FDA Adverse Event Injury Summary report: N

ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

MDR report key: 16522510 · Received March 10, 2023

Report

Report Number: 1820334-2023-00247
Event Type: Injury
Date Received: March 10, 2023
Date of Event: March 4, 2023
Report Date: June 30, 2023
Manufacturer: COOK INC
Product Code: MIH
UDI-DI: 10827002552378
PMA / PMN Number: P020018
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION ¿ EVALUATION: A VASCULAR SURGEON FROM (B)(6) PERFORMED AN ENDOVASCULAR AORTIC REPAIR WHERE THE MAIN BODY GRAFT HAD A PARTIAL TO TOTAL OCCLUSION AND THE ILIAC LEG GRAFTS OCCLUDED DURING THE PROCEDURE. THE PATIENT WAS A 62-YEAR-OLD FEMALE AT THE TIME OF THE EVENT. SHE HAD BEEN DIAGNOSED WITH AN ABDOMINAL AORTIC ANEURYSM AND HAD HISTORY OF GASTROINTESTINAL BLEEDS. SHE HAD VESSEL CALCIFICATION THAT WAS NON-CIRCUMFERENTIAL. THE PATIENT WAS AN INPATIENT IN THE INTENSIVE CARE UNIT. HER REQUIREMENT FOR INTENSIVE CARE AT THE FACILITY IS UNKNOWN. HOWEVER, SHE HAD BEEN PRESCRIBED HEPARIN BEFORE SHE UNDERWENT ENDOVASCULAR AORTIC REPAIR (EVAR). LIMITED NON-CONTRAST IMAGING WAS OBTAINED PRIOR TO THE EVAR PROCEDURE. THE PATIENT UNDERWENT EVAR ON (B)(6) 2023. DURING THE PROCEDURE, THERE WERE COMPLICATIONS WITH ACCESS SITES. MULTIPLE ACCESS SITES WERE MADE BILATERALLY. IF THE PATIENT¿S PULSE WAS NOT GOOD, THEN THAT SIDE WAS CLOSED AND THE OTHER SIDE WAS USED. MULTIPLE DOSES OF HEPARIN WERE GIVEN DURING THE PROCEDURE. HOWEVER, THE PATIENT REQUIRED BILATERAL THROMBECTOMIES TO ADDRESS THE OCCLUSION IN THE LEFT AND RIGHT ILIAC LEG GRAFTS. A COOK SALES REPRESENTATIVE WAS PRESENT DURING THE ACCESS SITE COMPLICATIONS AS WELL AS THE THROMBOSIS OCCURRING IN THE GRAFTS. THE PHYSICIAN HAD ORDERED HEPARIN EVERY ONE TO TWO HOURS AFTER THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER FACILITY DUE TO THE INABILITY TO ESTABLISH FLOW IN THE GRAFTS. BEFORE THE PATIENT WAS TRANSFERRED, BOTH ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG GRAFTS WERE OCCLUDED. THE PATIENT REQUIRED BILATERAL THROMBECTOMIES TO ADDRESS THE OCCLUSION IN THE LEFT AND RIGHT ILIAC LEG GRAFTS. THE PATIENT¿S OUTCOME IS UNKNOWN. DESPITE THE ACCESS SITE DIFFICULTIES, THE FOLLOWING COOK DEVICES WERE ABLE TO BE PLACED: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT, LOT NUMBER 14157760); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT, LOT NUMBER 15086640), PLACED IN THE LEFT COMMON ILIAC ARTERY; ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT, LOT NUMBER 15084649), PLACED IN THE RIGHT COMMON ILIAC ARTERY. ADDITIONALLY, OTHER NON-COOK DEVICES WERE PLACED DURING THE PROCEDURE. THE REPORT WILL FOCUS ON THE OCCLUSION OF THE LEFT LEG GRAFT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT; LOT:15086640). REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATION COULD BE CONDUCTED. MEDICAL IMAGING WAS REQUESTED; HOWEVER, THE FACILITY WAS UNABLE TO PROVIDE IMAGING FOR EXPERT REVIEW. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE RELATIVE TO THE REPORTED DEVICE FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 15086640 AND GRAFT SUBASSEMBLIES FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT. COOK ALSO REVIEWED PRODUCT LABELING. THE DEVICE WAS PACKAGED WITH IFU T_ZAAASZ_REV4. THE IFU INCLUDES THE FOLLOWING, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR PROPER PLACEMENT OF THE DEVICE. WARNINGS AND PRECAUTIONS: 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. 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. DILATATION OF THOSE 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. THE ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM IS NOT RECOMMENDED IN PATIENTS WHO CANNOT TOLERATE CONTRAST AGENTS NECESSARY FOR INTRAOPERATIVE AND POSTOPERATIVE FOLLOW-UP IMAGING. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS. SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; PLEASE SEE SECTION 4.3, PRE-PROCEDURE MEASUREMENTS TECHNIQUES, AND IMAGING. 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. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP. AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS SHOULD BE REGULARLY MONITOR FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. AT A MINIMUM, ANNUAL IMAGING IS REQUIRED, INCLUDING: 1) ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY (SEPARATION BETWEEN COMPONENTS OR STENT FRACTURE) AND 2) CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY, AND PROGRESSIVE DISEASE. IF RENAL COMPLICATIONS OR OTHER FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA, ABDOMINAL RADIOGRAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFORMATION. IMPLANT PROCEDURE: DO NOT CONTINUE ADVANCING ANY PORTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE WIRE GUIDE OR DELIVERY SYSTEM. STOP AND ASSESS THE CAUSE OF RESISTANCE; VESSEL, CATHETER OR GRAFT DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS, OR IN CALCIFIED OR TORTUOUS WEEK. 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. FLUOROSCOPY SHOULD BE USED DURING INTRODUCTION AND DEPLOYMENT TO CONFIRM PROPER OPERATION OF THE DELIVERY SYSTEM COMPONENTS, PROPER PLACEMENT OF THE GRAFT, AND DESIRED PROCEDURAL OUTCOME. EXCESSIVE OVERLAP 10 MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. ADVERSE EVENTS: POTENTIAL ADVERSE EVENTS: CLAUDICATION (E.G., BUTTOCK, LOWER LIMB); ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT. DEPLOYMENT; COMPONENT MIGRATION; COMPONENT SEPARATION FROM ANOTHER GRAFT COMPONENT; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; AND CORROSION. GRAFT OR NATIVE VESSEL OCCLUSION. SURGICAL CONVERSION TO OPEN REPAIR. PATIENT SELECTION AND TREATMENT: INDIVIDUALIZATION OF TREATMENT: 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). PATIENT¿S SUITABILITY FOR OPEN SURGICAL REPAIR. PATIENT¿S ABILITY TO TOLERATE GENERAL, REGIONAL, OR LOCAL ANESTHESIA. ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATH. FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT. 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. 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. AT A MINIMUM, ANNUAL IMAGING, AND ADHERENCE TO ROUTING POSTOPERATIVE FOLLOW-UP REQUIREMENTS IS REQUIRED AND SHOULD BE CONSIDERED A LIFE-LONG COMMITMENT TO THE PATIENT¿S HEALTH AND WELL-BEING. 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. ANEURYSM RUPTURE. MAY BE ASYMPTOMATIC, BUT USUALLY PRESENTS AS: 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). IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP: 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 ANEURYSM 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 CIRCUMSTANCE OF EACH INDIVIDUAL PATIENT. THE MINIMUM REQUIREMENT FOR PATIENT FOLLOW-UP (DESCRIBED IN THE INSTRUCTIONS FOR USE FOR 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 A LESS RELIABLE AND SENSITIVE DIAGNOSTIC METHOD COMPARED TO CT. EVIDENCE PROVIDED BY THE CUSTOMER, COMPLAINT HISTORY, DHR, MANUFACTURING DOCUMENTS, AND VERIFICATION TESTING SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED WITHOUT ADDITIONAL INFORMATION. OCCLUSION IS A KNOWN INHERENT RISK OF USING THE DEVICE PER THE IFU. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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.

Additional Manufacturer Narrative · 0

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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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 Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INITIAL REPORTER NAME & ADDRESS - CUSTOMER: (B)(6) MEDICAL CENTER, ADDRESS: (B)(6) , PHONE: (B)(6). 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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.