BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH DISSECTION ENDOVASCULAR STENT

    MDR report key: 10458448 · Received August 27, 2020

    Report

    Report Number
    3002808486-2020-00828
    Event Type
    Injury
    Date Received
    August 27, 2020
    Report Date
    June 28, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: FROM A PUBLICATION REVIEW, COOK MEDICAL BECAME AWARE OF A LITERATURE ARTICLE, "PLACEMENT OF A ZENITH DISSECTION ENDOVASCULAR SYSTEM IN THE DESCENDING THORACIC AORTA CAN HAMPER FURTHER SURGICAL AORTIC OPERATIONS". THE ARTICLE IS A CASE REPORT DESCRIBING A 52-YEAR-OLD MALE PATIENT WHO HAS AN ASCENDING AORTA REPLACEMENT FOR A TYPE A ACUTE AORTIC DISSECTION IN AUG2016. POST PROCEDURE CT SHOWED RESIDUAL DISSECTION FROM THE AORTIC ARCH TO THE RIGHT COMMON ILIAC ARTERY, A LARGE RE-ENTRY IN THE RIGHT COMMON ILIAC ARTERY AND AFTER 2 MONTHS ENLARGEMENT OF THE FALSE LUMEN. A THREE-STAGE OPERATION WAS PERFORMED WITH A TOTAL ARCH REPLACEMENT AND A FROZEN ELEPHANT TRUNK INSERTION, TEVAR WITH THE IMPLANTATION OF A TX2 STENTGRAFT AND TWO TXD STENTS, EVAR TO CLOSE RE-ENTRY FROM THE RIGHT COMMON ILIAC ARTERY. TWO YEARS LATER THE ABDOMINAL AORTIC FALSE LUMEN HAD EXPANDED FROM 16 TO 27MM AND IT WAS DECIDED TO PERFORM OPEN SURGICAL REPAIR. IT WAS REPORTED THAT THE PROCEDURE WAS MORE DIFFICULT THAN EXPECTED DUE TO A TXD STENT BEING LODGED INTO THE INTIMA. AFTER THE OPEN SURGERY THE PATIENT HAD A LONG RECOVERY DUE TO EMPHYSEMA AND POSSIBLE INFECTION. A CLINICAL ASSESSMENT OF THE REPORTED INFORMATION AND ARTICLE WAS PERFORMED. IT WAS ASSESSED THAT IT WAS UNLIKELY THAT THERE WERE ANY CONNECTION BETWEEN THE FALSE LUMEN ENLARGEMENT OR THE INFECTION AFTER THE OPEN SURGERY AND THE COOK DEVICES. BASED ON THE INFORMATION GIVEN IN THE ARTICLE NO EXACT CAUSE CAN BE ESTABLISHED AS TO WHY THE STENT BECAME EMBEDDED IN THE VESSEL WALL AND THEREBY MADE THE SUBSEQUENT OPEN SURGERY MORE DIFFICULT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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

    MANUFACTURERS REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: AT TWO MONTHS AFTER THE INITIAL OPERATION, CT REVEALED THAT THE THORACIC AORTA FALSE LUMEN HAD ENLARGED BY 5 MM OR MORE, AND THE TOTAL DIAMETER OF THE THORACIC AORTA HAD ENLARGED BY 5 MM TO APPROXIMATELY 52 MM. WITH THE AIM OF REMODELING THE AORTA, A THREE STAGE OPERATION WAS PLANNED, AS DESCRIBED BELOW. FOUR MONTHS AFTER THE ONSET OF DISSECTION, TOTAL AORTIC ARCH REPLACEMENT AND FROZEN ELEPHANT TRUNK INSERTION WERE PERFORMED AS THE FIRST STAGE OPERATION. SUBSEQUENTLY, AS A SECOND STAGE OPERATION, THORACIC ENDOVASCULAR REPAIR (TEVAR) USING A ZENITH! DISSECTION ENDOVASCULAR SYSTEM (COOK JAPAN CO., LTD, TOKYO, JAPAN) WAS PERFORMED WITH THE AIM OF EXPANDING THE TRUE LUMEN OF THE THORACO-ABDOMINAL AORTA. THE IMPLANTED DEVICES WERE A STENT GRAFT (TX-2 36 MME26 MM, 159 MM) FOR THE PROXIMAL PART AND TWO BARE STENTS (TX-D 36 MM, 164 MM) FOR MIDDLE AND DISTAL PART. FIVE MONTHS AFTER THE ONSET OF DISSECTION, THE THIRD STAGE ABDOMINAL AORTIC ENDOVASCULAR TREATMENT (EVAR) WAS PERFORMED WITH THE PURPOSE OF NOT ONLY CLOSING THE RE-ENTRY FROM THE RIGHT COMMON ILIAC ARTERY BUT ALSO TREATING ILIAC ANEURYSMS. THE EVAR PROCEDURE INVOLVED PLACING THE ILIAC STENT GRAFT (PXC 141000J; W.L. GORE & ASSOCIATE, FLAGSTAFF, AZ, USA) FROM BOTH COMMON ILIAC ARTERIES TO THE EXTERNAL ILIAC ARTERIES. THE MAIN BODY WAS A BA22-80/I16-40 (ENDOLOGIX, INC., IRVINE, CA, USA). THE DIAMETER OF THE THORACIC AORTA AFTER THE THIRD STAGE OPERATION WAS REDUCED BY APPROXIMATELY 5 MM COMPARED WITH THAT BEFORE THE FIRST STAGE OPERATION, INDICATING THAT THE SERIES OF SURGICAL TREATMENTS HAD BEEN EFFECTIVE. HOWEVER, TWO YEARS AFTER THE THREE-STAGE OPERATION (FIG. 1), CT SHOWED THAT THE THORACIC AORTA WAS OVER 60 MM IN DIAMETER AND THAT THE ABDOMINAL AORTIC FALSE LUMEN HAD EXPANDED FROM 16 MM TO 27 MM. IT WAS DETERMINED THAT THERAPEUTIC INTERVENTION FOR THE DISSECTING THORACO- ABDOMINAL AORTIC ANEURYSM WAS NECESSARY. ALTHOUGH TREATMENT WITH A BRANCHED STENT GRAFT WAS ALSO CONSIDERED, OPEN SURGICAL REPAIR WAS PERFORMED BECAUSE THE MAXIMUM ENDOVASCULAR TREATMENT AVAILABLE AT THE HOSPITAL HAD ALREADY BEEN CARRIED OUT. SURGERY THE PATIENT WAS PLACED IN THE RIGHT HEMI LATERAL POSITION AND THORACOTOMY WAS PERFORMED WITH RIB CROSS THORACOTOMY4 TO EXPOSE THE AORTA. EXTRACORPOREAL CIRCULATION WAS ESTABLISHED USING THE FEMORAL ARTERY FOR ARTERIAL DRAINAGE AND THE FEMORAL VEIN FOR VENOUS DRAINAGE. THE AORTA WAS REPLACED FROM THE DESCENDING AORTA TO THE INFRARENAL ABDOMINAL AORTA. THE ADAMKIEWICZ ARTERY WAS FOUND TO BE CONNECTED TO THE SEVENTH AND EIGHTH RIGHT INTERCOSTAL ARTERIES STARTING FROM THE FALSE LUMEN AND THE PLAN WAS TO USE IT FOR REVASCULARIZATION. BY SEGMENTAL AORTIC CLAMPING, THE PROXIMAL STUMP WAS MADE AT THE SITE OF THE TX-2 STENT GRAFT AND ANASTOMOSED WITH A 28 MM J GRAFT (JAPAN LIFELINE JAPAN CO., LTD, TOKYO, JAPAN). THE CLAMP WAS MOVED, AND THE TWO INTERCOSTAL ARTERIES WERE RECONSTRUCTED. THE AORTIC CLAMP WAS MOVED TO THE ABDOMINAL AORTA AND AN ATTEMPT WAS MADE TO REMOVE THE PREVIOUSLY IMPLANTED BARE STENT (TX-D), BUT IT WAS STUCK IN THE INTIMA AND IMPOSSIBLE TO REMOVE WHILE PRESERVING THE INTIMA. THUS, ANASTOMOSIS OF THE VISCERAL ARTERIES USING THE BUTTON TECHNIQUE WAS IMPOSSIBLE. THE VISCERAL ARTERIES WERE SUFFICIENTLY DISSECTED DISTALLY AND ANASTOMOSED END TO END TO THE BRANCH OF THE ARTIFICIAL GRAFT. THE ABDOMINAL AORTA WHERE THE TX-D HAD BEEN INSERTED WAS STUMPED TOGETHER WITH A BARE STENT AND THE ABDOMINAL AORTIC WALL WAS ANASTOMOSED TO THE BRANCHED ARTIFICIAL GRAFT; THEN THE OPERATION WAS COMPLETED. THE OPERATION TIME WAS 953 MINUTES AND THE EXTRACORPOREAL CIRCULATION TIME WAS 355 MINUTES. THE PATIENT SPENT 23 DAYS IN THE POST- OPERATIVE INTENSIVE CARE UNIT AND WAS TRANSFERRED TO A REHABILITATION HOSPITAL ON THE 82ND DAY. THE HOSPITALIZATION WAS PROLONGED BECAUSE RESPIRATORY FAILURE AND LEFT EMPYEMA NECESSITATED TRACHEAL INTUBATION FOR 11 DAYS AND TRACHEOSTOMY FOR 42 DAYS. POST-OPERATIVE CT REVEALED NO SIGNIFICANT RESIDUAL ANEURYSM (FIG. 2). BEFORE TRANSFER, THE PATIENT WAS ABLE TO WALK ON HIS OWN USING A WALKER. RENAL FUNCTION BEFORE TRANSFER WAS 1.56 MG/DL, INDICATING MILD RENAL DYSFUNCTION. TWO ADMISSIONS WERE NEEDED BECAUSE OF A FEVER THAT WAS SUSPECTED TO BE DUE TO THORACIC GRAFT INFECTION. THE FIRST WAS RELIEVED BY CONSERVATIVE TREATMENT, AND THE SECOND WAS RELIEVED BY DRAINAGE. FOUR MONTHS AFTER TRANSFER, CT SHOWED NO PSEUDOANEURYSM OR NEW ANEURYSM FORMATION. THE PATIENT CONSENTED TO THE PUBLICATION OF THIS REPORT. PATIENT OUTCOME: THE PATIENT SPENT 23 DAYS IN THE POST- OPERATIVE INTENSIVE CARE UNIT AND WAS TRANSFERRED TO A REHABILITATION HOSPITAL ON THE 82ND DAY. THE HOSPITALIZATION WAS PROLONGED BECAUSE RESPIRATORY FAILURE AND LEFT EMPYEMA NECESSITATED TRACHEAL INTUBATION FOR 11 DAYS AND TRACHEOSTOMY FOR 42 DAYS. POST-OPERATIVE CT REVEALED NO SIGNIFICANT RESIDUAL ANEURYSM (FIG. 2). BEFORE TRANSFER, THE PATIENT WAS ABLE TO WALK ON HIS OWN USING A WALKER. RENAL FUNCTION BEFORE TRANSFER WAS 1.56 MG/DL, INDICATING MILD RENAL DYSFUNCTION. TWO ADMISSIONS WERE NEEDED BECAUSE OF A FEVER THAT WAS SUSPECTED TO BE DUE TO THORACIC GRAFT INFECTION. THE FIRST WAS RELIEVED BY CONSERVATIVE TREATMENT, AND THE SECOND WAS RELIEVED BY DRAINAGE. FOUR MONTHS AFTER TRANSFER, CT SHOWED NO PSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922824 ZENITH DISSECTION ENDOVASCULAR STENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention