ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2021-02006
- Event Type
- Malfunction
- Date Received
- December 7, 2021
- Date of Event
- January 26, 2021
- Report Date
- April 25, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002242897
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# PR(B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A 65-YEAR OLD FEMALE IN FRENCH REIMBURSEMENT STUDY WITH AN AORTIC DISSECTION UNDERWENT A THORACIC AORTIC ENDOVASCULAR REPAIR (TEVAR) ON (B)(6) 2021, WHERE A ZDEG-P-42-164-PF (LOT# E3953000) (COMPLAINT DEVICE) AND A ZDEG-P-40-164-PF (LOT#E4006963) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED. THE PROXIMAL LOCATION OF THE DISSECTION WAS WITHIN THE DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN AND THE DISTAL LOCATION WAS THE LEFT COMMON ILIAC. THERE WERE NO SECONDARY OR RE-ENTRY TEARS. TORTUOSITY, OCCLUSIVE DISEASE, AND CALCIFICATION WERE UNABLE TO BE ASSESSED AT THE PROXIMAL SEAL ZONE. NO THROMBUS WAS OBSERVED. THE LEFT SUBCLAVIAN ARTERY WAS COMPLETELY COVERED BY THE GRAFT FABRIC AND REVASCULARIZATION WAS COMPLETED. A BALLOON WAS USED ON THE GRAFT DURING THE PROCEDURE (INFORMATION ABOUT THE BALLOON WAS NOT COLLECTED) TO FACILITATE ANATOMIC COMPLIANCE. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. 35 DAYS POST-PROCEDURE, A FOLLOW-UP CT WAS COMPLETED. THERE WAS NO PROGRESSION/GROWTH OF THE DISSECTION OR DEVELOPMENT OF A NEW ENTRY TEAR. THE THORACIC AND ABDOMINAL FALSE LUMENS WERE PARTIALLY THROMBOSED WITH BLOOD FLOW THROUGH THE PRIMARY TEAR DUE TO A TYPE IA ENDOLEAK. THE STUDY DEVICES WERE PATENT WITHOUT EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. 198 DAYS POST-PROCEDURE, A NON-CONTRAST FOLLOW-UP CT WAS COMPLETED. THERE WAS NO EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. OTHER MEASUREMENTS AND PERFUSION OF THE FALSE LUMEN WERE NOT ASSESSED. NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. BASED ON THE PROVIDED AND LIMITED INFORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE OF AN ENDOLEAK, EVEN THOUGH IFU STATES THAT ENDOLEAK IS A KNOWN ADVERSE EVENT. COOK WILL REOPEN THE COMPLAINT IF FURTHER INFORMATION IS RECEIVED. 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 ACCORDING TO THE INITIAL REPORTER: TYPE IA ENDOLEAK ON PROCEDURAL ANGIOGRAPHY. ON (B)(6) 2021 DURING THE INDEX PROCEDURE, A ZDEG-P-42-164-PF (LOT# E3953000) AND A ZDEG-P-40-164-PF (LOT#E4006963) WERE IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED ON EITHER DEVICE. NO OTHER DEVICES WERE PLACED. PRIMARY INDICATION FOR IMPLANT WAS AN AORTIC DISSECTION (DIAGNOSED (B)(6) 2020). THE PRIMARY TEAR WAS THE DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN. THE PROXIMAL LOCATION OF THE DISSECTION WAS WITHIN THE DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN. DISTAL LOCATION WAS THE LEFT COMMON ILIAC. HERE WERE NO SECONDARY OR RE-ENTRY TEARS. THE PROXIMAL SEAL ZONE TORTUOSITY, OCCLUSIVE DISEASE, AND CALCIFICATION WERE UNABLE TO BE ASSESSED. THERE WAS NO THROMBUS PRESENT. THE PROXIMAL LOCATION OF THE GRAFT HAS NOT BEEN REPORTED. THE LEFT SUBCLAVIAN ARTERY WAS COMPLETELY COVERED BY THE GRAFT FABRIC AND REVASCULARIZATION WAS COMPLETED. A BALLOON WAS USED ON THE GRAFT DURING THE PROCEDURE (INFORMATION ABOUT THE BALLOON WAS NOT COLLECTED) TO FACILITATE ANATOMIC COMPLIANCE. INFORMATION ON LOCATION OF THE BALLOON IS NOT AVAILABLE AT THIS TIME. THE STUDY DEVICES WERE PATENT WITHOUT DEVICE INTEGRITY ISSUES AT THE END OF THE PROCEDURE. THE THORACIC AND ABDOMINAL FALSE LUMENS WERE PARTIALLY THROMBOSED WITH BLOOD FLOW FROM A TYPE IA ENDOLEAK THROUGH THE PRIMARY TEAR. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021 (35 DAYS POST-PROCEDURE), A FOLLOW-UP CT WAS COMPLETED. THERE WAS NO PROGRESSION/GROWTH OF THE DISSECTION OR DEVELOPMENT OF A NEW ENTRY TEAR. THE THORACIC AND ABDOMINAL FALSE LUMENS WERE PARTIALLY THROMBOSED WITH BLOOD FLOW THROUGH THE PRIMARY TEAR DUE TO A TYPE IA ENDOLEAK. THE STUDY DEVICES WERE PATENT WITHOUT EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (48 DAYS POST-PROCEDURE), A FOLLOW-UP CT WAS COMPLETED. THERE WAS NO PROGRESSION/GROWTH OF THE DISSECTION OR DEVELOPMENT OF A NEW ENTRY TEAR. A TYPE IA (PROXIMAL) ENDOLEAK WAS REPORTED. THE THORACIC FALSE LUMEN WAS PATENT, AND THE ABDOMINAL FALSE LUMEN WAS COMPLETELY THROMBOSED. THE STUDY DEVICES WERE PATENT WITHOUT EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (198 DAYS POST-PROCEDURE), A NON-CONTRAST FOLLOW-UP CT WAS COMPLETED. THERE WAS NO EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. OTHER MEASUREMENTS AND PERFUSION OF THE FALSE LUMEN WERE NOT ASSESSED. PATIENT OUTCOME: NO PLANS FOR A SECONDARY INTERVENTION HAVE BEEN REPORTED. PATIENT REMAINS IN STUDY
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: TYPE IA ENDOLEAK ON PROCEDURAL ANGIOGRAPHY. ON (B)(6) 2021 DURING THE INDEX PROCEDURE, A ZDEG-P-42-164-PF (LOT# E3953000) AND A ZDEG-P-40-164-PF (LOT#E4006963) WERE IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED ON EITHER DEVICE. NO OTHER DEVICES WERE PLACED. PRIMARY INDICATION FOR IMPLANT WAS AN AORTIC DISSECTION (DIAGNOSED (B)(6) 2020). THE PRIMARY TEAR WAS THE DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN. THE PROXIMAL LOCATION OF THE DISSECTION WAS WITHIN THE DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN. DISTAL LOCATION WAS THE LEFT COMMON ILIAC. HERE WERE NO SECONDARY OR RE-ENTRY TEARS. THE PROXIMAL SEAL ZONE TORTUOSITY, OCCLUSIVE DISEASE, AND CALCIFICATION WERE UNABLE TO BE ASSESSED. THERE WAS NO THROMBUS PRESENT. THE PROXIMAL LOCATION OF THE GRAFT HAS NOT BEEN REPORTED. THE LEFT SUBCLAVIAN ARTERY WAS COMPLETELY COVERED BY THE GRAFT FABRIC AND REVASCULARIZATION WAS COMPLETED. A BALLOON WAS USED ON THE GRAFT DURING THE PROCEDURE (INFORMATION ABOUT THE BALLOON WAS NOT COLLECTED) TO FACILITATE ANATOMIC COMPLIANCE. INFORMATION ON LOCATION OF THE BALLOON IS NOT AVAILABLE AT THIS TIME. THE STUDY DEVICES WERE PATENT WITHOUT DEVICE INTEGRITY ISSUES AT THE END OF THE PROCEDURE. THE THORACIC AND ABDOMINAL FALSE LUMENS WERE PARTIALLY THROMBOSED WITH BLOOD FLOW FROM A TYPE IA ENDOLEAK THROUGH THE PRIMARY TEAR. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021 (35 DAYS POST-PROCEDURE), A FOLLOW-UP CT WAS COMPLETED. THERE WAS NO PROGRESSION/GROWTH OF THE DISSECTION OR DEVELOPMENT OF A NEW ENTRY TEAR. THE THORACIC AND ABDOMINAL FALSE LUMENS WERE PARTIALLY THROMBOSED WITH BLOOD FLOW THROUGH THE PRIMARY TEAR DUE TO A TYPE IA ENDOLEAK. THE STUDY DEVICES WERE PATENT WITHOUT EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (48 DAYS POST-PROCEDURE), A FOLLOW-UP CT WAS COMPLETED. THERE WAS NO PROGRESSION/GROWTH OF THE DISSECTION OR DEVELOPMENT OF A NEW ENTRY TEAR. A TYPE IA (PROXIMAL) ENDOLEAK WAS REPORTED. THE THORACIC FALSE LUMEN WAS PATENT, AND THE ABDOMINAL FALSE LUMEN WAS COMPLETELY THROMBOSED. THE STUDY DEVICES WERE PATENT WITHOUT EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (198 DAYS POST-PROCEDURE), A NON-CONTRAST FOLLOW-UP CT WAS COMPLETED. THERE WAS NO EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. OTHER MEASUREMENTS AND PERFUSION OF THE FALSE LUMEN WERE NOT ASSESSED. PATIENT OUTCOME: NO PLANS FOR A SECONDARY INTERVENTION HAVE BEEN REPORTED. PATIENT REMAINS IN STUDY
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 |
|---|---|---|---|---|---|---|---|
| 1852014 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3953000 | 10827002242897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |