Abre™ AB9U16150090Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169796379), received between Oct 26, 2021 and May 25, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 reports).

3 other recalls cover devices cleared under the same FDA submission (P200026); they may or may not involve this specific model.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Premature Activation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN ABRE STENT, A DEPLOYMENT ISSUE OCCURRED, PRE-DEPLOYMENT WHILE THE DEVICE WAS ON THE WAY TO THE TARGET SITE. THE SURGERY WAS DELAYED FOR 5 MINUTES DUE TO THE PRODUCT ISSUE. THE STENT DID NOT REMAIN IN THE PATIENT AND WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. NO VESSEL DAMAGE WAS REPORTED. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC 16X150 ABRE DEVICE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268703 ↗
• MalfunctionDec 2, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE USING THE ABRE STENT FOR TREATMENT OF A FIBROUS, STENOTIC LESION IDENTIFIED IN THE LEFT COMMON AND EXTERNAL ILIAC VEINS AT A PROXIMAL LOCATION. THE LESION EXHIBITED STENOSIS GREATER THAN 60%, MEASURED 120 CMIN LENGTH, AND THE VEIN DIAMETER WAS 14 MM, WITH MINIMAL TORTUOSITY AND CALCIFICATION. PATIENT ABNORMALITIES IN RELATION TO ANATOMY INCLUDED STENOSIS DUE TO POST THROMBOTIC SYNDROME. A 10 FR NON MEDTRONIC SHEATH WAS USED. VESSEL WAS PRE-DILATED WITH A NON MEDTRONIC DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET DURING ADVANCEMENT. DURING DEPLOYMENT, DIFFICULTY WAS NOTED AS THE STENT PARTIALLY DEPLOYED INTO A WINE GLASS SHAPE, THE THUMB WHEEL STOPPED ROLLING BACK. THE PHYSICIAN BROKE APART THE HANDLE WITH HEMOSTATS TO MANUALLY PULL THE DEPLOYMENT STRING. STRING LOOKED TO BE IN A LOOP SHAPE- HEAVY RESISTANCE IN PULLING STRING BACK (JUST LIKE THUMB WHEEL DIFFICULTY). SHEATH WAS PULLED BACK TO TRY TO REPOSITION IN HOPES TO EASE DEPLOYMENT AND TROUBLESHOOTING. A FEW STRONGER PULLS ON THE STRING AND THE STENT DEPLOYED. SOME STENT CELLS APPEARED NOTABLY LARGER, WHILE PROXIMAL CELLS AP

  Patient problems: Insufficient Information

  MAUDE report 23694956 ↗
• MalfunctionJun 12, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ABRE STENT, THE STENT WAS UNINTENTIONALLY DEPLOYED OUTSIDE OF THE TARGET SITE IN THE LEFT DISTAL EXTERNAL ILIAC VEIN, RESULTING IN INACCURATE DELIVERY AND DEPLOYMENT MORE PROXIMALLY THAN INTENDED. THE PROCEDURE WAS COMPLETED USING A NEW 16 X 150 MEDTRONIC ABRE DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY BUT WILL REQUIRE ACTIVE FOLLOW UP TO ENSURE VEIN PATENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192880 ↗
• MalfunctionMay 26, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS USING A STENT AB9U16150090 ABRE TO TREAT THE LEFT PROXIMAL PERIPHERAL VEIN, COMMON ILIAC VEIN (CIV). TARGET LESION WAS FIBROUS WITH NO DEGREE OF TORTUOSITY, MINIMAL DEGREE OF CALCIFICATION. 90% LESION STENOSIS, 150MM LESION LENGTH AND ARTERY/VEIN DIAMETER IS 14MM. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. 10FR CORDIS SHEATH AND A .035 INQWIRE GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED; THE VESSEL WAS NOT PRE-DILATED AND WAS POST-DILATED. A 12MM BOSTON CHARGER DILATION DEVICE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. DEPLOYMENT ISSUES WERE REPORTED DURING THE PROCEDURE, THE STENT HAD STARTED TO DEPLOY, DEPLOYMENT WHEEL CONTINUED TO SPIN BUT STENT WAS NOT DEPLOYING. PHYSICIAN REMOVED HANDLE, STRING WAS BROKEN. CUT DOWN THE STENT CATHETER TO EXPOSE MORE STRING, DID NOT WORK. ULTIMATELY DID PIN AND PULL. HOWEVER, THE STENT DEPLOYED SUCCESSFULLY WITHOUT INJURY/INTERV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084200 ↗
• InjuryMar 22, 2024Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO IMPLANT AN ABRE SELF-EXPANDING STENT WITH A 10FR NON-MEDTRONIC (BOSTON SCIENTIFIC) SHEATH AND AN 145 035 NON-MEDTRONIC (MERIT BENTSON) GUIDEWIRE DURING TREATMENT OF A 150MM SOFT TISSUE LESION IN THE PATIENT¿S RIGHT DISTAL EXTERNAL ILIAC VEIN (EIV). LESION EXHIBITED MORE THAN 50% STENOSIS. VEIN DIAMETER REPORTED AS 16MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED WITH A 16X6 NON-MEDTRONIC (CORDIS) DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. STENT DEFORMATION UPON DEPLOYMENT IN VIVO WAS REPORTED. THE STENT WAS OBSERVED TO HAVE SHORTENED. THE LENGTH OF THE DEPLOYED STENT IN VESSEL WAS 130MM. THE STENT PLACEMENT WAS NOT ADJUSTED AFTER INITIAL FLOWERING OF STENT. AN ADDITIONAL NON-MEDTRONIC (BOSTON WALLSTENT) STENT WAS REQUIRED. NO PATIENT INJURY REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959702 ↗
• MalfunctionJan 24, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE SELF-EXPANDING STENT WITH A 9FR SHEATH DURING PROCEDURE TO TREAT A LESION IN THE PATIENTS MID ILIAC VEIN. MODERATE VESSEL TORTUOSITY AND NO VESSEL CALCIFICATION ARE REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED WHEN READY TO DEPLOY. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A REPLACEMENT ABRE STENT WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569807 ↗
• InjuryAug 4, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A ABRE STENT TO TREAT A FIBROUS LESION IN THE LEFT DISTAL ILIAC VEIN.  EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU.  THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN USED A 16X150 ABRE AND SAID IT MEASURED JUST OVER 18MM AFTER DEPLOYMENT. PROCEDURE WAS COMPLETED BY PLACING A SECOND ABRE ON THE OTHER SIDE BECAUSE THE FIRST ONE WAS CROSSING OVER THE RIGHT ILIAC VEIN. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457849 ↗
• InjuryApr 4, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN ABRE SELF-EXPANDING STENT WAS USED FOR TREATMENT OF A LESION IN THE ILIAC ARTERY BOTH COMMON AND EXTERNAL. A 9FR SHEATH WAS USED. THE LESION WAS NOT PREDILATED IT WAS REPORTED THE PHYSICIAN A PLACED A 16MM X 150MM ABRE STENT IN THE PATIENT¿S LEFT COMMON INTO THE EXTERNAL ILIAC. A SMALL PART OF THE STENT IS IN THE VENA CAVA. AFTER PLACING THE STENT, IVUS WAS USED TO MEASURE THE STENT AND IT MEASURED 18MM+. THE PHYSICIAN BELIEVES THE STENT IS AN 18MM STENT BUT WAS PACKAGED IN A 16MM BOX/PACKAGING. THE PATIENT IS PLANNED TO BE BROUGHT BACK IN 3 WEEKS TO STENT THE OTHER SIDE DUE TO THE STENT MEASURING 18MM+ AND A PORTION OF IT IS IN THE VENA CAVA AND INFRINGING ON THE RIGHT SIDE OF THE VENA CAVA. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16671929 ↗
• MalfunctionJan 17, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ABRE STENT WAS INTENDED TO BE IMPLANTED IN THE PROXIMAL REGION OF THE ILIAC VEIN FOR TREATMENT OF A FIBROUS LESION. THERE WAS MILD TORTUOSITY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES. IT WAS REPORTED THE STENT WAS PLACED IN POSITION AND THE RED TAB WAS PULLED. AT THIS POINT THE THUMB WHEEL WAS BEING ACTIVATED TO DEPLOY STENT. THERE WAS STRONG RESISTANCE AND THE THUMB WHEEL WOULD NOT MOVE. THE DEVICE WAS REMOVED FROM PATIENT AND REPLACED WITH ANOTHER ABRE STENT. NO PATIENT INJURY WAS REPORTED WITH THIS EVENT. WHEN THE STENT WAS RETURNED TO THE MANUFACTURING FACILITY IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16181895 ↗
• InjurySep 14, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN ABRE STENT SYSTEM FOR THE TREATMENT OF A CALCIFIED LESION WITH 50% STENOSIS IN THE RIGHT PROXIMAL COMMON ILIAC VEIN.  A 9FR NON-MDT SHEATH AND .035 GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DEPLOYMENT ISSUES WERE EXPERIENCED AND THE DEVICE WAS UNABLE TO DEPLOY. RESISTANCE WAS ENCOUNTERED AND FORCE WAS APPLIED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. THE THUMBWHEEL WAS DIFFICULT TO ROTATE ON THE 1ST AND 2ND ROTATION, BUT THE PHYSICIAN PRESSED HARD TO ROTATE THUMBWHEEL. 3RD AND 4TH ROTATION WAS MORE DIFFICULT TO ROTATE AND THEN THE THUMBWHEEL STOPPED AND WOULDN'T ROTATE ANY FURTHER. THE PHYSICIAN BROKE THE HANDLE, REMOVED THE CLIP AND USED PIN/PULL METHOD TO DEPLOY THE STENT. THE ABRE STENT ENLONGATED SO THEY HAD TO RE LINE WITH 3 ADDITIONAL ABRE STENTS.

  Patient problems: Insufficient Information

  MAUDE report 15416463 ↗
• MalfunctionJun 23, 2022Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE SELF-EXPANDING STENT ALONG WITH A 9FR SHEATH AND WHOLEY GUIDEWIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL CONFLUENCE OF COMMON ILIAC VEIN WITH GREATER THAN 50% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. STENT DEFORMED IN VIVO DURING POSITIONING/DEPLOYMENT OCCURRED. PHYSICIAN COMPLETED THE PROCEDURE. A 6MM X 40MM EVERCROSS PTA WAS USED TO DILATE THE STENT DISTAL EDGE. THE LENGTH OF DEPLOYED STENT IN VESSEL WAS 150MM. A NON-MEDTRONIC 14MM X40 DEVICE WAS USED TO PRE DILATE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DISTAL EDGE OF THE STENT APPEARED COMPRESSED AT THE FIRST FEW MM OF THE STENT DEPLOYMENT. THE REMAINDER OF THE STENT DEPLOYED SUCCESSFULLY. THE PHYSICIAN UTILIZED A 6X40 EVERCROSS TO POST DILATED THE COMPRESSED DISTAL EDGE OF STENT. THE BALLOON TRACKED EASILY AND UPON A FEW ATMOSPHERES OF PRESSURE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786104 ↗
• InjuryFeb 24, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT PRESENTED WITH VENOUS STASIS, SWELLING AND NON-HEALING VENOUS LEG ULCERS. DIAGNOSED WITH SYMPTOMATIC NON-THROMBOTIC ILIAC VEIN LESION OF RIGHT EIV, CEAP 6. AN ABRE SELF-EXPANDING STENT WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC VEIN (OVERLYING RIGHT INTERNAL ILIAC ARTERY COMPRESSION). THE PATIENT WAS HYDRATED. IVUS WAS USED FOR VESSEL SIZING. PHYSICIAN MEASURED THE EIV TO BE ROUGHLY 12-14 AND CIV TO BE ROUGHLY 15MM, AND ELECTED A 16MM DIAMETER STENT IN EIV. WHILE THE PATIENT WAS OF LARGE BODY HABITUS, THE PHYSICIAN DID NOT WANT TO USE AN 18MM DIAMETER STENT BECAUSE HE THOUGHT THE OVERSIZING WOULD HAVE BEEN EXTREME AND WOULD LEAD TO PATIENT PAIN. PHYSICIAN STATED HE WOULD ELECT THE SAME SIZE STENT IF THEY DID THE PROCEDURE AGAIN. IVUS WAS USED THROUGHOUT INDEX PROCEDURE. FOCAL 95% AREA STENOSIS CONFIRMED ON IVUS. IVUS USED POST PROCEDURE TO CONFIRM STENT PLACEMENT. THE STENT DID NOT LAND IN A CURVE. THE STENT COVERED THE FULL AREA OF STENOSIS. THERE WAS NORMAL DELIVERY OF THE STENT. EVERYTHING LOOKED GREAT AT TIME OF DEPLOYMENT. THE PATIENT WAS BEING SEEN IN WOUND CARE CLINIC WEEKLY PRIOR TO AND FOLLOWING STENT PLACEMENT. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT DEVE

  Patient problems: Insufficient Information

  MAUDE report 13590035 ↗
• InjuryJan 4, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN ATTEMPTED TO USE AN ABRE SELF EXPANDING STENT WITH A NON-MEDTRONIC 13F (INARI) SHEATH AND NON-MEDTRONIC (BSC AMPLATZ SUPER STIFF) GUIDEWIRE DURING TREATMENT OF A 250MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT'S LEFT COMMON AND EXTERNAL ILIAC VEINS. ARTERY DIAMETER REPORTED AS 14MM. SLIGHT VESSEL TORTUOSITY REPORTED. THERE WAS NO  DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED.  PRIOR TO STENT PLACEMENT THE PATIENT NECESSITATED THROMBECTOMY WITH A NON-MEDTRONIC (INARI) CLOTTRIEVER AND FLOWTRIEVER. UTILIZATION OF A NON-MEDTRONIC (BOSTON SCIENTIFIC ANGIOJET) ATHERECTOMY DEVICE WAS ALSO EMPLOYED. ALL VEINS WERE SERIALLY PREDILATED FROM 12MM-14MM WITH APPROPRIATE ANGIOPLASTY BALLOONS. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT SYSTEM WAS ADVANCED ACROSS THE LESION VIA POPLITEAL VEIN ACCESS WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK PIN WAS REMOVED JUST PRIOR TO STENT DEPLOYMENT WITH MUCH DIFFICULTY. T

  Patient problems: Insufficient Information

  MAUDE report 13153514 ↗
• MalfunctionDec 8, 2021Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE ABRE VENOUS SELF EXPANDING STENT DURING PROCEDURE TO TREAT PROXIMAL LEFT COMMON ILIAC VEIN AND IVC. THE VESSEL HAD NO TORTUOSITY OR CALCIFICATION. THE VESSEL EXHIBITED STENOSIS AS FOLLOWS LCIV REF (10.1+21.4)/2=15.75 LCIV (9.6+17.6)/2=13.6 LEIV REF (12.8+14.9)/2=13.85 LEIV(7/7+12.9)/2=10.3 RCIV REF (15.7+21.2)/2=18.45 RCIV (7.0+21.9)/2= 14.45 REIV REF(14.1+18.3)/2=15.2 REIV (8+14.1)/2=11.05. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT AFTER STENT WAS POST DILATED IT EXTENDED APPROXIMATELY 1.5CM INTO THE IVC.PRIOR TO POST DILATION THE STENT WAS AT THE OSTIUM OF THE CONFLUENCE. THE LESION WAS PRE-DILATED WITH A 16X40MM PRE-DILATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE FINDINGS WERE DISCOVERED DURING FINAL VENOGRAM RUN. PROCEDURE WAS THEN COMPLETED WITHOUT ANY FURTHER ACTIONS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960570 ↗
• MalfunctionOct 26, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE ABRE VENOUS SELF EXPANDING STENT DURING PROCEDURE TO TREAT NON CALCIFIED SOFT TISSUE LESION IN THE DISTAL RIGHT FEMORAL VEIN. THE VESSEL HAD LITTLE TORTUOSITY AND EXHIBITED 70% STENOSIS. THE ARTERY DIAMETER WAS 14MM AND LESION LENGTH WAS 150MM. A NON MEDTRONIC 10 FR SHEATH AND 0.035'' GUIDEWIRE WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WERE DEPLOYMENT/PARTIAL DEPLOYMENT ISSUES. THERE WAS NO DAMAGE TO DEPLOYMENT MECHANISM OR HANDLE PRIOR TO DEPLOYMENT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS NOT PRE-DILATED.  NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE THUMB SWITCH WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND LOCK PIN WAS REMOVED JUST PRIOR TO DEPLOYMENT ONCE THE DEVICE CROSSED THE LESION SITE. THE PHYSICIAN STARTED TO TURN THE THUMB WHEEL TO RETRACT THE SHEATH AND DEPLOY THE STENT. THE AUDIBLE CLICKS WERE HEARD ONCE THE SHEATH STARTED TO RETRACT, THEN AFTER ROUGHLY 2CM OF STENT DEPLOYMENT THE SHEATH STOPPED RETRACTING EVEN THOUGH THE THUMBWH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697901 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200026. One submission often covers many models, so check the product and lot details in each record.

• Z-1098-2026 · Dec 4, 2025 · Open, Classified
  Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G1410
• Z-0464-2022 · Nov 19, 2021 · Terminated
  Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
• Z-1532-2021 · Mar 16, 2021 · Terminated
  Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous