WALLSTENT® Endoprosthesis H965402130Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729203971), received between Oct 12, 2018 and Jul 7, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Break; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT SHAFT BREAK, REMOVAL DIFFICULTY, AND PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DELIVERED INTO THE BODY AND DEPLOYED AFTER REACHING THE LESION SITE. DURING THE DEPLOYMENT, THE DELIVERY SHAFT WAS FRACTURED, AND THE TAIL END COULD NOT BE PULLED. AFTER MANY ROTATIONS, THE STENT COULD NOT BE PULLED. THE STENT WAS ONLY DEPLOYED AT THE TIP END, AND THE BACK PART WAS NOT DEPLOYED. THE PHYSICIAN USED THE ADJUSTABLE CURVED SHEATH TO PULL OUT THE STENT AFTER MANY ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738421 ↗
• MalfunctionNov 13, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT HAD PULMONARY MALIGNANCY AND SUPERIOR VENA CAVA COMPRESSION. A 12MM X 90MM WALLSTENT ENDOPROSTHESIS STENT SELF EXPANDING WAS SELECTED FOR USE IN THE SUPERIOR VENA CAVA. DURING THE PROCEDURE, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT THE STENT HAD KINK MARKS, WHICH WERE CONFIRMED AFTER THE STENT WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548017 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EMBOLIZATION AND THROMBOSIS OCCURRED. THE PATIENT WAS ADMITTED FOR AN ILIAC VEIN EMBOLISM AND UNDERWENT MULTIPLE PROCEDURES ON (B)(6) 2025, INCLUDING INFERIOR VENA CAVA ANGIOGRAPHY, FILTER IMPLANTATION, LEFT LOWER EXTREMITY ANGIOGRAPHY, BALLOON DILATION, AND LEFT ILIAC VEIN STENT PLACEMENT. A 75CM WALLSTENT UNI WAS SELECTED FOR USED. THE PROCEDURE REVEALED LEFT ILIAC VEIN STENOSIS, AFTER BALLOON DILATION, A STENT WAS PLACED. HOWEVER, REPEATED EMBOLIZATION OF THE INFLOW TRACT CAUSED BLOOD STASIS AND THROMBOSIS. RE-INTERVENTIONAL TREATMENT, INCLUDING THROMBECTOMY, BALLOON DILATION AND CATHERIZATION THROMBOLYSIS REDUCED THE THROMBOSIS AND RESTORED BLOOD FLOW. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Embolism/Embolus; Thrombosis/Thrombus

  MAUDE report 22940301 ↗
• MalfunctionApr 11, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 25% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. UPON RELEASING, IT WAS NOTED THAT THE STENT WAS DIFFICULT TO DELIVER, AND PRE-DELIVERY WAS FAILED. THE STENT WAS PULLED OUT, AND IT WAS NOTED THAT THERE WERE BURRS AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21828818 ↗
• MalfunctionJan 30, 2025Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12X90/8FR WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT BE DEPLOYED, AND IT WAS DIFFICULT TO WITHDRAW. THE PROCEDURE WAS NOT COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277039 ↗
• MalfunctionOct 31, 2024Positioning Failure; Mechanical Problem; Activation, Positioning or Separation Problem; Positioning Failure; Mechanical Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO RE-CONSTRAIN. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT LOWER LIMB VEIN. A WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT REACHED THE LESION. HOWEVER, THE STENT WAS DEPLOYED LESS THAN 50% AND A RESISTANCE WAS OBVIOUS. THE STENT WAS HALF RE-CONSTRAINED AND WAS REMOVED DIRECTLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579127 ↗
• MalfunctionJul 12, 2024Difficult to Flush; Activation, Positioning or Separation Problem; Material Deformation; Difficult to Flush; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT UNDERWENT STENT IMPLANTATION OF THE 80% STENOSED TARGET LESION LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED SUPERIOR VENA CAVA. DURING THE PROCEDURE, THE GUIDEWIRE AND SHEATH WERE PLACED AFTER THE LEFT FEMORAL VEIN WAS PUNCTURED. THE GUIDEWIRE WAS REPLACED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE IN THE INFERIOR VENA CAVA (IVC) AFTER THE LESION LOCATION WAS DETERMINED THROUGH ANGIOGRAPHY. DUE TO THE STENOSIS AT THE LESION SITE, PRE-DILATION WAS PERFORMED WITH A MUSTANG BALLOON 12*80. A 12X90/8FR, 75CM WALLSTENT ENDOPROSTHESIS STENT WAS SELECTED FOR USE. THERE WAS SLIGHT RESISTANCE WHEN FLUSHING THE STENT. AFTER THE STENT REACHED THE LESION AND HALF OF THE STENT WAS DEPLOYED, GREAT RESISTANCE OCCURRED WHEN WITHDRAWING THE OUTER SHEATH OF THE STENT. THE STENT WAS RECAPTURED AND REMOVED AS A WHOLE AFTER MULTIPLE ATTEMPTS. WHEN PUSHING OUT THE STENT, OUTSIDE THE PATIENT, IT WAS FOUND THAT THE STENT WAS KINKED. A 12*90 WALLSTENT WAS USED INSTEAD, AND AFTER POST-DILATION WITH A BALLOON, THE PROCEDURE WAS COMPLETED WITH GOOD RESULTS. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729575 ↗
• MalfunctionDec 20, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. THE PROCEDURE WAS PERFORMED VIA SELECTIVE VENOGRAPHY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VENOUS THROMBOSIS OF LOWER EXTREMITY. A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT UNI WAS SELECTED FOR USE. IT WAS DURING PROCEDURE THAT IT WAS FOUND THAT THE STENT WAS UNINTENTIONALLY DEPLOYED OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367467 ↗
• MalfunctionNov 14, 2023Mechanical Problem; Failure to Advance; Material Deformation; Mechanical Problem; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS DAMAGED AND DIFFICULT TO RECONSTRAINED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. PRE-DILATATION WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC (BSC) BALLOON, AND A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED BUT FAILED TO CROSS THE LESION ALONG WITH A NON-BSC SHEATH. HOWEVER, ANGIOGRAPHY SHOWED THE TIP OF THE STENT WAS EXPOSED AND PARTIALLY DAMAGED. IN ADDITION, THE STENT WAS INADEQUACY RECONSTRAINED DURING WITHDRAWAL. THE DEVICE WAS SIMPLY REMOVED AS A WHOLE TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136032 ↗
• InjurySep 1, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE PATIENT WAS BEING TREATED FOR COMPUTED TOMOGRAPHY INTERVENTIONAL THERAPY OF LOWER LIMBS. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ILIAC VEIN. A 2X90/8FR UNI PLUS HALO 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE LENGTH OF THE STENT WAS FOUND TO BE TOO SHORT AND INSUFFICIENT. FURTHERMORE, THE LENGTH OF THE LESION WAS 15 TO 16 CENTIMETERS (CM) WHILE THE SIZE OF THE STENT PRIOR TO PROCEDURE WAS 9CM AND 6 TO 7CM AFTER ADVANCING. THE STENT HAS BEEN IMPLANTED IN THE BLOOD VESSEL AND CANNOT BE REMOVED; THEREFORE, ANOTHER OF THE SAME DEVICE WAS THEN USED TO COVER THE LESION IN ORDER TO EXTEND ITS LENGTH. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670481 ↗
• MalfunctionJun 22, 2023Mechanical Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Mechanical Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH ILIAC VEIN COMPRESSION. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. A 12X90/8FR WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS DEPLOYED HALFWAY, IT BECAME STUCK AND COULD NO LONGER BE DEPLOYED. ATTEMPTS WERE MADE TO WITHDRAW THE DEVICE, BUT STENT COULD NOT BE WITHDRAWN. THE STENT WAS REMOVED AS A WHOLE AND UPON INSPECTION OUTSIDE PATIENT, IT WAS NOTED THAT THE DELIVERY SHEATH WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE STENT COULD NOT BE RECONSTRAINED AND COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED THROUGH A 10F UNSPECIFIED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187366 ↗
• MalfunctionMay 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. AFTER LESION PREPARATION, A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. HOWEVER, PRIOR TO IMPLANTING, IT WAS FOUND THAT THE STENT WAS FRACTURED. IN ORDER TO AVOID ADVERSE EVENTS AFTER IMPLANTATION, A NEW STENT WAS UNPACKED AND SUCCESSFULLY IMPLANTED, AND THE DAMAGED STENT WAS SEALED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876538 ↗
• MalfunctionApr 7, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEIN. A 12X90/8FR 75CM WALLSTENT UNI STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE DESPITE OF MANY ATTEMPTS, IT WAS FAILED TO DEPLOY, AND IT WAS NOTICED THAT THE STENT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LOWER EXTREMITY VEIN, AND THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702580 ↗
• MalfunctionJul 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT ENDOPROSTHESIS, IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15018244 ↗
• MalfunctionMar 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 12X90/8FR 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING OF THE DEVICE, THE STENT STRUTS WERE NOTICED TO BE KINKED AND DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722834 ↗
• MalfunctionFeb 8, 2022Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17JAN2022. IT WAS REPORTED THAT STENT DEPLOYMENT FAILURE OCCURRED. THE PATIENT HAD THROMBOSIS ON BOTH LOWER LIMBS AND NEEDED 5 WALLSTENT STENTS TO BE IMPLANTED. A 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS ADVANCED FOR TREATMENT AS A SECOND STENT; HOWEVER, IT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS DETACHED AND THE STENT WIRES WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13485429 ↗
• InjuryDec 22, 2021Difficult to Remove; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Difficult to Remove; Activation, Positioning or Separation Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT STENT COULD NOT BE DEPLOYED, SO IT WAS CUT AND REMOVED. A 12MM X 90MM WALLSTENT UNI WAS SELECTED FOR USE IN A STENTING PROCEDURE IN THE SEVERELY STENOSED ILIAC VEIN. AFTER ADVANCING THE DEVICE TO THE LESION, THE STENT COULD NOT BE FULLY DEPLOYED. THE PHYSICIAN CUT AND REMOVED THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 13067503 ↗
• MalfunctionSep 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB VEIN. A 12X90/8FR 75CM WALLSTENT UNI WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT STRUT WAS KINKED AND COULD NOT BE CONTINUED WHEN IT WAS DEPLOYED AT 40%. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550016 ↗
• MalfunctionJan 19, 2021Activation Failure; Activation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-JAN-2021. IT WAS REPORTED THAT STENT DEPLOYMENT FAILURE OCCURRED. A 12MMX90MMX75CM WALLSTENT UNI STENT WAS USED, HOWEVER; THE DEVICE WAS UNABLE TO FULLY DEPLOY. THE DEVICE WAS REMOVED AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE STENT WAS SEPARATED FROM THE DEPLOYMENT SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11197139 ↗
• MalfunctionAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN A LOWER EXTREMITY VEIN. A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443031 ↗
• MalfunctionMay 1, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE RE-CONSTRAINED. TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12X90/8FR 75CM WALLSTENT UNI WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS FOUND THAT THE LESION COULD NOT BE COVERED WHEN ONE THIRD OF THE STENT WAS DEPLOYED. THE PHYSICIAN WITHDREW THE DEVICE, BUT THE STENT COULD NOT BE FULLY WITHDRAWN INTO THE DELIVERY SYSTEM. THE PHYSICIAN WITHDREW THE STENT FROM THE PATIENT'S BODY BUT IT WAS OBSERVED THAT IT COULD NOT BE WITHDRAWN DURING THE VITRO EXAMINATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018333 ↗
• MalfunctionJul 16, 2019Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-JUN-2019. IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. A 12X90/8FR UNI PLUS HALO 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS DIFFICULT TO RELEASE INSIDE THE PATIENT AFTER MANY ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794257 ↗
• MalfunctionOct 12, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS A DEEP VEIN THROMBOSIS LOCATED IN THE LOWER EXTREMITY. A 12X90/8FR 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED BUT FAILED TO CROSS THE SUPERFICIAL FEMORAL VEIN DESPITE SEVERAL ATTEMPTS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT WAS RETURNED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. IT IS NOT KNOWN WHEN DEPLOYMENT OCCURRED. THE INVESTIGATOR SUCCESSFULLY DEPLOYED THE STENT WITHOUT RESISTANCE OR ANY ISSUES BEING EXPERIENCED. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED DAMAGE TO THE DISTAL WIRES OF THE DEPLOYED STENT. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960228 ↗