ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT
Report
- Report Number
- 3002808486-2023-00140
- Event Type
- Malfunction
- Date Received
- May 10, 2023
- Report Date
- November 11, 2025
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002231815
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURERS REF# (B)(4). E3) OCCUPATION: ULTRA SOUND MANAGER. G4) SIMILAR TO DEVICE MARKETED UNDER 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.
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT IS REPORTED THAT ON 14MAR2019 A 73-YEAR-OLD FEMALE PATIENT IN THE FRENCH REIMBURSEMENT STUDY #16-16 UNDERWENT THORACIC ENDOVASCULAR REPAIR (TEVAR). DURING THE INDEX PROCEDURE, A ZDEG-PT-40-32-205-PF (COMPLAINT DEVICE) WAS IMPLANTED WITHOUT DIFFICULTY. THE PATIENT¿S PRE-EXISTING CONDITIONS WERE LISTED AS "HISTORY OF SEPSIS WITH A URINARY STARTING POINT IN 2017, URINARY ONSET SEPSIS/PYELONEPHRITIS, HYPERTENSION, AND ACTIVE SMOKER (1 PACK/DAY)". THE PRIMARY INDICATION WAS AORTIC ANEURYSM. THE PATIENT HAD MODERATE PAIN/DISCOMFORT IN THEIR BACK, LEG, RIGHT BUTTOCK, AND A SMALL PULPAL LESION OF THE TOE OF THE LEFT FOOT. PRE-PROCEDURE IMAGING SHOWED THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, RIGHT RENAL ARTERY, LEFT RENAL ARTERY, AND RIGHT INTERNAL ILIAC ARTERY WERE PATENT. THE RIGHT COMMON ILIAC, LEFT COMMON ILIAC, AND LEFT INTERNAL ILIAC WERE OCCLUDED. REGARDING THE PROXIMAL SEAL ZONE, NO TORTUOSITY, OCCLUSIVE DISEASE, OR CALCIFICATION WAS NOTED. THROMBUS WAS CIRCUMFERENTIAL. PROCEDURE ANGIOGRAPHY SHOWED PROXIMAL ZONE OF GRAFT IMPLANTATION AT ZONE 4. THE LEFT SUBCLAVIAN ARTERY WAS NOT COVERED BY THE GRAFT FABRIC. NO EVIDENCE OF SEPARATION OR DEVICE INTEGRITY ISSUES. A TYPE IB-DISTAL ENDOLEAK WAS PRESENT WITH LOCATION SPECIFIED AS DISSECTION GRAFT (ZDEG). (CURRENT COMPLAINT). PER ADDITIONAL INFORMATION, THE PATIENT DID NOT RECEIVE TREATMENT FOR THIS ENDOLEAK AND DID NOT HAVE ANY ADVERSE EFFECTS RELATED TO THE ENDOLEAK. AS PER REPORTED INFORMATION, THE PATIENT PRESENTED IN THE EARLY POST-OPERATIVE PERIOD AN ACUTE MESENTERIC ISCHEMIA. THE COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THE DIAGNOSIS AND ALSO SHOWED A RENAL AND SPLENIC INFARCTION. ON (B)(6) 2019 (TWO DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED MULTI-ORGAN FAILURE DUE TO MULTIPLE EMBOLI RELATED TO THE STUDY PROCEDURE. THE PATIENT DIED ON (B)(6) 2019 (30 DAYS POST-PROCEDURE), DUE TO DISCONTINUATION OF CARE IN PALLIATIVE CARE UNIT. THE SITE NOTED, ¿MULTIPLE EMBOLI, SPLENIC, RENAL, DIGESTIVE MEDULLARY, INVOLVEMENT, PARAPLEGIA¿. AN AUTOPSY WAS NOT PERFORMED. A DEATH REPORT/IN-HOSPITAL EVALUATION AT DEMISE WAS COMPLETED. THE SITE SELECTED COMPLICATION OF IMPLANT PROCEDURE AS RELATEDNESS OF DEATH. (PATIENT DEATH IS HANDLED IN RELATED COMPLAINT). IN RELATED COMPLAINT, A CLINICAL ASSESSMENT WAS MADE BASED ON AVAILABLE INFORMATION AT THAT TIME POINT, WHICH INCLUDED A DEATH REPORT. OF RELEVANCE TO CURRENT COMPLAINT, IT IS MENTIONED THAT THE COMPLAINT DEVICE WAS USED TO TREAT AN ABDOMINAL ANEURYSM. FURTHERMORE, PER MEDICAL ADVISOR, THE TYPE 1B ENDOLEAK IS UNRELATED TO THE SEQUENCE OF EVENT LEADING TO PATIENT DEATH. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. BASED ON THE LIMITED PROVIDED INFORMATION AND INVESTIGATION, IT HAS NOT BEEN POSSIBLE TO ESTABLISH A CAUSE FOR THE INADEQUATE SEAL LEADING TO A TYPE 1B ENDOLEAK AS NOTHING IS KNOWN ABOUT ANATOMY/DISEASE STATE IN THE DISTAL SEAL ZONE. IT IS NOTED THAT COMPLAINT DEVICE WAS USED FOR TREATMENT OF ABDOMINAL AORTIC ANEURYSM, WHICH IS OUTSIDE OF INSTRUCTION FOR USE FOR THIS DEVICE. 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 ACCORDING TO INITIAL REPORTER: ON (B)(6) 2019, DURING THE INDEX PROCEDURE, A ZDEG (LOT# E3711250) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF PROXIMAL OVERSIZING WAS NOT REPORTED. ADDITIONAL STAGED PROCEDURES ARE PLANNED FOR AFTER THE ZDEG IMPLANT PROCEDURE. PRIMARY INDICATION FOR IMPLANT WAS AORTIC ANEURYSM. THE PATIENT HAD MODERATE PAIN/DISCOMFORT IN THEIR BACK, LEG, RIGHT BUTTOCK, AND A SMALL PULPAL LESION OF THE TOE OF THE LEFT FOOT. PRE-PROCEDURE IMAGING SHOWED THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, RIGHT RENAL ARTERY, LEFT RENAL ARTERY, AND RIGHT INTERNAL ILIAC ARTERY WERE PATENT. THE RIGHT COMMON ILIAC, LEFT COMMON ILIAC, AND LEFT INTERNAL ILIAC WERE OCCLUDED. NO TORTUOSITY, OCCLUSIVE DISEASE, OR CALCIFICATION WAS NOTED. THROMBUS WAS CIRCUMFERENTIAL. PROCEDURE ANGIOGRAPHY SHOWED PROXIMAL ZONE OF GRAFT IMPLANTATION AT ZONE 4. THE LEFT SUBCLAVIAN ARTERY WAS NOT COVERED BY THE GRAFT FABRIC. NO EVIDENCE OF SEPARATION OR DEVICE INTEGRITY ISSUES. TYPE IB-DISTAL ENDOLEAK WAS PRESENT WITH LOCATION SPECIFIED AS DISSECTION GRAFT (ZDEG) (B)(4). POST-PROCEDURE IMAGING HAS NOT BEEN REPORTED ON. ON (B)(6) 2019 (2 DAYS POST-PROCEDURE) A SECONDARY INTERVENTION WAS DONE DUE TO ABDOMINAL EPIGASTRIC PAIN. OPEN SURGICAL REPAIR WAS DONE DUE TO INADEQUATE ACCESS AND MULTIPLE EMBOLISMS. THE DEVICE WAS NOT EXPLANTED, AND THE SECONDARY INTERVENTION WAS DEEMED UNSUCCESSFUL DUE TO EXTENSION OF ISCHEMIC LESIONS AND SMALL BOWEL RESECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2019, (30 DAYS POST-PROCEDURE). ON (B)(6) 2019, (2 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED MULTI-ORGAN FAILURE DUE TO MULTIPLE EMBOLI RELATED TO THE STUDY PROCEDURE. THE PATIENT DIED ON (B)(6) 2019, (30 DAYS POST-PROCEDURE), DUE TO DISCONTINUATION OF CARE IN PALLIATIVE CARE UNIT. THE SITE NOTED, ¿MULTIPLE EMBOLI, SPLENIC, RENAL, DIGESTIVE MEDULLARY, INVOLVEMENT, PARAPLEGIA¿. AN AUTOPSY WAS NOT PERFORMED. A DEATH REPORT/IN-HOSPITAL EVALUATION AT DEMISE WAS COMPLETED. THE SITE SELECTED COMPLICATION OF IMPLANT PROCEDURE AS RELATEDNESS OF DEATH. THIS WAS PREVIOUSLY REPORTED (B)(4). PATIENT OUTCOME: THE PATIENT DIED ON (B)(6) 2019, (30 DAYS POST-PROCEDURE). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE ENDOLEAK.
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 |
|---|---|---|---|---|---|---|---|
| 216476 | ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3711250 | 10827002231815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female |