BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 6450226 · Received March 31, 2017

    Report

    Report Number
    2953200-2017-00499
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    December 17, 2015
    Report Date
    April 27, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (MODIFICATION AND USED IN SCA).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: IATROGENIC SUBCLAVIAN ARTERY PERFORATION RESCUED BY OPERATOR-MODIFIED GRAFT STENT. CHIH-HUNG LAI1, CHUNG-LIN TSAI1, WEI-CHUN CHANG, CHIEH-SHOU SU, AND WEN-LIENG LEE. AN ENDURANT STENT GRAFT SYSTEMS WAS IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF SEVERE STENOSIS IN THE PROXIMAL LEFT SUB CLAVIAN ARTERY. PERCUTANEOUS REVASCULARIZATION WAS DONE VIA RIGHT FEMORAL ARTERY APPROACH, AND SEVERE LEFT SCA STENOSIS WAS CONFIRMED (SUPPLEMENTARY VIDEO 1, ONLY ONLINE). DIRECT STENTING IN THE LEFT SCA WAS CARRIED OUT WITH A BALLOON-EXPANSIBLE EXPRESS LD 10×25 MM STENT (BOSTON SCIENTIFIC CORPORATION, (B)(4)) UP TO 8 ATMOSPHERES FOR 13 SECONDS. HOWEVER, SEVERE SHORTNESS OF BREATH AND HYPOTENSION DEVELOPED AFTER STENTING. THE BLOOD PRESSURE WAS DOWN TO 88/56, AND THE HEART RATE WAS UP TO 90. THE OXYGEN SATURATION WAS DOWN TO 74%. EMERGENT INTUBATION, FLUID INFUSION, INOTROPIC AGENT WITH NOREPINEPHRINE WERE GIVEN. THE IMMEDIATE ANGIOGRAPHY SHOWED VASCULAR PERFORATION IN THE STENTED SEGMENT OF LEFT SCA (SUPPLEMENTARY VIDEO 2, ONLY ONLINE). EMERGENCY BALLOON INFLATION WITHIN THE STENT WAS DONE WITH AN 8×40 MM BALLOON. THE CARDIOVASCULAR SURGEON WAS ALSO CONSULTED. HOWEVER, DUE TO THE HIGH SURGICAL RISK OF BYPASS, ENDOVASCULAR TREATMENT WAS SUGGESTED. WE DECIDED TO DO A RETROGRADE APPROACH THROUGH THE LEFT BRACHIAL ARTERY BY SURGICAL CUT-DOWN. SINCE THERE WAS NO SUITABLE GRAFT STENT IN OUR CATH LAB, WE MODIFIED AND CUT THE ILIAC EXTENSION OF SELF- EXPANDING ENDURANT II GRAFT STENT 10×82 MM (MEDTRONIC, (B)(4)), WHICH WAS ORIGINALLY DESIGNED TO TREAT ABDOMINAL AORTIC ANEURYSMS (AAA), TO A SUITABLE LENGTH (AROUND 30 MM). AFTER RETROGRADE WIRING, AN OPERATOR-MODIFIED ENDURANT II GRAFT STENT WAS DEPLOYED IN THE STENT SEGMENT AND THE PERFORATION WAS SEALED SUCCESSFULLY. AFTER STENTING OF THE GRAFT STENT, HOWEVER, SLOW FLOW OF LEFT COMMON CAROTID ARTERY (LCCA) WAS NOTED, AND ANGIOGRAPHY CONFIRMED THE NEAR TOTAL OCCLUSION OF THE LCCA, OCCLUDED BY THE SCA GRAFT STENT. A FIRM WIRE (CONQUEST PRO, ASAHI (B)(4)) WAS SUCCESSFULLY ADVANCED OUTSIDE THE GRAFT STENT AND INTO THE LCCA. DESPITE SEQUENT BALLOON DILATIONS AT THE BIFURCATION SITE, THE FLOW TO THE LCCA WAS STILL POOR. INTRAVASCULAR ULTRASOUND ALSO CONFIRMED THE SEVERE COMPROMISE OF THE LCCA OSTIUM WHICH WAS CAUSED BY THE GRAFT STENT. THEREFORE, WE PUT A BALLOON-EXPANSIBLE CAROTID STENT, EXPRESS 7×37 MM (BOSTON SCIENTIFIC CORPORATION), FROM THE LCCA TO THE LEFT BRACHIOCEPHALIC ARTERY. TIMI III FLOW OF THE LCCA WAS RESTORED AFTER STENTING. INTRAVASCULAR ULTRASOUND ALSO CONFIRMED PROPER EXPANSION OF THE LCCA STENT. THE FOLLOW-UP CHEST RADIOGRAPHY REVEALED LEFT-SIDE HEMOTHORAX. AFTER THORACOCENTESIS WITH DRAINAGE AND PROPER CARE, THE PATIENT WAS DISCHARGED. TILL NOW, THE PATIENT HAS BEEN FREE FROM SYMPTOMS FOR SIX MONTHS. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: OCCLUSION. ABSTRACT: SUBCLAVIAN ARTERY (SCA) PERFORATION IS A RARE COMPLICATION WHILE PERFORMING SCA INTERVENTION. IN OUR PRESENT REPORT, A (B)(6) FEMALE, WITH STENOSIS OF THE LEFT SCA AND SITUS INVERSUS, PRESENTED WITH EXERCISE-INDUCED LEFT ARM WEAKNESS. THE SCA STENOSIS WAS TREATED WITH DIRECT STENTING WITH A BALLOON-EXPANSIBLE EXPRESS LD 10×25 MM STENT. HOWEVER, IT CAUSED IATROGENIC SCA PERFORATION AND HEMOTHORAX. THE PERFORATION WAS SEALED BY ENDOVASCULAR REPAIR WITH OPERATOR-MODIFIED ENDURANT II GRAFT STENT, WHICH COMPLICATED WITH OCCLUSION OF LEFT COMMON CAROTID ARTERY. AND, THE CAROTID ARTERY WAS RESCUED BY ANOTHER STENT. THE GRAFT STENT, WHICH WAS ORIGINALLY DESIGNED FOR ABDOMINAL AORTIC ANEURYSM, CAN BE MODIFIED TO SUITABLE LENGTH AND TAKE AS A RESCUE STENT OF LARGE VESSEL WITH IATROGENIC PERFORATION. DUE TO STRONG RADIAL FORCE OF GRAFT STENT, PRESERVATION OF LARGE SIDE BRANCHES SHOULD BEEN WATCHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232826 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention