ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2023-00057
- Event Type
- Injury
- Date Received
- March 9, 2023
- Date of Event
- October 29, 2020
- Report Date
- December 20, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002242767
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A 74-YEAR-OLD FEMALE PATIENT UNDERWENT THORACIC ENDO VASCULAR AORTIC REPAIR (TEVAR) FOR TREATMENT OF AN AORTIC ANEURYSM. (B)(6) 2019, DURING THE INDEX PROCEDURE, A ZDEG-P-32-202-PF (LOT# E3844931) WAS IMPLANTED WITHOUT DIFFICULTY. THE PROCEDURE WAS DONE PERCUTANEOUSLY VIA RIGHT AND LEFT FEMORAL ACCESS SITE. A BALLOON WAS USED TO DILATE THE SUPERIOR MESENTERIC ARTERY TO BE ABLE TO PASS THROUGH. THE ZTA DEVICE WAS PLACED THE BELOW SUBCLAVIAN ARTERY AND THE ZDEG DEVICE WAS PLACED DISTALLY TO THE ZTA WITH PROXIMAL FIXATION INSIDE THE ZTA DEVICE. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND NO SEPARATION OF DEVICES. PROCEDURAL ANGIOGRAPHY SHOWED A TYPE IA PROXIMAL ENDOLEAK AND REPORTED THIS ENDOLEAK WAS WITHIN THE ZTA DEVICE ((B)(4)). ON (B)(6) 2020 (514 DAYS POST-PROCEDURE), A CT REVEALED A TYPE IIIA ENDOLEAK WITHIN THE ZDEG STUDY DEVICE AND A GRAFT FROM ANOTHER MANUFACTURER AT THE RIGHT RENAL ARTERY. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH A GRAFT FROM ANOTHER MANUFACTURER AT THE RIGHT RENAL ARTERY, ENDOVASCULARLY TO TREAT THE TYPE IIIA ENDOLEAK. PER SITE, THE DEVICES INVOLVED WAS THE ZDEG DEVICE, BUT AS AN ENDOLEAK TYPE IIIA, THE ENDOLEAK ALSO INVOLVED THE STENT AT THE RIGHT RENAL ARTERY. THE TREATMENT WAS SUCCESSFUL. FOLLLOW-UP CT SCANS FROM (B)(6) 2021 (759 DAYS POST PROCEDURE) AND (B)(6) 2021 (862 DAYS POST PROCEDURE), REVEALED A TYPE IIIA ENDOLEAK OF THE ZDEG DEVICE. IT IS UNKNOWN WHETHER THIS IS A NEW ENDOLEAK. NO SECONDARY INTERVENTIONS HAVE BEEN REPORTED. A POST OPERATIVE CT STUDY (514 DAYS POST-PROCEDURE) WAS PROVIDED AND REVIEWED BY AN IMAGING EXPERT. ACCORDING TO THE IMAGING REVIEW THE ZDEG WAS A CUSTOM FENESTRATED ENDOGRAFT IMPLANTED FROM THE ZTA-P THROUGH THE ABDOMINAL AORTA. THE TYPE IIIA ENDOLEAK WAS BETWEEN ONE AF THE FENESTRATIONS OF THE ZDEG AND A BRIDGING STENT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ZDEG IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH SYMPTOMATIC DISSECTION OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR. CONSEQUENTLY, USE OF ZDEG DEVICE FOR TREATMENT OF A THORACOABDOMINAL ANEURYSM IS OUTSIDE OF INTENDED USE. ADDITIONALLY, DEVICE MODIFICATION IS NOT SUPPORTED BY THE IFU OR CLINICAL TESTING OF THE DEVICE. BASED ON THE PROVIDED INFORMATION AND IMAGING REVIEW IT HAS NOT BEEN POSSIBLE TO ESTABLISH A CONCLUSIVE CAUSE OF THE REPORTED EVENT AS THE STENT GRAFT WAS MODIFIED BEFORE USE. 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.
MANUFACTURER REF# (B)(4). INVESTIGATION SUBMITTED 08MAR2023 IS STILL VALID. 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). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED 13DEC2023: PATIENT OUTCOME. ADDITIONAL INTERVENTION TO TREAT THE TYPE III ENDOLEAK: THERE WAS AN EVAR WITH STENT DONE RELATED TO THE 12 MOUNTH IMAGING.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: TYPE IIIA-PROXIMAL ENDOLEAK REPORTED ON (B)(6) 2020. (B)(6) 2019, DURING THE INDEX PROCEDURE, A ZDEG-P-32-202-PF (LOT# E3844931) WAS IMPLANTED WITHOUT DIFFICULTY. PROCEDURAL ANGIOGRAPHY SHOWED A TYPE IA PROXIMAL ENDOLEAK AND REPORTED THIS ENDOLEAK WAS WITHIN THE ZTA DEVICE. PRIMARY INDICATION FOR IMPLANT WAS AORTIC ANEURYSM AND PRE-PROCEDURAL IMAGING INFORMATION WAS NOT PROVIDED AT THIS TIME. THE PROCEDURE WAS DONE PERCUTANEOUSLY VIA RIGHT AND LEFT FEMORAL ACCESS SITE. A BALLOON WAS USED TO DILATE THE SUPERIOR MESENTERIC ARTERY TO BE ABLE TO PASS THROUGH. THE GRAFT FABRIC DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND NO SEPARATION OF DEVICES. PROCEDURAL ANGIOGRAPHY SHOWED A TYPE IA PROXIMAL ENDOLEAK AND REPORTED THIS ENDOLEAK WAS WITHIN THE ZTA DEVICE. ON (B)(6) T2020 (514 DAYS POST-PROCEDURE), A CT REVEALED A TYPE IIIA ENDOLEAK WITHIN THE ZDEG STUDY DEVICE AND THE GRAFT (DEVICE FROM ANOTHER MANUFACTURER) AT THE RIGHT RENAL ARTERY. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON THE SAME DAY (514 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT STENT TO THE RIGHT RENAL ARTERY, ENDOVASCULARLY. THE DEVICES INVOLVED WAS THE ZDEG DEVICE, BUT AS AN ENDOLEAK TYPE IIIA, THE ENDOLEAK ALSO INVOLVED THE STENT AT THE RIGHT RENAL ARTERY. (B)(6) 2021 (759 DAYS POST PROCEDURE), A CT REVEALED TYPE IIIA ENDOLEAK OF THE ZDEG DEVICE WAS REPORTED. THE ZDEG DEVICE WAS PROXIMAL, AND THE DISTAL DEVICE INVOLVED WAS THE GRAFT (DEVICE FROM ANOTHER MANUFACTURER). DEVICE IS PATENT AND NO DEVICE INTEGRITY ISSUES OR SEPARATION OF THE DEVICE HAVE BEEN REPORTED. NO DEVICE MIGRATION HAS OCCURRED. ON (B)(6) 2021 (862 DAYS POST PROCEDURE), A CT REVEALED TYPE IIIA ENDOLEAK OF THE ZDEG DEVICE WAS REPORTED. THE ZDEG DEVICE WAS PROXIMAL, AND THE DISTAL DEVICE INVOLVED WAS THE GRAFT (DEVICE FROM ANOTHER MANUFACTURER). THE DEVICE IS PATENT AND NO DEVICE INTEGRITY ISSUES OR SEPARATION OF THE DEVICES HAVE BEEN REPORTED. NO DEVICE MIGRATION HAS OCCURRED. ADDITIONAL INFORMATION RECEIVED 08MAR2023: INDICATION FOR THE PROCEDURE WITH THE ZDEG DEVICE WAS AORTIC ANEURYSM. THE ZTA WAS ALSO IMPLANTED AS PART OF THE INDEX PROCEDURE FOR TREATMENT OF THE AORTIC ANEURYSM WITH THE ZDEG DEVICE ON (B)(6) 2019. THE INDICATION FOR THE PROCEDURE ON (B)(6) 2020 WHERE THE GRAFT FROM ANOTHER MANUFACTURER AT THE RIGHT RENAL ARTERY WHERE. IMPLANTED WAS TYPE IIIA ENDOLEAK WHICH INVOLVED THE ZDEG DEVICE AND ALSO INVOLVED THE STENT AT THE RIGHT RENAL ARTERY. PATIENT OUTCOME: NO SECONDARY INTERVENTIONS RELATED TO DEVICE HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1573735 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3844931 | 10827002242767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Life Threatening |