ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2024-00237
- Event Type
- Malfunction
- Date Received
- November 11, 2024
- Date of Event
- May 13, 2024
- Report Date
- July 16, 2025
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002242842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER REF#: (B)(4). (G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K) P160014. 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). THE SITE HAS REPORTED THAT THE INFOLDING WAS NOT DUE TO DEVICE DEFICIENCY BUT DUE TO INSERTION BETWEEN THE ZDEG AND ZTA. THE EVENT IS THEREFORE NO LONGER REPORTABLE TO FDA. 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). BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE SITE, IT IS DETERMINED THAT THE EVENT FOR THIS PR# IS REPORTABLE. D1) CORRECTED FROM "ZTA-PT-38-34-217 (E4471088)" TO "ZDEG-P-36-204-PF (E4427054)". D4) FIELDS UPDATED TO MATCH CORRECTION IN D1. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT WAS RAISED BASED ON THE ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY, WCE-1713. ON (B)(6) 2024, THE PATIENT WAS URGENTLY TREATED FOR ACUTE THORACIC AORTIC DISSECTION TYPE B WITH PLACEMENT OF A ZTA-PT-38-34-217 (DISTAL) AND A ZDEG 36-204 (PROXIMAL) (COMPLAINT DEVICE). FOLLOW-UP IMAGING COMPLETED 119 DAYS POST-PROCEDURE REVEALED A DEVICE INFOLDING. THE SITE INDICATED THE DEVICE ISSUE DID NOT LEAD TO ANY MEDICAL ISSUES OR ADVERSE EVENTS AND DID NOT REQUIRE SECONDARY INTERVENTION. THE SITE HAS CLARIFIED THAT THE INFOLDING OCCURRED IN THE ZDEG DEVICE IN THE FIRST STENT OF THE ENDOGRAFT AND THAT IT HAD LITTLE CLINICAL VALUE. THE SUSPECTED CAUSE OF THE DEVICE INFOLDING WAS ¿PROBABLY THE ANGULATION OR THE SHORT LANDING ZONE¿. PRE-IMPLANT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS RECEIVED AND REVIEWED ALONG WITH A COMPLAINT REPORT DATED (B)(6) 2024 BY AN IMAGING EXPERT ON (B)(6) 2024. PER THE IMAGING REVIEW FINDINGS, ¿TO SEAL AGAINST NORMAL AORTIC WALL, THE ZDEG WOULD HAVE NEEDED TO COVER THE LSA ORIGIN. ASSUMING ZDEG IMPLANTATION AT THE LEFT CCA TRAILING EDGE AND THE ZTA EXTENSION TO THE CA ORIGIN, THE ZTA WOULD HAVE OVERLAPPED THE ZDEG 79.3MM. ADDITIONALLY, THE OVERLAP WOULD HAVE BEGUN SUPERIOR AND EXTEND INFERIOR THROUGH THE ACUTE AORTIC ANGULATION.¿ AS THE IMAGING REVIEWER ONLY HAD PRE-IMPLANT CTA, THE INFOLDING COULD NOT BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. THE INSTRUCTION FOR USE (IFU) STATES THAT IMPROPER COMPONENT PLACEMENT IS AN ADVERSE EVENT THAT MAY OCCUR AND/OR REQUIRE INTERVENTION. FURTHERMORE, THE IFU HAS INSTRUCTIONS ON SUITABLE VASCULAR MORPHOLOGY FOR ENDOVASCULAR REPAIR INCLUDING PROXIMAL FIXATION SITE OF AT LEAST 20 MM AND LOCALIZED ANGULATION LESS THAN 45 DEGREES. PER THE PROVIDED INFORMATION AND IMAGING, THE MOST LIKELY CAUSE FOR THE ENDOGRAFT INFOLDING WAS THE ANGULATION OR THE SHORT LANDING ZONE, WHERE THE ACUTE AORTIC ANGULATION IS ALSO VISIBLE ON THE PRE-IMPLANT IMAGES THAT WERE PROVIDED. 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 STUDY: (B)(4), ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY: FOLLOW-UP IMAGING COMPLETED 119 DAYS POST-PROCEDURE REVEALED DEVICE INFOLDING. ON (B)(6) 2024, THE PATIENT WAS URGENTLY TREATED FOR ACUTE THORACIC AORTIC DISSECTION TYPE B WITH PLACEMENT OF A ZTA-PT-38-34-217 (DISTAL) AND A ZDEG 36-204 (PROXIMAL). THE SITE INDICATED STAGED PROCEDURE(S) IS PLANNED BUT HAS NOT YET COMPLETED STAGED PROCEDURE FORMS. PROCEDURE IMAGING NOTED PATENT THORACIC FALSE LUMEN WITH TYPE 1A FLOW FROM THE PRIMARY TEAR, HOWEVER, 1 DAY POST-PROCEDURE, IMAGING REVEALED PARTIALLY THROMBOSED THORACIC FALSE LUMEN WITH FLOW FROM SECONDARY TEAR(S) IN ZONE 5. FOLLOW-UP IMAGING COMPLETED 119 DAYS POST-PROCEDURE REVEALED A COMPLETELY THROMBOSED THORACIC FALSE LUMEN AND A DEVICE ISSUE. THE SITE NOTED THAT THE ¿ADDITIONAL PROXIMAL COMPONENT (ZTA-P/PT-)¿ DISPLAYED INFOLDING. PATIENT OUTCOME: THE SITE INDICATED THE DEVICE ISSUE DID NOT LEAD TO ANY MEDICAL ISSUES OR ADVERSE EVENTS AND DID NOT REQUIRE SECONDARY INTERVENTION.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
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 |
|---|---|---|---|---|---|---|---|
| 944801 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G24284 | E4427054 | 10827002242842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |