BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

    MDR report key: 11075423 · Received December 28, 2020

    Report

    Report Number
    3002808486-2020-01176
    Event Type
    Death
    Date Received
    December 28, 2020
    Report Date
    June 9, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A FEMALE PATIENT UNDERWENT EVAR FOR HER INTRAMURAL HEMATOMA AND THORACOABDOMINAL ANEURYSM. IT WAS REPORTED THAT THE PATIENTS ACCESS VESSELS WERE A MAXIMUM OF 7 MM. TWO COMPETITOR STENTGRAFTS, A TBRANCH AND A TBE WAS IMPLANTED. AFTER THE IMPLANT OF THE TWO COMPETITOR STENTGRAFTS THE PATIENT HAD CARDIAC CHANGES WITH S-T ELEVATION THAT REQUIRED URGENT EVALUATION OF A CARDIOLOGIST. WHEN THE CARDIOLOGIST GAVE ALL CLEAR TO PROCEED THE TBRANCH AND THE TBE (COMPLAINT DEVICE) WAS IMPLANTED. AT COMPLETION OF PROCEDURE IT WAS NOTED THAT THE RIGHT EXTERNAL ILIAC ARTERY HAD RUPTURED, AND TWO COVERED STENTS FROM A COMPETITOR WERE IMPLANTED TO CONTROL THE BLEEDING. A FOLLOW-UP CTA WAS DONE PRIOR TO THE PATIENT BEING DISCHARGED. 6-7 DAYS POST-OP THE PATIENT REPORTED ABDOMINAL PAIN AND AN AMBULANCE WAS CALLED, HOWEVER, THE PATIENT DIED. THE CORONER HAS REPORTED THAT HER CAUSE OF DEATH WAS EXTRAVASATION FROM A STENT IN HER RIGHT EXTERNAL ILIAC ARTERY AND SUBSEQUENT CARDIAC EVENT. THE SURGEON HAS STATED THAT UNDER NO CIRCUMSTANCES DOES HE BELIEVE IT WAS BECAUSE OF THE COOK DEVICES USED. HE SAID IT WAS ¿CAUSED FROM THE COVERED STENTS WHICH WERE IMPLANTED IN THE EXTERNAL ILIAC ARTERY FOR THE RUPTURE¿. THIS COMPLAINT ADDRESSES THE TBE AND THE RELATED COMPLAINT (B)(4) ADDRESSES THE TBRANCH USED. A CLINICAL ASSESSMENT OF THE REPORTED INFORMATION WAS MADE. PER THE CLINICAL ASSESSMENT ALTHOUGH THERE IS NO DIRECT INFORMATION ABOUT THE ORDER OF IMPLANTATION, IT IS LIKELY THAT THE TBE-DEVICE WAS IMPLANTED SUBSEQUENTLY TO THE T-BRANCH FOR WHICH THE DIAMETER DISCREPANCY IS DESCRIBED (IN RELATED COMPLAINT). ON THESE GROUNDS IT IS UNLIKELY, THAT THE TBE-DEVICE CAUSED THE RUPTURE OF THE REIA ALTHOUGH THE SHEATH EXCHANGE INHERENT TO ITS USE MAY HAVE EXERTED A FORCE ON THE REIA THAT COULD THEORETICALLY HAVE CONTRIBUTED TO THE RUPTURE. IT WAS ASSESSED THAT THE PATIENT SUSTAINED A LIFE-THREATENING INJURY FROM THE INCORRECT USE OF THE COOK DEVICES FROM WHICH SHE DIED SHORTLY AFTER. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATIONS. THE INSTRUCTIONS FOR USE SENT WITH THIS DEVICE STATES THAT THE TBE IS INDICATED FOR PATIENTS WITH ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS AND THAT THE OPERATOR MUST NOT CONTINUE ADVANCING ANY PORTION OF THE INTRODUCTION SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE WIRE GUIDE OR INTRODUCTION SYSTEM AS VESSEL OR CATHETER DAMAGE MAY OCCUR. THE INTRODUCTION SYSTEM FOR THE TBE-24-80-PF USED IN THIS COMPLAINT IS STATED TO BE 7.7 MM IN OUTER DIAMETER. BASED ON THE REPORTED INFORMATION IT IS LIKELY THAT THE RUPTURE OF THE EXTERNAL ILIAC ARTERY WAS CAUSED BY A USER ERROR AS THE DEVICE WAS USED IN A PATIENT WITH ACCESS VESSELS INCOMPATIBLE WITH THE 7.7 MM OD INTRODUCTION SYSTEM. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P070016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT HAD X 2 THORACIC GRAFTS FROM ANOTHER MANUFACTURER INSERTED PRIOR TO THE T-BRANCH DEVICE AND TBE. PRE-CASE DISCUSSED THE T-BRANCH WAS IN A 22FR DELIVERY SYSTEM WITH OD 8.5MM'S. PATIENTS ACCESS VESSELS WERE MAXIMUM OF 7MM'S. A CONDUIT WAS DISCUSSED PRE-CASE HOWEVER THE PHYSICIAN DECIDED TO PROCEED WITHOUT A CONDUIT. POST INSERTION OF THE X 2 THORACIC GRAFTS FROM ANOTHER MANUFACTURER PATIENT HAD CARDIAC CHANGES WITH S-T ELEVATION AND REQUIRED AN ON-TABLE. CARDIOLOGIST GAVE ALL CLEAR TO PROCEED. STENTING OF THE EIA WAS REQUIRED AFTER X 4 SHEATH EXCHANGES TO THE REIA WITH X 2 THORACIC STENTS, T-BRANCH & TBE DEVICES IMPLANTED. AT COMPLETION OF PROCEDURE IT WAS NOTED THAT THE REIA HAD RUPTURED, X 2 COVERED STENTS WERE IMPLANTED TO CONTROL THE BLEEDING. THE PHYSICIAN REPORTS A FOLLOW-UP CTA WAS DONE PRIOR TO PATIENT BEING DISCHARGED, HOWEVER HE WAS NOTIFIED THAT WHEN SHE WENT HOME ABOUT 6-7 DAYS POST-OP SHE REPORTED ABDOMINAL PAIN, AN AMBULANCE WAS CALLED AND SHE COULD NOT BE RESUSCITATED. THE CORONER HAS REPORTED THAT HER CAUSE OF DEATH WAS EXTRAVASATION FROM A STENT IN HER REIA AND SUBSEQUENT CARDIAC EVENT. THE PHYSICIAN HAS CONFIRMED THAT THE X2 COVERED STENT USED TO CONTROL THE BLEEDING WAS NOT FROM COOK MEDICAL. PATIENT OUTCOME: PATIENT DIED BETWEEN (B)(6) 2020. THE CORONER HAD REPORTED THAT HER CAUSE OF DEATH WAS EXTRAVASATION FROM A STENT IN HER REIA AND SUBSEQUENT CARDIAC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540653 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3748472 10827002526478

    Patients

    Seq Age Sex Outcome Treatment
    1 Death