Absolute Pro 1012536-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648176166), received between Feb 11, 2019 and Feb 4, 2026 — classified as 10 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 4, 2026Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LEFT EXTERNAL ILIAC ARTERY TO COMMON FEMORAL ARTERY (CFA) OCCLUSION. A 6.0X80MM SUPERA STENT WAS IMPLANTED IN THE CFA. AN 8.0X80MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED OVER A COMMAND 18 GUIDE WIRE TO BE PLACED BETWEEN THE SUPERA AND THE ILIAC LEG OF THE ABDOMINAL AORTIC STENT (EXTERNAL ILIAC ARTERY SEGMENT). AFTER THE SES WAS DELIVERED TO THE TARGET LESION THROUGH THE ABDOMINAL STENT, THE PHYSICIAN OPENED THE LOCK AND BEGAN ROLLING THE RELEASE ROLLER. AFTER ROLLING CONTINUOUSLY FOR 8-9 CIRCLES, NO STENT DEPLOYMENT WAS DETECTED UNDER IMAGING, AND THE THUMBWHEEL STOPPED ROLLING; THEREFORE, THE SES WAS REMOVED FROM THE ANATOMY. AFTER WITHDRAWAL, THE SES RE-ENTERED THE SHEATH ALONG WITH THE COMMAND18; HOWEVER, RESISTANCE WAS NOTED. UPON CAREFUL EXAMINATION OF THE IMAGE, IT WAS DISCOVERED THAT THE ABSOLUTE STENT WAS FULLY DEPLOYED WITHIN THE PREVIOUSLY DEPLOYED NON-ABBOTT ABDOMINAL MAIN STENT. THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WAS PUNCTURED AND A COMMAND 18 GUIDE WIRE WAS PASSED THROUGH THE STENT AND AN ATTEMPT WAS MADE TO USE A 8X60MM ARMADA 35 BALLOON DILATATION CATHETER FOR DILATATION. AFTER FIXING THE STENT,

  Patient problems: Foreign Body In Patient

  MAUDE report 24258591 ↗
• MalfunctionJan 19, 2026Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). THE 8.0X80MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION OVER A .014 NON-ABBOTT GUIDE WIRE; HOWEVER, WHEN THE STENT WAS DEPLOYED HALFWAY THE THUMBWHEEL GOT STUCK AND COULD NOT BE MOVED. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-ABBOTT 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 24108859 ↗
• MalfunctionAug 14, 2025Off-Label Use; Material Separation; Mechanical Jam; Activation Failure; Off-Label Use; Material Separation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CHRONIC PATIENT EAR RINGING WITH STENT PLACEMENT IN THE SIGMOID SINUS VEIN WITH HEAVY TORTUOSITY. THE 9X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE INTENDED LOCATION WITH RESISTANCE DUE TO THE SIGNIFICANT TORTUOSITY. THE STENT WAS ATTEMPTED TO BE RELEASED; HOWEVER, THE STENT WAS ONLY PARTIALLY DEPLOYED WHEN THE THUMBWHEEL BECAME STUCK. THEREFORE, THE SESS WAS REMOVED AND DURING REMOVAL RESISTANCE WAS ALSO NOTED AND THE PARTIALLY DEPLOYED STENT BECAME INTERTWINED WITH THE GUIDE WIRE (GW) AND INTRODUCER SHEATH. THE SESS WAS ABLE TO BE REMOVED TOGETHER WITH THE GW AND INTRODUCER SHEATH. AFTER REMOVAL, THE STENT WAS NOTED TO HAVE BECAME STRETCHED AND THE DELIVERY SHEATH HAD A SEPARATION. TO CONTINUE THE PROCEDURE, A 8X80MM ABSOLUTE PRO SESS WAS ADVANCED TO THE INTENDED LOCATION WITHOUT ISSUE; HOWEVER, WHEN THE HANDLE OF THE SESS WAS UNLOCKED THE THUMBWHEEL BECAME STUCK AFTER ON 3MM OF THE SENT BECAME EXPOSED. THE SECOND SESS WAS REMOVED FROM THE PATIENT AND THE STENT SHEATH WAS NOTED TO BE SEPARATED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808664 ↗
• InjuryJul 9, 2025Difficult to Remove; Failure to Advance; Activation Failure; Difficult to Remove; Failure to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE INTERNAL ILIAC ARTERY. A 8X80MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION WHEN THE DEVICE FELT "RESTRICTED" [RESISTANCE]; THEREFORE, THE SES COULD NOT BE IMPLANTED. THE DEVICE WAS DIFFICULT TO REMOVE SO THE DECISION WAS MADE TO DISASSEMBLE THE HANDLE AND EVERYTHING WAS REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460160 ↗
• InjuryFeb 18, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE COMMON ILIAC ARTERY. AFTER A 8X80MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS PREPARED WITH NO NOTED ISSUES, THE DEVICE WAS ADVANCED TO THE LESION AND ATTEMPTED TO BE DEPLOYED; HOWEVER, DURING DEPLOYMENT THE THUMBWHEEL WAS NOTED TO JAM AND THE STENT COULD ONLY BE PARTIALLY DEPLOYED. THE PHYSICIAN DECIDED TO TAKE APART THE HANDLE OF THE SES AND MANUALLY DEPLOY THE STENT FROM THE DELIVERY CATHETER. THE STENT WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392286 ↗
• InjuryDec 19, 2024Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking; Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY WITH MILD TORTUOSITY. THE 8.0X80MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING DEPLOYED WHEN THE WHEEL LOCKED. THE HANDLE WAS OPENED AND MANUALLY DEPLOYED THE STENT; HOWEVER, THE STENT WAS NOTED TO BE ELONGATED ABOUT 20MM. 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 20978953 ↗
• InjuryJul 31, 2024Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE 8.0X80MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER WHEN ATTEMPTING DEPLOYMENT, THE THUMBWHEEL WOULD NOT TURN. THE SES WAS RETRACTED HOWEVER THE STENT DEPLOYED ACROSS THE RIGHT COMMON TO LEFT COMMON ILIAC ARTERY. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19872131 ↗
• InjuryOct 26, 2023Break; Malposition of Device; Break; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION RIGHT SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 5.0X100MM BALLOON CATHETER. AN UNSPECIFIED ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING DEPLOYED; HOWEVER, THE STENT JUMPED FORWARD 2CM PROXIMAL TO TREATMENT AREA. THE STENT WAS RETRACTED DISTALLY, BUT THE STENT FRACTURED AND THERE WAS RESIDUAL STENOSIS AFTER AN 8MM BALLOON ANGIOPLASTY. AN UNSPECIFIED 8X39MM BALLOON-EXPANDABLE STENT WAS PLACED OVER THE FRACTURED STENT AND NO RESIDUAL STENOSIS WAS DEMONSTRATE AFTER PLACEMENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18013229 ↗
• InjuryMay 1, 2023Entrapment of Device; Off-Label Use; Difficult to Advance; Mechanical Jam; Activation Failure; Entrapment of Device; Off-Label Use; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TRANSVERSE SINUS WITH MODERATE TORTUOSITY. A NON-ABBOTT 6F GUIDE WIRE WAS USED FIRST BUT FAILED. ANOTHER NON-ABBOTT DEVICE WAS ADVANCED THROUGH THE GUIDE SHEATH. THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE ANGLES AROUND THE LESION CAUSED SOME RESISTANCE AND PRESSURE ON THE DELIVERY SYSTEM. THE SHEATH WAS PULLED BACK TO EXPOSE THE STENT; HOWEVER, THE STENT WAS PARTIALLY DEPLOYED (APPROXIMATELY 20 MM) AND THE THUMBWHEEL WOULDN'T MOVE. AT THIS POINT, THE STENT FAILED TO DEPLOY AND THE SESS COULD NOT BE REMOVED. THE HANDLE WAS REMOVED AND SURGICAL CUT DOWN WAS PERFORMED TO RETRIEVE DEVICE FROM THE ANATOMY. THERE WAS A ONE HOUR DELAY IN THE PROCEDURE DUE TO THE NEED FOR SURGERY AND THE PATIENT WAS HOSPITALIZED ONE ADDITIONAL DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845150 ↗
• InjuryJul 12, 2022Off-Label Use; Stretched; Device Damaged by Another Device; Off-Label Use; Stretched; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT HAS A PREVIOUS BYPASS OF THE SFA AND THE OSTIUM DID NOT LOOK GOOD. THE 8X80 MM ABSOLUTE PRO SELF EXPANDING STENT (SES) WAS DEPLOYED PROXIMALLY IN THE SFA AND AN 8X18 MM ABSOLUTE PRO STENT WAS DEPLOYED VERY DISTAL TO THE FIRST ABSOLUTE PRO STENT. THERE WAS NO ISSUE DURING DEPLOYMENT OF EITHER DEVICE; HOWEVER, IT WAS NOTED THAT THE FIRST ABSOLUTE PRO STENT LOOKED STRETCHED AT THE END WHERE THE MARKER IS LOCATED. THEREFORE, A THIRD ABSOLUTE PRO STENT WAS DEPLOYED TO OVERLAP THE FIRST STENT TO COVER THE DEFORMITY. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS SPECULATED A WIRE MAY HAVE INTERACTED WITH THE STENT AFTER DEPLOYMENT WHEN TREATING BELOW THE STENT, WHICH CAUSED THE STRETCHING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991659 ↗
• MalfunctionJun 9, 2022Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN EXTERNAL ILIAC ARTERY. THE 8.0X80MM ABSOLUTE SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, RESISTANCE WAS NOTED WITH THE THUMBWHEEL. THE SESS WAS REMOVED WITHOUT ISSUE AS THE SESS COULD NOT DEPLOY; HOWEVER, IT IS UNKNOWN IF THE DEVICE PARTIALLY OR COMPLETELY FAILED TO DEPLOY. ANOTHER SAME SIZE ABSOLUTE 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 14647090 ↗
• InjuryMar 9, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A RIGHT COMMON ILIAC ARTERY. AN ABSOLUTE PRO 8X80X135 SELF EXPANDING STENT (SES) WAS INSERTED AND DEPLOYED. HOWEVER, WHEN REMOVING THE BALLOON CATHETER, IT WAS NOTICED THE STENT HAD BECOME CAUGHT ON THE CATHETER. WHEN THE DELIVERY CATHETER WAS REMOVED FROM THE ANATOMY, IT WAS OBSERVED THE STENT HAD BECOME STRETCHED AND 1/2 OF IT HAD COME OUT OF THE ANATOMY WHILE REMOVING THE CATHETER. THEREFORE, THE PHYSICIAN MADE THE DECISION TO TRANSFER THE PATIENT TO SURGERY AND REMOVE THE DELIVERY CATHETER AND THE REMAINING PORTION OF THE STENT. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445999 ↗
• InjuryFeb 2, 2021Difficult or Delayed Positioning; Material Separation; Material Deformation; Mechanical Jam; Activation Failure; Difficult or Delayed Positioning; Material Separation; Material Deformation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD CALCIFICATION IN THE LEFT EXTERNAL ILIAC ARTERY. AN UNSPECIFIED SHEATH, .035 GUIDE WIRE AND BALLOON WERE USED FOR PRE-DILATATION. AN 8.0 X 80 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT WAS PARTIALLY DEPLOYED WHEN RESISTANCE TURNING THE THUMBWHEEL WAS NOTED. FLUOROSCOPY WAS DIFFICULT TO SEE. DUE TO THE SIGNIFICANT AMOUNT OF RESISTANCE, THE PHYSICIAN HELD PRESSURE ON THE THUMBWHEEL AND PULLED BACK THE DEVICE TO REMOVE THE SHEATH. HOWEVER, A SMALL PIECE OF THE STENT WAS NOTED TO BE STICKING OUT AND THE STENT IMPLANT SEPARATED AT THE ACCESS SITE. THIS CAUSED A CLINICALLY SIGNIFICANT DELAY AS A SURGEON WAS CALLED TO REPLACE THE SHEATH. THE PATIENT WAS TRANSFERRED TO SURGERY AND A SMALL CUTDOWN WAS PERFORMED AND THE SEPARATED PIECE OF THE STENT WAS REMOVED SUCCESSFULLY WITH NO COMPLICATIONS. THE PATIENT OUTCOME WAS GOOD AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269315 ↗
• MalfunctionOct 26, 2020Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Material Deformation; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Material Deformation; Physical Resistance/Sticking

  SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE LESION WAS NON-TORTUOUS. ALTHOUGH THERE WAS NO RESISTANCE NOTED, THE ABSOLUTE PRO HAD TO TRAVERSE THROUGH OLD PARTIALLY OCCLUDED STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737790 ↗
• MalfunctionMay 18, 2020Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE EXTERNAL ILIAC ARTERY. THE ABSOLUTE PRO STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND AROUND MID-DEPLOYMENT, THE THUMBWHEEL STOPPED WORKING; HOWEVER, WITH SOME TROUBLESHOOTING, THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067659 ↗
• MalfunctionDec 26, 2019Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED AND TORTUOUS ILIAC ARTERY. THE ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION VIA A 6 FRENCH CROSS OVER SHEATH. DEPLOYMENT WAS INITIATED. IT WAS NOTED THAT THE THUMBWHEEL WAS DIFFICULT TO TURN, SEEMING STICKY AND DEPLOYMENT WAS DIFFICULT; HOWEVER, THE STENT WAS DEPLOYED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520653 ↗
• MalfunctionDec 5, 2019Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE 8.0X80MM ABSOLUTE PRO STENT WAS DEPLOYED IN THE TARGET LESION WITH DIFFICULTY DUE TO RESISTANCE WITH THE THUMBWHEEL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418765 ↗
• MalfunctionNov 18, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, NON-TORTUOUS RIGHT COMMON ILIAC ARTERY. THE 8.0X80MM ABSOLUTE PRO STENT WAS DEPLOYED WITHOUT ISSUE AND WHEN THE 6F SHEATH WAS REMOVED IT WAS NOTED THAT THE STENT CAME WITH IT AS IT HAD BEEN DEPLOYED PARTIALLY IN THE SHEATH. A NEW SHEATH AND NEW 9.0X80MM ABSOLUTE PRO WERE 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 Consequences Or Impact To Patient

  MAUDE report 9335858 ↗
• MalfunctionSep 3, 2019Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RIGHT ILIAC ARTERY. THE 8.0 X 80 MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM WAS ADVANCED TO THE LESION AND WHILE ATTEMPTING TO DEPLOY THE STENT, THE THUMB WHEEL STOPPED ADVANCING FORWARD OR BACKWARD AFTER 1 CM. THE STENT REMAINED COMPLETELY SHEATHED BUT WAS DEPLOYED MANUALLY IN THE TARGET LESION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8956622 ↗
• MalfunctionFeb 11, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY THAT WAS STENOSED. WHEN THE ABSOLUTE PRO VASCULAR 8.0/80 MM SELF-EXPANDING STENT SYSTEM WAS PLACED IN THE CORRECT LOCATION AND THE CATHETER PULLED BACK, THE STENT PARTIALLY DEPLOYED (FLOWERED), EVEN BEFORE THE HANDLE WAS UNLOCKED; HOWEVER, IT WAS SAFELY REMOVED WITHOUT ISSUE. ANOTHER SAME SIZE ABSOLUTE PRO VASCULAR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8329857 ↗