XIENCE Skypoint™ 1804225-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648233043), received between Jan 12, 2021 and Jan 21, 2026 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 2.25X38 MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2025 THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT WITH CHEST PAIN THAT HAD WORSENED OVER THE PAST 4 DAYS. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE PATIENT WAS FOUND TO HAVE ELEVATED TROPONIN LEVELS AND AN ANTERIOR STEMI (ST ELEVATION MYOCARDIAL INFARCTION) WITH IN-STENT THROMBOSIS OF THE LAD. CARDIAC CATHETERIZATION SHOWED 99% STENOSIS IN THE PROXIMAL TO MID LAD WITH MODERATE CALCIUM AND THROMBUS. THE PATIENT WAS TREATED WITH SHOCKWAVE IVL (INTRAVASCULAR LITHOTRIPSY) AND A DRUG COATED BALLOON. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING. THE PATIENT'S PRIOR PRESCRIPTION FOR PLAVIX WAS REPLACED WITH BRILINTA. THE PATIENT ALSO HAD WORSENING CONGESTIVE HEART FAILURE. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION WITH OXYGEN AND HOME HEALTH CARE (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Heart Failure/Congestive Heart Failure; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 24129725 ↗
• InjuryJan 26, 2024Adverse 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 CHRONIC ISCHEMIC HEART DISEASE AND NON-ST ELEVATION MYOCARDIAL INFARCTION, HAD TWO XIENCE SKYPOINT (2.25X38MM, 3.0X38MM) STENTS IMPLANTED. ON (B)(6) 2023, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE AND POST PROCEDURAL CARDIAC DISTURBANCES. ON (B)(6) 2023, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE AND HYPERTENSIVE HEART. THROMBECTOMY WAS PERFORMED AND RESPIRATORY VENTILATION FOR 24-96 CONSECUTIVE HOURS. DISCHARGED ON (B)(6) 2023 TO HOME WITH HOME HEALTH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 18585445 ↗
• MalfunctionMar 9, 2023Difficult 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 90% STENOSED LESION IN THE DISTAL CIRCUMFLEX (DCX) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO THE ANATOMY. THE DISTAL TIP OF THE SDS WAS NOTED TO BE FLARED; THEREFORE, THE SDS WAS REMOVED FROM PATIENT AND DIFFICULTY WAS NOTED DURING REMOVAL ALSO DUE TO THE ANATOMY. 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 16514256 ↗
• InjuryDec 1, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION THROUGH THE GRAFT OF LEFT INTERIOR MAMMARY ARTERY TO LEFT ANTERIOR DESCENDING (LIMA TO LAD) ARTERY WITH SEVERE TORTUOSITY, CALCIFICATION AND STENOSIS. THE 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED THREE TIMES TO ADVANCE TO THE TARGET LESION; HOWEVER, FAILED TO CROSS AND AFTER THE THIRD ATTEMPT, THE STENT DISLODGED FROM THE BALLOON NEAR THE SHEATH. THE STENT WAS RETRIEVED USING A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETING WITHOUT STENTING. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896567 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF UNSTABLE ANGINA. ON (B)(6) 2022, THE 2.25X38MM XIENCE SKYPOINT STENT WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED DUE TO CHEST PAIN. NO TREATMENT WAS PERFORMED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 15413031 ↗
• MalfunctionJun 24, 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, 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. A 2.25X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND COULD NOT REACH THE LESION TO BE TREATED. THE DES WAS REMOVED, ALSO WITH RESISTANCE FROM THE ANATOMY, AND A A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY 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 14802668 ↗
• InjuryMay 5, 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 RIGHT CORONARY ARTERY (RCA) WITH NO CALCIFICATION AND NO TORTUOSITY. ON (B)(6) 2021, TWO STENTS WERE IMPLANTED, A 2.75X38MM AND A 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS). ONE STENT WAS IMPLANTED ON THE RIGHT DISTAL RCA AND ANOTHER STENT ON THE MID TO PROXIMAL RCA. ON (B)(6) 2022, THE PATIENT RETURNED TO THE HOSPITAL AND IT WAS OBSERVED THAT BOTH IMPLANTED STENTS HAD BECOME COMPLETELY OCCLUDED AND THROMBOSIS WAS CONFIRMED. TWO ADDITIONAL STENTS WERE USED TO TREAT THE OCCLUSION. ANGIOGRAPHY WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14288933 ↗
• InjuryApr 12, 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 LEFT ANTERIOR DESCENDING ARTERY. THE UNKNOWN XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE INITIAL PROCEDURE. HOWEVER, NINE HOURS LATER ST ELEVATIONS INCREASED AND EKG CHANGES WERE NOTED. THE PATIENT SUFFERED A MYOCARDIAL INFRACTION AND ACUTE STENT-THROMBOSIS WAS CONFIRMED BY ANGIOGRAPHY. A SECOND DOSE OF 180MG OF BERLINETTA WAS GIVEN. THE PATIENT REMAINED HOSPITALIZED FOR ANOTHER NIGHT BUT NOTED TO BE STABLE. NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 14088144 ↗
• MalfunctionFeb 21, 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 (RCA) THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 80% STENOSED. A XIENCE SKYPOINT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. RESISTANCE WAS MET DURING REMOVAL DUE TO INTERACTION WITH THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573418 ↗
• InjuryJan 13, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Malposition of Device; Material Deformation; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Malposition of Device; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X38MM XIENCE SKYPOINT DRUG ELUTING STENT SYSTEM (DESS) WAS ADVANCED TO THE TARGET LESION AND DEPLOYMENT WAS INITIATED. THE BALLOON WAS INFLATED TWICE AT 12 ATMOSPHERES (ATM) AND HELD FOR 20 SECONDS; HOWEVER, THE STENT BECAME DOG BONE SHAPED AND DID NOT RELEASE FROM THE BALLOON. DURING REMOVAL OF THE DES FROM THE ANATOMY, THE DES BLOCKED THE LEFT MAIN TRUNK (LMT) RESULTING IN UNSTABLE BLOOD PRESSURE FOR THE PATIENT CAUSING CARDIAC ARREST. THE STENT WAS IMPLANTED IN THE LMT, USING FORCE. CARDIOPULMONARY RESUSCITATION WAS INITIATED AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Foreign Body In Patient; Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 13255548 ↗
• MalfunctionDec 22, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED AND THE 2.25X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. A GUIDE CATHETER EXTENSION WAS ALSO ATTEMPTED BUT STILL THE SDS COULD NOT CROSS. THERE WAS ALSO RESISTANCE WITH THE ANATOMY DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH BALLOON DILATATION ONLY. 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 13059912 ↗
• MalfunctionDec 10, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). THE 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS. RESISTANCE WAS MET WITH THE ANATOMY DURING REMOVAL. THE DEVICE WAS REMOVED INDEPENDENTLY. THERE WERE NO OTHER ISSUES SUCH AS SHAFT SEPARATION OR STENT DISLODGEMENT. 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 12980578 ↗
• MalfunctionDec 7, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED RIGHT POSTERIOR ATRIO-VENTRICULAR LESION THAT WAS 99% STENOSED. A 2.25X38MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY AND RESISTANCE DURING REMOVAL WAS ALSO MET WITH ANATOMY. 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 12955300 ↗
• MalfunctionNov 12, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.25X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE SDS WAS REMOVED WITH RESISTANCE NOTED WITH THE LESION. 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 12807321 ↗
• MalfunctionOct 28, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED DISTAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. A 2.25X38MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WAS ALSO MET WITH ANATOMY. A 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 12712256 ↗
• MalfunctionJul 19, 2021Difficult 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 ATRIOVENTRICULAR NODE ARTERY THAT IS 99% STENOSED. A 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) ATTEMPTED TO BE ADVANCED, HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. RESISTANCE WITH ANATOMY WAS ALSO NOTED DURING THE REMOVAL OF THE SDS. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY 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 12193208 ↗
• MalfunctionJul 13, 2021Difficult 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 CALCIFIED, 90% STENOSED LESION IN THE HEAVILY TORTUOUS RIGHT CORONARY ARTERY (RCA). A 2.25X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND WAS CAUGHT IN THE CALCIFIED LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY, AND THE STENT WAS NOTED AS FLARED. ADDITIONAL BALLOON DILATATION WAS PERFORMED, AND A NEW 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 12160969 ↗
• MalfunctionJul 1, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 99% STENOSED LESION IN THE HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE MET AND COULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED WITH RESISTANCE MET, AND A NON-ABBOTT DEVICE 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 12105041 ↗
• MalfunctionMar 9, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS POSTERIOR LATERAL WITH 99% STENOSIS. THE 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND GOT CAUGHT IN THE CALCIFIED LESION. THE SDS WAS PULLED OUT. AFTER REMOVAL, THE STENT WAS NOTED TO BE FLARED. A NEW 2.25X38MM XIENCE SKYPOINT 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: Insufficient Information

  MAUDE report 11448672 ↗
• MalfunctionJan 12, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.25X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) SYSTEM COULD NOT CROSS THE LESION DUE TO THE ANATOMY. DURING REMOVAL, THE DEVICE WAS DIFFICULT TO REMOVE AND TOOK SEVERAL ATTEMPTS BEFORE IT WAS FINALLY REMOVED IN ONE PIECE FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11155889 ↗