ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2024-00072
- Event Type
- Injury
- Date Received
- May 3, 2024
- Date of Event
- September 20, 2021
- Report Date
- October 24, 2024
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002242712
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER REF#: (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS. 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.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: DURING A POST MARKED CLINICAL FOLLOW-UP (PMCF) STUDY COOK BECAME AWARE OF THIS EVENT. A 51-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE ON (B)(6) 2017, WHERE ZDEG-PT-30-202-PF (COMPLAINT DEVICE) WAS IMPLANTED WITHIN ZONE 3 ALONG WITH THE ZTA-P-30-201 WITHOUT DIFFICULTY. THE REPORTED DEGREE OF OVERSIZING WAS 10%. A MOLDING BALLOON WAS USED FOR STENT GRAFT OPPOSITION AT THE OVERLAP BETWEEN THE TWO STENT GRAFTS. THE LEFT SUBCLAVIAN ARTERY WAS COMPLETELY COVERED BY THE STENT GRAFT BUT WAS REVASCULARIZED DURING THE STUDY PROCEDURE. PRIMARY INDICATION FOR IMPLANT WAS AN AORTIC DISSECTION. THE PRIMARY TEAR WAS DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN ARTERY (LSA). THE PROXIMAL LOCATION OF THE DISSECTION WAS AORTA AT LEFT SUBCLAVIAN WITH DISTAL LOCATION AORTIC AT CELIAC WITH NO RE-ENTRY TEAR. THE PROXIMAL SEAL ZONE HAD MILD TORTUOSITY WITH NO CALCIFICATION, OCCLUSIVE DISEASE, OR THROMBUS. ON (B)(6) 2017 (TEN DAYS POST-PROCEDURE) THE POST-PROCEDURE CT (COMPUTER TOMOGRAPHY) WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN WERE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. THE PATIENT WAS DISCHARGED ON (B)(6) 2017. A 30-DAY FOLLOW-UP CT WAS NOT COMPLETED. ON (B)(6) 2018 (101 DAYS POST-PROCEDURE) THE SIX-MONTH CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN WERE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON (B)(6) 2019 (490 DAYS POST-PROCEDURE) THE 12-MONTH FOLLOW-UP CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN WERE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON THE SAME DAY THE PATIENT EXPERIENCED A HEMATOMA ABOVE CELIAC ARTERY, 40MM IN MAXIMUM DIAMETER WITH NO TREATMENT. PER THE REPORTED ADDITIONAL INFORMATION, THE HEMATOMA WAS NOT RELATED TO THE ZTA-P-30-201. ON (B)(6) 2019 (693 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED PARIETAL FLOATING THROMBUS. TREATMENT INCLUDED CHANGE OF MEDICATION. ON (B)(6) 2019 (693 DAYS POST-PROCEDURE) THE TWO-YEAR FOLLOW-UP CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN ARE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON (B)(6) 2020 (1058 DAYS POST PROCEDURE) THE THREE -YEAR FOLLOW-UP CT WAS COMPLETED. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH SECONDARY TEAR DISTAL TO THE STENT GRAFT. THE ABDOMINAL FALSE LUMEN REMAINS COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (1400 DAYS-POST PROCEDURE), THE FOUR-YEAR FOLLOW-UP CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN ARE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITH NO EVIDENCE OF SEPARATION OR MIGRATION. IT WAS NOTED ON THE CT OF AN INTRA-PROSTHETIC THROMBUS WHICH WAS REPORTED AS A DEVICE INTEGRITY ISSUE AND THE SITE RELATED THIS TO THE STUDY DEVICE. THE LOCATION OF THIS THROMBUS WAS REPORTED AS THE SAME AS THE LOCATION OF THE PARIETAL FLOATING THROMBUS REVEALED ON (B)(6) 2019. THE PATIENT WAS PRESCRIBED XARELTO AS ADDITIONAL MEDICAL TREATMENT AS LIFE TREATMENT. THE CAUSE OF THE INTRA-PROSTHETIC THROMBUS WAS NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. OCCLUSION OF DEVICE LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU (INSTRUCTIONS FOR USE). SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NO FURTHER INFO IS RECEIVED. NO IMAGING WAS PROVIDED EITHER. BASED ON THE LIMITED PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE OF THE THROMBUS FORMATION. IT IS NOTED THAT ZTA DEVICE (NON-COMPLAINT DEVICE) IS USED FOR TREATMENT OF DISSECTION WHICH IS OUTSIDE THE INTENDED USE FOR THIS TYPE OF DEVICE. ZTA DEVICES ARE INTENDED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSM OF THE DESCENDING THORACIC AORTA. 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.
MANUFACTURERS REF# (B)(4). 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.
DESCRIPTION OF EVENT ACCORDING TO STUDY: INTRA-PROSTHETIC THROMBUS AT 4-YEAR FOLLOW-UP CT. ON (B)(6) 2017, DURING THE INDEX PROCEDURE, A ZDEG-PT-30-202-PF (LOT#: E3559012) WAS IMPLANTED WITHIN ZONE 3 ALONG WITH THE ZTA-P-30-201 (LOT#: E3505283) WITHOUT DIFFICULTY. THE REPORTED DEGREE OF OVERSIZING WAS 10%. A MOLDING BALLOON WAS USED FOR GRAFT OPPOSITION AT THE OVERLAP BETWEEN THE TWO GRAFTS. THE LEFT SUBCLAVIAN ARTERY WAS COMPLETELY COVERED BY THE GRAFT BUT WAS REVASCULARIZED DURING THE STUDY PROCEDURE. PRIMARY INDICATION FOR IMPLANT WAS AN AORTIC DISSECTION. THE PRIMARY TEAR WAS DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN (LSA). THE PROXIMAL LOCATION OF THE DISSECTION WAS AORTA AT LEFT SUBCLAVIAN WITH DISTAL LOCATION AORTIC AT CELIAC WITH NO RE-ENTRY TEAR. THE PROXIMAL SEAL ZONE HAD MILD TORTUOSITY WITH NO CALCIFICATION, OCCLUSIVE DISEASE, OR THROMBUS. ON (B)(6) 2017 (TEN DAYS POST-PROCEDURE), THE POST-PROCEDURE WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN ARE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. THE PATIENT WAS DISCHARGED ON (B)(6) 2017. A 30-DAY FOLLOW-UP CT WAS NOT COMPLETED. ON (B)(6) 2018 (101 DAYS POST-PROCEDURE), THE SIX-MONTH CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN ARE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON (B)(6) 2019 (490 DAYS POST-PROCEDURE), THE 12-MONTH FOLLOW-UP CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN ARE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON THE SAME DAY THE PATIENT EXPERIENCED A HEMATOMA ABOVE CAELIAC ARTERY, 40MM IN MAXIMUM DIAMETER WITH NO TREATMENT. ON (B)(6) 2019 (693 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED PARIETAL FLOATING THROMBUS. TREATMENT INCLUDED CHANGE OF MEDICATION. ON (B)(6) 2019 (693 DAYS POST-PROCEDURE), THE TWO-YEAR FOLLOW-UP CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN ARE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON (B)(6) 2020 (1058 DAYS POST PROCEDURE), THE THREE -YEAR FOLLOW-UP CT WAS COMPLETED. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH SECONDARY TEAR DISTAL TO THE STENT GRAFT. THE ABDOMINAL FALSE LUMEN REMAINS COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITHOUT SEPARATION, MIGRATION, OR ANY DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (1400 DAYS-POST PROCEDURE), THE FOUR-YEAR FOLLOW-UP CT WAS COMPLETED. THE THORACIC AND ABDOMINAL FALSE LUMEN ARE COMPLETELY THROMBOSED. THE DEVICE WAS PATENT WITH NO EVIDENCE OF SEPARATION OR MIGRATION. IT WAS NOTED ON THE CT OF AN INTRA-PROSTHETIC THROMBUS WHICH WAS REPORTED AS A DEVICE INTEGRITY ISSUE AND THE SITE RELATED THIS TO THE STUDY DEVICE. NO TREATMENT SCHEDULED AT THIS TIME.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED 31JUL2024: IS ANY ADDITIONAL TREATMENT (MEDICAL OR SURGICAL) OR ANY ADDITIONAL FOLLOW-UP CT PLANNED IN THE FUTURE? MEDICAL: XARELTO (RIVAROXABAN/LIFE TREATMENT) 10MG/J.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1277780 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3559012 | 10827002242712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Life Threatening |