Absolute Pro 1012534-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 08717648176012), received between Apr 7, 2017 and Jul 27, 2026 — classified as 30 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (17 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Mechanical Jam

  It was reported that the procedure was to treat a de novo, moderately calcified superficial femoral artery lesion with 99% stenosis. A 6x100 mm Absolute Pro self-expanding stent was advanced along a 0.014 inch guide wire. However, during deployment, the wheel became stuck and was unable to roll. During removal, the stent became elongated and was deployed partially in healthy tissue and partially in the lesion. A new non-Abbott stent was used to maintain the vessel and 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 50046150 ↗
• InjuryJul 6, 2026Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH MODERATE CALCIFICATION. THE 6X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED AND THE STENT FRACTURED. A SNARE WAS USED TO RETRIEVE MOST OF THE STENT AND A COVERED STENT WAS USED TO TRAP THE REST THAT COULD NOT BE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25724903 ↗
• InjuryApr 29, 2026Off-Label Use; Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 6.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT DELIVERY SYSTEM WAS ADVANCED. ONCE AT THE LESION, RESISTANCE WAS MET WITH THE THUMBWHEEL. THE STENT WAS DEPLOYED AT THE TARGET LESION; HOWEVER, THE STENT CAME OUT AS ONE LONG WIRE [STRETCHED/ELONGATED], SO AN UNSPECIFIED COVERED STENT WAS NEEDED TO PIN THE ABSOLUTE PRO STENT AGAINST THE LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033241 ↗
• MalfunctionApr 21, 2026Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE 6.0X100MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT THE THUMBWHEEL WAS DIFFICULT TO TURN AND THE STENT WAS DIFFICULT TO DEPLOY; HOWEVER ULTIMATELY DEPLOYED IN THE TARGET LESION. 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 24939703 ↗
• MalfunctionJan 8, 2026Improper 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 LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO TORTUOSITY. THE 6X100MM ABS PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED ON A 0.14 VIPER GUIDE WIRE (GW) THROUGH A 6F SHEATH TO THE TARGET LESION; HOWEVER, THE THUMBWHEEL WOULD NOT TURN AND AS A RESULT THE STENT COMPLETELY FAILED TO DEPLOY. THE SESS WAS REMOVED FROM THE PATIENT. ANOTHER SAME SIZE ABS PRO VASCULAR SESS WAS ADVANCED ON THE SAME GW WITH THE SAME SHEATH. DURING DEPLOYMENT OF THE SECOND SESS, THE THUMBWHEEL WAS STICKING AND DIFFICULT TO TURN; HOWEVER, THE STENT WAS ULTIMATELY ABLE TO BE DEPLOYED. 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 24000411 ↗
• InjuryOct 15, 2025Stretched; Difficult to Advance; Mechanical Jam; Activation Failure; Stretched; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ACCESS TO THE LESION WAS GAINED THROUGH A 6 FR SHEATH AND A 6.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS SUCCESSFULLY IMPLANTED WITH NO NOTED ISSUES. AT THIS POINT, A 6.0X100MM ABSOLUTE PRO SES WAS ADVANCED TO THE LESION OVER A .035 SUPRA CORE GUIDEWIRE THROUGH RESISTANCE WITH THE ANATOMY; HOWEVER DURING DEPLOYMENT THE THUMBWHEEL WAS NOTED TO JAM AND THE STENT COULD ONLY BE PARTIALLY DEPLOYED. FOLLOWING THIS THE PHYSICIAN DECIDED, AGAINST THE SALES REPRESENTATIVE DEGRESSION, TO DISASSEMBLE THE HANDLE AND MANUALLY DEPLOY THE STENT. THEREFORE THE SES WAS LEFT IN THE ANATOMY FULLY DEPLOYED AND PARTIALLY ELONGATED IN THE SFA. THERE WERE NO REMEDIAL ACTIONS PERFORMED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295817 ↗
• InjuryOct 6, 2025Material Separation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERIOR FEMORAL ARTERY (SFA). THE 6.0X100MM ABSOLUTE PRO WAS ADVANCED TO THE TARGET LESION WITH SOME RESISTANCE FELT WITH ANATOMY. WHEN ATTEMPTING TO DEPLOY THE STENT ONLY PARTIALLY DEPLOYED, THE THUMBWHEEL TURNED; HOWEVER, DID NOT DEPLOY THE REST THE OF THE STENT. THEREFORE, THE PHYSICIAN PULLED BACK THE DELIVERY SYSTEM IN ORDER TO DEPLOY THE REST OF THE STENT AND THE STENT DEPLOYED; HOWEVER, THE STENT DID FRACTURE (SEPARATED INTO TWO). THEREFORE, A NON-ABBOTT STENT WAS USED TO JAIL THE ABSOLUTE STENT INTO THE VESSEL WALL. THE GUIDE WIRE USED WAS A .018 UNSPECIFIED GUIDE WIRE. THERE WAS 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 23223872 ↗
• MalfunctionMay 27, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. AN ORBITAL ATHERECTOMY DEVICE FROM ANOTHER MANUFACTURER WOULD NOT TURN ON OR RUN AND THE 6X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) DID NOT FULLY DEPLOY THE STENT. THE DEVICES WERE REPLACED AND THE PROCEDURE WAS COMPLETED. 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 22089310 ↗
• MalfunctionMar 31, 2025Premature Activation; Difficult to Advance; Mechanical Jam; Activation Failure; Premature Activation; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X100 ABS PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH RESISTANCE OVER A NON-ABBOTT 0.035 GUIDE WIRE (GW); HOWEVER, THE SESS WAS ABLE TO REACH THE TARGET LESION. THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT THE THUMBWHEEL WAS STUCK AND THE STENT COMPLETELY FAILED TO DEPLOY. THEREFORE, THE SESS WAS REMOVED FROM THE PATIENT AND ANOTHER 6X100MM ABS PRO WAS ABLE TO BE ADVANCED OVER THE SAME GW AND IMPLANTED WITHOUT ISSUE. THEN, A 6X80MM ABS PRO SESS WAS ADVANCE AND INTENDED TO IMPLANTED PROXIMAL TO THE PREVIOUSLY IMPLANTED STENT; HOWEVER, THE 6X80MM SESS FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY AND THE SHEATH OF THE STENT WAS NOTED TO BE STRETCHED (BROKE). THE 6X80MM SESS WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE 6X100 ABS PRO STENT IMPLANT WAS EXPOSED 3 MM FROM THE DISTAL END OF THE SHEATH. THE STENT SHEATH WAS RETRACTED 6 MILLIMETERS (MM) FROM THE BASE OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732488 ↗
• InjuryMar 26, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE AORTIC BIFURCATION WITH MODERATE TORTUOSITY. USING THE ACCESS VIA RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), THE 6X100MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION ON A 0.035 NON-ABBOTT GUIDE WIRE (GW) WITH RESISTANCE DUE TO THE ANATOMY. THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WAS ONLY ABLE TO BE PARTIALLY DEPLOYED WHEN THE THUMBWHEEL BECAME STUCK. THEREFORE, THE PHYSICIAN OPENED UP THE HANDLE OF THE SESS TO ATTEMPT TO MANUALLY DEPLOY THE STENT, BUT THE STENT COULD NOT BE COMPLETELY DEPLOYED. THE SESS WAS REMOVED FROM THE PATIENT AND DURING REMOVAL RESISTANCE WAS NOTED WITH THE ANATOMY AND FORCE WAS APPLIED. THE STENT BECAME SEPARATED IN 2 PIECES. AN UNSPECIFIED BALLOON WAS USED TO EMBED THE SEPARATED PORTION OF THE STENT THAT REMAINED IN THE PATIENT INTO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21698437 ↗
• MalfunctionMar 26, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X100MM ABSOLUTE PRO SELF-EXPANDING STENT WAS SUCCESSFULLY DEPLOYED, IN THE LESION USING A 6F SHEATH AND OVER A NON-ABBOTT GUIDEWIRE; HOWEVER, DURING DEPLOYMENT THE DELIVERY CATHETER WAS NOTED TO SPLIT OPEN. THEREFORE, THE DELIVERY CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH STANDARD POST-DILATATION OF THE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697825 ↗
• InjuryNov 27, 2024Difficult or Delayed Activation; Difficult to Advance; Physical Resistance/Sticking; Difficult or Delayed Activation; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND 90% STENOSED, DE NOVO, LESION IN THE SUPERFICIAL FEMORAL ARTERY USING THREE ABSOLUTE PRO SELF-EXPANDING STENT SYSTEMS (SESS). AN UNSPECIFIED 0.035 GUIDE WIRE WAS ADVANCED, AND THE FIRST 6.0X80 ABSOLUTE PRO SESS WAS ADVANCED; HOWEVER, UNSPECIFIED RESISTANCE WAS NOTED, MAKING TRACKING DIFFICULT. DEPLOYMENT WAS INITIATED AND NOTED AS DIFFICULT DUE TO STIFFNESS IN TURNING THE THUMBWHEEL. AFTER STENT DEPLOYMENT, THE PHYSICIAN NOTED THE STENT WAS NOT FULLY EXPANDED, NECESSITATING THE USE OF A 6.0X200MM DILATATION CATHETER BALLOON TO FULLY EXPAND THE STENT. AFTER BALLOON EXPANSION, THE STENT JUMPED FORWARD BETWEEN 2MM AND 5MM, REMAINING PARTIALLY IN THE TARGET LESION AND ALSO IN HEALTH TISSUE. THE SECOND 6.0X80MM ABSOLUTE PRO WAS ADVANCED AND EXPERIENCED THE SAME OCCURRENCE. NEXT, THE THIRD 6.0X60MM ABSOLUTE PRO WAS DEPLOYED AND EXPERIENCED THE SAME OCCURRENCE; HOWEVER, THIS STENT REMAINED IN PLACE AFTER BALLOON EXPANSION. A FOURTH 6.0X100MM ABSOLUTE PRO WAS IMPLANTED TO TREAT THE TARGET AREAS LEFT UNCOVERED BY THE PREVIOUS STENTS MOVING FORWARD. THIS STENT ALSO ENCOUNTERED UNSPECIFIED RESISTANCE DURING ADVANCEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799761 ↗
• InjurySep 18, 2024Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS UNSPECIFIED CIRCULATORY VESSEL. THE 6X100MM ABS PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE THUMBWHEEL WOULD NOT SPIN AND THE STENT COULD NOT BE DEPLOYED. THE HANDLE OF THE SESS WAS OPENED AND THE STENT WAS THEN ABLE TO BE DEPLOYED IN THE TARGET LESION. THERE WAS ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248230 ↗
• MalfunctionAug 28, 2024Difficult 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 SUPERFICIAL FEMORAL ARTERY. THE 6X100MM ABSOLUTE PRO LL SELF EXPANDING STENT (SES) WAS ADVANCED OVER AN UNSPECIFIED 0.035 GUIDE WIRE TO THE TARGET SITE. THE THUMBSLIDE WAS DIFFICULT TO ADVANCE, AND AFTER MULTIPLE ATTEMPTS PUSHING THE THUMBSLIDE THE STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089246 ↗
• MalfunctionJul 29, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THE 6.0X100 MM ABSOLUTE PRO LL SELF EXPANDING STENT DELIVERY SYSTEM (SESS) PARTIALLY DEPLOYED IN THE SUPERFICIAL FEMORAL ARTERY; THE STENT FLOWERED. THE STENT WAS NOT IMPLANTED, THE SESS WAS REMOVED FROM THE ANATOMY AND WHEN IT WAS ON THE TABLE, THE STENT FULLY DEPLOYED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856846 ↗
• MalfunctionJul 2, 2024Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. THE 6X100 ABSOLUTE PRO SELF-EXPENDING STENT SYSTEM(SESS) WAS ADVANCED OVER A 0.035 SUPRACORE GUIDE WIRE TO THE TARGET LESION. THE THUMBWHEEL BECAME STUCK AND THE STENT PARTIALLY DEPLOYED A COUPLE OF MILLIMETERS. THE SESS WAS WITHDRAWN AND ANOTHER SAME SIZE ABSOLUTE PRO 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 19659538 ↗
• MalfunctionMar 7, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION AND 80% STENOSIS. PEDAL ACCESS WAS GAINED WITH A NON-ABBOTT 6F SHEATH. THE 6X100 ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THE VESSEL WAS PREPARED BY CLEARING THE CALCIUM PRIOR TO STENTING. THE ABSOLUTE PRO SESS WAS ADVANCED TO THE POSTERIOR TIBIAL ARTERY THEN INTO THE POPLITEAL WHEN THE SESS MET RESISTANCE WITH THE CALCIUM AND COULD NOT BE ADVANCED ANY FURTHER. THE SESS WAS GOING TO BE BACKED OUT OF THE 6FR SHEATH TO BE REMOVED; HOWEVER, THE TIP OF THE DEVICE BECAME CAUGHT ON THE 6FR SHEATH AND BOTH DEVICES HAD TO BE REMOVED AS A SINGLE UNIT. NOTHING WAS LEFT IN THE PATIENT AND NO REPLACEMENT DEVICE WAS USED. THE PROCEDURE WAS ABORTED AND PRESSURE WAS HELD AT THE ACCESS SITE TO ACHIEVE HEMOSTASIS. 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 18859295 ↗
• InjuryDec 19, 2023Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID TO DISTAL SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS PRE-DILATATED WITH 4X80MM ARMADA BALLOON AND THE 6.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT WAS DEPLOYED. HOWEVER, POST DEPLOYMENT THE STENT BEGAN TO UNRAVELED AND PART OF THE STENT SEPARATED. ANOTHER 4.0X60MM ARMADA BALLOON WAS USED TO DILATE AGAIN AND A 6.0X200MM NON-ABBOTT STENT WAS USED TO EMBEDDED THE SEPARATED PORTION INTO THE VESSEL WALL. A 6.39MM OMNILINK STENT WAS THEN IMPLANTED IN THE PROXIMAL SFA DISTAL TO THE PROFUNDA ORIGIN. 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 18360447 ↗
• InjuryDec 5, 2023Material Separation; Difficult or Delayed Activation; Difficult to Advance; Material Separation; Difficult or Delayed Activation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). USING A 6FR SHEATH, THE 6.0X100MM ABSOLUTE PRO STENT WAS ADVANCED TO THE TARGET LESION AND DEPLOYED; HOWEVER, THE STENT WAS NOTED TO HAVE SEPARATED IN TWO PIECES. THEREFORE, A 6.0X60 MM ABSOLUTE PRO STENT WAS ADVANCED TO BE IMPLANTED BETWEEN THE GAP OF THE BROKEN STENT; HOWEVER, WOULD NOT CROSS THE IMPLANTED STENT. THE 6.0X100MM ABSOLUTE PRO STENT REMAINS IN THE PATIENT NOT FULLY APPOSED TO THE VESSEL. THE PROCEDURE WAS ABORTED. THE PATIENT IS REPORTED TO BE RETURNING TO THE HOSPITAL IN TWO WEEKS TO ATTEMPT FURTHER TREATMENT OF THE TARGET LESION AND BROKEN STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271449 ↗
• InjuryOct 20, 2023Improper 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 AN OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE TORTUOSITY. THE 6.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED; HOWEVER, SOME RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT STARTED TO FLOWER. THE SESS WAS REMOVED WITHOUT ISSUES. A SECOND 6.0X100MM ABSOLUTE PRO SESS WAS ADVANCED TO THE TARGET LESION AND WAS BEING DEPLOYED, HOWEVER, THE THUMBWHEEL STOPPED WORKING HALFWAY THROUGH THE STENT DEPLOYMENT. THE STENT WAS PARTIALLY DEPLOYED. THE THUMBWHEEL WAS PUSHED FORWARD WITH FORCE TO ATTEMPT TO FULLY DEPLOY THE STENT BUT FAILED. THE HANDLE WAS OPENED AND AN ATTEMPT TO DEPLOY THE STENT WAS MADE BUT FAILED AGAIN. THE STENT WAS ATTEMPTED TO BE PULLED INTO THE SHEATH BUT WAS UNSUCCESSFUL AND A CUTDOWN HAD TO BE PERFORMED TO REMOVE THE PARTIALLY DEPLOYED STENT. NOTHING WAS LEFT IN THE ANATOMY. THERE WAS PROLONGED HOSPITALIZATION. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 17981051 ↗
• MalfunctionOct 20, 2023Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE TORTUOSITY. THE 6.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED; HOWEVER, SOME RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT STARTED TO FLOWER. THE SESS WAS REMOVED WITHOUT ISSUES. A SECOND 6.0X100MM ABSOLUTE PRO SESS WAS ADVANCED TO THE TARGET LESION AND WAS BEING DEPLOYED, HOWEVER, THE THUMBWHEEL STOPPED WORKING HALFWAY THROUGH THE STENT DEPLOYMENT. THE STENT WAS PARTIALLY DEPLOYED. THE THUMBWHEEL WAS PUSHED FORWARD WITH FORCE TO ATTEMPT TO FULLY DEPLOY THE STENT BUT FAILED. THE HANDLE WAS OPENED AND AN ATTEMPT TO DEPLOY THE STENT WAS MADE BUT FAILED AGAIN. THE STENT WAS ATTEMPTED TO BE PULLED INTO THE SHEATH BUT WAS UNSUCCESSFUL AND A CUTDOWN HAD TO BE PERFORMED TO REMOVE THE PARTIALLY DEPLOYED STENT. NOTHING WAS LEFT IN THE ANATOMY. THERE WAS PROLONGED HOSPITALIZATION. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 17980968 ↗
• InjuryOct 17, 2023Premature Activation; Patient-Device Incompatibility; Mechanical Jam; Activation Failure; Premature Activation; Patient-Device Incompatibility; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT LOWER EXTREMITY WITH CRITICAL LIMB ISCHEMIA WITH GANGRENE AND CELLULITIS OF TOES. THE LESION WAS ACCESSED WITH AN 0.018 GUIDE WIRE AND A STIFF MICRO PUNCTURE SHEATH AND THEN A NON-ABBOTT GUIDE WIRE AND A 5FR SHEATH. UP AND OVER ACCESS WAS PERFORMED AND WAS SOMEWHAT CHALLENGING DUE TO ACUTE ANGLES, MILD TORTUOSITY, AND THE PRESENCE OF STENTS. IT WAS POSSIBLE TO GET DOWN TO THE RIGHT DISTAL EXTERNAL ILIAC ARTERY; HOWEVER, THERE WAS DIFFICULTY AND A SPARTA CORE GUIDE WIRE WAS ABLE TO GET TO THE LESION SO THAT BALLOON ANGIOPLASTY COULD BE PERFORMED TO RECANALIZE THE PRESENT OCCLUSION FROM ABOVE THE KNEE POPLITEAL ARTERY TO THE ENTIRE SUPERFICIAL FEMORAL ARTERY USING A 5X100 MM BALLOON. AT THIS TIME THE WIRE WAS EXCHANGED BACK TO A NON-ABBOTT 0.035 GUIDE WIRE SYSTEM AND THERE WAS PERSISTENT STENOSIS AT THE ADDUCTOR CANAL AND DIFFUSE ATHEROSCLEROTIC DISEASE THROUGHOUT THE ENTIRE SUPERFICIAL FEMORAL ARTERY. IT WAS ATTEMPTED TO PLACE THE 6X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS), HOWEVER, THE DEPLOYMENT MECHANISM COMPLETELY LOCKED ONTO ITSELF AND THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS BACKED OVER THE WIRE

  Patient problems: Foreign Body In Patient

  MAUDE report 17950582 ↗
• InjuryJul 21, 2023Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE 6.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, DURING REMOVAL THE DELIVERY SYSTEM BECAME STUCK WITH A STENT IN THE TIBIAL ARTERY THAT HAD BEEN IMPLANTED IN A PREVIOUS PROCEDURE. THE DELIVERY SYSTEM DRAGGED AND CRUSHED THE IMPLANTED STENT IN THE TIBIAL ARTERY CAUSING VESSEL DAMAGE AND THE VESSEL HAD TO BE CLAMPED-OFF. DURING, MULTIPLE ATTEMPTS TO REMOVE THE DELIVERY SYSTEM OF THE SESS THE WIRE ACCESS WAS LOST AND THE 3-4 CM OF THE DELIVERY SYSTEM REMAINED IN THE POSTERIOR TIBIAL ARTERY AND THE REMAINDER OF THE DELIVERY SYSTEM WAS OUTSIDE THE PATIENT'S FOOT. LATER THE SAME DAY, CUT-DOWN SURGERY WAS PERFORMED TO REMOVE THE DELIVERY SYSTEM OF THE SESS AND RESTORE FLOW TO ARTERY. THERE WAS NO ADVERSE SEQUELA. THE ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17375183 ↗
• InjuryMar 9, 2023Material Separation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking; Material Separation; 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 SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. ATHERECTOMY AND PRE-DILATATION WERE PERFORMED. THE VESSEL WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). THE 6.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. HOWEVER, THE THUMBWHEEL GOT STUCK ON THE THIRD TURN DURING DEPLOYMENT. THE PHYSICIAN PUSHED BACK AND FORTH ON THE THUMBWHEEL AND THE WHEEL BECAME UNSTUCK. TURNING WAS STILL DIFFICULT AND THE PHYSICIAN HAD TO USE FORCE TO TURN THE WHEEL. THE STENT WAS ABLE TO BE DEPLOYED BUT WHEN THE PHYSICIAN LOOKED AT THE DEPLOYED STENT, A FRACTURE WAS NOTED IN THE MIDDLE OF THE STENT WHICH SEPARATED IN 2 PIECES. X-RAY WAS USED TO VERIFY THE STENT SEPARATION. THE DEVICE WAS WITHDRAWN WITHOUT ISSUE FROM THE PATIENT ANATOMY. THE SEPARATED IMPLANTED STENT WAS BALLOONED WITH A 6.0MM BALLOON POST DEPLOYMENT. THERE WAS NO HARM TO THE PATIENT. 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 16512582 ↗
• InjuryMar 8, 2023Device Dislodged or Dislocated; Mechanical Jam; Activation Failure; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT DURING A LEFT SUPERFICIAL FEMORAL ARTERY INTERVENTION, THE 6X100MM ABSOLUTE PRO VASCULAR STENT SYSTEM WAS ADVANCED TO THE LESION AND DEPLOYMENT ATTEMPTED BUT THE THUMBWHEEL STOPPED TURNING AFTER THE STENT WAS EXPOSED AND FLOWERED, SO AN ATTEMPT WAS MADE TO REMOVE THE DEVICE INCLUDING THE STENT, BUT THE STENT DEPLOYED IN THE LEFT COMMON FEMORAL ARTERY AND WAS LEFT THERE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A SECOND ABSOLUTE PRO VASCULAR WAS IMPLANTED WITHOUT ISSUE IN THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16503121 ↗