ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2020-01550
- Event Type
- Injury
- Date Received
- August 24, 2020
- Date of Event
- August 5, 2020
- Report Date
- March 1, 2021
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B7 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.
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.
IT WAS REPORTED THAT BY DR.(B)(6) FROM THE CARDIOVASCULAR SURGERY DEPARTMENT AT (B)(6) HOSPITAL, (B)(6) JAPAN THAT A PATIENT HAD A RIGHT ILIAC LEG GRAFT OCCLUSION AFTER EVAR. THE PATIENT WAS REPORTED TO BE A 56-YEAR-OLD MALE WHO HAD BEEN DIAGNOSED WITH AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT HIS ¿NEUTRAL FAT¿ (ASSUMED TO BE TRIGLYCERIDES) WAS EQUAL OR HIGHER THAN 1100. HE WAS ALSO REPORTED TO HAVE HAD HISTORY OF SMOKING. THE PATIENT UNDERWENT ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2016. ON THE MORNING OF (B)(6) 2020 THE PATIENT PRESENTED TO THE HOSPITAL WITH PAIN IN THE RIGHT LEG. A COMPUTED TOMOGRAPHY SCAN (CT) REVEALED ¿MASSIVE BLOOD CLOTS¿ IN THE RIGHT ILIAC LEG GRAFT. PERFUSION THROUGH THE PERIPHERAL SIDE WAS CONFIRMED. IT WAS REPORTED THAT THE DECREASE IN PERFUSION IN THE PERIPHERAL SIDE DUE TO BLOOD CLOTS IN THE RIGHT ILIAC LEG GRAFT WAS CAUSING THE PATIENT'S LEG PAIN. ON (B)(6) 2020 AN ADDITIONAL PROCEDURE WAS COMPLETED. A WIRE GUIDE WAS PLACED THROUGH THE OCCLUSION INSIDE THE RIGHT ILIAC LEG GRAFT. BLOOD CLOTS WERE CONFIRMED AT THE PROXIMAL EDGE OF THE RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RP:NZSLE-20-74-ZT, LOT NUMBER 5914795 OR 6140972) AND INSIDE THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-24-96-ZT, LOT NUMBER 6509336) GRAFT. IT WAS DECIDED THAT NEW GRAFTS WOULD BE USED IN BOTH THE RIGHT AND LEFT ILIAC ARTERIES TO PREVENT BLOOD/CLOTS FROM TRAVELING TO THE CONTRALATERAL SIDE AND TO AVOID DISPROPORTIONATE EXPANSION FORCE. COMPETITOR¿S GRAFTS WERE PLACED AND THE PROCEDURE WAS COMPLETED AFTER CONFIRMING IMPROVEMENT IN BLOOD FLOW. IT IS UNKNOWN IF THE REPORTED LEG PAIN HAD IMPROVED AFTER THE SECONDARY INTERVENTION. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, THE CUSTOMER PROVIDED A PRE-IMPLANTATION CTA AS WELL AS A CTA 4.5 YEARS POST IMPLANT, WHICH WAS SENT FOR EXPERT IMAGE REVIEW. IMAGE REVIEW CONFIRMED OCCLUSION IN THE ZSLE LEG GRAFT. THE IMAGE REVIEWER ALSO CONFIRMED MURAL THROMBUS IN THE MAIN BODY GRAFT (TFFB-24-96-ZT) AS A LIKELY EXTENSION OF THE ZSLE THROMBUS. THIS EVENT IS REPORTED IN MDR# 1820334-2020-02001. IMAGE REVIEW ALSO NOTES THAT BOTH ZSLE GRAFTS ARE INSERTED 4.5 MM SUPERIOR TO THE FLOW DIVIDER. THE DEAD SPACE CREATED BY THIS WAS FILLED WITH THROMBUS. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT CONTROLS AND INSPECTIONS ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DESIGN HISTORY FILE (DHF) FOUND THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. ADDITIONALLY, IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD (DHR). THE CUSTOMER REPORTED THAT THE DEVICE THAT OCCLUDED WAS A ZENITH SPIRAL-Z AAA ILIAC LEG GRAFT, RPN: ZSLE-20-74-ZT. HOWEVER, IN THE PROCEDURE 2 GRAFT OF THIS SIZE WERE PLACED. ONE GRAFT WAS FROM LOT 5914795 AND THE OTHER WAS FROM LOT 6140972. IT IS NOT KNOWN WHICH GRAFT WAS THE ONE THAT BECAME OCCLUDED. THE DHR FOR DEVICE LOT 5914795 WAS REVIEWED AND NO NONCONFORMANCES WERE FOUND. THE DHR FOR DEVICE LOT 6140972 WAS REVIEWED AND ONE NONCONFORMANCE WAS FOUND FOR HOT SEAL INADEQUATE, WHICH WAS REWORKED AND SUBSEQUENTLY REINSPECTED BEFORE PROCEEDING THROUGH THE MANUFACTURING PROCESS. BASED ON REVIEW OF THE DEVICE MASTER RECORD AND DEVICE HISTORY RECORD, THERE IS OBJECTIVE EVIDENCE THAT ALL MANUFACTURING STEPS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT THE COMPLAINT DEVICE WAS BUILT TO SPECIFICATION. A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INSTRUCTIONS 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. THE ZENITH SPIRAL-Z AAA ILIAC LEG HAS NOT BEEN EXPLICITLY EVALUATED CLINICALLY; HOWEVER ITS PERFORMANCE IS REPRESENTED BY THE ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG (A PREVIOUS VERSION OF THE DEVICE), WHICH HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: KEY ANATOMICAL ELEMENTS THAT FALL OUTSIDE THE SIZING REQUIREMENTS SPECIFIED IN THE APPROPRIATE MAIN BODY OR RENU INSTRUCTIONS FOR USE. 4.4 DEVICE SELECTION STRICT ADHERENCE TO THE ZENITH SPIRAL-Z AAA ILIAC LEG IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE. APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING OR COMPRESSION. 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. 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). ENDOPROSTHESIS: OCCLUSION. GRAFT OR NATIVE VESSEL OCCLUSION. 7 PATIENT SELECTION AND TREATMENT 7.1 INDIVIDUALIZATION OF TREATMENT THE RISKS AND BENEFITS SHOULD BE CAREFULLY CONSIDERED FOR EACH PATIENT BEFORE USE OF THE ZENITH SPIRAL-Z AAA ILIAC LEG. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE, BUT ARE NOT LIMITED TO: PATIENT¿S AGE AND LIFE EXPECTANCY CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY) THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT. 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 GRAFT LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG¿ DEVICE-RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE AND DEATH. 11 DIRECTIONS FOR USE ANATOMICAL REQUIREMENTS. ILIOFEMORAL ACCESS SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIUM AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES. ARTERIAL CONDUIT TECHNIQUES MAY BE REQUIRED. 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. IF THERE IS ANY TENDENCY FOR THE MAIN BODY GRAFT TO MOVE DURING THIS MANEUVER, HOLD IT IN POSITION BY STABILIZING THE GRAY POSITIONER ON THE IPSILATERAL SIDE. 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, INSPECTION OF THE PROVIDED IMAGING, AND THE RESULTS OF THE INVESTIGATION, THE MOST LIKELY CAUSE FOR OCCLUSION WAS TRACED TO THE PATIENT'S CONDITION OF HYPERTRIGLYCERIDEMIA AND LIFESTYLE (SMOKING). ADDITIONALLY, THROMBUS FORMATION IS A KNOWN INHERENT RISK OF THESE DEVICES. 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.
NO ADDITIONAL INFORMATION REGARDING THE EVENT DESCRIPTION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS WAS RECEIVED ON 14OCT2020. A SECONDARY PROCEDURE WAS COMPLETED ON (B)(6) 2020. A WIRE GUIDE WAS PLACED THROUGH THE OCCLUSION INSIDE THE RIGHT ILIAC LEG GRAFT. BLOOD CLOTS WERE CONFIRMED AT THE PROXIMAL EDGE OF THE RIGHT ILIAC LEG GRAFT AND INSIDE THE MAIN BODY GRAFT. TWO COMPETITOR'S GRAFTS WERE PLACED IN THE RIGHT ILIAC ARTERY. ONE COMPETITOR'S GRAFT WAS PLACED IN THE LEFT ILIAC ARTERY. IT WAS REPORTED THAT THIS WAS COMPLETED TO PREVENT THE CLOTS FROM TRAVELING TO THE CONTRALATERAL SIDE AND TO AVOID DISPROPORTIONATE EXPANSION FORCE. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING IMPROVEMENT IN BLOOD FLOW. IT IS UNKNOWN IF THE PAIN REPORTED IN THE LEG HAD RESOLVED AFTER THE PROCEDURE.
NO ADDITIONAL INFORMATION REGARDING PATIENT DETAILS OR THE EVENT DESCRIPTION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
LOT #: UNSURE, BUT COULD BE 5914795 OR 6140972. CUSTOMER (PERSON): (B)(6). (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 FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OCCLUDED WHILE IMPLANTED IN THE PATIENT'S RIGHT SIDE. ON THE (B)(6) 2016, A MALE PATIENT UNDERWENT AN EVAR PROCEDURE TO TREAT A AAA WITH A ZENITH FLEX MAIN BODY AND TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS. ON (B)(6) 2020, THE PATIENT PRESENTED AT THE HOSPITAL WITH PAIN IN THEIR RIGHT LEG. CT IMAGING REVEALED MASSIVE BLOOD CLOTS OCCLUDING THE RIGHT ILIAC LEG GRAFT. BLOOD WAS STILL PERFUSING THROUGH THE PERIPHERAL SIDE, THOUGH AT A DECREASED RATE. AN ADDITIONAL PROCEDURE IS PLANNED FOR A UNKNOWN DATE TO OCCLUDE THE RIGHT INTERNAL ILIAC ARTERY WITH A VASCULAR PLUG AND PLACE TWO COMPETITOR'S STENTS FROM INSIDE THE ILIAC LEG GRAFT TO THE EXTERNAL ILIAC ARTERY TO MAKE THE OCCLUDED SIDE PATIENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910617 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | CODA 32| TFFB-24-96-ZT/ 6509336| ZSLE-20-74-ZT/ 5914795 OR 6140972 |