ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
Report
- Report Number
- 3002808486-2017-00828
- Event Type
- Injury
- Date Received
- March 15, 2017
- Date of Event
- February 27, 2017
- Report Date
- March 3, 2017
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002236131
- 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). MANUFACTURER 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): P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AS THE NEW ARCH DISSECTION ENTRY TEAR OCCURRED AT A MINIMUM OF 8MM PROXIMAL TO THE SEALING STENT, THE NEW DISSECTION WAS LIKELY NOT DIRECTLY RELATED TO THE SEALING STENT. HOWEVER, IT MAY HAVE BEEN CAUSED DURING IMPLANTATION AND THEREFORE INDIRECTLY RELATED TO THE ENDOGRAFT. AN INTIMAL TEAR SECONDARY TO THE SEALING STENT, TOO SMALI TO RESOLVE BY CTA, CANNOT BE EXCLUDED. SINCE THE PROVIDED PRE-IMPLANTATION SCAN WAS PERFORMED THREE MONTHS PRIOR TO IMPLANTATION, IT IS POSSIBLE THAT THE NEW DISSECTION OCCURRED DURING THIS INTERVAL. THE BARBED TX2 STENT GRAFT WAS IMPLANTED IN A FUSIFORM AORTIC DILATION. THE DILATION INDICATED THAT THIS SEGMENT WAS DISEASED. THIS SEGMENT WOULD HAVE BEEN AT GREATER RISK OF INTIMAL INJURY. A NORMAL SEAL ZONE WAS AVAILABLE MORE PROXIMALLY. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. 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 INITIAL REPORTER: ON (B)(6) 2016: TYPE B AORTIC DISSECTION OCCURRED. THE PATIENT'S SYMPTOMS ARE STABLE, AND IT WAS FOLLOW-UP WITH USING ANTIHYPERTENSIVE. HOWEVER, IT WAS OBSERVED ACUTE ENLARGEMENT OF FALSE LUMEN. ON (B)(6) 2017: THE STENT GRAFT PLACEMENT WAS PERFORMED TO REPAIR OF TYPE B AORTIC DISSECTION. THE PROCEDURE WAS PERFORMED AS LABELED. BALLOONING (TOUCH UP) WAS NOT PERFORMED AFTER PLACEMENT OF THE STENTGRAFT. ON (B)(6) 2017: IT WAS CONFIRMED THE DEVELOPMENT OF TYPE A AORTIC DISSECTION BY CONTRAST CT. AORTIC ARCH REPLACEMENT WILL BE PLANNED TO PERFORM ON (B)(6) 2017. PATIENT OUTCOME: TYPE A DISSECTION OCCURRED.
(B)(4). SIMILAR TO DEVICE UNDER 510(K): P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2016: TYPE B AORTIC DISSECTION OCCURRED. THE PATIENT'S SYMPTOMS ARE STABLE, AND IT WAS FOLLOW-UP WITH USING ANTIHYPERTENSIVE. HOWEVER, IT WAS OBSERVED ACUTE ENLARGEMENT OF FALSE LUMEN. ON (B)(6) 2017: THE STENT GRAFT PLACEMENT WAS PERFORMED TO REPAIR OF TYPE B AORTIC DISSECTION. THE PROCEDURE WAS PERFORMED AS LABELED. BALLOONING (TOUCH UP) WAS NOT PERFORMED AFTER PLACEMENT OF THE STENTGRAFT. ON (B)(6) 2017: IT WAS CONFIRMED THE DEVELOPMENT OF TYPE A AORTIC DISSECTION BY CONTRAST CT. AORTIC ARCH REPLACEMENT WILL BE PLANNED TO PERFORM ON (B)(6) 2017. PATIENT OUTCOME: TYPE A DISSECTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189182 | ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | 10827002236131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Life Threatening| R |