BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABRE VENOUS SELF-EXPANDING STENT SYSTEM

    MDR report key: 24751909 · Received April 1, 2026

    Report

    Report Number
    2183870-2026-00152
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    August 15, 2023
    Report Date
    April 10, 2026
    Manufacturer
    COVIDIEN
    Product Code
    QAN
    UDI-DI
    00643169796430
    PMA / PMN Number
    P200026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NICKEL ALLERGY COMPLICATING ILIAC VEIN STENT REQUIRING EXPLANATION 2025 THE AUTHOR(S). PUBLISHED BY ELSEVIER INC. ON BEHALF OF SOCIETY FOR VASCULAR SURGERY. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY-NC-ND LICENSE (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY-NC-ND/4.0/). HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.102093 B3 DATE OF PUBLICATION MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION TO NOTIFY DATE TO B3 AND G3: DATE OF NOTIFY IS 12-MAR-2026 AND NOT 13- MARCH-2026 ADDITIONAL INFORMATION: THE INITIAL STENT PLACEMENT TOOK PLACE ON (B)(6) 2023 AT (B)(6). ARTERY DIAMETER REPORTED AS 16-18MM. FIBROUS TARGET LESION. MINIMAL VESSEL TORTUOSITY AND CALCIFICATION REPORTED. AT THE TIME OF INITIAL STENT IMPLANTATION PROCEDURE PATIENT HAD KNOWN ALLERGIES TO CLINDAMYCIN, GABOPENTIN AND GLUTEN. NO KNOWN NICKEL ALLERGY PRIOR TO IMPLANT OF THE ABRE. THE PATIENT SUBSEQUENTLY HAD A CONFIRMED ALLERGIC REACTION TO NICKEL DIAGNOSED BY THE (B)(6) MEDICAL CENTER. AT THE TIME OF STENT PLACEMENT, (B)(6) REPORTED THAT THE PATIENT DID NOT INFORM THEM OF A NICKEL ALLERGY. THE PATIENT HAD A REACTION TO THE NICKEL IN THE ABRE AND SUBSEQUENTLY HAD THE ABRE REMOVED AT THE (B)(6) MEDICAL CENTER. STENT WAS EXPLANTED INTACT AND ILIAC VEIN WAS SUCCESSFULLY RECONSTRUCTED. IMAGE ANALYSIS: A NUMBER OF IMAGES WERE PROVIDED FOR EVALUATION IN THE LITERATURE ARTICLE. FIGURE 1, SHOWS PATIENTS SYMPTOMS WERE REPRODUCIBLE WITH PLACEMENT OF A SIMILAR NITINOL STENT ON HER FOREARM IN CLINIC. FIGURE 2, PREOPERATIVE COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED HER STENT EXTENDING FROM HER LEFT COMMON ILIAC VEIN INTO THE INFERIOR VENA CAVA (IVC) WITH AN ASSOCIATED THROMBUS LINING THE STENT, CONCERNING FOR ONGOING INFLAMMATION. FIGURE 3, PREOPERATIVELY, BILATERAL URETERAL STENTS WERE PLACED TO AID IN IDENTIFICATION OF THE URETERS GIVEN EXPECTED INFLAMMATION AT THE AORTIC BIFURCATION. A MIDLINE LAPAROTOMY WAS PERFORMED, AND THE RETROPERITONEUM OVERLYING THE AORTA WAS INCISED. SUBSTANTIAL INFLAMMATION AROUND THE AORTA BIFURCATION AND LEFT ILIAC VEIN WAS ENCOUNTERED. FIGURE 4, A 10-CM BOVINE PERICARDIAL PATCH WAS USED FOR RECONSTRUCTION OF THE IVC AND LEFT ILIAC VEIN TO PREVENT ANY SIGNIFICANT NARROWING MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ABSTRACT ESSENTIALLY ALL ENDOVASCULAR STENTS, BOTH STAINLESS STEEL AND NITINOL, CONTAIN A NICKEL COMPONENT. INCIDENCE OF NICKEL HYPE RSENSITIVITY IS COMMON, BUT NICKEL HYPERSENSITIVITY DOES NOT ALWAYS RESULT IN CLINICALLY SIGNIFICANT REACTIONS. THIS 43- YEAR-OLD WOMAN PRESENTED WITH HIVES, URTICARIA, AND MALAISE AFTER NITINOL STENT PLACEMENT IN HER LEFT ILIAC VEIN FOR MAYTHURNER SYNDROME. SHE UNDERWENT OPEN STENT EXPLANATION AND RECONSTRUCTION OF HER INFERIOR VENA CAVA AND LEFT COMMON ILIAC VEIN WITH SUBSEQUENT RESOLUTION OF SYMPTOMS. THE LOW INCIDENCE OF STENT-RELATED ALLERGY DOES NOT WARRANT PREOPERATIVE TESTING, BUT WE ADVOCATE FOR THOROUGH PREPROCEDURAL DISCUSSION IN HIGH-RISK PATIENTS. FOR SYMPTOMATIC PATIENTS, EXPLANATION CAN BE EFFECTIVE. THE PATIENT IS A 43-YEAR-OLD WOMAN WITH A HISTORY OF LEFT LOWER EXTREMITY VENOUS INSUFFICIENCY AND DEEP VENOUS THROMBOSIS (DVT) SECONDARY TO ORAL CONTRACEPTIVE USE. SHE RECEIVED A NITINOL CONTAINING ABRE (MEDTRONIC) LEFT ILIAC VEIN STENT FOR PRESUMED MAY-THURNER SYNDROME AT AN OUTSIDE FACILITY. IMMEDIATELY AFTER IMPLANTATION, SHE DEVELOPED MULTIFOCAL FACIAL EDEMA, HIVES, AND URTICARIA. SHE WAS SEEN BY AN ALLERGIST WHO DIAGNOSED HER WITH A NICKEL ALLERGY. HER SYMPTOMS PERSISTED DESPITE DAILY ANTIHISTAMINES AND A RANITIDINE (ZANTAC) INHALER. SHE WAS ALSO INSTRUCTED TO CARRY AN EPIPEN. SHE WAS FIRST SEEN IN OUR CLINIC 5 MONTHS POSTOPERATIVE, AT WHICH TIME SHE REPORTED A LONGSTANDING HISTORY OF METAL ALLERGIES. HER SYMPTOMS WERE REPRODUCIBLE WITH PLACEMENT OF A SIMILAR NITINOL STENT ON HER FOREARM IN CLINIC (FIG 1). PREOPERATIVE COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED HER STENT EXTENDING FROM HER LEFT COMMON ILIAC VEIN INTO THE INFERIOR VENA CAVA (IVC) WITH AN ASSOCIATED THROMBUS LINING THE STENT, CONCERNING FOR ONGOING INFLAMMATION (FIG 2). WITH A DIAGNOSED NICKEL ALLERGY AND PERSISTENT SYMPTOMS, SHE WAS CONSENTED FOR OPEN STENT EXPLANTATION AND ILIAC VEIN RECONSTRUCTION, APPROXIMATELY 4 MONTHS AFTER THE ORIGINAL IMPLANTATION. PREOPERATIVELY, BILATERAL URETERAL STENTS WERE PLACED TO AID IN IDENTIFICATION OF THE URETERS GIVEN EXPECTED INFLAMMATION AT THE AORTIC BIFURCATION. A MIDLINE LAPAROTOMY WAS PERFORMED, AND THE RETROPERITONEUM OVERLYING THE AORTA WAS INCISED. SUBSTANTIAL INFLAMMATION AROUND THE AORTA BIFURCATION AND LEFT ILIAC VEIN WAS ENCOUNTERED (FIG 3). THE AORTA AND BILATERAL ILIAC ARTERIES WERE CIRCUMFERENTIALLY MOBILIZED. OWING TO SIGNIFICANT INFLAMMATION, MOBILIZATION OF THE IVC CONFLUENCE AND LEFT ILIAC VEIN WAS LIMITED. CONTROL OF THESE VESSELS WAS OBTAINED OUTSIDE OF THE INFLAMMATORY FIELD. AFTER HEPARINIZATION, A LONG INCISION WAS PERFORMED FROM THE DISTAL COMMON ILIAC VEIN ONTO THE IVC. WIRE CUTTERS WERE REQUIRED TO FREE THE STENT, AND IT WAS EXPLANTED INTACT. DENSELY ADHERENT CHRONIC THROMBUS WAS NOTED WITHIN THE IVC AND ILIAC VEIN, WHICH WAS REMOVED. OWING TO SUBSTANTIAL SCARRING, THE VENOUS VESSELS COULD NOT BE CLOSED PRIMARILY. A 10-CM BOVINE PERICARDIAL PATCH WAS USED FOR RECONSTRUCTION OF THE IVC AND LEFT ILIAC VEIN TO PREVENT ANY SIGNIFICANT NARROWING (FIG 4). FINAL INSPECTION DID NOT DEMONSTRATE COMPRESSION OF THE LEFT ILIAC VEIN, AND THE ABDOMEN WAS CLOSED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED HOME ON POSTOPERATIVE DAY 7 ON ASPIRIN AND APIXABAN GIVEN HER HISTORY OF PROVOKED DVT, DECREASED ACTIVITY LEVEL POSTOPERATIVELY, AND KNOWN INTRALUMINAL STENT THROMBUS. BY 2 MONTHS POSTOPERATIVE, HER ALLERGY SYMPTOMS HAD RESOLVED AND VENOUS DUPLEX ULTRASOUND EXAMINATION DEMONSTRATED NO EVIDENCE OF DVT. SHE WAS TRANSITIONED TO INDEFINITE ASPIRIN MONOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814370 ABRE VENOUS SELF-EXPANDING STENT SYSTEM STENT, ILIAC VEIN QAN COVIDIEN B490586 00643169796430

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention