UNKNOWN
Report
- Report Number
- 1820334-2021-02217
- Event Type
- Injury
- Date Received
- September 24, 2021
- Report Date
- April 15, 2022
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION ¿ EVALUATION. (B)(6), MD INFORMED COOK OF A JOURNAL ARTICLE, ¿RELINING OF INFRARENAL STENT GRAFT WITH PRELOADED MODIFIED GORE EXCLUDER FOR OCCULT ENDOLEAK WITH SAC EXPANSION¿. AS REPORTED IN THE LITERATURE, AN 86 YEAR OLD MALE PATIENT UNDERWENT AN EVAR (ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR) PROCEDURE WITH A ZENITH FLEX ENDOVASCULAR GRAFT IN 2010. POSTOPERATIVELY, THE PATIENT'S ANEURYSM HAD INITIALLY BEEN STABLE AT 5.2CM FROM 5.5CM, AND A TYPE2 ENDOLEAK WAS NOTED FROM THE PATENT INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERIES. AT 5 YEARS, THIS HAD EXPANDED TO 6.3CM, AND WAS TREATED WITH EMBOLIZATION. THE PATIENT WAS FOUND TO HAVE A CONTINUED ANEURYSM (AAA) GRAFT EXPANSION 10 YEARS AFTER UNDERGOING THE EVAR DUE TO AN OCCULT ENDOLEAK MEANING ¿HIDDEN¿. ACCORDING TO THE JOURNAL ARTICLE MULTIPLE HIGH-RESOLUTION CONTRAST STUDIES, INCLUDING MULTIPHASE CTAS COULD NOT IDENTIFY ANY SOURCE OF SAC FILLING, INCLUDING A TYPE I, II, OR III ENDOLEAK. AT LEAST 10 TO 12 MM OF PROXIMAL GRAFT APPOSITION WAS STILL PRESENT, AND A TRANSFEMORAL ARTERIOGRAM ALSO FAILED TO DEMONSTRATE ANY ENDOLEAK, INCLUDING A SLOW TYPE IA ENDOLEAK. ALTHOUGH THE SITE COULD EXPLANT THE GRAFTS, THE PATIENT¿S COMORBIDITIES AND PREFERENCES WERE PROHIBITIVE. THE PATIENT UNDERWENT RELINING OF THE STENT GRAFT WITH A MODIFIED GORE EXCLUDER DEVICE. PATIENT WAS DISCHARGED HOME THE NEXT DAY. STABILIZATION OF THE EXPANSION AND SOME SHRINKAGE OF THE ANEURYSM WAS NOTED AT THE PATIENT¿S SIX MONTH FOLLOW-UP. THE DEVICE IS UNKNOWN AND ONLY REFERENCED IN THE LITERATURE AS A ¿ZENITH FLEX (COOK MEDICAL INC., BLOOMINGTON, IN)¿ . THEREFORE, DOCUMENTATION WAS PULLED USING INFORMATION REGARDING A ZENITH FLEX AAA ENDOVASCULAR MAIN BODY GRAFT (TFFB BODY STENT GRAFT). A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. THE JOURNAL ARTICLE DID INCLUDE AXIAL IMAGES FROM A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED AT ONE MONTH, AND THEN AT 5, 8 AND 10 YEAR INTERVALS SHOWING THE MEASUREMENTS OF INCREASE IN THE SIZE OF THE ANEURYSM. ALSO INCLUDED WAS A CTA IMAGE SIX MONTHS AFTER TOTAL RELINING SHOWING SOME SHRINKAGE OF THE ANEURYSM. THE ARTICLE ALSO INCLUDED A THREE-DIMENSIONAL RECONSTRUCTION OF PREOPERATIVE CTA SHOWING A 26 MM MAIN BODY GRAFT AND 13 MM ILIAC LIMBS AS WELL AS IMAGES SHOWING THE REPAIR TECHNIQUES, HOWEVER THE IMAGES DO NOT SHOW ENDOLEAK AS THE AUTHORS DESCRIBE IT AS OCCULT MEANING "HIDDEN". ACCORDING TO THE AUTHORS, ONCE THE GRAFT WAS RELINED, ANEURYSM EXPANSION STABILIZED AND SHOWED SOME REGRESSION AT THE 6 MONTH FOLLOW UP. IN RESPONSE TO THIS INCIDENT, COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION. HOWEVER, COOK DID REVIEW THE DEVICE MASTER RECORD (DMR) AND FOUND THE APPROPRIATE CONTROLS ARE IN PLACE WITHIN THE MANUFACTURING PROCESS TO DETECT NON-CONFORMANCES RELATED TO THIS FAILURE MODE. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE FAILURE ANALYSIS, COMPLAINT HISTORY, MANUFACTURING DOCUMENTS, AND VERIFICATION TESTING, SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_ZAAAF_REV 5 ¿ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE Z-TRAK INTRODUCTION SYSTEM,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 1 DEVICE DESCRIPTION 1.1 AORTIC MAIN BODY AND ILIAC LEG COMPONENTS THE MODULES ARE FULLY STENTED TO PROVIDE STABILITY AND THE EXPANSILE FORCE NECESSARY TO OPEN THE LUMEN OF THE GRAFT DURING DEPLOYMENT. ADDITIONALLY, THE COOK-Z STENTS PROVIDE THE NECESSARY ATTACHMENT AND SEAL OF THE GRAFT TO THE VESSEL WALL. THE BARE SUPRARENAL STENT AT THE PROXIMAL END OF THE GRAFT CONTAINS BARBS THAT ARE PLACED AT 3 MM INCREMENTS FOR ADDITIONAL FIXATION OF THE DEVICE. TO FACILITATE FLUOROSCOPIC VISUALIZATION OF THE STENT GRAFT, GOLD RADIOPAQUE MARKERS ARE POSITIONED AS FOLLOWS: ONE ON THE LATERAL ASPECT OF THE MOST DISTAL STENT ON THE CONTRALATERAL LIMB OF THE BIFURCATED SECTION OF THE MAIN BODY AND FOUR IN A CIRCUMFERENTIAL ORIENTATION WITHIN 2 MM OF THE MOST SUPERIOR ASPECT OF THE GRAFT MATERIAL. 4 WARNINGS AND PRECAUTIONS: 4.1 GENERAL ¿ ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING AN ENLARGING ANEURYSM, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. ¿ 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 ¿ THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IS DESIGNED TO TREAT AORTIC NECK DIAMETERS NO SMALLER THAN 18 MM AND NO LARGER THAN 32 MM. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IS DESIGNED TO TREAT PROXIMAL AORTIC NECKS (DISTAL TO THE LOWEST RENAL ARTERY) OF AT LEAST 15 MM IN LENGTH. ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5 - 20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. ¿ KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION (>60 DEGREES FOR INFRARENAL NECK TO AXIS OF AAA OR >45 DEGREES FOR SUPRARENAL NECK RELATIVE TO THE IMMEDIATE INFRARENAL NECK); SHORT PROXIMAL AORTIC NECK (<15 MM); AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15 MM OF PROXIMAL AORTIC NECK LENGTH); AND CIRCUMFERENTIAL THROMBUS AND/OR CALCIFICATION AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IN THE PRESENCE OF ANATOMICAL LIMITATIONS, A LONGER NECK MAY BE REQUIRED TO OBTAIN ADEQUATE SEALING AND FIXATION. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE ATTACHMENT AND SEALING AT THE FIXATION SITES. NECKS EXHIBITING THESE KEY ANATOMICAL ELEMENTS MAY BE MORE CONDUCIVE TO GRAFT MIGRATION OR ENDOLEAK. ¿ 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 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. ¿ MULTIPLE LARGE, PATENT LUMBAR ARTERIES, MURAL THROMBUS AND A PATENT INFERIOR MESENTERIC ARTERY MAY ALL PREDISPOSE A PATIENT TO TYPE II ENDOLEAKS. PATIENTS WITH UNCORRECTABLE COAGULOPATHY MAY ALSO HAVE AN INCREASED RISK OF TYPE II ENDOLEAK OR BLEEDING COMPLICATIONS. DIAMETERS UTILIZING CT, DIAMETER MEASUREMENTS SHOULD BE DETERMINED FROM THE OUTER WALL TO OUTER WALL VESSEL DIAMETER (NOT LUMEN MEASUREMENT) TO HELP WITH PROPER DEVICE SIZING AND DEVICE SELECTION. THE CONTRAST-ENHANCED SPIRAL CT SCAN MUST START 1 CM SUPERIOR TO THE CELIAC AXIS AND CONTINUE THROUGH THE FEMORAL HEADS AT AN AXIAL THICKNESS SLICE OF 3 MM OR LESS. 4.4 DEVICE SELECTION: ¿ STRICT ADHERENCE TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE (TABLES 10.5.1 THROUGH 10.5.2). 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: ¿ APPROPRIATE PROCEDURAL IMAGING IS REQUIRED TO SUCCESSFULLY POSITION THE ZENITH FLEX AAA ENDOVASCULAR GRAFT AND ASSURE ACCURATE APPOSITION TO THE AORTIC WALL. ¿ INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS. 5.2 POTENTIAL ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ ENDOLEAK ¿ ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; BARB SEPARATION AND CORROSION 6.5 ENDOLEAK MANAGEMENT: TYPE III ENDOLEAKS CAUSED BY GRAFT DEFECTS, INADEQUATE SEAL OR DISCONNECTION OF THE MODULAR COMPONENTS WERE TREATED WITH ADDITIONAL BALLOONING OR PROSTHESES. AS REPORTED BY THE ANGIOGRAPHIC CORE LAB, THERE WERE NO TYPE IV ENDOLEAKS DURING THE U.S. CLINICAL STUDY. THE GRAFT MATERIAL USED TO MANUFACTURE THE ZENITH AAA ENDOVASCULAR GRAFT IS OF STANDARD THICKNESS AND IS THE SAME MATERIAL USED IN OPEN SURGICAL PROCEDURES. 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 FLEX AAA ENDOVASCULAR GRAFT. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: ¿ PATIENT'S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR ¿ NON-ANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSM: ¿ WITH A LENGTH OF AT LEAST 15 MM, ¿ WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 32 MM AND NO LESS THAN 18 MM, ¿ WITH AN ANGLE LESS THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND ¿ WITH AN ANGLE LESS THAN 45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA ¿ ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5 TO 20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) ¿ FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT. 8 PATIENT COUNSELING INFORMATION: PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. PHYSICIANS SHOULD REFER PATIENTS TO THE PATIENT GUIDE REGARDING RISKS OCCURRING DURING OR AFTER IMPLANTATION OF THE DEVICE. PROCEDURE-RELATED RISKS INCLUDE CARDIAC, PULMONARY, NEUROLOGIC, BOWEL AND BLEEDING COMPLICATIONS. DEVICE RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE, AND DEATH 10.5 DEVICE 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. 11 DIRECTIONS FOR USE: ANATOMICAL REQUIREMENTS ¿ PROXIMAL AORTIC NECK LENGTHS SHOULD BE A MINIMUM OF 15 MM WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF 18 ¿ 32 MM. PRE-IMPLANT DETERMINANTS VERIFY FROM PRE-IMPLANT PLANNING THAT THE CORRECT DEVICE HAS BEEN SELECTED. DETERMINANTS INCLUDE: 1. FEMORAL ARTERY SELECTION FOR INTRODUCTION OF THE MAIN BODY SYSTEM (I.E., DEFINE RESPECTIVE CONTRALATERAL AND IPSILATERAL ILIAC ARTERIES). 2. ANGULATION OF AORTIC NECK, ANEURYSM, AND ILIAC ARTERIES. 3. QUALITY OF THE AORTIC NECK. 4. DIAMETERS OF INFRARENAL AORTIC NECK AND DISTAL ILIAC ARTERIES. 5. DISTANCE FROM RENAL ARTERIES TO THE AORTIC BIFURCATION. 6. LENGTH FROM THE AORTIC BIFURCATION TO THE INTERNAL ILIAC ARTERIES/ATTACHMENT SITE(S). 7. ANEURYSM(S) EXTENDING INTO THE ILIAC ARTERIES MAY REQUIRE SPECIAL CONSIDERATION IN SELECTING A SUITABLE GRAFT/ARTERY INTERFACE SITE. 8. CONSIDER THE DEGREE OF VASCULAR CALCIFICATION. 11.1.5 MAIN BODY PLACEMENT: 4. BEFORE INSERTION, POSITION MAIN BODY DELIVERY SYSTEM ON PATIENT¿S ABDOMEN UNDER FLUOROSCOPY TO DETERMINE THE ORIENTATION OF THE CONTRALATERAL LIMB RADIOPAQUE MARKER. THE SIDEARM OF THE HEMOSTATIC VALVE MAY SERVE AS AN EXTERNAL REFERENCE TO THE CONTRALATERAL LIMB RADIOPAQUE MARKER. 5. INSERT MAIN BODY DELIVERY SYSTEM OVER THE WIRE, INTO THE FEMORAL ARTERY WITH ATTENTION TO SIDEARM REFERENCE. CAUTION: MAINTAIN WIRE GUIDE POSITION DURING DELIVERY SYSTEM INSERTION. CAUTION: TO AVOID ANY TWIST IN THE ENDOVASCULAR GRAFT, DURING ANY ROTATION OF THE DELIVERY SYSTEM, BE CAREFUL TO ROTATE ALL THE COMPONENTS OF THE SYSTEM TOGETHER (FROM OUTER SHEATH TO INNER CANNULA). 6. ADVANCE DELIVERY SYSTEM UNTIL THE FOUR GOLD RADIOPAQUE MARKERS (WHICH ARE POSITIONED 2 MM FROM THE MOST PROXIMAL SEGMENT OF THE GRAFT MATERIAL) ARE JUST INFERIOR TO THE MOST INFERIOR RENAL ORIFICE. 7. VERIFY POSITION OF WIRE GUIDE IN THE THORACIC AORTA. ENSURE THE GRAFT SYSTEM IS ORIENTED SUCH THAT THE CONTRALATERAL LIMB IS POSITIONED ABOVE AND ANTERIOR TO THE ORIGIN OF THE CONTRALATERAL ILIAC. IF THE CONTRALATERAL LIMB RADIOPAQUE MARKER IS NOT PROPERLY ALIGNED, ROTATE THE ENTIRE SYSTEM UNTIL IT IS CORRECTLY POSITIONED HALFWAY BETWEEN A LATERAL AND AN ANTERIOR POSITION ON THE CONTRALATERAL SIDE. ¿ A MARKER FORMATION OF A ¿ INDICATES AN ANTERIOR POSITION OF THE SHORT (CONTRALATERAL) LIMB. ¿ A MARKER FORMATION OF A ¿ INDICATES A POSTERIOR POSITION OF THE SHORT (CONTRALATERAL) LIMB. ¿ A MARKER FORMATION OF A / INDICATES A LATERAL POSITION OF THE SHORT (CONTRALATERAL) LIMB. NOTE: RADIOPAQUE CANNULA ON EACH STENT BETWEEN THE RENAL ARTERIES AND THE CONTRALATERAL LIMB ALIGN WITH THE CONTRALATERAL LIMB RADIOPAQUE MARKER. 8. REPEAT THE ANGIOGRAM TO VERIFY THE FOUR GOLD RADIOPAQUE MARKERS ARE 2 MM OR MORE BELOW THE MOST INFERIOR RENAL ORIFICE. NOTE: VERIFY CONTRALATERAL LIMB IS AT LEAST 5 MM ABOVE THE AORTIC BIFURCATION AND IN DESIRED LOCATION FOR CANNULATION. FINAL ANGIOGRAM 1. POSITION ANGIOGRAPHIC CATHETER JUST ABOVE THE LEVEL OF THE RENAL ARTERIES. PERFORM ANGIOGRAPHY TO VERIFY THAT THE RENAL ARTERIES ARE PATENT AND THAT THERE ARE NO ENDOLEAKS. VERIFY PATENCY OF INTERNAL ILIAC ARTERIES. 2. CONFIRM THERE ARE NO ENDOLEAKS OR KINKS AND VERIFY POSITION OF PROXIMAL GOLD RADIOPAQUE MARKERS. REMOVE THE SHEATHS, WIRES, AND CATHETERS. 12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP: 12.1 GENERAL ¿ THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADDITIONAL FOLLOW-UP. PATIENTS SHOULD BE COUNSELED ON THE IMPORTANCE OF ADHERING TO THE FOLLOW-UP SCHEDULE, BOTH DURING THE FIRST YEAR AND AT YEARLY INTERVALS THEREAFTER. PATIENTS SHOULD BE TOLD THAT REGULAR AND CONSISTENT FOLLOW-UP IS A CRITICAL PART OF ENSURING THE ONGOING SAFETY AND EFFECTIVENESS OF ENDOVASCULAR TREATMENT OF AAA¿S ¿ PHYSICIANS SHOULD EVALUATE PATIENTS ON AN INDIVIDUAL BASIS AND PRESCRIBE THEIR FOLLOW-UP RELATIVE TO THE NEEDS AND CIRCUMSTANCES OF EACH INDIVIDUAL PATIENT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE STENT GRAFT) SHOULD RECEIVE FOLLOW-UP AT MORE FREQUENT INTERVALS. ¿ THE COMBINATION OF CONTRAST AND NON-CONTRAST CT IMAGING PROVIDES INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, PROGRESSIVE DISEASE, FIXATION LENGTH AND OTHER MORPHOLOGICAL CHANGES. ¿ DUPLEX ULTRASOUND IMAGING MAY PROVIDE INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY AND PROGRESSIVE DISEASE. IN THIS CIRCUMSTANCE, A NON-CONTRAST CT SHOULD BE PERFORMED TO USE IN CONJUNCTION WITH THE ULTRASOUND. ULTRASOUND MAY BE A LESS RELIABLE AND SENSITIVE DIAGNOSTIC METHOD COMPARED TO CT. 12.4 ULTRASOUND IMAGING MAY BE PERFORMED IN PLACE OF CONTRAST CT WHEN PATIENT FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA. ULTRASOUND MAY BE PAIRED WITH NON-CONTRAST CT. A COMPLETE AORTIC DUPLEX IS TO BE VIDEOTAPED FOR MAXIMUM ANEURYSM DIAMETER, ENDOLEAKS, STENT PATENCY AND STENOSIS. INCLUDED ON THE VIDEOTAPE SHOULD BE THE FOLLOWING INFORMATION AS OUTLINED BELOW: ¿ TRANSVERSE AND LONGITUDINAL IMAGING SHOULD BE OBTAINED FROM THE LEVEL OF THE PROXIMAL AORTA DEMONSTRATING MESENTERIC AND RENAL ARTERIES TO THE ILIAC BIFURCATIONS TO DETERMINE IF ENDOLEAKS ARE PRESENT UTILIZING COLOR FLOW AND COLOR POWER ANGIOGRAPHY (IF ACCESSIBLE). ¿ SPECTRAL ANALYSIS CONFIRMATION SHOULD BE PERFORMED FOR ANY SUSPECTED ENDOLEAKS. ¿ TRANSVERSE AND LONGITUDINAL IMAGING OF THE MAXIMUM ANEURYSM SHOULD BE OBTAINED. 12.6 ADDITIONAL SURVEILLANCE AND TREATMENT ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ¿ ANEURYSMS WITH TYPE III ENDOLEAK ¿ ANEURYSM ENLARGEMENT, =5 MM OF MAXIMUM DIAMETER (REGARDLESS OF ENDOLEAK STATUS) ¿ MIGRATION ¿ INADEQUATE SEAL LENGTH CONSIDERATION FOR REINTERVENTION OR CONVERSION TO OPEN REPAIR SHOULD INCLUDE THE ATTENDING PHYSICIAN'S ASSESSMENT OF AN INDIVIDUAL PATIENT'S CO-MORBIDITIES, LIFE EXPECTANCY AND THE PATIENT'S PERSONAL CHOICES. PATIENTS SHOULD BE COUNSELED THAT SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER BASED AND OPEN SURGICAL CONVERSION ARE POSSIBLE FOLLOWING ENDOGRAFT PLACEMENT. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. MULTIPLE HIGH-RESOLUTION CONTRAST STUDIES, INCLUDING MULTIPHASE CTAS COULD NOT IDENTIFY ANY SOURCE OF SAC FILLING, INCLUDING A TYPE I, II, OR III ENDOLEAK. AT LEAST 10 TO 12 MM OF PROXIMAL GRAFT APPOSITION WAS STILL PRESENT, AND A TRANSFEMORAL ARTERIOGRAM ALSO FAILED TO DEMONSTRATE ANY ENDOLEAK, INCLUDING A SLOW TYPE IA ENDOLEAK. THE SITE REFERRED TO THE ENDOLEAK AS BEING OCCULT (MEANING HIDDEN). IT SHOULD BE NOTED THAT ENDOLEAK IS A KNOWN INHERENT RISK OF USING THIS DEVICE. 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 PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED IN THE LITERATURE "RELINING OF INFRARENAL STENT-GRAFT WITH PRELOADED MODIFIED GORE EXCLUDER FOR OCCULT ENDOLEAK WITH SAC EXPANSION" THAT A PATIENT DEVELOPED EITHER AN OCCULT TYPE III ENDOLEAK OR ENDOTENSION FOLLOWING IMPLANTATION OF AN UNSPECIFIED COOK ZENITH GRAFT. THE LITERATURE DESCRIBES A CASE IN WHICH RELINING WAS PERFORMED FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE DUE TO SAC EXPANSION. AS THERE WAS NO IDENTIFIABLE ENDOLEAK, ENDOTENSION WAS SUSPECTED. TECHNICAL CHALLENGES DURING THE CASE WERE REPORTED TO BE SHORT DISTANCE FROM THE RENAL ARTERIES TO THE FLOW DIVIDER AS WELL AS SIGNIFICANT METAL ARTIFACT. ULTIMATELY, THESE CHALLENGES WERE ADDRESSED BY MANUALLY ADJUSTING THE LENGTH OF A COMPETITOR GRAFT TO A SHORTER DESIRED LENGTH PRIOR TO IMPLANTING IT DURING A SECONDARY PROCEDURE. THE CONTRALATERAL GATE WAS PRELOADED, ALLOWING THE USE OF SNARE-RIDE TECHNIQUE FOR GATE CANNULATION AND FOR OVERCOMING THE METAL ARTIFACT HINDERING VISUALIZATION. THE PATIENT PRESENTED WITH CONTINUED ANEURYSM SAC EXPANSION 10 YEARS AFTER UNDERGOING THE INITIAL EVAR PROCEDURE WITH COIL AND COVERAGE OF THE RIGHT HYPOGASTRIC ARTERY IN WHICH THE SUBJECT DEVICE WAS IMPLANTED. POSTOPERATIVELY, THE ANEURYSM WAS INITIALLY STABLE, MEASURING 5.2 CM FROM 5.5 CM. A TYPE II ENDOLEAK WAS IDENTIFIED FROM THE PATENT INFERIOR MESENTERIC AND LUMBAR ARTERIES. AT 5 YEARS POSTOPERATIVELY, THE ANEURYSM HAD EXPANDED TO 6.3 CM AND THE LUMBAR AND INFERIOR MESENTERIC ARTERIES WERE COIL EMBOLIZED. OVER THE FOLLOWING THREE YEARS, SLOW EXPANSION TO 7.6 X 8.1 CM (IN DOUBLE OBLIQUE DIMENSIONS) OCCURRED, SO THE PATIENT UNDERWENT CT-GUIDED TRANSLUMBAR POLYVINYL ALCOHOL LARGE PARTICLE EMBOLIZATION OF THE ANEURYSM SAC. SURVEILLANCE INCLUDED "MULTIPLE 1-MM SLICE COMPUTED TOMOGRAPHY ANGIOGRAPHIES (CTAS), DUPLEX ULTRASOUNDS AND A TRANSFEMORAL AORTOGRAM THAT FAILED TO DEMONSTRATE A SOURCE OF SAC FILLING IN THE SETTING OF CONTINUED GROWTH TO 9.1 X 10.4CM AT 10 YEARS". DUE TO THE LARGE DIAMETER AND EXPANSION OF 7 MM OVER A 6 MONTH PERIOD, INTERVENTION WAS RECOMMENDED. TO ADDRESS THE OCCULT ENDOLEAK/ENDOTENSION, TOTAL RELINING OF THE INFRARENAL REPAIR WAS PLANNED. IT WAS REPORTED THAT "CENTER-LINE FLOW IMAGING DEMONSTRATED A 26MM MAIN BODY WITH SUPRARENAL FIXATION AND 13MM LIMBS" AND THAT "THE DISTANCE FROM LOWEST RENAL ARTERY TO FLOW DIVIDER WAS 60MM". A 31 MM COMPETITOR GRAFT WAS SELECTED TO BE USED WITH A TECHNIQUE INVOLVING PRELOADING THE CONTRALATERAL GATE. UNDER GENERAL ENDOTRACHEAL ANESTHESIA, BILATERAL PERCUTANEOUS FEMORAL ACCESS WAS OBTAINED. A COMPETITOR SHEATH WAS ADVANCED TO THE LEVEL OF THE RENAL ARTERIES. A COMPETITOR ENDOPROSTHESIS WAS ADVANCED OVER A STIFF WIRE SUCH THAT THE DISTAL PORTION OF THE CONTRALATERAL GATE WAS JUST OUTSIDE THE SHEATH. THE FIRST TRIGGER WIRE WAS RELEASED TO DEPLOY TO THE CONTRALATERAL GATE, LEAVING THE IPSILATERAL LIMB CONSTRAINED. THE USER(S) "IDENTIFIED THE EXTERNALIZED PORTION OF THE GATE, WHICH HAD FLOWERED OPEN" AND "THE LOWEST 20MM OF THE GATE WAS TRIMMED WITH A HEAVY SCISSORS". UNDER DIRECT VISION, "THIS WAS CANNULATED WITH A 5F X 10CM SHEATH, PERMITTING PASSAGE OF A 0.018INCH WIRE THROUGH THE GATE AS A PRELOADED WIRE". THE 5FR SHEATH WAS THEN WITHDRAWN, AND THE MAIN BODY AND WIRE WERE ADVANCED TOGETHER TO THE LOWEST RENAL ARTERY. THE COMPETITOR SHEATH WAS THEN WITHDRAWN OVER THE DEVICE TO DEPLOY TO THE GATE. SIGNIFICANT METAL ARTIFACT WAS NOTED, WHICH MADE VISUALIZATION DIFFICULT. AFTER EXCHANGING THE 0.018INCH WIRE FOR A DIFFERENT ONE, A SNARE WAS ADVANCED ABOVE THE OLD FLOW DIVIDER FROM THE IPSILATERAL SIDE. A GLIDE WIRE WAS ADVANCED FROM THE CONTRALATERAL SIDE AND CAPTURED BY THE SNARE. USING THE SNARE-RIDE TECHNIQUE, THE SNARE CARRIED THE CONTRALATERAL WIRE THROUGH THE GATE AND THE PROCEDURE WAS COMPLETED BY RAISING THE BIFURCATION 2 CM WITH KISSING ILIAC LIMBS. IT WAS REPORTED THAT "POSTOPERATIVE COURSE WAS UNEVENTFUL"; THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. CTA IMAGING PERFORMED ONE-MONTH AFTER REVEALED STABILITY OF THE ANEURYSM. IMAGING AT SIX MONTHS REVEALED REGRESSION TO 8.7 X 10.3CM. THE ARTICLE USES THIS CASE TO DEMONSTRATE "THE APPROACH OF TOTAL RELINING OF AN INFRARENAL STENT-GRAFT TO ADDRESS A SUSPECTED OCCULT ENDOLEAK OR ENDOTENSION WITH SAC EXPANSION". SEVERAL IMAGING STUDIES WERE UNABLE TO IDENTIFY AN ENDOLEAK, AND THERE WAS STILL AT LEAST 10-12 MM OF GRAFT APPOSITION. SEVERAL OPTIONS FOR A SECONDARY PROCEDURE WERE CONSIDERED, BUT WERE NOT AS FAVORABLE. AFTER THOROUGH EVALUATION OF THE PATIENT'S IMAGING, THE USER SUSPECTED EITHER AN OCCULT TYPE III ENDOLEAK OR ENDOTENSION, SO A TOTAL INFRARENAL RELINING SECONDARY PROCEDURE WAS PERFORMED TO ACHIEVE SAC SEALING. MIRZA, ALEEM K., ET AL. ¿RELINING OF INFRARENAL STENT-GRAFT WITH PRELOADED MODIFIED GORE EXCLUDER FOR OCCULT ENDOLEAK WITH SAC EXPANSION.¿ JVS-CIT JOURNAL OF VASCULAR SURGERY- CASES, INNOVATIONS AND TECHNIQUES, SVS- SOCIETY FOR VASCULAR SURGERY, 21 JULY 2021, WWW.JVSCIT.ORG/ARTICLE/S2468-4287(21)00136-2/FULLTEXT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1423645 | UNKNOWN | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | Required Intervention |