ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2021-02111
- Event Type
- Death
- Date Received
- September 8, 2021
- Date of Event
- December 28, 2020
- Report Date
- December 6, 2021
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: D10. INVESTIGATION-EVALUATION. COOK BECAME AWARE ON (B)(6) 2021 OF AN EVENT WITH A 90-YEAR-OLD MALE PATIENT WHERE THE SUPRARENAL STENT SEPARATED FROM THE MAIN BODY CAUSING AN ENDOLEAK. THE PATIENT ARRIVED IN THE EMERGENCY ROOM AT OSPEDALIERO-UNIVERSITY PISAN HOSPITAL ON (B)(6) 2021 IN SHOCK. THE SURGEON ATTEMPT TO SAVE THE PATIENT BY PERFORMING AN OPEN SURGICAL REPAIR. HOWEVER, THIS WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. THE INITIAL ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE WAS PERFORMED ON (B)(6) 2014. THE PATIENT'S INFRARENAL AORTIC NECK WAS DESCRIBED AS A "REVERSE FUNNEL." THE LENGTH OF THE INFRARENAL NECK WAS 15MM IN DIAMETER. THE INFRARENAL AORTA MEASURED 23MM PROXIMALLY AND 25.8MM DISTALLY. THE PATIENT HAD DILATATION OF DISTAL RIGHT COMMON ILIAC ARTERY. DURING THE EVAR PROCEDURE, THE FOLLOWING COOK DEVICES WERE IMPLANTED: RPN: ZALB-30-98 (PRODUCT LOT 5296988), RPN: ZSLE-20-90-ZT (PRODUCT LOT 5202817), RPN: ZSLE-16-90-ZT (PRODUCT LOT 5183468). THE PHYSICIAN ALSO USED A COOK CODA-32 BALLOON (PRODUCT LOT UNKNOWN) DURING THE PROCEDURE PER THE INSTRUCTIONS FOR USE. A SYRINGE WAS USED TO INFLATE THE DEVICE. IT WAS REPORTED THAT THE GRAFT WAS NOT ALTERED IN ANY WAY DURING THE INITIAL EVAR PROCEDURE. THE PATIENT COMPLETED A FOLLOW-UP VISIT ON (B)(6) 2020, APPROXIMATELY SIX YEARS AFTER THE INITIAL EVAR PROCEDURE. THE COMPUTED TOMOGRAPHY (CT) SCAN COMPLETED AT THE FOLLOW-UP VISIT SHOWED A TYPE 1A ENDOLEAK ON THE MAIN BODY GRAFT AND TYPE 1B ENDOLEAK ON THE RIGHT ILIAC LEG GRAFT. A REINTERVENTION TO RELINE THE ENDOVASCULAR AORTIC GRAFTS WAS NEEDED, BUT THE PATIENT REFUSED TREATMENT AT THAT TIME. IT WAS REPORTED THE PATIENT HAD A REVERSE FUNNEL NECK, LENGTH 15MM DIAMETERS 23MM PROXIMAL, 25,8MM DISTAL. THE PHYSICIAN DETERMINED THE DEATH OF THE PATIENT WAS DEVICE RELATED. THE SALES REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DEVICE DRAWING, DEVICE SPECIFICATIONS, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. PRE AND POST-OPERATIVE IMAGING WAS PROVIDED TO THE MANUFACTURER AND REVIEWED. THE ZALB-30-98 BARE STENT AND SEALING SEPARATION CAUSED A TYPE 1A ENDOLEAK AND EVENTUALLY AAA RUPTURE. THE CONICAL (INVERTED FUNNEL) ANEURYSM NECK WAS OUTSIDE THE IFU. BY AT LEAST FOUR YEARS, THE MAINBODY WAS ENTIRELY DEPENDENT ON THE BARE STENT FOR ANCHORING BECAUSE SUPERIOR ANEURYSM GROWTH LEFT THE SEALING STENT UNSUPPORTED. RIGHT SUPRARENAL AND SEALING STENT SUTURES MAY HAVE ALREADY SEPARATED BY FOUR YEARS. THIS COMPLAINT CONCERNED A ZSLE-16-90-ZT TYPE 1B ENDOLEAK. A FOCAL RIGHT CIA ANEURYSM INFERIOR TO THE ZSLE DID NOT IMPACT THE ZSLE DISTAL SEAL ZONE. THE SEAL REMAINED INTACT THROUGH SIX YEARS. ALTHOUGH THERE WAS SLIGHTLY LEFT CIA ARTERY EXPANSION AROUND THE DISTAL END OF THE LEFT ZSLE-24-90 AT SIX YEARS, THE LEFT CIA ARTERY WAS STILL SEALED FROM THE AAA OVER A 59.1MM LENGTH. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT PROPER PROCEDURES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 5183468 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. ADDITIONALLY, 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. ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS, 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. 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 SHEATHS. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OF 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. DILATATION 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. SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; PLEASE SEE SECTION 4.3, PRE-PROCEDURE MEASUREMENT TECHNIQUES, AND IMAGING. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING. CLINICAL EXPERIENCE INDICATES THAT CONTRAST-ENHANCED SPIRAL COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) WITH 3-D RECONSTRUCTION IS THE STRONGLY RECOMMENDED IMAGING MODALITY TO ACCURATELY ASSESS PATIENT ANATOMY PRIOR TO TREATMENT WITH THE ZENITH SPIRAL-Z AAA ILIAC LEG. IF CONTRAST-ENHANCED SPIRAL CTA WITH 3-D RECONSTRUCTION IS NOT AVAILABLE, THE PATIENT SHOULD BE REFERRED TO A FACILITY WITH THESE CAPABILITIES. LENGTHS. 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 ANEURYSM OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP. 4.5 IMPLANT PROCEDURE. INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE INTERNAL ILIAC ARTERIES. AVOID DAMAGING THE GRAFT OR DISTURBING GRAFT POSITIONING AFTER PLACEMENT IN THE EVENT RE-INSTRUMENTATION (SECONDARY INTERVENTION) OF THE GRAFT IS NECESSARY. 5 ADVERSE EVENTS. 5.2 POTENTIAL ADVERSE EVENTS. ANEURYSM ENLARGEMENT. CLAUDICATION (E.G., BUTTOCK, LOWER LIMB). ENDOLEAK. 8 PATIENT COUNSELING INFORMATION. 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 OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP. 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) LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG. ANEURYSM RUPTURE MAY BE ASYMPTOMATIC, BUT USUALLY PRESENTS AS: PAIN; NUMBNESS; WEAKNESS IN THE LEGS; ANY BACK, CHEST ABDOMINAL OR GROIN PAIN; DIZZINESS; FAINTING; RAPID HEARTBEAT OR SUDDEN WEAKNESS. 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 (SEE SECTION 5.1, OBSERVED ADVERSE EVENTS AND SECTION 5.2, POTENTIAL ADVERSE EVENTS). THE PHYSICIAN SHOULD COMPLETE THE PATIENT I.D., CARD AND GIVE IT TO THE PATIENT SO THAT HE/SHE CAN CARRY IT WITH HIM/HER AT ALL TIMES. THE PATIENT SHOULD REFER TO THE CARD ANYTIME HE/SHE VISITS ADDITIONAL HEALTH PRACTITIONERS, PARTICULARLY FOR ANY ADDITIONAL DIAGNOSTIC PROCEDURES (E.G., MRI). 12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP. 12.1 GENERAL. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE 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 AAAS. PHYSICIANS SHOULD EVALUATE PATIENTS ON AN INDIVIDUAL BASIS AND PRESCRIBE FOLLOW-UP RELATIVE TO THE NEEDS AND CIRCUMSTANCES OF EACH INDIVIDUAL PATIENT. THE MINIMUM REQUIREMENT FOR PATIENT FOLLOW-UP (DESCRIBED IN THE INSTRUCTIONS FOR USE OF THE ZENITH AAA DEVICE THAT WAS USED) SHOULD BE MAINTAINED EVEN IN THE ABSENCE OF CLINICAL SYMPTOMS (E.G., PAIN, NUMBNESS, WEAKNESS). 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 LESS RELIABLE AND SENSITIVE DIAGNOSTIC METHOD COMPARED TO CT. COOK HAS CONCLUDED THE DEVICE LABELING CONTAINS APPROPRIATE WARNINGS, PRECAUTIONS AND INSTRUCTIONS TO THE USER RELATED TO THE REPORTED FAILURE. BASED ON THE PROVIDED EVIDENCE FROM THE CUSTOMER, IMAGING PROVIDED, AND INTERNAL INVESTIGATION ACTIVITIES, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. COOK HAS CONCLUDED THAT PATIENT ANATOMY, PREEXISTING CONDITIONS, OR DEVICE PLACEMENT MAY HAVE BEEN THE CAUSE OF THE ENDOLEAK. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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.
IT WAS REPORTED THAT "THE TYPE 1B ENDOLEAK IS DUE TO THE DISTAL EVOLUTION OF THE PATHOLOGY".
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
SUSPECT MEDICAL DEVICE: ZSLE-20-90-ZT (LOT: 5202817) OR ZSLE-16-90-ZT (LOT: 5183468). THE ZENITH LOW PROFILE MAIN BODY GRAFT THAT DETACHED AND MIGRATED IS NOT CLEARED FOR SALE IN THE U.S. THIS DEVICE IS NOT SAME OR SIMILAR TO A DEVICE SOLD IN THE U.S. 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 TYPE 1B ENDOLEAK OCCURRED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. DURING THE IMPLANT PROCEDURE ON (B)(6) 2014, THE PATIENT RECEIVED A ZENITH LOW PROFILE MAIN BODY GRAFT, A LEFT ILIAC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT, AND A RIGHT ILIAC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT. DURING THE PROCEDURE, THE RIGHT COMMON ILIAC ARTERY WAS DILATED DISTALLY. THE PHYSICIAN DECIDED TO LAND PROXIMALLY TO THE DILATION SITE WITHOUT COVERING THE INTERNAL ILIAC ARTERY. THE GRAFT WAS EXTENDED A SECOND TIME. ON (B)(6) 2020, DURING THE SIX-YEAR FOLLOW-UP VISIT, A RIGHT TYPE 1B ENDOLEAK, SUBJECT OF THIS REPORT, WAS IDENTIFIED. IN ADDITION, A TYPE 1A ENDOLEAK WAS IDENTIFIED AS A RESULT OF MAIN BODY STENT DETACHMENT AND MIGRATION. IT WAS INDICATED THAT RE-INTERVENTION WAS NEEDED; HOWEVER, THE PATIENT REFUSED TREATMENT. ON (B)(6) 2021, THE ANEURYSM RUPTURED. AN EMERGENCY OPEN SURGICAL REPAIR WAS PERFORMED UNSUCCESSFULLY AND THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1337022 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 5183468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Male | Required Intervention| D | CODA-32| COOK LEFT ZSLE-20-90-ZT| COOK RPN: ZALB-30-98, LOT NUMBER 5296988| UNKNOWN LEFT ZSLE| ZALB-30-98 |