ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2024-00247
- Event Type
- Malfunction
- Date Received
- November 28, 2024
- Date of Event
- June 20, 2024
- Report Date
- May 14, 2025
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURERS REF # (B)(4). D1-D4) CORRECTED FROM ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENT TO ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT 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.
MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR/CN# IS NO LONGER REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2024, THE PATIENT WAS URGENTLY TREATED FOR ACUTE THORACIC AORTIC DISSECTION TYPE B WITH PLACEMENT OF A ZDEG-P-30-202-PF (COMPLAINT DEVICE) AND ZTA-P-32-201. ON (B)(6) 2024, 56 DAYS POST-PROCEDURE, CT (COMPUTER TOMOGRAPHY) REVEALED A THROMBUS INSIDE ZDEG-P-30-202-PF. NO EVIDENCE OF DEVICE ISSUE WAS REPORTED. NO TREATMENT INFORMATION WAS PROVIDED REGARDING THE THROMBUS. NO IMAGING WAS PROVIDED FOR THE INVESTIGATION. THROMBUS IS A KNOWN POTENTIAL ADVERSE EVENT. NOTHING INDICATES THAT THE EVENT IS RELATED TO A FAULT CONDITION OF THE DEVICE, THE THROMBUS IS ASSESSED AS AN ADVERSE EFFECT INHERENT TO THIS TYPE OF PROCEDURE WHY THE EVENT IS ASSESSED TO BE A SIDE EFFECT. 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.
MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. 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 INFORMATION RECEIVED 19MAR2025: ¿ THE THROMBUS REPORTED WAS ACTUALLY IN THE ZDEG-P-30-202-PF (LOT# E4386825) THAT WAS ALSO IMPLANTED DURING THE STUDY PROCEDURE, PROXIMAL TO THE ZTA. THE ZTA WAS NOT AFFECTED. ¿ ON THE PROCEDURE AND 1-MONTH FOLLOW-UP IMAGING, THE THORACIC FALSE LUMEN WAS PREVIOUSLY NOTED AS COMPLETELY THROMBOSED WHILE THE ABDOMINAL FALSE LUMEN WAS PATENT WITH SOURCE OF FLOW UNKNOWN (INCLUDED IN ORIGINAL COMPLAINT). FOR BOTH TIME POINTS, THE SITE UPDATED THE THORACIC FALSE LUMEN TO PARTIALLY THROMBOSED WITH SOURCE OF FLOW UNKNOWN.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ((B)(6): ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY) OSTIAL OCCLUSION OF THE LEFT SUBCLAVIAN ARTERY WAS REPORTED 56 DAYS POST-PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS URGENTLY TREATED FOR ACUTE THORACIC AORTIC DISSECTION TYPE B WITH PLACEMENT OF A ZTA-P-32-201. PRE-PROCEDURE IMAGING DATA INDICATES THE PRIMARY TEAR LOCATION IS UNKNOWN. PROCEDURE IMAGING REVEALED PATENT ABDOMINAL FALSE LUMEN WITH UNKNOWN SOURCE OF FLOW, NO PATENCY OR DEVICE ISSUES. ON (B)(6) 2024, 56 DAYS POST-PROCEDURE, FOLLOW-UP IMAGING REVEALED PATENT ABDOMINAL FALSE LUMEN WITH UNKNOWN SOURCE OF FLOW, OCCLUDED LEFT SUBCLAVIAN ARTERY, AND NO DEVICE ISSUES. NO TREATMENT IS NOTED. THE SITE DETERMINED THE EVENT TO BE RELATED TO THE STUDY DEVICE, NOTING ¿THE PATIENT IS NOT ARTHRITIC.¿ THE SITE ALSO ASSESSED THE EVENT AS RELATED TO THE STUDY PROCEDURE, NOTING ¿IT APPEARED AFTER THE STUDY PROCEDURE.¿ THE SITE PROVIDED THIS ADDITIONAL INFORMATION: ¿THE CT SCAN ON (B)(6) 2024 SHOWED A THROMBUS IN THE UPPER PART OF THE STENT AT THE EMERGENCE OF THE LEFT SUBCLAVIAN ARTERY. HOWEVER, DOWNSTREAM PATENCY WAS PRESERVED.¿ PATIENT OUTCOME: THE EVENT IS NOTED AS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2615200 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G24271 | E4386825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |