Absolute Pro 1012535-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08717648176098), received between Mar 21, 2017 and Apr 8, 2026 — classified as 1 death, 13 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (16 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Stretched; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT EXTERNAL ILIAC ARTERY. THE 7X100 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC AND THE SHEATH WAS ADVANCED IN ORDER TO PLACE AN OMNILINK ELITE STENT IN THE COMMON ILIAC ARTERY. THE SHEATH SNAGGED ON THE ABSOLUTE PRO STENT AND CAUSED THE STENT TO BECOME STRETCHED. THE OMNILINK STENT WAS ABLE TO BE DEPLOYED WITHOUT ISSUE AND AN ADDITIONAL STENT WAS USED IN THE EXTERNAL ILIAC TO COVER PART OF THE STRETCHED ABSOLUTE PRO STENT. THE PATIENT HAD A GREAT RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820958 ↗
• MalfunctionDec 29, 2025Break; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Mechanical Jam; Activation Failure; Break; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Mechanical Jam; Activation Failure

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT AN ARMADA BALLOON WAS ADDITIONALLY USED IN THE SAME PROCEDURE WITHOUT ISSUE. AT THE TARGET LESION, WHEN ATTEMPTING TO DEPLOY THE 7X100MM ABSOLUTE PRO SELF-EXPANDING STENT, THE THUMBWHEEL SLIGHTLY MOVED RESULTING IN THE STENT BECOMING PARTIALLY DEPLOYED. AFTER, THE THUMBWHEEL WOULD NO LONGER ROTATE, AND WHEN THE STENT SYSTEM WAS BEING REMOVED, THE STENT BECAME FULLY DEPLOYED INTRODUCER SHEATH. THE STENT WAS NOTED TO BECOME BENT, STRETCHED STENT AND HAVE BROKEN STRUTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909129 ↗
• MalfunctionNov 26, 2025Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS 70% STENOSED. THE ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED, BUT WAS VERY DIFFICULT TO DEPLOY AS THE THUMBWHEEL WAS EXTREMELY DIFFICULT TO ROLL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. THERE AS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662666 ↗
• MalfunctionNov 11, 2025Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Difficult to Advance; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS ACCESSED VIA THE RIGHT COMMON FEMORAL ARTERY. DURING ADVANCEMENT OF THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) OVER A 0.018" GUIDEWIRE, RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION, RESISTANCE WAS MET WITH THE THUMBWHEEL; HOWEVER, THE ABSOLUTE PRO VASCULAR SES WAS ULTIMATELY DEPLOYED. IT WAS ALSO REPORTED THE JADE BALLOON BURST DUE TO CALCIUM. 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 23526308 ↗
• InjuryAug 5, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 60-80% STENOSED. THE 7.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS NOT PREPPED WITH THE STYLET IN. WHEN THE ABSOLUTE PRO SES WAS DEPLOYED AT THE LESION, THE STENT COULD NOT BE FULLY RELEASED. THE ABSOLUTE PRO WAS DISASSEMBLED IN AN ATTEMPT TO RELEASE THE STENT, HOWEVER, DURING REMOVAL OF THE ABSOLUTE PRO STENT DELIVERY SYSTEM, RESISTANCE WAS MET DUE TO ANATOMY AND THE DEPLOYED STENT WAS ALSO PULLED PACK AND FREE-FLOATING IN THE ILIAC ARTERY. AN UNSPECIFIED STENT WAS USED TO EMBED THE ABSOLUTE PRO STENT INTO THE ILIAC ARTERY AND A NEW ABSOLUTE PRO STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22718338 ↗
• InjuryMar 13, 2025Malposition of Device; Physical Resistance/Sticking; Malposition of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT EXTERNAL ILIAC ARTERY. DURING THE DEPLOYMENT OF A 7X100MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) THE THUMBWHEEL WAS NOTED TO LOCK RESULTING IN THE STENT BEING IMPLANTED OUTSIDE THE TARGET LESION AND IN HEALTHY TISSUE. THEREFORE, THE PATIENT WAS SUBJECT TO UNDERGO AN ADDITIONAL PROCEDURE ON (B)(6) 2025, IN WHICH A NON-ABBOTT STENT WAS DEPLOYED TO CRUSH THE ABSOLUTE PRO SES AGAINST THE VESSEL WALL AND TO TREAT THE BIFURCATED LESION. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21595076 ↗
• MalfunctionNov 19, 2024Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION. THE 7.0X100MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION; DURING DEPLOYMENT OF THE STENT, THE WHEEL ONLY MADE ONE CLICK AND WOULD NOT ADVANCE ANY FURTHER. WHEN THE SES WAS WITHDRAWN, THE STENT DISLODGED IN THE SHEATH. THE SHEATH WITH THE STENT INSIDE WAS REMOVED FROM THE PATIENT ANATOMY. THE PHYSICIAN DECIDED TO END THE PROCEDURE, THERE WERE NO STENTS IMPLANTED. 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 20722566 ↗
• InjuryOct 18, 2024Entrapment of Device; Difficult or Delayed Activation; Entrapment of Device; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CTO LESION IN THE ILIAC ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 7X100M ABS PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCE TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, WHEN PULLING THE SHEATH BACK TO PLACE THE STENT AND THEN DEPLOYING THE STENT, APPROXIMATELY 5MM OF THE STENT WAS NOTED TO HAVE BEEN DEPLOYED IN THE SHEATH. THEREFORE, CUT DOWN SURGERY WAS PERFORMED TO CUT OF THE PORTION OF THE STENT THAT HAD BEEN DEPLOYED IN THE SHEATH. 95% OF THE STENT WAS NOTED TO HAVE BEEN DEPLOYED IN THE TARGET LESION WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483639 ↗
• DeathOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A BIFURCATION OF THE AORTA. TWO NON-ABBOTT GORE COVERED STENTS WERE PLACED ON THE RIGHT AND LEFT ILIAC AT THE BIFURCATION. THE 100% OCCLUDED SEVERELY CALCIFIED EXTERNAL ILIAC WAS PRE-DILATED WITH A 4.0 ARMADA BALLOON. A 7.0X100M ABSOLUTE PRO SELF EXPANDING STENT WAS THEN DEPLOYED. A 7.0X120MM ARMADA 35 BALLOON DILATATION CATHETER WAS THEN USED FOR POST DILATATION. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES WHEN THE PATIENT STARTED FEELING PAIN. THE PATIENT WAS GIVEN PAIN MEDICATION; HOWEVER, THEN THE PATIENT CODED (CARDIAC ARREST). CPR WAS STARTED INCLUDING CHEST COMPRESSIONS. WHILE PERFORMING CPR, AN ANGIOGRAM WAS PERFORMED AND A PERFORATION WAS NOTED IN THE EXTERNAL ILIAC ARTERY THAT WAS BEING POST DILATED. CPR WAS PERFORMED FOR 15 MINUTES, BUT AFTER TEN MINUTES OF CPR THERE WAS NO PULSE. A BLOOD TRANSFUSION WAS ADMINISTERED AND BALLOON DILATATION WAS PERFORMED AT THE PERFORATION TO STOP THE BLEEDING WHILE THEY OBTAINED A COVERED STENT. A COVERED STENT WAS DEPLOYED TO TREAT THE PERFORATION, BUT ULTIMATELY, THE PATIENT WAS UNABLE TO BE RESUSCITATED AND EXPIRED. THE PHYSICIAN COMMENTED THAT HE SHOULD HAVE USED THE COVERED STENT INSTEAD OF T

  Patient problems: Cardiac Arrest; Pain; Perforation of Vessels

  MAUDE report 20465235 ↗
• MalfunctionOct 14, 2024Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POPLITEAL ARTERY. THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER THE THUMBWHEEL HAD A LOT OF RESISTANCE AND WAS DIFFICULT TO SLIDE. A BIT OF FORCE WAS USED AND THE ABSOLUTE PRO STENT WAS DEPLOYED. DURING THE SAME PROCEDURE THE PATIENT EXPERIENCED CLAUDICATION IN THE LEG IT WAS NOTED THAT A PREVIOUSLY IMPLANTED 6.0X150 SUPERA PERIPHERAL STENT WAS HEAVILY RESTENOSED IN THE DISTAL END OF THE LESION. A LITTLE BITE OF CLOT WAS TREATED WITH A NON-ABBOTT 6X50 STENT. THERE WAS NO ADVERSE PATIENT SEQUELA 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 20440775 ↗
• InjuryOct 8, 2024Material Separation; Mechanical Jam; Activation Failure; Material Separation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE DEPLOYMENT OF A 7X100MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) THE THUMBWHEEL WAS NOTED TO JAM CAUSING THE STENT TO ONLY BE PARTIALLY DEPLOYED. THE PHYSICIAN DECIDED TO REMOVE THE SES AND THE INTRODUCER SHEATH AS A SINGLE UNIT, HOWEVER 2MM OF THE STENT WERE NOTED TO SEPARATE IN THE ANATOMY. THE SEPARATED STENT WAS EMBEDDED TO THE VESSEL WALL USING BALLOON ANGIOPLASTY. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20395244 ↗
• MalfunctionAug 20, 2024Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION AND 80% STENOSIS. CORONARY ORBITAL ATHERECTOMY WAS PERFORMED, REDUCING THE VESSEL CALCIFICATION DRASTICALLY. PREDILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON OVER A NON-ABBOTT GUIDE WIRE. THE 7.0 X 100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM WAS ADVANCED OVER THE SAME GUIDE WIRE. RESISTANCE WITH THE TORTUOSITY OF THE STEEP ILIAC BIFURCATION WAS NOTED TO REACH THE TARGET SITE. THE THUMBWHEEL WAS ENGAGED WITH NO ISSUE; HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED. THEREFORE, THE STENT WAS RETRACTED BACK INTO THE SHEATH AND REMOVED FROM THE ANATOMY. AN UNSPECIFIED DEVICE 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 20007976 ↗
• MalfunctionMar 19, 2024Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD TORTUOSITY VIA A RADIAL APPROACH. THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) DID NOT CROSS THE LESION AND THE OUTER LAYER, COATING WAS NOTED TO HAVE BUNCHED UP. THE DEVICE WAS REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE JACKET WAS DISLOCATED DISTAL TO THE STRAIN RELIEF AND CRACKED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937270 ↗
• InjuryMar 19, 2024Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, INITIAL INFORMATION ALSO REPORTED THAT A .014 GUIDEWIRE WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18935105 ↗
• MalfunctionAug 3, 2023Off-Label Use; Defective Device; Off-Label Use; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX). PRE-DILATATIONS WERE PERFORMED USING DIFFERENT SIZED ARMADA 18 BALLOONS WITHOUT ISSUES. IT WAS NOTED THAT THE STENT OF THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) LOOKED LONGER THAN WHAT IT SHOULD BE AND IT LOOKED MORE LIKE A 120MM. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 80MM ABSOLUTE PRO STENT. 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 17450719 ↗
• MalfunctionJun 28, 2023Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY. THE 3.0X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS DUE TO ANATOMY. THE DEVICE WAS REMOVED AND LESION WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON. A 7.0X100MM ABSOLUTE PRO STENT WAS ADVANCED WITHOUT ISSUE AND DEPLOYED SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT IT WAS NOTED THE THUMBWHEEL WAS VERY DIFFICULT TO TURN AND NEED EXTRA FORCE TO DEPLOY THE STENT. 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 17221193 ↗
• InjuryJun 19, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. AN ENDARTERECTOMY WAS PERFORMED ON THE LEFT COMMON FEMORAL ARTERY AND AN 11FR SHEATH WAS PLACED. A 7X100MM ABSOLUTE PRO SELF-EXPANDING STENT (SESS) WAS ADVANCED TO THE LEFT EXTERNAL ILIAC ARTERY AND DEPLOYED. THEN, THE 8X39MM OMNILINK STENT DELIVERY SYSTEM (SDS) WAS BROUGHT UP TO THE LEFT COMMON ILIAC ARTERY, THE PHYSICIAN THEN DECIDED NOT TO DEPLOY THE OMNILINK STENT AND REMOVE UNDEPLOYED FROM THE PATIENT. HOWEVER, DURING REMOVAL THE OMNILINK STENT BECAME CAUGHT ON THE ABSOLUTE PRO STENT AND THE STENT OF THE OMNILINK CAME OFF THE BALLOON. THE DELIVERY SYSTEM OF THE OMNILINK WAS REMOVED FROM THE PATIENT; HOWEVER, THE DISLODGE STENT FLOATED THROUGH ABSOLUTE PRO STENT WHERE IT BECAME ENTANGLED WITHIN THE DISTAL PORTION OF THE ABSOLUTE PRO. THEREFORE, PHYSICIAN REMOVED BOTH STENTS FROM THE PATIENT VIA A SMALL INCISION IN THE ENDARTERECTOMY PATCH WITH A SNIP TOOL. THERE WAS NO ADVERSE PATIENT SEQUELA. A 8X100 ABSOLUTE PRO STENT IN THE LEFT EXTERNAL ILIAC TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154198 ↗
• InjuryNov 15, 2022Premature Activation; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Premature Activation; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SHARP ILIAC BIFURCATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH DISEASE IN THE OSTIUM OF THE ILIACS. LASER AND PRE-DILATATION WERE PERFORMED USING A 6.0MM BALLOON. THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE DELIVERED OVER A 300CM SPARTACORE WIRE (014) THROUGH A 6FRENCH (FR) SHEATH. WHILE DELIVERING THE STENT SYSTEM THROUGH THE BIFURCATION OF THE ILIACS, SOME RESISTANCE WAS FELT WITH THE ANATOMY, THEN NO RESISTANCE. SOMEHOW, THE SHEATH LOST ITS SUPPORT AND CAME BACK AND THE ABSOLUTE PRO ¿FLIPPED¿ ON ITSELF CAUSING THE SHAFT TO BE PROLAPSED [BENT] IN THE RIGHT ILIAC. THE PHYSICIAN ADVANCED THE STENT DELIVERY SYSTEM INTO THE AORTA THEN PULLED IT BACK SO THE TIP ENGAGED WITH THE LEFT ILIAC. THIS ALLOWED THE STENT SYSTEM TO ¿STRAIGHTEN¿ OUT. THE STENT DELIVERY SYSTEM WAS PULLED WITH GREAT RESISTANCE DUE TO THE BENT STENT DELIVERY SYSTEM AND ANATOMY BUT WAS EVENTUALLY ABLE TO PULL THE STENT DELIVERY SYSTEM OUT OF THE PATIENT. IT WAS THEN REALIZED THE STENT WAS INADVERTENTLY DEPLOYED IN THE PATIENT AT THE ILIAC/AORTA BIFURCATION. THE PHYSICIAN DECIDED TO EXTEND TREATMENT OF THE ILIACS BY PLAC

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15801339 ↗
• MalfunctionApr 25, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 80% STENOSED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 7X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND IMPLANTED AT THE TARGET LESION WITHOUT ISSUE. DURING REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE ANATOMY, RESISTANCE WAS MET BETWEEN THE ABSOLUTE PRO DELIVERY SYSTEM AND THE SHEATH, AND THE INNER CATHETER SEPARATED INTO 2 SEGMENTS IN THE ANATOMY, BUT REMAINED ON THE GUIDE WIRE AND WAS SUCCESSFULLY REMOVED WITH THE GUIDE WIRE 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 14195968 ↗
• MalfunctionMar 28, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE LEFT ILIAC ARTERY. THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) APPEARED TO HAVE A PARTIALLY DEPLOYED STENT ONCE IT GOT OUT OF THE SHEATH AND INTO THE ARTERY. THE SESS WAS REMOVED AND ANOTHER ABSOLUTE PRO VASCULAR SESS 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 13930389 ↗
• MalfunctionNov 3, 2021Premature Activation; Premature Activation

  IT WAS REPORTED AFTER UNPACKING A 7X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS), THE STENT WAS NOTED TO BE EXPOSED AND NOT FLOWERED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. 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 12748940 ↗
• MalfunctionApr 29, 2021Material Deformation; Mechanical Jam; Activation Failure; Material Deformation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS PERFORMED AND THE 6MM VESSEL WAS PRE-DILATED WITH A BALLOON DILATATION CATHETER. THE 7.0 X 100 MM ABSOLUTE PRO WAS ADVANCED TO THE TARGET LESION. DURING DEPLOYMENT, THE STENT DID NOT FULLY DEPLOY. THE STENT ONLY PARTIALLY DEPLOYED BECAUSE THE THUMBWHEEL STOPPED TURNING. WHEN RETRACTING THE DEVICE FOR REMOVAL, THE STENT STRETCHED AND GOT MANGLED. THE STENT WAS REMOVED WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS ABORTED. 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 11749239 ↗
• MalfunctionMar 25, 2021Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). A 7.0X100MM ABSOLUTE PRO WAS ADVANCED AND ATTEMPTED TO BE FULLY DEPLOYED: HOWEVER, THE DEVICE PARTIALLY DEPLOYED. IT WAS NOTED THAT THERE WAS DIFFICULTY IN TURNING THE THUMBWHEEL. THE DEVICE WAS REMOVED AND ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Insufficient Information

  MAUDE report 11569583 ↗
• MalfunctionFeb 26, 2021Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED ILIAC ARTERY. DURING DEPLOYMENT OF A 7.0X100MM ABSOLUTE PRO STENT, RESISTANCE WAS MET WHEN TURNING THE THUMBWHEEL AND THE STENT WAS PARTIALLY DEPLOYED. EXTRA FORCE HAD TO BE APPLIED TO SUCCESSFULLY DEPLOY THE STENT AT THE INTENDED SITE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389050 ↗
• MalfunctionNov 2, 2020Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS A REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. ACCESS TO THE VESSEL WAS OBTAINED VIA ANTEGRADE APPROACH, RIGHT SUPERFICIAL ARTERY USING 6F 45 CM SHEATH. THE HANDLE WAS UNLOCKED. THE PHYSICIAN WENT TO ROTATE THE THUMBWHEEL WITH GREAT RESISTANCE, AND THE STENT BEGAN TO UN-FLOWER SO HE KEPT ROTATING TO FULLY DEPLOY THE STENT. THE PHYSICIAN STATED THERE WAS LOTS OF RESISTANCE WITH THE THUMBWHEEL; HOWEVER, THE STENT WAS SUCCESSFULLY DEPLOYED IN THE CORRECT LOCATION. 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 10774990 ↗