ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER
Report
- Report Number
- 1820334-2018-00201
- Event Type
- Injury
- Date Received
- January 30, 2018
- Report Date
- July 18, 2018
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002551920
- PMA / PMN Number
- P020018
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION - EVALUATION: THE ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER WAS NOT RETURNED FOR EVALUATION. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. IMAGING WAS PROVIDED FOR REVIEW. A REVIEW OF THE PROVIDED IMAGING, DEVICE HISTORY RECORDS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA WAS PERFORMED DURING THE INVESTIGATION. PREOPERATIVE, 1 MONTH POSTOPERATIVE, AND 32-MONTH POSTOPERATIVE CT STUDIES WERE PROVIDED FOR IMAGE REVIEW. THE PROXIMAL NECK WAS ADEQUATE LENGTH FOR ENDOVASCULAR REPAIR. HOWEVER, THE AORTIC DIAMETER RANGED FROM 25 X 24 MM JUST BELOW THE LRA TO 23 X 19.6 MM AT THE DISTAL NECK. THE 30MM MAIN BODY DEVICE WAS OVERSIZED FOR THIS REVERSE TAPERED NECK. GRAFT OVERSIZING COULD RESULT IN A THROMBOSIS EVENT. BILATERAL COMMON ILIAC ARTERY ANEURYSMS ARE TREATED WITH FLARED ILIAC LEGS. THE RIGHT CIA (MEASURING 28.5 MM WITHIN THE DISTAL SEAL ZONE) IS INADEQUATELY TREATED WITH A 28MM DEVICE, AND THE LEFT CIA (MEASURING 24.2 MM WITHIN THE DISTAL SEAL ZONE) IS INADEQUATELY TREATED WITH A 24MM DEVICE. BOTH APPEAR SEALED AT 1 MONTH, WITH NO DISTAL ENDOLEAKS NOTED. THE RIGHT ILIAC LEG (ESC 28 X 80 MM) HAS 35 MM OVERLAP WITHIN THE IPSILATERAL LIMB. THERE WAS A SIGNIFICANT DISCREPANCY IN THE PROXIMAL POSITIONING OF BILATERAL ILIAC LEGS, WITH THE LEFT LEG PLACED 26 MM HIGHER THAN THE RIGHT LEG. THE PROXIMAL LEFT LEG EXTENDED UP INTO THE LUMEN OF THE MAIN BODY GRAFT WHILE THE PROXIMAL RIGHT LEG WAS BELOW THE FLOW DIVIDER. THIS SIGNIFICANT DISCREPANCY COULD CONTRIBUTE TO TURBULENT FLOW IN THE MAIN BODY GRAFT. MODERATE TORTUOSITY IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY RESULTS IN A 42-DEGREE BEND IN THE RIGHT ILIAC LEG AS IT EXITS THE IPSILATERAL LIMB OF THE MAIN BODY. A KINK HERE COULD CONTRIBUTE TO A THROMBOSIS EVENT. HOWEVER, THERE DOES NOT APPEAR TO BE ANY KINKING OR COMPROMISE OF THE GRAFT LUMEN AT THIS LEVEL ON THE 1-MONTH STUDY. THROMBOSIS CAN OCCUR FOR A VARIETY OF REASONS, SUCH AS GENETIC PREDISPOSITION, ILIAC TORTUOSITY, EXTERNAL COMPRESSION, PULSATION / REPETITIVE STENOSIS, IMPROPER OVERLAP, NARROW INNER ILIAC LUMEN, VESSEL DAMAGE, AND ROUGH SURFACES. TORTUOSITY, COMPRESSION, AND PULSATION CAN CREATE SHEAR FORCES WITHIN THE LEG THAT STIMULATE THROMBUS GROWTH. WHERE A SMALL THROMBUS HAS FORMED, THE CLOT CAN ENLARGE BECAUSE THE BLOOD FLOW SLOWS AROUND THE CLOT, ALLOWING CLOT-FORMING ELEMENTS TO BE DEPOSITED. PULSATION AND A SMALL INNER LUMEN CAN OCCUR THROUGH GRAFT OVERSIZING OR UNDERSIZING. THE IMAGE REVIEWER HAS INDICATED THAT THE PATIENT HAD A FUNNEL NECK REGION (25 X 24MM PROXIMALLY TO 23 X 19.6MM DISTALLY). THIS RESULTED IN OVERSIZING OF THE ZALB-30-98 IN THE DISTAL NECK. ACCORDING TO THE IFU (T_ZLPCIN_REV5) PROVIDED WITH THE MAINBODY ZALB DEVICE, THE INTENDED MAXIMUM DIAMETER ALONG THE PROXIMAL FIXATION SITE OF THE 30MM DIAMETER ZALB IS 25-26MM. THIS SIZING OF THE MAINBODY GRAFT IS WITHIN THE INDICATIONS OF THE IFU FOR THIS DEVICE, ALTHOUGH THIS OVERSIZED THE GRAFT IN THE DISTAL NECK REGION. THE IFU ALSO STATES, THAT PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20MM ID IN THE AORTA OR 7 TO 8 MM ID IN THE ILIACS) HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). THE POTENTIAL FOR THIS INCREASED RISK IN THESE PATIENTS MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. BECAUSE THE AORTIC VESSEL DIAMETER IN THE DISTAL NECK WAS LESS THAN 20 MM ID, THE NARROWED REGION COMPRESSING THE GRAFT LIKELY RESULTED IN FABRIC REDUNDANCY AND INCREASED SHEAR FORCES THROUGHOUT THE IMPLANTED GRAFTS, THUS INCREASING THE RISK OF THROMBUS FORMATION. ALSO, THROMBUS FORMATION WITHIN THE MAINBODY ZALB COULD HAVE PROPAGATED THROUGHOUT THE GRAFTS AS A RESULT OF TURBULENT FLOW FOLLOWING THE AORTIC NARROWING. IT WAS ALSO FOUND THAT THERE WAS A SIGNIFICANT DISCREPANCY IN THE PROXIMAL POSITIONING OF BILATERAL ILIAC LEGS, WITH THE LEFT LEG PLACED 26MM HIGHER THAN THE RIGHT LEG. THE PROXIMAL LEFT LEG EXTENDED UP INTO THE LUMEN OF THE MAIN BODY GRAFT WHILE THE PROXIMAL RIGHT LEG WAS BELOW THE FLOW DIVIDER. SINCE THE RIGHT ILIAC LEG (ESC-28-12-80-ZT) HAD 35MM OVERLAP WITHIN THE IPSILATERAL LIMB, THE CONTRALATERAL ZSLE GRAFT OVERLAP EXCEEDED 20MM ABOVE THE MAIN BODY BIFURCATION. IN THE IFU (T_ZAAASZ_REV3) PROVIDED WITH THE CONTRALATERAL ZSLE-24-74-ZT DEVICE IT STATES, EXCESSIVE OVERLAP OF 10MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS." ALSO, THE FLOW DISTURBANCE CAUSED BY THE DISCREPANCY BETWEEN THE PLACEMENT OF THE TWO LEG GRAFTS COULD CONTRIBUTE TO TURBULENT FLOW IN THE MAIN BODY GRAFT RESULTING IN AN INCREASED RISK OF THROMBUS FORMATION WITHIN THE ESC AND ZSLE GRAFTS. AN ESC-28-12-80-ZT WAS IMPLANTED ON THE RIGHT SIDE. THIS IS A CONVERTER GRAFT THAT WAS INVERTED AND IMPLANTED WITHIN THE IPSILATERAL GATE. ACCORDING TO THE IFU (T_EAAAZ_REV1) PROVIDED WITH THE ESC DEVICE, CONVERTERS CAN BE USED TO CONVERT A BIFURCATED GRAFT INTO AN AORTO-UNIILIAC GRAFT. EVEN THOUGH THIS WAS OUT OF THE ESC GRAFTS INTENDED USE AS STATED IN THE IFU, THERE IS NO EVIDENCE TO INDICATE THAT THIS CONTRIBUTED TO THE REPORTED THROMBUS FORMATION BUT CANNOT BE RULED OUT AS A POSSIBLE CONTRIBUTING FACTOR. TORTUOSITY AND CALCIFICATION PRESENT IN THE RIGHT COMMON ILIAC COULD ALSO BE A CONTRIBUTING FACTOR FOR THIS EVENT. IMAGE REVIEW REPORTED THE PROXIMAL RIGHT CIA HAS MODERATE TORTUOSITY AND CALCIFICATION BUT IS WIDELY PATENT AND MODERATE TORTUOSITY IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY RESULTS IN A 42-DEGREE BEND IN THE RIGHT ILIAC LEG AS IT EXITS THE IPSILATERAL LIMB OF THE MAIN BODY. A KINK HERE COULD CONTRIBUTE TO A THROMBOSIS EVENT. HOWEVER, THERE DOES NOT APPEAR TO BE ANY KINKING OR COMPROMISE OF THE GRAFT LUMEN AT THIS LEVEL ON THE 1-MONTH STUDY. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMITIES WERE NOTED. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU), LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THIS COMPLAINT IS CONFIRMED BASED ON IMAGE REVIEW FINDINGS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED OUT OF CURRENT SPECIFICATIONS BASED ON IMAGE REVIEW FINDINGS, REVIEW OF THE DEVICE HISTORY RECORD, AND DESIGN HISTORY FILES. WITH THE INFORMATION AND IMAGING PROVIDED, PATIENT ANATOMY AND DEVICE PLACEMENT LIKELY CAUSED THIS EVENT. THE USE OF THE ESC CONVERTER GRAFT OUTSIDE OF ITS INTENDED USE CANNOT BE RULED OUT AS A POSSIBLE CONTRIBUTING FACTOR. THE FIRST ROOT CAUSE FOR THIS EVENT IS LIKELY PRODUCT USE OR HANDLING RELATED. ¿ USER DID NOT FOLLOW INSTRUCTIONS/LABEL. THE PROXIMAL LEFT ILIAC LEG ROSE ABOVE THE FLOW DIVIDER BY OVER 20MM. THE RESULTING FLOW DISTURBANCE LIKELY INCREASED THE RISK OF THROMBUS FORMATION THROUGHOUT THE IMPLANTED GRAFTS. ALSO, THE ESC-28-12-80-ZT WAS NOT USED ACCORDING TO ITS INTENDED USE AS DESCRIBED IN THE IFU. THERE IS NO EVIDENCE TO INDICATE THAT THIS CONTRIBUTED TO THE REPORTED THROMBUS FORMATION BUT CANNOT BE RULED OUT AS A POSSIBLE CONTRIBUTING FACTOR. THE SECOND ROOT CAUSE IS LIKELY, PROCEDURE RELATED - PATIENT CONDITION RELATED TO OCCURRENCE. THE SEAL ZONE WAS FUNNEL SHAPED, REDUCING FROM 25 X 24MM PROXIMALLY TO 23 X 19.6MM DISTALLY. BECAUSE THE AORTIC VESSEL DIAMETER IN THE DISTAL NECK WAS LESS THAN 20 MM ID, THE NARROWED REGION COMPRESSING THE GRAFT LIKELY RESULTED IN FABRIC REDUNDANCY AND INCREASED SHEAR FORCES THROUGHOUT THE IMPLANTED GRAFTS, THIS ALONG WITH TORTUOSITY AND CALCIFICATION PRESENT IN THE RIGHT COMMON ILIAC COULD HAVE INCREASED THE RISK OF THROMBUS FORMATION WITHIN THE ESC-28-12-80-ZT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE. 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.
THE PHYSICIAN DID NOT PERFORMED ANY ADDITIONAL PROCEDURES ON THE PATIENT. THE PATIENT WAS A CLAUDICANT AND HIS ABI¿S WERE THE SAME AS PRE EVAR SO HE DECIDED AGAINST OFFERING TREATMENT.
(B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THE ESC-28-12-80-ZT (G55192, LOT: 5365707) GRAFT WAS DEPLOYED OUTSIDE THE PATIENT ¿ INVERTED AND THEN RELOADED BACK INTO THE SHEATH BEFORE INSERTION IN THE PATIENT. THE PATIENT WAS NOT PRESCRIBED ANY ANTICOAGULANTS. THE PATIENT DID NOT HAVE ANY PREDISPOSITION THAT WOULD CAUSE CLOTTING. ADDITIONAL INFORMATION RECEIVED ON 06/18/2018. THE PHYSICIAN ADVISED THAT HE DID NOT PERFORM ANY OTHER TREATMENT ON THE PATIENT. HE SAID THE PATIENT WAS A CLAUDICANT AND HIS ABI¿S WERE THE SAME AS PRE-EVAR SO HE DECIDED AGAINST OFFERING TREATMENT.
IT WAS REPORTED A (B)(6) MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2015. THE PATIENT WAS IMPLANTED WITH A Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER IN THE RIGHT ILIAC LIMB, A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY AND A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG IN THE LEFT ILIAC LIMB. AS REPORTED ON (B)(6) 2018, THE PATIENT HAS DEVELOPED PAIN AND CLAUDICATION AND THERE IS TOTAL OCCLUSION OF ALL THREE EVAR GRAFTS. IT HAS BEEN INDICATED THAT THE PATIENT REQUIRES ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A FOLLOW-UP REQUEST HAS BEEN MADE BUT NOT YET RECEIVED REGARDING DETAILS ON ANY PLANNED OR PERFORMED SURGICAL/MEDICAL INTERVENTION. THIS EVENT INVOLVES THREE DEVICES THAT WERE REPORTED TO BE TOTALLY OCCLUDED. MFR. REPORT # 1820334-2018-00201 CAPTURES THE RIGHT ILIAC LIMB OCCLUSION AND MFR. REPORT # 1820334-2018-00202 CAPTURES THE LEFT LIMB OCCLUSION. A REPORT IS NOT BEING FILED FOR THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (CATALOG # ZALB-30-98) REPORTED TO BE TOTALLY OCCLUDED AS THIS DEVICE IS NOT SOLD IN THE US AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC. THAT IS MARKETED IN THE US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 70589 | ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55192 | 5365707 | 10827002551920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |