ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
Report
- Report Number
- 3002808486-2018-00887
- Event Type
- Injury
- Date Received
- August 8, 2018
- Date of Event
- July 15, 2018
- Report Date
- April 9, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002236148
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K) 070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER: E2016032. WILLIAM COOK (B)(4) (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF#: (B)(4). MFR SITE: NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404. REGISTRATION NO: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IN THE CURRENT COMPLAINT IT IS REPORTED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL IN EMERGENCY, AS THE PATIENT WAS A RISK OF AORTIC RUPTURE POSSIBLY DUE TO A STENT GRAFT INDUCED NEW ENTRY TEAR LOCATED AT THE DISTAL EDGE OF THE ZTEG-2PT-42-32-205-PF (COMPLAINT DEVICE). THE PATIENT UNDERWENT URGENT TREATMENT. A ZTA-P-32-155-W1 WAS PLACED IN THE DISTAL SIDE OF THE ZTEG, THEN BLOOD FLOW THROUGH THE ENTRY WAS CONFIRMED TO BE BLOCKED AND THE PROCEDURE WAS FINISHED. AFTER THE PROCEDURE, THE PATIENT IS REPORTED TO HAVE HAD A FAVORABLE OUTCOME. ACCORDING TO THE INFORMATION REPORTED IN THE COMPLAINT, THE PATIENT HAD 851 DAYS PRIOR TO THE EVENT UNDERGONE TEVAR WITH THE ZTEG-2PT-42-32-205-PF AND GZSD-36-164-2 IMPLANTED IN THE THORACIC AORTA AND GZSD-36-164-2 IN THE THORACICABDOMINAL AORTA. THE PATIENT WAS REPORTED SUITABLE FOR THE PROCEDURE AND THE PROCEDURE HAD BEEN CONDUCTED AS LABELLED. A PRE-SECONDARY INTERVENTION MULTIPHASE CTA WAS PROVIDED FOR THE INVESTIGATION. IT WAS NOTED IN THE IMAGING REVIEW: "A NEW ENTRY TEAR THROUGH THE INTIMA OF A CHRONIC DISSECTION AT THE END OF THE ZTEG IS CONFIRMED". "THE INTIMA OF THE CHRONIC DISSECTION COULD NOT REMODEL. CONSEQUENTLY, THE SHORT AXIS OF THE CHRONICALLY OVALIZED TRUE LUMEN EXPERIENCED GREATER RADIAL FORCE FROM THE ZTEG, COMPARED TO THE OVERLAPPING GZSD.". AS PER FINDINGS IN THE IMAGING REVIEW: "THE THICKENED INTIMA OF A CHRONIC DISSECTION CONSTRAINED THE ZTEG AND DISSECTION TO AN OVALIZED LUMEN, RATHER THAN REMODELING TO A CIRCLE. BECAUSE THIS WAS PRESENT EVEN FAR REMOVED FROM THE ACUTE FALSE LUMEN PERFUSION, THE OVALIZED LUMEN WAS CHRONIC RATHER THAN AN ACUTE CHANGE FROM FALSE LUMEN PRESSURIZATION". "THE SHORT AXIS OF THIS OVALIZED LUMEN ABRUPTLY DECREASED 4MM AT THE END OF THE ZTEG. AT THIS POINT, CONTRAST EXTENDED FROM THE TRUE LUMEN INTO THE FALSE LUMEN THROUGH A TEAR IN THE CHRONICALLY THICKENED INTIMA". "BECAUSE THE FALSE LUMEN WAS LOCATED ON THE OUTER AORTIC CURVATURE, THE ZTEG END WAS POINTED BY A 20 DEGREE AORTIC DIRECTION CHANGE INTO THE CHRONICALLY THICKENED INTIMA". THE LIKELY CAUSE OF THIS EVENT IS LIKELY RELATED TO THE INABILITY OF THE DISSECTION INTIMA TO REMODEL, AND CONSEQUENTLY THAT THE SHORT AXIS OF THE CHRONICALLY OVALIZED TRUE LUMEN EXPERIENCED GREATER RADIAL FORCE FROM THE ZTEG, COMPARED TO THE OVERLAPPING GZSD. AORTIC DAMAGE INCLUDING PERFORATION AND DISSECTION IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU AND CURRENT PACKAGE INSERT. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. 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 INITIAL REPORTER: ON (B)(6) 2016: A MALE PATIENT, WHO IS CURRENTLY (B)(6), HAD UNDERGONE TEVAR WITH ZTEG-2PT-42-32-205-PF AND GZSD-36-164-2 PLACED IN THE THORACIC AORTA AND GZSD-36-164-2 IN THE THORACICABDOMINAL AORTA BY FEMORAL ARTERY APPROACH. THE PATIENT WAS SUITABLE FOR THE PROCEDURE AND THE PROCEDURE HAD BEEN CONDUCTED AS LABELLED. ON (B)(6) 2018: THE PATIENT WAS TRANSPORTED TO THE HOSPITAL IN EMERGENCY FOR THREATENED AORTIC RUPTURE POSSIBLY DUE TO STENT GRAFT INDUCED NEW ENTRY LOCATED AT THE DISTAL EDGE OF THE STENT GRAFT. SINCE URGENT TREATMENT WAS REQUIRED, ONE ZTA-P-32-155-W1 WAS BROUGHT FROM THEIR STOCK. THE ZTA- WAS ADDITIONALLY PLACED IN THE DISTAL SITE OF THE PREVIOUSLY PLACED STENT GRAFT, THEN THE BLOOD FLOW THROUGH THE ENTRY WAS CONFIRMED TO BE BLOCKED AND THE PROCEDURE WAS FINISHED. ADDITIONAL INFORMATION RECEIVED FROM REP: THE NEW TEAR WAS CREATED IN THE INTIMA AT THE DISTAL EDGE OF THE STENT GRAFT POSSIBLY DUE TO STENT GRAFT INDUCED NEW ENTRY. THE MEDIA COULD NOT HOLD THE BLOOD PRESSURE BECAUSE IT HAD ALREADY BEEN WEAKENED AS HAVING CAUSED DISSECTION IN THE PAST, SO THE BLOOD FLOW PRESSED EVEN THE ADVENTITIA, THEN RESULTED IN THREATENED AORTIC RUPTURE. ADDITIONAL INFORMATION PROVIDED 01AUG2018: THE NEW ENTRY TEAR WAS SEEN ONLY IN THE INTIMA. THE MEDIA HAD NO NEW TEAR, BUT JUST WEAKENED DUE TO DISSECTION IN THE PAST. (THE DISSECTION IN THE PAST WAS TREATED IN 2016 WITH ZENITH). DID NOT ESCALATE TO COMPLETE AORTIC RUPTURE WITH RUPTURE OF THE ENTIRETY OF THE AORTIC WALL, INCLUDING THE ADVENTITIA, BEFORE THE ZTA WAS INSERTED. PATIENT OUTCOME: ON (B)(6) 2018 AFTER THE PROCEDURE: THE PATIENT HAD A FAVOURABLE OUTCOME.
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 |
|---|---|---|---|---|---|---|---|
| 607082 | ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3298533 | 10827002236148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |