WITH RESISTANCE NOTED WITH THE ANATOMY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. 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 12976514 ↗
• MalfunctionNov 15, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE 4.00X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY WHEN REMOVING THE SDS. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. 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 12817013 ↗
• MalfunctionOct 26, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). DILATATION OF THE LESION WAS PERFORMED AND THE 4.00X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE NOTED WITH THE ANATOMY DURING REMOVAL OF THE SDS. A DRUG COATED BALLOON 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 12699347 ↗