ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION
Report
- Report Number
- 3002808486-2024-00109
- Event Type
- Injury
- Date Received
- June 18, 2024
- Report Date
- November 28, 2024
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURERS REF# (B)(4). THIS COMPLAINT IS LOGGED BASED ON INFORMATION FROM ABSTRACTS PRESENTED AT THE 52ND ANNUAL MEETING OF THE JAPANESE SOCIETY FOR VASCULAR SURGERY. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): UNKNOWN, BUT REFERRED TO AS A ZENITH TX2 COMPONENT MARKETED UNDER 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). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE AS ESBE-26-80-T-PF HAVE NO SIMILAR DEVICE MARKETED IN US. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS IS INFORMATION FROM ABSTRACTS PRESENTED AT THE 52ND ANNUAL MEETING OF THE JAPANESE SOCIETY FOR VASCULAR SURGERY. TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) FOR CHRONIC TYPE B DISSECTING ANEURYSM (CDAA) THAT HAS ENLARGED THE FALSE LUMEN AND FORMED AN ANEURYSM SHOWS THAT AORTIC REMODELING IS POOR IN THE ACUTE PHASE, AND ENTRY CLOSURE ALONE DOES NOT REDUCE THE ENLARGED FALSE LUMEN, AND NO REDUCTION IN RISK OF RUPTURE HAS BEEN REPORTED. PARTICULARLY IN DEBAKEY TYPE 3B, THERE IS A RISK OF FALSE LUMEN EXPANSION DUE TO RESIDUAL RE-ENTRY. HERE, WE REPORT A CASE OF ABDOMINAL DEBRANCH AND TEVAR PERFORMED FOR A TYPE B DISSECTING AORTIC ANEURYSM THAT HAD ENLARGED IN ANEURYSM DIAMETER AFTER TEVAR. THE PATIENT WAS A 71-YEAR-OLD MALE WHO UNDERWENT PARTIAL DESCENDING AORTA REPLACEMENT AT ANOTHER HOSPITAL FOR DEBAKEY TYPE 3B TYPE THAT DEVELOPED IN 2006. POSTOPERATIVE CT (COMPUTER TOMOGRAPHY) EXAMINATION REVEALED RESIDUAL ENTRY AND ENLARGEMENT OF THE DESCENDING AORTA, SO TEVAR (USING COOK ZENITH TX2 CUFF, 26-80 AND VALIANT, 32-28-150) WAS PERFORMED IN 2015 AND THE PATIENT WAS FOLLOWED UP. A CONTRAST-ENHANCED CT SCAN IN 2021 SHOWED THAT THE FALSE LUMEN OF THE DESCENDING AORTA WAS THROMBOSED, BUT CONTRAST MEDIUM WAS FOUND TO BE MIXED IN, AND THE MAXIMUM DIAMETER WAS 58 MM, AND THE ABDOMINAL AORTA HAD EXPANDED TO 48 MM, MAKING IT SUITABLE FOR SURGERY. THE FALSE LUMEN WAS PATENT FROM THE CELIAC ARTERY LEVEL TO THE RIGHT EXTERNAL ILIAC ARTERY (EIA), AND RE-ENTRY WAS OBSERVED IN THE RIGHT EIA. ABDOMINAL BRANCHES OTHER THAN THE RIGHT RENAL ARTERY BRANCHED FROM THE TRUE LUMEN. IT WAS DETERMINED THAT THE ANEURYSM DIAMETER ENLARGEMENT WAS CAUSED BY RE-ENTRY OF THE RIGHT EIA AND ENDOLEAKS FROM THE LUMBAR ARTERY AND INTERCOSTAL ARTERY. THE DIAMETER OF THE BLOOD VESSEL ON THE DISTAL SIDE OF THE PREVIOUS TEVAR WAS MORE THAN 50 MM AND CANNOT BE TREATED WITH ARTIFICIAL BLOOD VESSEL REPLACEMENT, SO THE PLAN WAS TO PERFORM TEVAR AFTER PERFORMING ABDOMINAL DEBRANCH. THE SURGERY WAS APPROACHED THROUGH A MIDLINE ABDOMINAL INCISION, AND ARTIFICIAL BLOOD VESSEL REPLACEMENT (J-GRAFT 2010) WAS PERFORMED BELOW THE RENAL ARTERY. THE CENTRAL SIDE WAS ANASTOMOSED WITH A DOUBLE BARREL, AND THE BODY OF THE ARTIFICIAL BLOOD VESSEL WAS SET TO 60 MM TO SERVE AS A LANDING ZONE DURING TEVAR LATER. THE DISTAL ANASTOMOSIS WAS BETWEEN THE LEFT COMMON ILIAC ARTERY AND THE RIGHT EXTERNAL ILIAC ARTERY. THE INTERNAL ILIAC ARTERY WAS RECONSTRUCTED IN THE RIGHT LEG. A QUADRILATERAL ABDOMINAL VASCULAR GRAFT (INTERGARD 140706) WAS ANASTOMOSED END-TO-SIDE TO THE LEFT LEG, THE ABDOMINAL QUADRANTS WERE RECONSTRUCTED, AND THE BASES OF EACH WERE LIGATED. THE IMA WAS TIED FINELY. TWO MONTHS LATER, TEVAR (USING RELAY PLUS AU-2825028) WAS PERFORMED FROM THE DISTAL END OF THE PREVIOUS STENT GRAFT TO THE BODY OF THE Y-SHAPED ARTIFICIAL BLOOD VESSEL. POSTOPERATIVE CONTRAST-ENHANCED CT EXAMINATION SHOWED THAT ALL RECONSTRUCTED ABDOMINAL BRANCHES WERE PATENT, AND NO ENDOLEAKS WERE OBSERVED. THE DIAMETER OF THE DESCENDING AORTA HAS DECREASED TO 50 MM, AND THE PATIENT IS PROGRESSING WELL. THIS COMPLAINT ADDRESSES A TYPE 2 ENDOLEAK REGARDING COOK ZENITH TX2 DEVICE. NO IMAGING WAS PROVIDED FOR THE INVESTIGATION. NOTHING IN THE PROVIDED INFORMATION INDICATES A FAULT DEVICE. TYPE 2 ENDOLEAKS ARE DUE TO PATIENT¿S OWN ANATOMY AND PHYSIOLOGY AND IS PROCEDURE-RELATED/A SIDE-EFFECT. IT IS NOTED THAT TX2 (ESBE-T) DEVICE IS USED IN COMBINATION WITH VALIANT, WHICH IS OUTSIDE OF INTENDED USE FOR THIS TYPE OF DEVICE. ACCORDING TO THE IFU (INSTRUCTIONS FOR USE), DISTAL EXTENSIONS ARE USED FOR EXTENDING THE DISTAL END OF AN IN SITU ENDOVASCULAR GRAFT OR INCREASING THE LENGTH OF OVERLAP BETWEEN GRAFT COMPONENTS. 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). D4) CORRECTED FROM "UNKNOWN" TO "ESBE-26-80-T-PF". 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.
DESCRIPTION OF EVENT ACCORDING TO LITERATURE: THIS IS INFORMATION FROM ABSTRACTS PRESENTED AT THE 52ND ANNUAL MEETING OF THE JAPANESE SOCIETY FOR VASCULAR SURGERY: THORACIC ENDO VASCULAR AORTIC REPAIR (TEVAR) FOR CHRONIC TYPE B DISSECTING ANEURYSM THAT HAS ENLARGED THE FALSE LUMEN AND FORMED AN ANEURYSM SHOWS THAT AORTIC REMODELING IS POOR IN THE ACUTE PHASE, AND ENTRY CLOSURE ALONE DOES NOT REDUCE THE ENLARGED FALSE LUMEN, AND NO REDUCTION IN RISK OF RUPTURE HAS BEEN REPORTED. PARTICULARLY IN DEBAKEY TYPE 3B, THERE IS A RISK OF FALSE LUMEN EXPANSION DUE TO RESIDUAL RE-ENTRY. HERE, WE REPORT A CASE OF ABDOMINAL DEBRANCH AND TEVAR PERFORMED FOR A TYPE B DISSECTING AORTIC ANEURYSM THAT HAD ENLARGED IN ANEURYSM DIAMETER AFTER TEVAR. THE PATIENT WAS A 71-YEAR-OLD MALE WHO UNDERWENT PARTIAL DESCENDING AORTA REPLACEMENT AT ANOTHER HOSPITAL FOR DEBAKEY TYPE 3B TYPE THAT DEVELOPED IN 2006. POSTOPERATIVE CT EXAMINATION REVEALED RESIDUAL ENTRY AND ENLARGEMENT OF THE DESCENDING AORTA, SO TEVAR (USING COOK ZENITH TX2 CUFF, 26-80 AND VALIANT, 32-28-150) WAS PERFORMED IN 2015 AND THE PATIENT WAS FOLLOWED UP. A CONTRAST-ENHANCED CT SCAN IN 2021 SHOWED THAT THE FALSE LUMEN OF THE DESCENDING AORTA WAS THROMBOSED, BUT CONTRAST MEDIUM WAS FOUND TO BE MIXED IN, AND THE MAXIMUM DIAMETER WAS 58 MM, AND THE ABDOMINAL AORTA HAD EXPANDED TO 48 MM, MAKING IT SUITABLE FOR SURGERY. THE FALSE LUMEN WAS PATENT FROM THE CELIAC ARTERY LEVEL TO THE RIGHT EXTERNAL ILIAC ARTERY (EIA), AND RE-ENTRY WAS OBSERVED IN THE RIGHT EIA. ABDOMINAL BRANCHES OTHER THAN THE RIGHT RENAL ARTERY BRANCHED FROM THE TRUE LUMEN. IT WAS DETERMINED THAT THE ANEURYSM DIAMETER ENLARGEMENT WAS CAUSED BY RE-ENTRY OF THE RIGHT EIA AND ENDOLEAKS FROM THE LUMBAR ARTERY AND INTERCOSTAL ARTERY. THE DIAMETER OF THE BLOOD VESSEL ON THE DISTAL SIDE OF THE PREVIOUS TEVAR WAS MORE THAN 50 MM AND CANNOT BE TREATED WITH ARTIFICIAL BLOOD VESSEL REPLACEMENT, SO THE PLAN WAS TO PERFORM TEVAR AFTER PERFORMING ABDOMINAL DEBRANCH. THE SURGERY WAS APPROACHED THROUGH A MIDLINE ABDOMINAL INCISION, AND ARTIFICIAL BLOOD VESSEL REPLACEMENT (J-GRAFT 2010) WAS PERFORMED BELOW THE RENAL ARTERY. THE CENTRAL SIDE WAS ANASTOMOSED WITH A DOUBLE BARREL, AND THE BODY OF THE ARTIFICIAL BLOOD VESSEL WAS SET TO 60 MM TO SERVE AS A LANDING ZONE DURING TEVAR LATER. THE DISTAL ANASTOMOSIS WAS BETWEEN THE LEFT COMMON ILIAC ARTERY AND THE RIGHT EXTERNAL ILIAC ARTERY. THE INTERNAL ILIAC ARTERY WAS RECONSTRUCTED IN THE RIGHT LEG. A QUADRILATERAL ABDOMINAL VASCULAR GRAFT (INTERGARD 140706) WAS ANASTOMOSED END-TO-SIDE TO THE LEFT LEG, THE ABDOMINAL QUADRANTS WERE RECONSTRUCTED, AND THE BASES OF EACH WERE LIGATED. THE IMA WAS TIED FINELY. TWO MONTHS LATER, TEVAR (USING RELAY PLUS AU-2825028) WAS PERFORMED FROM THE DISTAL END OF THE PREVIOUS STENT GRAFT TO THE BODY OF THE Y-SHAPED ARTIFICIAL BLOOD VESSEL. POSTOPERATIVE CONTRAST-ENHANCED CT EXAMINATION SHOWED THAT ALL RECONSTRUCTED ABDOMINAL BRANCHES WERE PATENT, AND NO ENDOLEAKS WERE OBSERVED. THE DIAMETER OF THE DESCENDING AORTA HAS DECREASED TO 50 MM, AND THE PATIENT IS PROGRESSING WELL.
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 |
|---|---|---|---|---|---|---|---|
| 2338675 | ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |