ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2017-02162
- Event Type
- Injury
- Date Received
- October 31, 2017
- Date of Event
- September 27, 2017
- Report Date
- June 28, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346618
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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). EVENT IS NO LONGER REPORTABLE IN US BASED ON THE COMPLETED INVESTIGATION. NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404. REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: DEVICE KINK IS REPORTED. THIS COMPLAINT HAS BEEN REOPENED AS IMAGING WAS RECEIVED. IT IS REPORTED IN THE COMPLAINT FILE THAT THE PRIMARY INDICATION FOR THE TEVAR WAS A THORACIC AORTIC ANEURYSM. A CT-SCAN OF (B)(6) 2017 (44 DAYS PRE-PROCEDURE) SHOWED A PROXIMAL NECK LENGTH OF 40 MM. THE ANEURYSM DIAMETER WAS 75 MM. THE DISTAL NECK LENGTH WAS 34 MM AND THE DISTAL NECK DIAMETER 36 MM. THERE WAS CIRCUMFERENTIAL CALCIFICATION OF MAIN ACCESS VESSEL BUT NO THROMBUS IN AORTIC NECKS. ON (B)(6) 2017 DURING THE INDEX PROCEDURE, A ZTA-PT-46-42-233 WAS IMPLANTED IN THE PATIENT. THE PROXIMAL ZONE OF IMPLANTATION WAS ZONE 3. THE PROCEDURE WAS CONSIDERED SUCCESSFUL. NO REPORTABLE EVENTS OR UNUSUAL TECHNICAL OBSERVATIONS WERE OBSERVED ON COMPLETION ANGIOGRAM. FOLLOW-UP CT-SCAN WAS COMPLETED 26 DAYS POST-PROCEDURE (B)(6) 2017). IT SHOWED A MAXIMUM ANEURYSM DIAMETER OF 81 MM AND A TOTAL LENGTH OF COVERED AORTA OF 20 MM. ON THAT CT-SCAN A KINK WAS OBSERVED. THE SAME WAS OBSERVED ON AN X-RAY 31 DAYS POST-PROCEDURE. NO INTERVENTIONS WERE PERFORMED IN RELATION TO THE OCCURRENCE. THE PATIENT IS REPORTED TO REMAIN IN THE STUDY. THE ANGIOGRAPHY STUDY AT THE TIME OF REPAIR AND A 3 WEEK POSTOPERATIVE CT STUDY PROVIDED FOR THE INVESTIGATION, WERE REVIEWED. AS PER FINDINGS IN THE IMAGING REVIEW: "THE ANGIOGRAPHY PROCEDURE IS DATED (B)(6) 2017." ... "THERE IS MODERATE LUMEN DILATION OF THE MID DESCENDING THORACIC AORTA. AN ALPHA THORACIC ZTA DEVICE (46 X 42 X 233 MM TAPERED COMPONENT) IS ADVANCED AND DEPLOYED DISTAL TO THE LSA. SUBSEQUENT AORTOGRAM SHOWS A PATENT STENT GRAFT WITH NO ENDOLEAK NOTED. THERE IS MODERATE ANGULATION OF THE GRAFT BETWEEN THE 5TH AND 7TH STENT SEGMENTS WITH PARTIAL OVERLAPPING OF THE 5TH AND 6TH STENTS ALONG THE LESSER CURVE OF THE ANGULATION. THERE ALSO APPEARS TO BE MILD OVERLAPPING OF THE 1ST AND 2ND STENTS ALONG THE LESSER CURVE DUE TO ARCH CURVATURE. THE DISTAL STENT GRAFT APPEARS TO BE STRAIGHT." "THE 3 WEEK POSTOPERATIVE CT STUDY, DATED (B)(6) 17, IS REVIEWED. THE PROXIMAL ZTA GRAFT BEGINS 22 MM DISTAL TO THE LSA. THE PROXIMAL GRAFT DIAMETER IS 35 TO 37 MM. THERE IS AT LEAST 25 MM LENGTH OF PROXIMAL SEAL. THE MAXIMUM TAA DIAMETER IS 83.5 X 77.3 MM. NO ENDOLEAK IS SEEN. THERE IS AT LEAST 54 MM LENGTH OF DISTAL SEAL WITH A DISTAL GRAFT DIAMETER MEASURING 29 TO 31 MM. THE DISTAL GRAFT LANDS 88 MM ABOVE THE CELIAC TRUNK. THE TOTAL GRAFT LENGTH IS 198 MM." AS PER OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE PATIENT¿S ANATOMY FROM THE IMAGING REVIEW: "THERE IS SIGNIFICANT ANGULATION OF THE MID AND DISTAL DESCENDING THORACIC AORTA, MEASURING 86 DEGREES AND 93 DEGREES, RESPECTIVELY. THE FIRST ANGULATION INVOLVES THE SEGMENT TREATED WITH THE ZTA DEVICE. THERE IS NO KINKING OF THE ZTA DEVICE EVIDENT ON THE IMAGES PROVIDED. THE AREA OF PARTIAL STENT OVERLAPPING BETWEEN THE 5TH AND 6TH STENTS IS, RATHER, NORMAL APPEARANCE OF THE GRAFT CONFORMING TO THE LESSER CURVE OF THE SIGNIFICANT AORTIC ANGULATION. THERE DOES NOT APPEAR TO BE ANY SIGNIFICANT GRAFT NARROWING OR THROMBUS FORMATION AT THIS LEVEL. ..." THE IFU RECOMMENDS THAT NO LOCALIZED ANGULATION SHOULD BE LARGER THAN 45 DEGREES. DURING THE PREVIOUSLY PERFORMED INVESTIGATION FOR THIS COMPLAINT, IT WAS NOTED FROM THE REPORTED INFORMATION THAT ON (B)(6) 2017 THE TOTAL LENGTH OF COVERED AORTA WAS 20MM, AND CONFIRMATION OF THE LENGTH WAS REQUESTED WITHOUT RECEIVING A REPLY. FROM THE CURRENT INVESTIGATION, NO COMPROMISED PROXIMAL OR DISTAL SEAL WAS INDICATED FROM THE REVIEW OF THE IMAGING FROM THAT DATE, THE TOTAL GRAFT LENGTH WAS NOTED TO BE 198 MM AND THERE WERE NO OBSERVATIONS OF ENDOLEAK. IN ADDITION IT WAS NOTED FROM THE REPORTED INFORMATION, THAT AN ANEURYSM DIAMETER OF 75 MM WAS REPORTED TO BE OBSERVED FROM A 44 DAYS PRE-PROCEDURE CT-SCAN (B)(6) 2017) WHICH HAS NOT BEEN PROVIDED FOR THE INVESTIGATION. FROM THE 26 DAY POST-PROCEDURE CT A MAXIMUM ANEURYSM DIAMETER OF 81MM WAS REPORTED. INFORMATION ON ANEURYSM DIAMETER ON THE DAY OF THE PROCEDURE IS NOT AVAILABLE. HOWEVER, FROM THE IMAGING REVIEW NO ENDOLEAK WAS NOTED ON COMPLETION ANGIOGRAM OR ON THE 3 WEEK POSTOPERATIVE CT STUDY WHICH POTENTIALLY COULD CONTRIBUTE TO ANEURYSM ENLARGEMENT, NO INTERVENTIONS HAVE BEEN REPORTED AND THE REPORTED INFORMATION DOES NOT INDICATE THAT ANY ANEURYSM ENLARGEMENT OCCURRED POST-PROCEDURE. THE COMPLAINT OF DEVICE KINK IS NOT CONFIRMED, AS THE KINK COULD NOT BE OBSERVED ON THE 26 DAYS POST-PROCEDURE (B)(6) 2017) CT IMAGING FROM WHICH THE KINK WAS REPORTED 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.
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). INVESTIGATION IS STILL IN PROGRESS
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DESCRIPTION OF EVENT ACCORDING TO STUDY: THE PRIMARY TEVAR INDICATION FOR THIS PATIENT WAS A TAA MAX DIAMETER >= 6 CM. ON (B)(6) 2017 (44 DAYS PRE-PROCEDURE), THE PATIENT HAD A CT-SCAN WHICH SHOWED A PROXIMAL NECK AND LENGTH OF 40 MM. THE ANEURYSM DIAMETER WAS 75 MM. THE DISTAL NECK LENGTH WAS 34 MM AND THE DISTAL NECK DIAMETER 36 MM. THERE WAS CIRCUMFERENTIAL CALCIFICATION OF MAIN ACCESS VESSEL BUT NO THROMBUS IN AORTIC NECKS. ON (B)(6) 2017 DURING THE INDEX PROCEDURE THE PATIENT HAD FOLLOWING COOK DEVICE IMPLANTED: ¿ CATALOG # ZTA-PT-46-42-233, LOT # E3576760. THE PROCEDURE WAS CONSIDERED SUCCESSFUL. PROXIMAL ZONE OF STENT GRAFT IMPLANTATION WAS ZONE 3 USING THE ISHUMARUS CLASSIFICATION. OF ADDITIONAL PROCEDURES DURING INDEX PROCEDURE, A LEFT FEMORAL BYPASS SURGERY WAS PERFORMED. NO REPORTABLE EVENTS OR UNUSUAL TECHNICAL OBSERVATIONS WERE OBSERVED ON COMPLETION ANGIOGRAM. ON (B)(6) 2017 (26 DAYS POST-PROCEDURE), THE ONE MONTH FOLLOW-UP CT-SCAN WAS COMPLETED. IT SHOWED A MAXIMUM ANEURYSM DIAMETER OF 81 MM AND A TOTAL LENGTH OF COVERED AORTA OF 20 MM. ON THAT CT-SCAN A KINK WAS OBSERVED. THE SAME WAS OBSERVED ON AN XRAY ON (B)(6) 2017 (31 DAYS POST-PROCEDURE). NO INTERVENTIONS WAS PERFORMED IN RELATION TO THIS. NO INFORMATION WAS RECEIVED REGARDING WHETHER THIS HAD AN IMPACT ON THE PATIENT OR NOT. PATIENT OUTCOME: THE PATIENT REMAINS IN THE STUDY.
EXEMPTION NUMBER E2016032. (B)(4). MANUFACTURERS REF# (B)(4). (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT CONCERNS A PATIENT WITH TAA WHO UNDERWENT TEVAR. 26 DAYS POST-PROCEDURE A KINK WAS OBSERVED. NO INTERVENTIONS WERE PERFORMED IN RELATION TO THIS. ADDITIONALLY, THE SITE REPORTED A TOTAL LENGTH OF COVERED AORTA OF 20 MM. AS THIS SEEMS UNLIKELY, ORIGINATOR HAS REQUESTED THE SITE FOR CONFIRMATION OF THE LENGTH, BUT NOT RECEIVED A REPLY. AS NO IMAGING WAS PROVIDED IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. COOK WILL REOPEN THIS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769529 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | 10827002346618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Life Threatening |