ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2019-02962
- Event Type
- Malfunction
- Date Received
- November 26, 2019
- Report Date
- March 31, 2020
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION: THE COMPLAINANT, DR. (B)(6) FROM (B)(6) HOSPITAL LOCATED 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 6. WITH THE INFORMATION PROVIDED, THE COMPLAINT DEVICE IS EITHER AN RPN ZSLE-16-74-ZT (LOT # 6132727) OR AN RPN ZSLE-16-90-ZT (LOT # 5558972). 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. THE IMPLANT DATE FOR THIS PATIENT WAS (B)(6) 2015 AND THE OCCLUSION DATE WAS NOT PROVIDED FOR THIS INVESTIGATION. 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), DRAWING, 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 CONTROLS AND INSPECTIONS ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DHRS FOR BOTH POTENTIAL DEVICES AND THEIR RELATED SUB-ASSEMBLY LOTS REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH FOUND NO OTHER REPORTED EVENTS ASSOCIATED WITH EITHER LOT. BOTH THE ZSLE-16-74-ZT AND THE ZSLE-16-90-ZT ARE ONE-DEVICE LOTS, GIVING NO INDICATION OF NON-CONFORMING PRODUCT IN HOUSE. BECAUSE THERE ARE ADEQUATE INSPECTION ACTIVITIES IN PLACE, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES, AND NO OTHER LOT-RELATED COMPLAINTS RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT INSTRUCTIONS OF USE (IFU), [T_ZAAASZ_REV3] ¿ZENITH® SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK¿ INTRODUCTION SYSTEM¿, PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS AND PRECAUTIONS; GENERAL PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES.; PATIENT SELECTION, TREATMENT AND FOLLOW-UP ADEQUATE ILIAC OR FEMORAL ACCESS IS 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 14 FRENCH TO 16 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 TO 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.; IMPLANT PROCEDURE SYSTEMIC ANTICOAGULATION SHOULD BE USED DURING THE IMPLANT PROCEDURE BASED ON HOSPITAL- AND PHYSICIAN-PREFERRED PROTOCOL. IF HEPARIN IS CONTRAINDICATED, AN ALTERNATIVE ANTICOAGULANT SHOULD BE CONSIDERED. USE CAUTION DURING MANIPULATION OF CATHETERS, WIRES AND SHEATHS WITHIN AN ANEURYSM. SIGNIFICANT DISTURBANCES MAY DISLODGE FRAGMENTS OF THROMBUS, WHICH CAN CAUSE DISTAL EMBOLIZATION, OR MAY RUPTURE THE ANEURYSM. EXCESSIVE OVERLAP 10 MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS.; ADVERSE EVENTS; 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); EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION; ENDOPROSTHESIS: OCCLUSION; GRAFT OR NATIVE VESSEL OCCLUSION; RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ARTERY OCCLUSION, CONTRAST TOXICITY, INSUFFICIENCY, FAILURE); DIRECTIONS FOR USE; ZENITH SPIRAL-Z AAA ILIAC LEG SYSTEM; CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT; INTRODUCE THE CONTRALATERAL ILIAC LEG DELIVERY SYSTEM INTO THE ARTERY. ADVANCE SLOWLY UNTIL AT LEAST ONE STENT OF THE ILIAC LEG GRAFT OVERLAPS WITHIN THE MAIN BODY AND NOT PAST THE RADIOPAQUE MARKER BAND POSITIONED 30 MM FROM THE PROXIMAL END OF THE ILIAC LEG GRAFT INSIDE THE CONTRALATERAL LIMB OF THE MAIN BODY.; CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY, A MINIMUM OVERLAP OF ONE STENT, AND A MAXIMUM OVERLAP OF 30 MM WITHIN THE MAIN BODY ENDOVASCULAR GRAFT.; IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT; ADVANCE SLOWLY UNTIL THE IPSILATERAL ILIAC LEG GRAFT OVERLAPS A MINIMUM OF ONE STENT INSIDE THE IPSILATERAL LIMB OF THE MAIN BODY.; CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF THE PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE WAS NOT ESTABLISHED. THROMBUS FORMATION WITHIN THE GRAFT IS LISTED AS A POTENTIAL ADVERSE EFFECT IN THE PRODUCT IFU AND IS A KNOWN INHERENT RISK OF THESE DEVICES. THE FAILURE MODE CAN ALSO POSSIBLY BE TRACED TO PATIENT CONDITION AND UNINTENDED USE ERROR. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. A REQUEST TO INITIATE CAPA WAS SUBMITTED AND NO DECISION WAS MADE TO ESCALATE TO CAPA. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
TITLE: CONSULTANT VASCULAR AND ENDOVASCULAR SURGEON. (B)(6). MFG SITE FOR DEVICES: COOK INC. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
SUSPECT MEDICAL DEVICE: EXACT RPN OF COMPLAINT DEVICE IS UNKNOWN. DEVICE WAS A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, EITHER A ZSLE-16-74-ZT, LOT 6132727 OR A ZSLE-16-90-ZT, LOT 5558972. CONCOMITANT PRODUCTS: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, TFFB-30-96-ZT, LOT: 5205477. (B)(6). REPORT SOURCE - OTHER: (B)(6); INTERNAL PERSONNEL. 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 FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OCCLUDED. TWO LIMBS AND A MAIN BODY WERE IMPLANTED DURING AN INFRARENAL AORTIC ANEURYSM REPAIR ON (B)(6) 2015. IT IS UNKNOWN WHICH OF THE TWO LIMBS OCCLUDED AND WHEN THE OCCLUSION WAS NOTED. IT IS UNKNOWN IF A RE-INTERVENTION WAS REQUIRED DUE TO THE OCCLUSION. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1174510 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY 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 | SEE H10. |