ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
Report
- Report Number
- 9680654-2025-00015
- Event Type
- Injury
- Date Received
- May 19, 2025
- Report Date
- July 8, 2025
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PLEASE NOTE THAT THE INFORMATION IN THIS REPORT HAS BEEN TAKEN FROM REVIEW OF A JOURNAL ARTICLE: "EVALUATION OF POSSIBLE SOURCES OF POLYMER EMBOLIZATION AFTER FENESTRATED AORTIC REPAIRS MIMICKING SPINAL CORD ISCHEMIA" (HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101765).
PLEASE NOTE THAT THE INFORMATION IN THIS REPORT HAS BEEN TAKEN FROM REVIEW OF A JOURNAL ARTICLE: "EVALUATION OF POSSIBLE SOURCES OF POLYMER EMBOLIZATION AFTER FENESTRATED AORTIC REPAIRS MIMICKING SPINAL CORD ISCHEMIA" (HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101765). THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO IMAGING WAS RECEIVED TO ASSIST WITH THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED. DESPITE THREE REQUESTS, NO ADDITIONAL INFORMATION WAS RECEIVED. THE MEDICAL DIRECTOR REVIEWED THE INFORMATION PRESENTED IN THE ARTICLE AND STATED THAT THE REPORTED EVENT OF ERYTHEMATOUS PAPULAR RASH ON POST-OPERATIVE DAY 12 COULD BE A POSSIBLE EFFECT OF THE DEVICE, POSSIBLY BEING CAUSED BY HYDROPHILIC COATING EMBOLIZATION. THE MEDICAL DIRECTOR STATED THAT IT WOULD BE IMPOSSIBLE TO PROVE THAT IT WAS RELATED TO THE DEVICE AS IT COULD BE RELATED TO THE PROCEDURE AS WELL. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE PHOTOS TAKEN OF THE COMPLAINT DEVICE DURING MANUFACTURE AND THE ¿CHARTS APPROVED¿ COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE STATES: 1.3 DISTAL BIFURCATED BODY GRAFT THE ZENITH FENESTRATED AAA ENDOVASCULAR DISTAL BIFURCATED BODY GRAFT HAS ONE LONG IPSILATERAL ILIAC LIMB AND ONE SHORT CONTRALATERAL LIMB. TO FACILITATE FLUOROSCOPIC VISUALIZATION OF THE STENT GRAFT, THERE IS A RADIOPAQUE MARKER AT THE GRAFT BIFURCATION, AT THE DISTAL END OF THE CONTRALATERAL LIMB, AND AT THE END (CONTRALATERAL SIDE) OF THE GRAFT. 4.1 GENERAL USE INFORMATION ¿ LACK OF NON-CONTRAST CT IMAGING MAY RESULT IN FAILURE TO APPRECIATE ILIAC OR AORTIC CALCIFICATION, WHICH MAY PRECLUDE ACCESS OR RELIABLE DEVICE FIXATION AND SEAL. ¿ THE LONG-TERM PERFORMANCE OF FENESTRATED ENDOVASCULAR GRAFTS, INCLUDING THE STENTS PLACED IN FENESTRATIONS/SCALLOPS, HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS, CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT, OR STENOSIS/OCCLUSION OF VESSELS ACCOMMODATED BY FENESTRATIONS) SHOULD RECEIVE ENHANCED FOLLOW-UP. 5. ADVERSE EVENTS POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION. ¿ GENITOURINARY COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ISCHEMIA, EROSION, FISTULA, INCONTINENCE, HEMATURIA, INFECTION). ¿ CLAUDICATION (E.G. BUTTOCK, LOWER LIMB). ¿ NEUROLOGIC LOCAL OR SYSTEMIC COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., CONFUSION, STROKE, TRANSIENT ISCHEMIC ATTACK, PARAPLEGIA, PARAPARESIS, PARALYSIS). THE REPORTED EVENT IS LISTED AMONGST THE POTENTIAL ADVERSE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE IFU. A CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT COULD NOT BE DETERMINED FROM THE INVESTIGATION DUE TO LIMITED INFORMATION AVAILABLE. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. SHOULD ADDITIONAL INFORMATION BE RECEIVED AT ANY TIME IN THE FUTURE THE INVESTIGATION MAY BE UPDATED, AND AN ADDITIONAL REPORT MAY BE SUPPLIED. 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.
EVENT INFORMATION TAKEN FROM REVIEW OF A JOURNAL ARTICLE IN: J VASC SURG CASES INNOV TECH. 2025 MAR 4;11(3):101765. DOI: 10.1016/J.JVSCIT.2025.101765. A SINGLE-INSTITUTION RETROSPECTIVE REVIEW OF 111 PATIENTS UNDERGOING FENESTRATED/BRANCHED ENDOVASCULAR AORTIC REPAIR WITH COOK ZENITH DEVICES WAS PERFORMED FROM 2012 TO 2022. WE PRESENT TWO UNIQUE PRESENTATIONS OF HPE (1.8%) IN PATIENTS WHO UNDERWENT FENESTRATED ENDOVASCULAR REPAIR OF COMPLEX ABDOMINAL AORTIC ANEURYSMS (AAAS), WITH COOK ZENITH FENESTRATED DEVICES. BOTH PATIENTS EXPERIENCED LOWER EXTREMITY NEUROLOGICAL DEFICITS MIMICKING SPINAL CORD ISCHEMIA WITH THE DEVELOPMENT OF A CONCOMITANT LOWER EXTREMITY RASH IN THE POSTOPERATIVE PERIOD. BOTH PATIENTS CONSENTED TO THE PUBLICATION OF THEIR CASES. TO GARNER A DEEPER UNDERSTANDING OF THE IMPLICATED DEVICES, OUR GROUP EXAMINED THE INSTRUMENTS ROUTINELY USED AT OUR INSTITUTION DURING FENESTRATED ENDOVASCULAR REPAIRS. USING A COMBINATION OF SCANNING ELECTRON MICROSCOPY (SEM) AND ENERGY DISPERSIVE X-RAY SPECTROSCOPY (EDX), BOTH A PATIENT CASE SAMPLE (DERMAL BIOPSY SPECIMEN OF RASH AREA TARGETING FOREIGN MATERIAL VISIBLE WITHIN DERMAL VESSELS) AND A COMPREHENSIVE COLLECTION OF THE STANDARD DEVICES USED AT OUR INSTITUTION FOR COMPLEX AORTIC ENDOVASCULAR REPAIRS WERE ANALYZED. HEREIN, WE REPORT THE FIRST COMPREHENSIVE INVESTIGATION INTO CLINICAL HPE MATERIAL ULTRASTRUCTURE AND ELEMENTAL COMPOSITION ALONG WITH THAT OF POTENTIAL SOURCE DEVICES. THE DATA YIELD A SMALL SUBSET OF CANDIDATE EMBOLIC SOURCE DEVICES WITH SEM/EDX SIGNATURES MATCHING THE TYPE OF POLYMER EMBOLUS DEMONSTRATED IN THE PATIENT CASE. THE PATIENTS INVOLVED IN THE STUDY CONSENTED TO THE PUBLICATION OF THEIR CASES. PATIENT 1: A 70-YEAR-OLD MALE PATIENT INITIALLY PRESENTED WITH A 3.7-CM JUXTARENAL AAA. AT AGE 73, THE ANEURYSM HAD INCREASED IN SIZE TO 5.5 CM. HIS OTHER COMORBIDITIES INCLUDED CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION, DYSLIPIDEMIA, PROSTATE CANCER, AND REMOTE CHOLECYSTECTOMY AND APPENDECTOMY. HE UNDERWENT ENDOVASCULAR REPAIR VIA BILATERAL PERCUTANEOUS FEMORAL ARTERY ACCESS WHEREBY TWO 20F GORE DRYSEAL FLEX INTRODUCER SHEATHS (W. L. GORE & ASSOCIATES, FLAGSTAFF, AZ) WERE PLACED BILATERALLY. A COOK ZENITH FENESTRATED PROXIMAL MAIN BODY ENDOGRAFT WITH TWO 6 X 8 MM RENAL ARTERY FENESTRATIONS WAS ADVANCED FROM THE LEFT GROIN VIA THE 20F ZENITH DELIVERY SHEATH AND DEPLOYED. THE RENAL ARTERIES WERE CANNULATED AND STENTED WITH ICAST COVERED STENTS (ATRIUM MEDICAL CORPORATION, MERRIMACK, NH). A ZENITH FENESTRATED DISTAL BIFURCATED MAIN BODY DEVICE WAS DEPLOYED FOLLOWED BY BILATERAL ZENITH ZSLE ILIAC LIMB EXTENSIONS. THE PATIENT¿S HOSPITAL COURSE WAS UNEVENTFUL, AND HE WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 1. HE RETURNED FOR EVALUATION REPORTING BILATERAL LOWER EXTREMITY WEAKNESS, LEFT LOWER EXTREMITY PAIN, AND AN ERYTHEMATOUS PAPULAR RASH ON POD 12. HIS PHYSICAL EXAMINATION WAS NOTABLE FOR PRESERVED STRENGTH IN THE RIGHT LOWER EXTREMITY, FOUR OUT OF FIVE STRENGTH IN THE LEFT LOWER EXTREMITY, ABSENT LEFT PATELLAR REFLEX, BILATERAL ANKLE CLONUS, INTACT SENSATION OTHER THAN TO VIBRATION, AND AN INABILITY TO STAND OR AMBULATE EVEN WITH ASSISTANCE. MACULOPAPULAR LESIONS WERE NOTED ON THE LOWER BACK, ABDOMEN, AND BILATERAL LOWER EXTREMITIES AND FULL-THICKNESS PUNCH BIOPSIES WERE OBTAINED AFTER A DERMATOLOGY EVALUATION. OWING TO CONCERN FOR SPINAL CORD ISCHEMIA, MAGNETIC RESONANCE IMAGING OF THE SPINE WAS PERFORMED, DEMONSTRATING SIGNS OF SCATTERED MICROVASCULAR THORACIC SPINE INFARCTIONS BETWEEN THE T4 AND T12 CENTRAL SPINE. NO ANTERIOR CORD ABNORMALITIES WERE NOTED. BIOPSY OF SKIN LESIONS NOTED SERPIGINOUS BASOPHILIC STIPPLED MATERIAL WITHIN THE DERMAL CAPILLARIES, CONSISTENT WITH EMBOLIZED POLYMER. A FULL NEUROLOGICAL RECOVERY WAS ACHIEVED WITHIN 10 DAYS AND THE RASH RESOLVED OVER 2 MONTHS. PATIENT 2: A 67-YEAR-OLD MALE PATIENT WAS FOUND TO HAVE A 5.6-CM JUXTARENAL AAA. HIS OTHER COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE TREATED WITH FOUR-VESSEL CORONARY ARTERY BYPASS, ATRIAL FIBRILLATION, AND DYSLIPIDEMIA. HE UNDERWENT ENDOVASCULAR REPAIR WITH PERCUTANEOUS BILATERAL GROIN ACCESS WITH A 22-F DRYSEAL IN THE RIGHT AND A 20-F ZENITH DELIVERY SHEATH ON THE LEFT. A ZENITH FENESTRATED PROXIMAL MAIN BODY WITH AN 8-MM FENESTRATION FOR THE SUPERIOR MESENTERIC ARTERY AND TWO 6 X 8 MM FENESTRATIONS FOR EACH RENAL ARTERY WAS DEPLOYED. THE SUPERIOR MESENTERIC ARTERY AND RIGHT RENAL ARTERY WERE STENTED WITH GORE VBX STENTS AND THE LEFT RENAL ARTERY WITH AN ICAST STENT. THE ZENITH FENESTRATED DISTAL BIFURCATED MAIN BODY WAS DEPLOYED FOLLOWED BY BILATERAL ZENITH ZSLE ILIAC LIMB EXTENSIONS. ON POD1, HE BEGAN TO HAVE PROGRESSIVE BILATERAL LOWER EXTREMITY WEAKNESS, AND SEVERE HYPERALGESIA. HIS NEUROLOGICAL EXAMINATION WAS NOTABLE FOR FOUR OUT OF FIVE LEFT LOWER EXTREMITY MOTOR STRENGTH, AND REDUCED SENSATION TO LIGHT TOUCH, VIBRATORY SENSATION, AND PROPRIOCEPTION. HIS RIGHT LOWER EXTREMITY EXAMINATION WAS UNREMARKABLE; HOWEVER, THE PATIENT WAS UNABLE TO AMBULATE OR BEAR WEIGHT ON HIS LEFT LEG. A FULL NEUROLOGICAL WORKUP WAS PERFORMED AND NO EVIDENCE OF STROKE OR SPINAL CORD PATHOLOGY WAS NOTED ON ADVANCED IMAGING INCLUDING MAGNETIC RESONANCE IMAGING OF THE SPINE; AS A RESULT, A LUMBOSACRAL PLEXUS INJURY WAS CLINICALLY SUSPECTED. BY POD5, A DIFFUSE PETECHIAL BILATERAL LOWER EXTREMITY RASH WAS OBSERVED AND FULL-THICKNESS PUNCH BIOPSIES WERE PERFORMED. BY 6 WEEKS, THE RASH HAD RESOLVED MOSTLY, BUT VERY LITTLE NEUROLOGICAL RECOVERY HAD BEEN ACHIEVED. HISTOPATHOLOGY WAS NOTABLE FOR OCCLUDED VESSELS WITHIN THE MID-DERMIS CONTAINING BLUE GRAY SERPIGINOUS AND STIPPLED MATERIAL COMPATIBLE WITH POLYMER EMBOLI. THIS (B)(6) (PATIENT 1): HE RETURNED FOR EVALUATION REPORTING BILATERAL LOWER EXTREMITY WEAKNESS, LEFT LOWER EXTREMITY PAIN, AND AN ERYTHEMATOUS PAPULAR RASH ON POD 12. MACULOPAPULAR LESIONS WERE NOTED ON THE LOWER BACK, ABDOMEN, AND BILATERAL LOWER EXTREMITIES AND FULL-THICKNESS PUNCH BIOPSIES WERE OBTAINED AFTER A DERMATOLOGY EVALUATION. BIOPSY OF SKIN LESIONS NOTED SERPIGINOUS BASOPHILIC STIPPLED MATERIAL WITHIN THE DERMAL CAPILLARIES, CONSISTENT WITH EMBOLIZED POLYMER. (B)(6) (PATIENT 1): HE RETURNED FOR EVALUATION REPORTING BILATERAL LOWER EXTREMITY WEAKNESS, LEFT LOWER EXTREMITY PAIN, AND AN ERYTHEMATOUS PAPULAR RASH ON POD 12. HIS PHYSICAL EXAMINATION WAS NOTABLE FOR PRESERVED STRENGTH IN THE RIGHT LOWER EXTREMITY, FOUR OUT OF FIVE STRENGTH IN THE LEFT LOWER EXTREMITY, ABSENT LEFT PATELLAR REFLEX, BILATERAL ANKLE CLONUS, INTACT SENSATION OTHER THAN TO VIBRATION, AND AN INABILITY TO STAND OR AMBULATE EVEN WITH ASSISTANCE. OWING TO CONCERN FOR SPINAL CORD ISCHEMIA, MAGNETIC RESONANCE IMAGING OF THE SPINE WAS PERFORMED, DEMONSTRATING SIGNS OF SCATTERED MICROVASCULAR THORACIC SPINE INFARCTIONS BETWEEN THE T4 AND T12 CENTRAL SPINE. NO ANTERIOR CORD ABNORMALITIES WERE NOTED. (B)(6) (PATIENT 2): ON POD1, HE BEGAN TO HAVE PROGRESSIVE BILATERAL LOWER EXTREMITY WEAKNESS, AND SEVERE HYPERALGESIA. HIS NEUROLOGICAL EXAMINATION WAS NOTABLE FOR FOUR OUT OF FIVE LEFT LOWER EXTREMITY MOTOR STRENGTH, AND REDUCED SENSATION TO LIGHT TOUCH, VIBRATORY SENSATION, AND PROPRIOCEPTION. HIS RIGHT LOWER EXTREMITY EXAMINATION WAS UNREMARKABLE; HOWEVER, THE PATIENT WAS UNABLE TO AMBULATE OR BEAR WEIGHT ON HIS LEFT LEG. A FULL NEUROLOGICAL WORKUP WAS PERFORMED AND NO EVIDENCE OF STROKE OR SPINAL CORD PATHOLOGY WAS NOTED ON ADVANCED IMAGING INCLUDING MAGNETIC RESONANCE IMAGING OF THE SPINE; AS A RESULT, A LUMBOSACRAL PLEXUS INJURY WAS CLINICALLY SUSPECTED. (B)(6) (PATIENT 2): BY POD5, A DIFFUSE PETECHIAL BILATERAL LOWER EXTREMITY RASH WAS OBSERVED AND FULL-THICKNESS PUNCH BIOPSIES WERE PERFORMED.
EVENT INFORMATION TAKEN FROM REVIEW OF A JOURNAL ARTICLE IN: J VASC SURG CASES INNOV TECH. 2025 MAR 4;11(3):101765. DOI: 10.1016/J.JVSCIT.2025.101765. A SINGLE-INSTITUTION RETROSPECTIVE REVIEW OF 111 PATIENTS UNDERGOING FENESTRATED/BRANCHED ENDOVASCULAR AORTIC REPAIR WITH COOK ZENITH DEVICES WAS PERFORMED FROM 2012 TO 2022. WE PRESENT TWO UNIQUE PRESENTATIONS OF HPE (1.8%) IN PATIENTS WHO UNDERWENT FENESTRATED ENDOVASCULAR REPAIR OF COMPLEX ABDOMINAL AORTIC ANEURYSMS (AAAS), WITH COOK ZENITH FENESTRATED DEVICES. BOTH PATIENTS EXPERIENCED LOWER EXTREMITY NEUROLOGICAL DEFICITS MIMICKING SPINAL CORD ISCHEMIA WITH THE DEVELOPMENT OF A CONCOMITANT LOWER EXTREMITY RASH IN THE POSTOPERATIVE PERIOD. BOTH PATIENTS CONSENTED TO THE PUBLICATION OF THEIR CASES. TO GARNER A DEEPER UNDERSTANDING OF THE IMPLICATED DEVICES, OUR GROUP EXAMINED THE INSTRUMENTS ROUTINELY USED AT OUR INSTITUTION DURING FENESTRATED ENDOVASCULAR REPAIRS. USING A COMBINATION OF SCANNING ELECTRON MICROSCOPY (SEM) AND ENERGY DISPERSIVE X-RAY SPECTROSCOPY (EDX), BOTH A PATIENT CASE SAMPLE (DERMAL BIOPSY SPECIMEN OF RASH AREA TARGETING FOREIGN MATERIAL VISIBLE WITHIN DERMAL VESSELS) AND A COMPREHENSIVE COLLECTION OF THE STANDARD DEVICES USED AT OUR INSTITUTION FOR COMPLEX AORTIC ENDOVASCULAR REPAIRS WERE ANALYZED. HEREIN, WE REPORT THE FIRST COMPREHENSIVE INVESTIGATION INTO CLINICAL HPE MATERIAL ULTRASTRUCTURE AND ELEMENTAL COMPOSITION ALONG WITH THAT OF POTENTIAL SOURCE DEVICES. THE DATA YIELD A SMALL SUBSET OF CANDIDATE EMBOLIC SOURCE DEVICES WITH SEM/EDX SIGNATURES MATCHING THE TYPE OF POLYMER EMBOLUS DEMONSTRATED IN THE PATIENT CASE. THE PATIENTS INVOLVED IN THE STUDY CONSENTED TO THE PUBLICATION OF THEIR CASES. PATIENT 1: A 70-YEAR-OLD MALE PATIENT INITIALLY PRESENTED WITH A 3.7-CM JUXTARENAL AAA. AT AGE 73, THE ANEURYSM HAD INCREASED IN SIZE TO 5.5 CM. HIS OTHER COMORBIDITIES INCLUDED CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION, DYSLIPIDEMIA, PROSTATE CANCER, AND REMOTE CHOLECYSTECTOMY AND APPENDECTOMY. HE UNDERWENT ENDOVASCULAR REPAIR VIA BILATERAL PERCUTANEOUS FEMORAL ARTERY ACCESS WHEREBY TWO 20F GORE DRYSEAL FLEX INTRODUCER SHEATHS (W. L. GORE & ASSOCIATES, FLAGSTAFF, AZ) WERE PLACED BILATERALLY. A COOK ZENITH FENESTRATED PROXIMAL MAIN BODY ENDOGRAFT WITH TWO 6 X 8 MM RENAL ARTERY FENESTRATIONS WAS ADVANCED FROM THE LEFT GROIN VIA THE 20F ZENITH DELIVERY SHEATH AND DEPLOYED. THE RENAL ARTERIES WERE CANNULATED AND STENTED WITH ICAST COVERED STENTS (ATRIUM MEDICAL CORPORATION, MERRIMACK, NH). A ZENITH FENESTRATED DISTAL BIFURCATED MAIN BODY DEVICE WAS DEPLOYED FOLLOWED BY BILATERAL ZENITH ZSLE ILIAC LIMB EXTENSIONS. THE PATIENT¿S HOSPITAL COURSE WAS UNEVENTFUL, AND HE WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 1. HE RETURNED FOR EVALUATION REPORTING BILATERAL LOWER EXTREMITY WEAKNESS, LEFT LOWER EXTREMITY PAIN, AND AN ERYTHEMATOUS PAPULAR RASH ON POD 12. HIS PHYSICAL EXAMINATION WAS NOTABLE FOR PRESERVED STRENGTH IN THE RIGHT LOWER EXTREMITY, FOUR OUT OF FIVE STRENGTH IN THE LEFT LOWER EXTREMITY, ABSENT LEFT PATELLAR REFLEX, BILATERAL ANKLE CLONUS, INTACT SENSATION OTHER THAN TO VIBRATION, AND AN INABILITY TO STAND OR AMBULATE EVEN WITH ASSISTANCE. MACULOPAPULAR LESIONS WERE NOTED ON THE LOWER BACK, ABDOMEN, AND BILATERAL LOWER EXTREMITIES AND FULL-THICKNESS PUNCH BIOPSIES WERE OBTAINED AFTER A DERMATOLOGY EVALUATION. OWING TO CONCERN FOR SPINAL CORD ISCHEMIA, MAGNETIC RESONANCE IMAGING OF THE SPINE WAS PERFORMED, DEMONSTRATING SIGNS OF SCATTERED MICROVASCULAR THORACIC SPINE INFARCTIONS BETWEEN THE T4 AND T12 CENTRAL SPINE. NO ANTERIOR CORD ABNORMALITIES WERE NOTED. BIOPSY OF SKIN LESIONS NOTED SERPIGINOUS BASOPHILIC STIPPLED MATERIAL WITHIN THE DERMAL CAPILLARIES, CONSISTENT WITH EMBOLIZED POLYMER. A FULL NEUROLOGICAL RECOVERY WAS ACHIEVED WITHIN 10 DAYS AND THE RASH RESOLVED OVER 2 MONTHS. PATIENT 2: A 67-YEAR-OLD MALE PATIENT WAS FOUND TO HAVE A 5.6-CM JUXTARENAL AAA. HIS OTHER COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE TREATED WITH FOUR-VESSEL CORONARY ARTERY BYPASS, ATRIAL FIBRILLATION, AND DYSLIPIDEMIA. HE UNDERWENT ENDOVASCULAR REPAIR WITH PERCUTANEOUS BILATERAL GROIN ACCESS WITH A 22-F DRYSEAL IN THE RIGHT AND A 20-F ZENITH DELIVERY SHEATH ON THE LEFT. A ZENITH FENESTRATED PROXIMAL MAIN BODY WITH AN 8-MM FENESTRATION FOR THE SUPERIOR MESENTERIC ARTERY AND TWO 6 X 8 MM FENESTRATIONS FOR EACH RENAL ARTERY WAS DEPLOYED. THE SUPERIOR MESENTERIC ARTERY AND RIGHT RENAL ARTERY WERE STENTED WITH GORE VBX STENTS AND THE LEFT RENAL ARTERY WITH AN ICAST STENT. THE ZENITH FENESTRATED DISTAL BIFURCATED MAIN BODY WAS DEPLOYED FOLLOWED BY BILATERAL ZENITH ZSLE ILIAC LIMB EXTENSIONS. ON POD1, HE BEGAN TO HAVE PROGRESSIVE BILATERAL LOWER EXTREMITY WEAKNESS, AND SEVERE HYPERALGESIA. HIS NEUROLOGICAL EXAMINATION WAS NOTABLE FOR FOUR OUT OF FIVE LEFT LOWER EXTREMITY MOTOR STRENGTH, AND REDUCED SENSATION TO LIGHT TOUCH, VIBRATORY SENSATION, AND PROPRIOCEPTION. HIS RIGHT LOWER EXTREMITY EXAMINATION WAS UNREMARKABLE; HOWEVER, THE PATIENT WAS UNABLE TO AMBULATE OR BEAR WEIGHT ON HIS LEFT LEG. A FULL NEUROLOGICAL WORKUP WAS PERFORMED AND NO EVIDENCE OF STROKE OR SPINAL CORD PATHOLOGY WAS NOTED ON ADVANCED IMAGING INCLUDING MAGNETIC RESONANCE IMAGING OF THE SPINE; AS A RESULT, A LUMBOSACRAL PLEXUS INJURY WAS CLINICALLY SUSPECTED. BY POD5, A DIFFUSE PETECHIAL BILATERAL LOWER EXTREMITY RASH WAS OBSERVED AND FULL-THICKNESS PUNCH BIOPSIES WERE PERFORMED. BY 6 WEEKS, THE RASH HAD RESOLVED MOSTLY, BUT VERY LITTLE NEUROLOGICAL RECOVERY HAD BEEN ACHIEVED. HISTOPATHOLOGY WAS NOTABLE FOR OCCLUDED VESSELS WITHIN THE MID-DERMIS CONTAINING BLUE GRAY SERPIGINOUS AND STIPPLED MATERIAL COMPATIBLE WITH POLYMER EMBOLI. THIS (B)(6) (PATIENT 1): HE RETURNED FOR EVALUATION REPORTING BILATERAL LOWER EXTREMITY WEAKNESS, LEFT LOWER EXTREMITY PAIN, AND AN ERYTHEMATOUS PAPULAR RASH ON POD 12. MACULOPAPULAR LESIONS WERE NOTED ON THE LOWER BACK, ABDOMEN, AND BILATERAL LOWER EXTREMITIES AND FULL-THICKNESS PUNCH BIOPSIES WERE OBTAINED AFTER A DERMATOLOGY EVALUATION. BIOPSY OF SKIN LESIONS NOTED SERPIGINOUS BASOPHILIC STIPPLED MATERIAL WITHIN THE DERMAL CAPILLARIES, CONSISTENT WITH EMBOLIZED POLYMER. (B)(6) (PATIENT 1): HE RETURNED FOR EVALUATION REPORTING BILATERAL LOWER EXTREMITY WEAKNESS, LEFT LOWER EXTREMITY PAIN, AND AN ERYTHEMATOUS PAPULAR RASH ON POD 12. HIS PHYSICAL EXAMINATION WAS NOTABLE FOR PRESERVED STRENGTH IN THE RIGHT LOWER EXTREMITY, FOUR OUT OF FIVE STRENGTH IN THE LEFT LOWER EXTREMITY, ABSENT LEFT PATELLAR REFLEX, BILATERAL ANKLE CLONUS, INTACT SENSATION OTHER THAN TO VIBRATION, AND AN INABILITY TO STAND OR AMBULATE EVEN WITH ASSISTANCE. OWING TO CONCERN FOR SPINAL CORD ISCHEMIA, MAGNETIC RESONANCE IMAGING OF THE SPINE WAS PERFORMED, DEMONSTRATING SIGNS OF SCATTERED MICROVASCULAR THORACIC SPINE INFARCTIONS BETWEEN THE T4 AND T12 CENTRAL SPINE. NO ANTERIOR CORD ABNORMALITIES WERE NOTED. (B)(6) (PATIENT 2): ON POD1, HE BEGAN TO HAVE PROGRESSIVE BILATERAL LOWER EXTREMITY WEAKNESS, AND SEVERE HYPERALGESIA. HIS NEUROLOGICAL EXAMINATION WAS NOTABLE FOR FOUR OUT OF FIVE LEFT LOWER EXTREMITY MOTOR STRENGTH, AND REDUCED SENSATION TO LIGHT TOUCH, VIBRATORY SENSATION, AND PROPRIOCEPTION. HIS RIGHT LOWER EXTREMITY EXAMINATION WAS UNREMARKABLE; HOWEVER, THE PATIENT WAS UNABLE TO AMBULATE OR BEAR WEIGHT ON HIS LEFT LEG. A FULL NEUROLOGICAL WORKUP WAS PERFORMED AND NO EVIDENCE OF STROKE OR SPINAL CORD PATHOLOGY WAS NOTED ON ADVANCED IMAGING INCLUDING MAGNETIC RESONANCE IMAGING OF THE SPINE; AS A RESULT, A LUMBOSACRAL PLEXUS INJURY WAS CLINICALLY SUSPECTED. (B)(6) (PATIENT 2): BY POD5, A DIFFUSE PETECHIAL BILATERAL LOWER EXTREMITY RASH WAS OBSERVED AND FULL-THICKNESS PUNCH BIOPSIES WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2050069 | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM A. COOK AUSTRALIA, PTY LTD | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male |