WALLSTENT® Endoprosthesis H965403130Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729204015), received between Aug 1, 2019 and Jul 13, 2026 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Premature Activation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. DURING DEVICE DELIVERY, THE STENT BECAME DISLODGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25806683 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A SELF-EXPANDING 75CM WALLSTENT ENDOPROSTHESIS WAS CHOSEN FOR VENOUS RECANALIZATION AND STENT PLACEMENT IN THE LOWER EXTREMITY. WHEN THE PACKAGE WAS OPENED, THE CATHETER OUTSIDE THE STENT WAS FOUND TO BE BROKEN, WITH A ROUGH SURFACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521880 ↗
• MalfunctionMar 5, 2026Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT STENT FAILURE TO DEPLOY AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON REACHING THE LESION SITE, THE PULL ROD WAS RETRACTED TO RELEASE THE STENT, BUT THE STENT FAILED TO DEPLOY. DIFFICULTY WITHDRAWING THE STENT ALONG THE GUIDEWIRE WAS NOTED AND AN EXTERNAL ATTEMPT TO RELEASE THE PULL ROD WHERE IT COULD BE RETRACTED WAS MADE, HOWEVER, THE STENT STILL FAILED TO DEPLOY. 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 24521389 ↗
• MalfunctionFeb 13, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE STENT WAS DAMAGED. 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 24337580 ↗
• InjuryFeb 12, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED CAUSING PAIN AND VESSEL TRAUMA. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP OF THE STENT WAS IRREGULAR IN SHAPE AND HAD ABNORMAL PROTRUDES, WHICH CAUSED SEVERE PAIN TO THE PATIENT. AFTER REMOVAL, IT WAS NOTED THAT THE VESSEL'S INTIMA HAD BEEN TORN AND DAMAGED, AND IT HAD BECOME ATTACHED TO THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE 50% STENOSED TARGET LESION WAS NOTED. THE SHAPE OF THE STENT'S TIP END WAS IRREGULAR WITH ABNORMAL PROTRUSIONS. WHEN IT WAS RELEASED, THE PATIENT EXPERIENCED SEVERE PAIN. UPON WITHDRAWAL, IT WAS OBSERVED THAT THE INNER LINING OF THE BLOOD VESSEL WAS TORN AND DAMAGED AND THE ABNORMAL PROTRUDING STENT AND THERE WAS NO TREATMENT AVAILABLE FOR THE TIME BEING.

  Patient problems: Pain; Perforation of Vessels

  MAUDE report 24327448 ↗
• MalfunctionDec 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTER THAT THE STENT FAILED TO DEPLOY RESULTING IN PROCEDURE CANCELLATION. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED PROPERLY DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED COMPLETELY AND INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS CONCLUDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS CANCELLED AS A RESULT OF THE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864530 ↗
• MalfunctionSep 11, 2025Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PROFILE PROBLEM OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. A 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED AS IT WAS FOUND THAT THE LENGTH OF THE STENT MAY BE TO THE HEART. THE ORIGINAL STENT MEASURED 90 MM BUT WAS 150 MM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO FURTHER COMPLICATIONS NOTED AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED. THE PRODUCT INNER POUCH MATCHES THE OUTER CARTON/SHELF CARTON. THE STENT WAS FOUND TO BE THE WRONG SIZE TO THE LESION LENGTH WHILE INSIDE THE PATIENT'S BODY, WITH 1/3 OF IT INSIDE THE PATIENT'S HEART. THE STENT WAS FULLY RE-CONSTRAINED DURING WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026551 ↗
• MalfunctionApr 2, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE UPON ANALYSIS COMPLETED ON (B)(6)2025. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 14X90/9 WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE PATIENT; HOWEVER, THE PRODUCT WAS UNABLE TO TRAVERSE THE LESION. AS A RESULT, THE PHYSICIAN SUBSEQUENTLY WITHDREW THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753526 ↗
• MalfunctionFeb 3, 2025Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT AND DEFORMATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR STENT IMPLANTATION. HOWEVER, BEFORE THE STENT IMPLANTATION, IT WAS NOTED THAT PART OF THE TIP OF THE STENT HAD BEEN DEPLOYED WITHOUT INITIATING DEPLOYMENT. SUBSEQUENTLY, THE STENT WAS DEFORMED. THE STENT WAS RECONSTRAINED PRIOR TO REMOVAL BUT THERE WAS RELATIVELY HIGH RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294081 ↗
• MalfunctionDec 13, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26NOV2024. IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ILIAC VEIN COMPRESSION. A 14 MM X 90 MM, 9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR STENTING. HOWEVER, DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED DUE TO GREAT RESISTANCE WHEN IT WAS HALF DEPLOYED. THE STENT WAS DIRECTLY RECAPTURED AND REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS UNHARMED, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924356 ↗
• MalfunctionAug 27, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS NOT SMOOTH. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VENAE LOWER LIMB VESSEL. A 14X90/9FR 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS DIFFICULT TO PUSH. UPON REMOVAL, IT WAS OBSERVED THAT THE SURFACE OF THE STENT WAS NOT SMOOTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077489 ↗
• MalfunctionMay 21, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT WAS UNLOADED UPON DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THE STENT HAD COMPLETELY DISLODGED IN THE SHEATH UNDER FLUOROSCOPY WHEN IT ALMOST REACHED THE LESION. THE STENT WAS NOT RE-CONSTRAINED DURING WITHDRAWAL. THE SHEATH AND THE DISLODGED DELIVERY SYSTEM WERE SLOWLY PULLED OUT ALL TOGETHER FROM THE PATIENT. THE STENT WAS FOUND TO BE COMPLETELY DEPLOYED AND EXPANDED IN THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361526 ↗
• MalfunctionJan 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI WAS SELECTED FOR TREATMENT IN THE ILIAC ARTERY. WHEN A SECOND RELEASE OF STENT WAS DONE, IT WAS NOTED THAT THIS DEVICE WAS DEFORMED ON THE TIP. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME PRODUCT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426869 ↗
• MalfunctionNov 14, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT POSITIONING DIFFICULTIES WERE ENCOUNTERED. THE PATIENT WAS TO UNDERGO ILIAC VEIN STENT IMPLANTATION. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS ILIAC VEIN. AFTER THE LESION WAS PRE-DILATED WITH A 12.6 NON-BOSTON SCIENTIFIC BALLOON CATHETER, A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS SHRINKING BADLY, AND IT COULD NOT REACH THE POSITION AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136165 ↗
• MalfunctionMay 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED UNDER X-RAY THAT THE METAL WIRES OF THE STENT WERE BROKEN AND THE DEVICE COULD NOT BE IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 60-70% STENOSED, NON-CALCIFIED AND NON-TORTUOUS. IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED AND NOT BROKEN AS PREVIOUSLY REPORTED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT WITH THE STENT NOT FULLY RECONSTRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876542 ↗
• MalfunctionApr 14, 2023Positioning Failure; Failure to Advance; Material Deformation; Material Integrity Problem; Positioning Failure; Failure to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH ADVANCED LUNG CANCER WITH SEVERE SPACE-OCCUPYING LESION. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED AN OVER 85% STENOSED TARGET LESION LOCATED IN THE SEVERELY TORTUOUS SUPERIOR VENA CAVA. THE PATIENT WAS PLACED IN SUPINE POSITION AND PUNCTURE WAS PERFORMED THROUGH THE RIGHT FEMORAL ARTERY WITH A 10F PUNCTURE SHEATH. A 0.035 AMPLATZ GUIDEWIRE WAS THEN ADVANCED TO THE LESION AND PRE-DILATATION WAS PERFORMED WITH A 6X100, 8X100, AND 12X80 MUSTANG BALLOON CATHETERS. DUE TO SEVERE TORTUOSITY OF THE BLOOD VESSEL, THE BALLOON RETRACTED SEVERELY AFTER CROSSING. SUBSEQUENTLY, A 14X90/9FR 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, AFTER MULTIPLE ATTEMPTS TO CROSS THE LESION, THE STENT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE COVER OF THE STENT AND THE STENT ITSELF WERE DAMAGED. DEPLOYMENT WAS TESTED OUTSIDE THE PATIENT BODY BUT THERE WAS DIFFICULTY ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742988 ↗
• MalfunctionNov 29, 2022Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT STENT FAILURE TO DEPLOY OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 75CM WALLSTENT ENDOPROSTHESIS SELECTED FOR USE. PRIOR TO THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED UPON FLUSHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15881774 ↗
• InjuryOct 18, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE SEVERELY STENOSED, 30-40MM TARGET LESION WAS LOCATED IN ILIAC VEIN. AFTER THE GUIDEWIRE WAS INSERTED AND PRE-DILATION WAS PERFORMED, A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE PROXIMAL OF THE STENT WAS SHRINKED AT 1-1.5CM. THE LESION WAS OVERLAPPED WITH ANOTHER 16X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT AND PRE-DILATED AGAIN WITH BALLOON CATHETER. THE VESSEL MONORLOGY WAS GOOD BUT THE PROXIMAL PART OF SECOND STENT WAS ALSO SHRINKED AT ABOUT 2CM, WHICH AFFECTED THE POSITIONING. A BALLOON WAS USED TO PUSH THE STENT AHEAD AT THE OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626592 ↗
• MalfunctionAug 23, 2022Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A LOWER EXTREMITY VEIN. A 14X90/9FR WALLSTENT ENDOPROSTHESIS WAS ADVANCED; HOWEVER, DURING INTRODUCTION, THE STENT DEPLOYED IN ADVANCE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280391 ↗
• MalfunctionAug 11, 2022Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT STRUT WAS KINKED AND COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214348 ↗
• MalfunctionJun 24, 2022Mechanical Problem; Activation, Positioning or Separation Problem; Material Deformation; Mechanical Problem; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED AND DIFFICULT TO RECONSTRAINED. THE PATIENT UNDERWENT ILIAC VEIN STENTING AND LEFT FEMORAL VEIN PUNCTURE. THE PHYSICIAN ADVANCED THE GUIDEWIRE AND SHEATH, THEN THE PHYSICIAN PERFORMED HIGH PRESSURE IMAGING THROUGH THE SHEATH. AFTER THE LESION POSITION WAS CONFIRMED, THE PHYSICIAN ADVANCED THE GUIDEWIRE TO THE PROPER POSITION IN INFERIOR VENA CAVA. THE PHYSICIAN USED A 6X100 MUSTANG AND 12X60 XXL BALLOON CATHETERS WERE USED FOR PRE-DILATATION. THE PHYSICIAN CONFIRMED COMMON ILIAC OSTIAL AND DECIDED TO IMPLANT A 14X90/9FR 75CM WALLSTENT ENDOPROSTHESIS. THE STENT WAS DEPLOYED INSIDE THE PATIENT, BUT UNDER DSA, THE PHYSICIAN COULD SEE THE STENT GOT STUCK IN THE HALF WAY OF DEPLOYMENT, AND IT COULD NOT CONTINUE TO DEPLOY. THE PHYSICIAN CONSTRAINED THE STENT AND RE-DEPLOYED THE STENT. BUT WHEN IT CAME TO THE SAME POSITION, THE STENT COULD NOT DEPLOY AS WELL AS COULD NOT RECONSTRAINED. SO THE PHYSICIAN RETRIEVED THE DEVICE BY SIMPLY PULLING IT OUT FROM THE PATIENT. AFTER RETRIEVING THE STENT OUT OF THE PATIENT, IT WAS FOUND THE STENT DELIVERY OUTER SHEATH WAS KINKED. THE STENT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14803191 ↗
• MalfunctionApr 6, 2022Difficult or Delayed Positioning; Material Deformation; Difficult or Delayed Positioning; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 14X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS HARD TO RELEASE AND WAS STUCK. IT WAS NOTED THAT THE STENT WAS A BIT OUT OF SHAPE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14029747 ↗
• MalfunctionFeb 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED TO USE. HOWEVER, DURING THE PROCEDURE, THE TIP OF STENT STRUT WAS LIFTED UP AND BENT WHEN FLUSHING AND COULD NOT BE WITHDRAWN FOR DEPLOYMENT. THE PROCEDURE WAS COMPLETED ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544161 ↗
• InjuryJan 5, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE STENT FORESHORTENED. THE 50% STENOSED LOWER EXTREMITY VEIN WAS TREATED WITH BALLOON EXPANSION AND VENOUS STENTING. A 14MM X 90M WALLSTENT UNI STENT WAS IMPLANTED. ANOTHER 14MM X 90M WALLSTENT UNI STENT WAS PLANNED. WHILE DELIVERING THE SECOND STENT NORMALLY, HALF OF THE STENT OVERLAPPED THE PREVIOUSLY PLACED ONE, AND IT WAS DEPLOYED SLOWLY. WHEN THE STENT WAS FULLY DEPLOYED, IT APPEARED THAT THE STENT WAS SEVERELY SHORTENED. THE OVERLAPPED PORTION OF THE TWO STENTS WAS LESS THAN 1CM. A BALLOON WAS USED, AND THE TWO STENTS DETACHED FROM EACH OTHER. 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

  MAUDE report 13172721 ↗
• MalfunctionDec 22, 2021Positioning Failure; Difficult to Remove; Material Deformation; Positioning Failure; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT A STENT PARTIALLY DEPLOYED AND WAS DAMAGED AFTER IT WAS IMPLANTED. A 14MM X 90MMX 75CM, 9FRENCH WALLSTENT UNI SELF EXPANDING STENT WAS SELECTED TO TREAT 75% STENOSIS IN THE ILIAC VEIN. THE STENT WAS ADVANCED ALONG THE GUIDEWIRE TO THE LESION AND IT WAS POSITIONED ACCURATELY IN THE LESION. DURING DEPLOYMENT, THE STENT PARTIALLY DEPLOYED. IT COULD NOT DEPLOY AND COULD NOT BE WITHDRAWN. THE PHYSICIAN PULLED OUT THE DELIVERY SHAFT TO DEPLOY STENT. THE STENT WAS SEVERELY ELONGATED AND DEFORMED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE DEVICE WAS RECEIVED AND ANALYSIS WAS COMPLETED ON 25JAN2022. THE DEVICE WAS RETURNED WITH THE STENT DEPLOYED FROM THE DELIVERY SYSTEM. THE DEPLOYED STENT WAS NOT RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED NO DAMAGE OR ISSUES WITH THE STENT CUPS OR STENT HOLDER OF THE RETURNED DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED A SHAFT KINK LOCATED APPROXIMATELY 265MM DISTAL FROM THE DISTAL END OF THE T CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13068279 ↗