BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 8681858 · Received June 10, 2019

    Report

    Report Number
    9612164-2019-02242
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    September 1, 2018
    Report Date
    September 9, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: CATALOG NUMBER: VAMC4036C150TE, SERIAL NUMBER: UNKNOWN, USE BY DATE: UNKNOWN AND UPN# UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; FAVORABLE REMODELING AFTER HYBRID ARCH DEBRANCHING AND MODIFIED PROVISIONAL EXTENSION TO INDUCE COMPLETE ATTACHMENT TECHNIQUE IN TYPE A AORTIC DISSECTION ARKADIUSZ KAZIMIERCZAK, MD, PHD, TOMASZ JEDRZEJCZAK, MD, PHD, PAWEL RYNIO, MD, SZYMON WALIGÓRSKI, MD, PHD MEDICINE (2018) 97:37(E12409) DOI: HTTP://DX.DOI.ORG/10.1097/MD.0000000000012409 A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN THE AORTIC ARCH (VAMF3636C200TE) AND DESCENDING THROACIC AORTA (VAMC4036C150TE) FOR ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. THE PATIENT HAD PREVIOUSLY BEEN TREATED WITH A TUBE GRAFT TWO YEARS EARLIER. THE SIZES OF THE THORACIC, ABDOMINAL, AND INFRARENAL SEGMENTS OF THE AORTA WERE 38, 32, AND 26MM, RESPECTIVELY. THE TRUE LUMEN (TL) WAS COMPROMISED IN THE THORACIC AND ABDOMINAL AORTA, WITH DISTAL RE-ENTRY IN BOTH COMMON ILIAC ARTERIES. VISCERAL BRANCHES WERE PATENT AND SUPPLIED BY THE TL. THE LEFT RENAL ARTERY (LRA) WAS SUPPLIED BY THE FALSE LUMEN (FL). THE TL VOLUME WAS 87 ML, AND TOTAL FL VOLUME WAS 209 ML. CONTRAST-ENHANCED CTA SHOWED NO THROMBOSIS IN THE FL. IT WAS REPORTED THAT 6 MONTHS POST IMPLANT OF THE VALIANT CAPTIVIA, A CTA SHOWED FURTHER DISEASE PROGRESSION AND THE PATIENT EXPERIENCED CHEST PAIN. THE SIZE OF THE THORACIC AORTA INCREASED TO 49MM, THAT OF THE ABDOMINAL AORTA INCREASED TO 36MM, AND THAT OF THE INFRARENAL AORTA INCREASED TO 30MM. THE VALIANT CAPTIVIA STENT GRAFT COLLAPSED BECAUSE OF FL EXPANSION. HOWEVER, THE VISCERAL BRANCHES DID NOT SHOW SUBSTANTIAL CHANGE. THE FOLLOWING NEW RISK FACTORS WERE APPARENT IN THE THORACIC AORTA: TOTAL AORTIC SIZE >4CM, FL SIZE >22MM, PARTIAL FL THROMBOSIS, AND FAST AORTIC GROWTH >5MM WITHIN 6 MONTHS. THE FL VOLUME INCREASED TO 248 ML. AS TREATMENT, A 200 MM NON-MEDTRONIC BARE METAL SELF-EXPANDABLE STENT WAS IMPLANTED IN THE VISCERAL AND INFRARENAL AORTA. A 46 X 200 MM TALENT THORACIC STENT GRAFT WAS DEPLOYED OVERLAPPING THE PREVIOUSLY IMPLANTED VALIANT CAPTIVIA AND THE NON-MEDTRONIC BARE METAL STENT. BALLOONING OF ALL DEVICES WAS PERFORMED WITH A NON-MEDTRONIC BALLOON CATHETER. 2 ENDURANT II ILIAC EXTENSION STENT GRAFTS WERE ALSO IMPLANTED BETWEEN THE RENAL ARTERIES AND BOTH COMMON ILIAC ARTERIES, WITHIN THE NON-MEDTRONIC BMS. THE ENDURANT II STENT GRAFTS WERE BALLOONED WITH 2 RELIANT BALLOON CATHETERS, USING THE KISSING BALLOON TECHNIQUE. FINAL ANGIOGRAPHY SHOWED NO FL LEAKAGE AND PATENCY OF ALL VISCERAL BRANCHES, INCLUDING THE PREVIOUSLY OCCLUDED LRA. NO FURTHER SYMPTOMS OR COMPLICATIONS WERE NOTED FOLLOWING THE INTERVENTION. ABSTRACT: RATIONALE: TYPE A AORTIC DISSECTION (TAAD) USUALLY REQUIRES EMERGENCY OPEN REPAIR OF THE ASCENDING AORTA. IN CASES OF DIFFUSE DISSECTION THAT SPREADS ALONG THE DESCENDING ANDABDOMINAL AORTA (TYPE I, DEBAKEY CLASSIFICATION), THE RISK OF ANEURYSMAL DEGENERATION VARIES BETWEEN 30% AND 50% DURING 5 YEARS AND INCREASES EVEN HIGHER DURING A LONGER FOLLOW-UP. THOSE PATIENTS MIGHT REQUIRE COMPLEX INTERVENTION TO PREVENT AORTIC RUPTURE. A COMBINATION OF HYBRID ARCH DEBRANCHING AND THE EXTENDED PROVISIONAL EXTENSION TO INDUCE COMPLETE ATTACHMENT (E-PETTICOAT) TECHNIQUE MIGHT BE AN AVAILABLE ALTERNATIVE IN SUCH CASES. THIS IS THE FIRST REPORT OF THE SUCCESSFUL USE OF THE E-PETTICOAT TECHNIQUE FOR TREATING DEGENERATIVE, DIFFUSE TAAD. PATIENT CONCERNS: ACUTE CHEST PAIN AND SYNCOPE WERE THE INITIAL SYMPTOMS OF DIFFUSE TAAD IN OUR 66-YEAR-OLD FEMALE PATIENT. OPEN REPLACEMENT OF THE ASCENDING AORTA FOLLOWED BY SURGICAL ARCH DEBRANCHING WAS PERFORMED AS A STAGED PROCEDURE. UNFORTUNATELY, PROGRESSIVE ANEURYSMAL DEGENERATION WAS REVEALED 6 MONTHS LATER IN THE THORACIC, ABDOMINAL, AND INFRARENAL AORTA WITH THE RECURRENCE OF CHEST AND LUMBAR PAIN. DIAGNOSES: COMPUTED ANGIOTOMOGRAPHY REVEALED SEVERE ANEURYSMAL DEGENERATION OF AORTIC DISSECTION IN THE THORACIC AND ABDOMINAL AORTA. INTERVENTION: THE E-PETTICOAT ENABLED GOOD REMODELING AND STOPPED DEGENERATION. OUTCOME: AT THE 2-YEAR FOLLOW-UP, GOOD REMODELING WITH COMPLETE FALSE LUMEN THROMBOSIS AND A STABLE AORTIC SIZE WERE CONFIRMED. LESSON: LIFELONG FOLLOW-UP IN EXTENSIVE TAAD SHOULD BE CONSIDERED. THE E-PETTICOAT TECHNIQUE IS AN AVAILABLE ALTERNATIVE TO FENESTRATED ENDOVASCULAR AORTIC REPAIR FOR DEGENERATIVE TAAD, AS IT PROMOTES FAVORABLE REMODELING AFTER SUCCESSFUL SURGERY OF THE ASCENDING AORTA. ABBREVIATIONS: BEVAR = BRANCHED ENDOVASCULAR AORTIC REPAIR, BMS-XL = EXTRA LARGE BARE METAL STENT, CERAB = COVERED ENDOVASCULAR RECO NSTRUCTION OF AORTIC BIFURCATION, CTA = COMPUTED ANGIOTOMOGRAPHY, E-PETTICOAT = EXTENDED PROVISIONAL EXTENSION TO INDUCE COMPLETE ATTACHMENT, FEVAR = FENESTRATED ENDOVASCULAR AORTIC REPAIR, FL = FALSE LUMEN, IA = INNOMINATE ARTERY, KS = KISSING STENTS, LCCA = LEFT COMMON CAROTID ARTERY, LRA = LEFT RENAL ARTERY, PETTICOAT = PROVISIONAL EXTENSION TO INDUCE COMPLETE ATTACHMENT, RRA = RIGHT RENAL ARTERY, TAAD = TYPE A AORTIC DISSECTION, TL = TRUE LUMEN. KEYWORDS: AORTIC DISSECTION, CERAB, KISSING STENTS, MODIFIED PETTICOAT, PETTICOAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476924 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3636C200TE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention