ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2018-00432
- Event Type
- Injury
- Date Received
- April 11, 2018
- Report Date
- August 27, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
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): P140016. (B)(4). SIMILAR TO DEVICE UNDER 510(K): P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
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) (B)(4). H6) EC METHOD CODE: 4109 HISTORICAL DATA ANALYSIS. 4117 DEVICE NOT ACCESSIBLE FOR TESTING . EC RESULT CODE: 4247 CODE NOT AVAILABLE FOR THE SCHEDULED PROCEDURE WAS PERFORMED WITH A DIFFERENT DEVICE WITH A SMALLER SIZE THAN WAS INTENDED. EC CONCLUSION CODE: 4315 CAUSE NOT ESTABLISHED. SUMMARY OF INVESTIGATIONAL FINDINGS: THE PROCEDURE WAS PERFORMED WITH A DIFFERENT DEVICE THAN INTENDED, AS THE DESIRED DEVICE (ZTA-PT-44-40-179) WAS NOT DELIVERED IN TIME TO BE USED IN THE PROCEDURE. A SMALLER GRAFT SIZE (COMPLAINT DEVICE ZTA-PT-42-38-173) WAS USED INSTEAD, AND THE OUTCOME OF THE PROCEDURE WAS A TYPE IA ENDOLEAK. THE ENDOLEAK WAS CORRECTED WITH USE OF AN ADDITIONAL DEVICE ALONG WITH BALLOONING AFTERWARDS. NO IMAGING OR INFORMATION RELATED TO ANATOMY OF THE PATIENT WAS PROVIDED TO DETERMINE THE EXACT CAUSE OF THE REPORTED TYPE IA ENDOLEAK, HOWEVER THE USE OF A SMALLER GRAFT SIZE CAN LEAD TO A TYPE IA ENDOLEAK. THE IFU STATES THAT UNDERSIZING OR OVERSIZING MAY RESULT IN INCOMPLETE SEALING AND LISTS ENDOLEAK AS A POTENTIAL ADVERSE EVENT. 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 TO INITIAL REPORTER: INITIALLY, THE SURGEON WANTED TO USE A 44MM GRAFT TO LAND PROXIMALLY, AT THE LSA. SINCE DEVICE WAS NOT ON STOCK AND PROCEDURE ALREADY PLANNED THE PHYSICIAN DECIDED TO TRY THE ZTA-PT-42-38-173 INSTEAD. DUE TO A TYPE 1A LEAK HE USED ANOTHER ZTA-P-42-121 AND LANDED IT MORE PROXIMALLY. WE STILL HAD SOME FILLING OF THE SAC BUT THEN USED THE CODA BALLOON (WHICH IS USED RARELY IN THIS REGION) WHICH HELPED CREATE A BETTER SEAL. PATIENT OUTCOME: NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE OCCURRENCE.
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 |
|---|---|---|---|---|---|---|---|
| 264282 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |