BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 18787031 · Received February 27, 2024

    Report

    Report Number
    3002808486-2024-00040
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    September 1, 2023
    Report Date
    September 4, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002231785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: DURING A POST MARKED CLINICAL FOLLOW-UP (PMCF) STUDY COOK BECAME AWARE OF THIS EVENT. A 74-YEAR - OLD MALE PATIENT UNDERWENT ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2020, WHERE A ZDEG-PT-32-24-158-PF (COMPLAINT DEVICE) WAS IMPLANTED WITHOUT DIFFICULTY. THE DISTAL LANDING ZONE OF THE ZDEG DEVICE WAS 5CM AFTER AORTIC ISTHMUS. THE DIAMETER AND LENGTH OF THE DISTAL FIXATION SITE WAS REPORTED AS 28 MM AND 20MM ACCORDINGLY. THE DEGREE OF OVERSIZING WAS NOT REPORTED. PRIMARY INDICATION FOR IMPLANT WAS STABLE AORTIC DISSECTION. THE PROXIMAL LOCATION OF DISSECTION WAS PROXIMAL TO LEFT SUBCLAVIAN ARTERY, DISTAL TO LEFT COMMON CAROTID ARTERY. THE DISTAL LOCATION WAS THE RIGHT COMMON ILIAC ARTERY. THE GRAFT WAS IMPLANTED WITHIN ZONE 3. THE PROCEDURE ANGIOGRAPHY SHOWED THE STUDY DEVICES PATENT, WITH NO SEPARATION OF DEVICE OR EVIDENCE OF ANY DEVICE INTEGRITY ISSUES. 0N (B)(6) 2020 (3 DAYS POST-PROCEDURE) A FOLLOW-UP CT WAS DONE THAT SHOWED NO EVIDENCE OF DEVICE SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. PATIENT WAS DISCHARGED HOME THE SAME DAY. ON (B)(6) 2020 (53 DAYS POST-PROCEDURE) A CLINICAL ASSESSMENT WAS DONE WITH NO IMAGING. ON AN UNKNOWN DATE IN (B)(6) 2020 (AT LEAST 179 DAYS POST-PROCEDURE) A FOLLOW-UP CT WAS DONE. THERE WAS NO EVIDENCE OF DEVICE SEPARATION, MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (283 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED A PSEUDOANEURYSM WHICH WAS TREATED ENDOVASCULARLY WITH STENTING TO THE EXTERNAL ILIAC AND COMMON FEMORAL ARTERY. PER THE ADDITIONAL REPORTED INFORMATION, THE PSEUDOANEURYSM WAS NOT RELATED TO THE STUDY DEVICE. ON (B)(6) 2021 (495 DAYS POST-PROCEDURE), A 12-MONTH FOLLOW-UP CT WAS DONE. THERE WAS NOTED TO HAVE RETROGRADE PROGRESSION OF THE DISSECTION WITH NO NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE DEVICE WAS PATENT THERE WAS NO EVIDENCE OF DEVICE SEPARATION, MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021(509 DAYS POST-PROCEDURE) THE SITE REPORTED THAT THE PATIENT EXPERIENCED AORTIC ANEURYSM. ON (B)(6) 2021 THE PATIENT UNDERWENT SUCCESSFUL TREATMENT BY PLACEMENT OF A STENT IN THE SMA (EXCLUSION OF A DESCENDING THORACIC AORTIC ANEURYSM IN ITS SEGMENT III BY COVERED ENDOPROSTHESIS). ON (B)(6) 2021 (558 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED AN AORTIC ANEURYSM. THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT WITH SUCCESSFUL PLACEMENT OF LEFT RENAL STENT, RIGHT RENAL STENT AND SMA STENT. THE SITE ALSO STATED ¿PLACEMENT OF AN ANACONDA ENDOPROSTHESIS (4 WINDOWS). NO DEVICE WAS IMPLANTED TO EXTEND THE ZDEG ON (B)(6) 2021. ON AN UNKNOWN DATE IN (B)(6) 2022 (AT LEAST 606 DAYS POST-PROCEDURE) AN UNSCHEDULED FOLLOW-UP CT WAS DONE. THERE WAS NO EVIDENCE OF SEPARATION OF DEVICE, MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022 (838 DAYS POST-PROCEDURE) A 2-YEAR FOLLOW-UP CT WAS DONE. THERE WAS NOTED TO HAVE RETROGRADE PROGRESSION OF THE DISSECTION WITH NO NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE DEVICE WAS PATENT WITH NO EVIDENCE OF SEPARATION OF DEVICE, MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022 (872 DAYS POST PROCEDURE) THE PATIENT WAS TREATED ENDOVASCULAR WITH A LUMBAR COIL EMBOLIZATION, COVERED RIGHT ILIAC ARTERY STENT AND AMPLATZER. THE SITE STATES THAT ¿THERE REMAINS AN ANEURYSMAL CHANNEL ON THE RIGHT SIDE WHICH CONTINUES TO GROW DUE TO THE DISSECTION FROM THE RIGHT EXTERNAL ILIAC.¿ ON (B)(6) 2023 (1210 DAYS POST-PROCEDURE) A CLINICAL ASSESSMENT WAS DONE. THE SITE REPORTED A FOLLOW-UP CT WAS ALSO COMPLETED BUT HAVE PROVIDED NO DATA AT THIS TIME. ON AN UNKNOWN DATE IN (B)(6) 2023 (AT LEAST 1183 DAYS POST-PROCEDURE) A TYPE 1B DISTAL ENDOLEAK WAS REPORTED. PER THE ADDITIONAL REPORTED INFORMATION, A TYPE 1B ENDOLEAK REFERS TO THE BLOOD FLOW INTO FALSE LUMEN, THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD A RE-ENTRY TEAR IN THE DISTAL END OF THE ZDEG, WHICH IS REFERRED TO AS A TYPE 1B ENDOLEAK. ON (B)(6) 2023 PATIENT UNDERWENT SUCCESSFUL ENDOVASCULAR TREATMENT WITH A STENT TO THE COELIAC TRUNK, STENT TO SMA AND STENT TO LEFT RENAL ARTERY. ON (B)(6) 2024 (1312 DAYS POST-PROCEDURE) CT WAS DONE. ALL VESSELS WERE PATENT. THE STUDY DEVICE WAS PATENT WITH NO SEPARATION OF DEVICE, MIGRATION, OR DEVICE INTEGRITY ISSUES. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. NO IMAGING WAS PROVIDED FOR THE INVESTIGATION. ACCORDING TO IFU (INSTRUCTION FOR USE) AORTIC DAMAGE, INCLUDING PERFORATION AND DISSECTION IS NOTED TO BE POTENTIAL ADVERSE EVENTS. BASED ON THE PROVIDED INFORMATION IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE RE-ENTRY TEAR IN THE DISTAL END OF ZDEG. 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

    DESCRIPTION OF EVENT ACCORDING TO STUDY: (B)(6). (B)(6) 2020 DURING THE INDEX PROCEDURE, A ZDEG-PT-32-24-158-PF (LOT# 3697495) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED. PRIMARY INDICATION FOR IMPLANT WAS STABLE AORTIC DISSECTION. THE PROXIMAL LOCATION OF DISSECTION WAS PROXIMAL TO LEFT SUBCLAVIAN, DISTAL TO LEFT COMMON CAROTID. THE DISTAL LOCATION WAS THE RIGHT COMMON ILIAC. THE GRAFT WAS IMPLANTED WITHIN ZONE 3. THE PROCEDURE ANGIOGRAPHY SHOWED THE STUDY DEVICES PATENT, WITH NO SEPARATION OF DEVICE OR EVIDENCE OF ANY DEVICE INTEGRITY ISSUES. PATIENT WAS DISCHARGED HOME (B)(6) 2020 (3 DAYS POST-PROCEDURE) 0N (B)(6) 2020 (3 DAYS POST-PROCEDURE) A FOLLOW-UP CT WAS DONE THAT SHOWED NO EVIDENCE OF DEVICE SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2020 (53 DAYS POST-PROCEDURE) A CLINICAL ASSESSMENT WAS DONE WITH NO IMAGING. ON UNK DATE IN (B)(6) 2020 (AT LEAST 179 DAYS POST-PROCEDURE) A FOLLOW-UP CT WAS DONE. THERE WAS NO EVIDENCE OF DEVICE SEPARATION, MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (283 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED A PSEUDOANEURYSM WHICH WAS TREATED ENDOVASCULARLY WITH STENTING TO THE EXTERNAL ILIAC AND COMMON FEMORAL ARTERY. ON (B)(6) 2021 (495 DAYS POST-PROCEDURE), A 12 MONTH FOLLOW-UP CT WAS DONE. THERE WAS NOTED TO HAVE RETROGRADE PROGRESSION OF THE DISSECTION WITH NO NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE DEVICE WAS PATENT THERE WAS NO EVIDENCE OF DEVICE SEPARATION, MIGRATION OR DEVICE INTEGRITY ISSUES. ON(B)(6) 2021 (509 DAYS POST-PROCEDURE) THE SITE REPORTED THE PATIENT EXPERIENCED AORTIC ANEURYSM. ON (B)(6) 2021 THE PATIENT UNDERWENT SUCCESSFUL TREATMENT PLACEMENT OF A STENT IN THE SMA (EXCLUSION OF A DESCENDING THORACIC AORTIC ANEURYSM IN ITS SEGMENT III BY COVERED ENDOPROSTHESIS). ON (B)(6) 2021 (558 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED AN AORTIC ANEURYSM. THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT WITH SUCCESSFUL PLACEMENT OF LEFT RENAL STENT, RIGHT RENAL STENT AND SUPERIOR MESENTERIC ARTERY (SMA) STENT. THE SITE ALSO STATED ¿PLACEMENT OF AN ANACONDA ENDOPROSTHESIS (4 WINDOWS). ON AN UNK DATE IN (B)(6) 2022 (AT LEAST 606 DAYS POST-PROCEDURE) A UNSCHEDULED FOLLOW-UP CT WAS DONE. THERE WAS NO EVIDENCE OF SEPARATION OF DEVICE, MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022 (838 DAYS POST-PROCEDURE) A 2-YEAR FOLLOW-UP CT WAS DONE. THERE WAS NOTED TO HAVE RETROGRADE PROGRESSION OF THE DISSECTION WITH NO NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE DEVICE WAS PATENT WITH NO EVIDENCE OF SEPARATION OF DEVICE, MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6)2022 (872 DAYS POST PROCEDURE) THE PATIENT WAS TREATED ENDOVASCULAR WITH A LUMBAR COIL EMBOLIZATION, COVERED RIGHT ILIAC ARTERY STENT AND AMPLATZER. THE SITE STATES THAT ¿THERE REMAINS AN ANEURYSMAL CHANNEL ON THE RIGHT SIDE WHICH CONTINUES TO GROW DUE TO THE DISSECTION FROM THE RIGHT EXTERNAL ILIAC.¿ ON (B)(6) 2023 (1210 DAYS POST-PROCEDURE) A CLINICAL ASSESSMENT WAS DONE. THE SITE REPORTED A FOLLOW-UP CT WAS ALSO COMPLETED BUT HAVE PROVIDED NO DATA AT THIS TIME. ON AN UNKNOWN DATE IN (B)(6) 2023 (AT LEAST 1183 DAYS POST-PROCEDURE) A TYPE IB DISTAL ENDOLEAK WAS REPORTED. ON (B)(6) 2023 PATIENT UNDERWENT SUCCESSFUL ENDOVASCULAR TREATMENT WITH A STENT TO THE COELIAC TRUNK, STENT TO SMA AND STENT TO LEFT RENAL. ON (B)(6) 2024 (1312 DAYS POST-PROCEDURE) CT WAS DONE. ALL VESSELS WERE PATENT. THE STUDY DEVICE WAS PATENT WITH NO SEPARATION OF DEVICE, MIGRATION OR DEVICE INTEGRITY ISSUES. PATIENT OUTCOME: SUCCESSFUL SECONDARY INTERVENTION.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655838 ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G23178 E3967495 10827002231785

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention