ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2019-02978
- Event Type
- Injury
- Date Received
- November 27, 2019
- Report Date
- March 30, 2020
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION - EVALUATION: DR. (B)(6) FROM SUNDERLAND HOSPITAL IN THE UNITED KINGDOM INFORMED COOK ON 07NOV2019 OF 18 INCIDENTS OF LIMB OCCLUSIONS INVOLVING ZSLE, TFLE AND ZALL PREFIX DEVICES. THE PHYSICIAN REQUESTED INFORMATION FROM COOK WHILE PREPARING A PRESENTATION FOR VEITH SYMPOSIUM TITLED ¿WHEN LIMB OCCLUSION OCCURS AFTER AN EVAR, ENDOVASCULAR SOLUTIONS ARE THE WAY TO GO: TECHNICAL TIPS TO MAKE THEM SAFE AND EFFECTIVE¿. 18 CASES OF LIMB OCCLUSIONS INVOLVING COOK DEVICES (ZSLE, TFLE, ZALL) WERE INCLUDED IN THE PRESENTATION. THIS COMPLAINT FOCUSES ON PATIENT 9. FOR PATIENT 9, THE TWO IMPLANT DATES WERE PROVIDED ON (B)(6) 2011 AND (B)(6) 2018. THE FIRST DATE IS LIKELY THE ACTUAL DATE OF IMPLANTATION AND THE SECOND DATE IS LIKELY A SECONDARY INTERVENTION. BASED ON THE DEVICE INFORMATION FOR THE IMPLANTED DEVICES, THE COMPLAINT DEVICE IS EITHER ZALL-16-60 (LOT A867005), ZALL-16-84 (LOT A873564) OR TFLE-16-56 (LOT 2538127). IMAGING, PATIENT PRE-EXISTING CONDITIONS, MEDICATIONS PRESCRIBED, TREATMENT/INTERVENTIONS REQUIRED FOR THE THROMBUS FORMATION AND PATIENT OUTCOME WERE REQUESTED BUT NOT PROVIDED BY THE CUSTOMER FACILITY. 16 OF THE 18 REPORTED INCIDENTS OCCURRED BETWEEN 2007-2012. THE DATE OF OCCLUSION WAS NOT PROVIDED FOR THIS INVESTIGATION. IT IS UNKNOWN WHICH TREATMENT WAS REQUIRED FOR EACH PATIENT REPORTED. BASED ON THE CONTENT IN THE PRESENTATION, IT IS ASSUMED THAT ENDOVASCULAR TREATMENT WAS PERFORMED TO TREAT THE LIMB OCCLUSION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. DESIGN TESTING SHOWED THAT THE AFFECTED PRODUCTS ARE SAFE AND EFFECTIVE FOR THEIR INTENDED USE. A REVIEW OF THE DHRS FOR BOTH SUSPECTED DEVICES AND THEIR SUB-ASSEMBLY GRAFT COMPONENTS REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH FOUND NO OTHER EVENTS ASSOCIATED WITH EITHER LOT. ADDITIONALLY, BOTH SUSPECT DEVICES ARE ONE-DEVICE LOTS. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. ADDITIONALLY, THERE IS NO EVIDENCE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING FOR TFLE AND ZALL PREFIX DEVICES: THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDED WITH TFLE DEVICES STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: 4 WARNINGS AND PRECAUTIONS: "PATENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. ADEQUATE ILIAC OR FEMORAL ACCESS IF REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF A 16 FRENCH TO 22 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS." 5.2 POTENTIAL ADVERSE EVENTS "ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM CLAUDICATION (E.G., BUTTOCK, LOWER LIMB) GRAFT OR NATIVE VESSEL OCCLUSION" 8 PATIENT COUNSELING INFORMATION: "PHYSICIANS MUST ADVISE ALL PATIENTS THAT IT IS IMPORTANT TO SEEK PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE SIGNS OF LIMB OCCLUSION, ANEURYSM ENLARGEMENT OR RUPTURE. SIGNS OF LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG." 11 DIRECTIONS FOR USE 11.1.8 CONTRALATERAL LEG PLACEMENT AND DEPLOYMENT "4. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE BOTH INTERNAL ILIAC PATENCY AD A MINIMUM OVERLAP OF ONE FULL ILIAC LEG STENT (I.E., PROXIMAL STENT OF ILIAC LEG GRAFT, MAXIMUM OVERLAP OF 1.5 STENTS) WITHIN THE MAIN BODY ENDOVASCULAR GRAFT." 11.1.11 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT "2. ADVANCE SLOWLY UNTIL THE IPSILATERAL ILIAC LEG GRAFT OVERLAPS A MINIMUM OF ONE FULL ILIAC LEG STENT (I.E., PROXIMAL STENT OF ILIAC LEG GRAFT) INSIDE THE IPSILATERAL LIMB OF THE MAIN BODY. NOTE: IF AN OVERLAP OF GREATER THAN THREE ILIAC LEG STENTS IS REQUIRED (GREATER THAT TWO ILIAC LEG STENTS FOR 37, AND 54 MM LEG LENGTHS), IT MAY BE NECESSARY TO CONSIDER USE OF A LEG EXTENSION IN THE BIFURCATED AREA OF THE OPPOSITE SIDE." THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDED WITH ZALL PREFIX DEVICES STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: 4 WARNINGS AND PRECAUTIONS: "PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/ OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. ADEQUATE ILIAC OR FEMORAL ACCESS IF REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF A 16 FRENCH TO 22 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20 MM 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. DILATION OF THESE REGIONS WITH A NONCOMPLIANT BALLOON AND/OR STENT PLACEMENT MAY BE NECESSARY TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. ADDITIONALLY, THE COMPLETION ANGIOGRAM (WITH STIFF WIRE GUIDES REMOVED) SHOULD BE REVIEWED CAREFULLY O DETERMINE IF FURTHER TREATMENT IN THESE REGIONS IS NECESSARY (E.G., ADJUNCTIVE BALLOONING OR STENTING). FAILURE TO REMOVE THE STIFF WIRE GUIDE PRIOR TO THE ANGIOGRAM COULD MASK ANY LIMB KINKING OR NARROWING THAT MIGHT OCCUR WHEN THE WIRE GUIDE IS REMOVED. FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5 MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). REINTERVENTION (E.G., NONCOMPLIANT BALLOONING OR STENTING IN THESE REGIONS) SHOULD BE CONSIDERED TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. EXCESSIVE OVERLAP OF THE ILIAC LEG GRAFT WITHIN THE LIMB MAY INCREASE THE RISK OF LIMB THROMBOSIS. THE IDEAL OVERLAP BETWEEN THE ZALL LEG AND THE ZALB LIMB (APPROXIMATELY THREE STENT LENGTHS) CAN BE ACHIEVED BY ALIGNING THE GOLD MARK ON THE ILIAC LEG GRAFT WITH THE CHECK MARK ON THE MAIN BODY GRAFT CONTRALATERAL LIMB OR WITH THE GOLD MARK ON THE MAIN BODY GRAFT IPSILATERAL LIMB. IN ORDER TO ACCOMMODATE PATIENT ANATOMY, THE ZALL LEG GRAFT MAY BE DEPLOYED WITH 2.5 TO 3.5 STENTS' OVERLAP ON THE CONTRALATERAL SIDE OR 2.5 TO 4 STENTS' OVERLAP ON THE IPSILATERAL SIDE OF THE MAIN BODY GRAFT." 5 POTENTIAL ADVERSE EVENTS "ADVERSE EVENTS ASSOCIATED EITHER WITH THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT OF THE IMPLANTATION PROCEDURE THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM CLAUDICATION (E.G., BUTTOCK, LOWER LIMB) GRAFT OR NATIVE VESSEL OCCLUSION" 7 PATIENT COUNSELING INFORMATION "PHYSICIANS MUST ADVISE ALL PATIENTS THAT IT IS IMPORTANT TO SEEK PROMPT MEDICAL ATTENTION IF HE/SHE EXPERIENCES SIGNS OF LIMB OCCLUSION, ANEURYSM ENLARGEMENT OR RUPTURE. SIGNS OF LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG." 9.5 DEVICE DIAMETER SIZING GUIDELINES "THE CHOICE OF DIAMETER SHOULD BE DETERMINED FROM THE OUTER WALL TO OUTER WALL VESSEL DIAMETER AND NOT THE LUMEN DIAMETER. UNDERSIZING OR OVERSIZING MAY RESULT IN INCOMPLETE SEALING OR COMPROMISED FLOW." 10 DIRECTIONS FOR USE: 10.1.6 CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT "4. CONFIRM POSITION OF DISTAL END OF THE CONTRALATERAL ILIAC LEG GRAFT. REPOSITION THE CONTRALATERAL ILIAC LEG GRAFT IF NECESSARY TO ENSURE BOTH INTERNAL ILIAC PATENCY AND MINIMUM OVERLAP OF 2.5 STENTS (I.E., PROXIMAL STENT OF ILIAC LEG GRAFT, MAXIMUM OVERLAP OF 3.5 STENTS) WITHIN THE MAIN BODY ENDOVASCULAR GRAFT." 10.1.8 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 3. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY AND A MINIMUM OVERLAP OF 2.5 STENT (I.E., PROXIMAL STENT OF THE ILIAC LEG GRAFT, MAXIMAL OVERLAP OF 4 STENTS) WITHIN THE MAIN BOD ENDOVASCULAR GRAFT." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE WAS NOT ESTABLISHED AS THE COMPLAINT DEVICE/IMAGING WAS NOT PROVIDED BY THE USER FACILITY; HOWEVER, THROMBUS FORMATION IS A KNOWN RISK OF USING THIS DEVICE. COMMON CONTRIBUTING FACTORS FOR THROMBUS FORMATION INCLUDE PATIENT HYPERCOAGULABLE STATE, IMPLANTATION IN STENOSIS, TORTUOSITY AND/OR CALCIFICATION, DEVICE PLACEMENT AND OVERSIZING. APPROPRIATE MEASURES WERE TAKEN TO ADDRESS THIS FAILURE MODE. A CAPA FOR ZALL DEVICES WAS PREVIOUSLY OPENED TO ADDRESS THIS FAILURE MODE ON 28FEB2012 AND WAS CLOSED ON 01DEC2016 BASED ON NO INDICATION OF DEPLOYMENT ISSUES, NO MANUFACTURING NON-CONFORMANCES CONTRIBUTING TO THE EVENTS, AND THE COMPLAINT RATE BEING BELOW THE CLINICAL EVALUATION OBSERVATION RATE. ADDITIONALLY, ZALL DEVICES HAVE SINCE BEEN OBSOLETED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
SUSPECT MEDICAL DEVICE: EXACT RPN OF COMPLAINT DEVICE IS UNKNOWN. DEVICE WAS A ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG, EITHER A ZALL-16-60, LOT A867005, A ZALL-16-84, LOT A873564, OR A TFLE-16-56, LOT 2538127. COMMON DEVICE NAME: UNKNOWN AS THE EXACT RPN OF THE COMPLAINT DEVICE IS UNKNOWN. PROCODE OF THE TFLE IS MIH, BUT PROCODE OF THE ZALL DEVICES IS UNAVAILABLE. CONCOMITANT PRODUCTS: ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY , ZALB-28-98, LOT A875422. (B)(6). REPORT SOURCE: OTHER: (B)(6); INTERNAL PERSONNEL. PMA/510(K) #: UNKNOWN AS THE EXACT RPN OF THE COMPLAINT DEVICE IS UNKNOWN. PMA# OF THE TFLE IS P020018, BUT PMA# OF THE ZALL DEVICES IS UNAVAILABLE. (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 THAT A ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG OCCLUDED. THREE LIMBS AND ONE MAIN BODY WERE IMPLANTED IN A PATIENT. IT IS UNKNOWN WHICH OF THE THREE LIMBS OCCLUDED AND WHEN THE OCCLUSION WAS NOTED. THE INITIAL PROCEDURE WAS AN INFRARENAL AORTIC ANEURYSM REPAIR ON (B)(6) 2011. A SECONDARY INTERVENTION TOOK PLACE ON (B)(6) 2018. DETAILS ABOUT THIS PROCEDURE AND PATIENT OUTCOME AFTER THIS PROCEDURE IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS PROCEDURE BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1175284 | ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |