ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2021-00207
- Event Type
- Malfunction
- Date Received
- January 29, 2021
- Date of Event
- January 19, 2021
- Report Date
- June 30, 2022
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552323
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION: ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON 10JUN2022. IT WAS PREVIOUSLY REPORTED THAT THERE WAS A LOSS OF PATENCY IN THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-74-ZT, LOT NUMBER 7830557). HOWEVER, IT WAS CONFIRMED THAT THE LOSS OF PATENCY OCCURRED IN THE CUSTOM MADE FENESTRATED GRAFT. THE SUBJECT DEVICE IS NOT MANUFACTURED BY COOK INC., BUT RATHER BY WILLIAM COOK EUROPE (WCE). AS SUCH, COOK INC. WILL NOT BE SUBMITTING ANY FURTHER REPORTS REGARDING THIS DEVICE.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION (B)(6) INFORMED COOK ON (B)(6) 2021 OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-74-ZT) FROM LOT 7830557. A LACK OF PATENCY IN A LEG GRAFT WAS REPORTED DURING A FOLLOW-UP ON (B)(6) 2021. COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT NO TREATMENT WAS PERFORMED AS A RESULT OF THE REPORTED LOSS OF PATENCY. NO ADVERSE EFFECTS WERE REPORTED TO THE AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE 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. A REVIEW OF THE DESIGN HISTORY FILE (DHF) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT (7830557) AND A RELATED SUBASSEMBLY LOT REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. IT SHOULD BE NOTED THAT ZSLE DEVICES ARE DISTRIBUTED VIA ONE-DEVICE LOTS. AS 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 HAVE BEEN RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD AND THAT THE COMPLAINT LOT WAS MANUFACTURED TO CURRENT SPECIFICATIONS. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_ZAAASZ_REV3] ¿ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRACK INTRODUCTION SYSTEM,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿4 WARNINGS AND PRECAUTIONS 4.1 GENERAL PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. 4.2 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. 4.5 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. 5 ADVERSE EVENTS 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) 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) 11 DIRECTIONS FOR USE 11.1 ZENITH SPIRAL-Z AAA ILIAC LEG SYSTEM 11.1.4 CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 3. 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. 4. 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. 11.1.5 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 2. ADVANCE SLOWLY UNTIL THE IPSILATERAL ILIAC LEG GRAFT OVERLAPS A MINIMUM OF ONE STENT INSIDE THE IPSILATERAL LIMB OF THE MAIN BODY. 3. 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 PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT WAS UNABLE TO BE ESTABLISHED. HOWEVER, IT SHOULD BE NOTED THAT THROMBUS/OCCLUSION IS A KNOWN INHERENT RISK OF USING THIS DEVICE. 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.
ADDITIONAL INFORMATION WAS PROVIDED ON 14JUN2022 INDICATING THAT THE THERE WAS NO LOSS OF PATENCY IN THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG AS PREVIOUSLY REPORTED. THE ADDITIONAL INFORMATION PROVIDED ON 14JUN2022 INDICATED THAT THE LOSS IN PATENCY WAS IN THE CUSTOM MADE FENESTRATED GRAFT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
CUSTOMER (PERSON): PHONE - (B)(6). 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 THERE WAS A LOSS OF PATENCY IN THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG SEEN ON THE PATIENT'S FOUR-YEAR FOLLOW-UP. PRE-PROCEDURAL IMAGING ON (B)(6) 2017 SHOWED PATENT CELIAC, SUPERIOR MESENTERIC, AND RENAL ARTERIES. THE ANEURYSM WAS CLASSIFIED AS A JUXTARENAL, STABLE ANEURYSM WITH A MAXIMUM DIAMETER OF 55MM. THERE WERE NO RENAL INFARCTS. ON (B)(6) 2017, THE PATIENT HAD SEVEN DEVICES IMPLANTED WITHOUT DIFFICULTIES DURING DEPLOYMENT, INCLUDING 3 COOK DEVICES AND 4 COMPETITOR DEVICES. POST-PROCEDURAL IMAGING SHOWED NO ENDOLEAKS, DEVICE INTEGRITY ISSUES, OR OTHER TECHNICAL OBSERVATIONS. EARLIER ON (B)(6) 2017, A SERIOUS ADVERSE EVENT WAS REPORTED OF SUSPECTED MEDULLARY ISCHEMIA DUE TO HYPOPERFUSION OF THE ADAMKIEWICZ ARTERY AFTER THE GRAFT HAD BEEN PLACED. THE PATIENT WAS TREATED WITH AN EXTERNAL LUMBAR DERIVATION, WHICH WAS CONSIDERED PROCEDURE-RELATED. AT THE ONE MONTH FOLLOW UP ON (B)(6) 2017 (44 DAYS POST-PROCEDURE), FOLLOW-UP IMAGING SHOWED PATENT ARTERIES AND NO DEVICE ISSUES. THE MAXIMUM ANEURYSM DIAMETER REMAINED 55MM. ON (B)(6) 2017 (148 DAYS POST-PROCEDURE), AN OCCLUSION OF THE RIGHT LIMB OF THE BIFURCATED BODY WAS NOTED. THIS WAS TREATED WITH A FEMORAL-FEMORAL BYPASS, IN WHICH THE DATE OF EVENT IS UNKNOWN. THE EVENT WAS NOT CONSIDERED TO BE RELATED TO THE DEVICE OR INITIAL PROCEDURE. AT THE SIX-MONTH FOLLOW UP ON (B)(6) 2018 (228 DAYS POST-PROCEDURE), FOLLOW-UP IMAGING SHOWED PATENT ARTERIES, BUT A CONTINUED LACK OF PATENCY IN THE RIGHT ILIAC GRAFT LEG. NO OTHER DEVICE ISSUES WERE NOTED. ON (B)(6) 2018 (266 DAYS POST-PROCEDURE), A SECONDARY INTERVENTION WAS PERFORMED TO CORRECT THE OCCLUSION IN THE ILIAC LEG. THE SECONDARY INTERVENTION WAS DESCRIBED AS THE "TRANSVERSE INCISION OF THE TWO SCARPAS". CLARIFICATION OF THIS DESCRIPTION HAS BEEN REQUESTED. ON AN UNKNOWN DAY IN (B)(6) 2020, THE PATIENT HAD A STROKE AND WAS HOSPITALIZED, WHERE THEY WERE TREATED WITH MEDICATION. THIS EVENT WAS DEEMED UNRELATED TO THE STUDY DEVICE OR THE PROCEDURE. THIS COMPLAINT REFERENCES THE FOUR-YEAR FOLLOW-UP ON (B)(6) 2020 (1264 DAYS POST-PROCEDURE), WHERE FOLLOW-UP IMAGING SHOWED A MAXIMUM ANEURYSM DIAMETER OF 55MM. THE SUPERIOR MESENTERIC, CELIAC, AND RIGHT RENAL ARTERIES WERE PATENT. A LOSS OF PATENCY WAS FOUND IN THE LEFT ILIAC GRAFT LEG, AS WELL AS IN THE LEFT RENAL STENT GRAFT. NO ENDOLEAK WAS PRESENT AND THERE WAS NO SEPARATION OF COMPONENTS. THERE WAS NO EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2020, AN OCCLUSION OF THE FENESTRATED GRAFT IN THE LEFT RENAL (IN-STENT AND NATIVE VESSEL) WAS SEEN. NO TREATMENT WAS PROVIDED AND THIS EVENT IS CONSIDERED ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150434 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55232 | 7830557 | 10827002552323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | AAA-BIFURCATED-GRAFT| FEN-THORACO-ABDOMINAL-GRAFT| NON-COOK: BGP 2806_1, RENAL STENT, R| NON-COOK: BGP2701_1, CELIAC STENT| NON-COOK: BGP2701_1, SMA STENT| NON-COOK: BGP2806_1, RENAL STENT, L |