ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2024-00632
- Event Type
- Malfunction
- Date Received
- May 7, 2024
- Date of Event
- April 23, 2024
- Report Date
- August 21, 2024
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552354
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION ¿ EVALUATION: COOK WAS INFORMED OF AN EVENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-122-ZT ). A 75-YEAR-OLD MALE PATIENT UNDERWENT A COMMON RIGHT ILIAC PROCEDURE TO CORRECT A TYPE 1B ENDOLEAK. THE ILIAC EXTENSION ZSLE-13-107-ZT WAS IMPLANTED IN THE PATIENT IN THE RIGHT COMMON ILIAC FOLLOWED BY THE STENT ZSLE-13-122-ZT, WHICH UNDER RADIOLOGICAL GUIDANCE THE GRAFT WAS FOUND TO HAVE THE SAME LENGTH AS THE PREVIOUSLY IMPLANTED ENDOPROSTHESIS (ZSLE-13-107-ZT). THE SPECIALIST IDENTIFIED DEFECT AND PERFORMED MEASUREMENT COMPARING BOTH REFERENCES WITHIN THE PATIENT AND CONFIRMS THAT BOTH GRAFTS ARE THE SAME LENGTH, WHICH SHOULD NOT BE SO ACCORDING TO ITS REFERENCE. THE STENT WAS IMPLANTED IN THE PATIENT. THE FOCUS OF THIS REPORT (MFR. REFERENCE #1820334-2024-00632) IS THE ZSLE-13-122-ZT THAT WAS IDENTIFIED TO BE SHORTENED. MFR. REFERENCE #1820334-2024-00789 WILL ADDRESS THE TYPE 1B ENDOLEAK (ZSLE-13-107-ZT) DISCOVERED IN IMAGING REVIEW. MFR. REFERENCE #1820334-2024-00791 WILL ADDRESS THE TYPE 1B ENDOLEAK UNKNOWN ILIAC LEG GRAFT WHICH REQUIRED REINTERVENTION, ALSO DISCOVERED IN IMAGING REVIEW. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS FOR THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. HOWEVER, MEDICAL IMAGING WAS PROVIDED AND REVIEWED. THE IMPRESSION IS AS FOLLOWS: A TYPE 1B ENDOLEAK AFTER EVAR IS SEEN AROUND THE RIGHT ILIAC LEG DUE TO ANEURYSMAL DILATION OF THE RIGHT CIA. REPAIR IS ATTEMPTED WITH COIL EMBOLIZATION OF THE RIGHT HYPOGASTRIC ARTERY AND GRAFT EXTENSION INTO THE RIGHT EIA. THE FIRST ZSLE (13 X 107 MM) LEG GRAFT IS PLACED FROM THE MID IPSILATERAL LIMB TO THE PROXIMAL EIA BUT THE ENDOLEAK PERSISTS, LIKELY FROM INADEQUATE DISTAL SEAL (TYPE 1B). A SECOND ZSLE, LABELED ZSLE-13-122, IS INTRODUCED FOR FURTHER EXTENSION BUT THE CONSTRAINED GRAFT IS FOUND TO HAVE A SIMILAR LENGTH TO THE FIRST ZSLE. IT IS DEPLOYED HIGHER THAN THE 1ST ZSLE TO THE FLOW DIVIDER, AND THE DISTAL ASPECT LANDS WITHIN THE 1ST ZSLE WITH NO FURTHER EXTENSION OF THE DISTAL SEAL. ONCE DEPLOYED, THE LENGTH OF THE NEW LEG REMAINS SIMILAR TO THE 1ST ZSLE. THERE IS NO SIGNIFICANT TORTUOSITY AT THIS SEGMENT, AND BOTH LEG GRAFTS ARE WITHIN THE SAME LOCATION. GRAFT FORESHORTENING COULD BE DUE TO DEPLOYMENT TECHNIQUE, BUT THE CONSTRAINED GRAFT PRIOR TO DEPLOYMENT ALSO APPEARS SHORTER THAN EXPECTED. A CAUSE FOR GRAFT FORESHORTENING CANNOT BE DETERMINED FROM THE IMAGING PROVIDED. THE TYPE 1B ENDOLEAK PERSISTS AT THE END OF THE CASE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A COMPLAINT HISTORY SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE 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. 4 WARNINGS AND PRECAUTIONS: 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP: SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; PLEASE SEE SECTION 4.3, PRE-PROCEDURE MEASUREMENT TECHNIQUES, AND IMAGING. ALL LENGTHS AND DIAMETERS OF THE DEVICES NECESSARY TO COMPLETE THE PROCEDURE SHOULD BE AVAILABLE TO THE PHYSICIAN, ESPECIALLY WHEN PREOPERATIVE CASE PLANNING MEASUREMENTS (TREATMENTS DIAMETERS/LENGTHS) ARE NOT CERTAIN. THIS APPROACH ALLOWS FOR GREATER INTRAOPERATIVE FLEXIBILITY TO ACHIEVE OPTIMAL PROCEDURAL OUTCOMES. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING: LENGTHS: UTILIZING CT, LENGTH MEASUREMENTS SHOULD BE DETERMINED TO ACCURATELY ASSESS LENGTH AS WELL AS PLANNING ZENITH ALPHA SPIRAL-Z ENDOVASCULAR LEG COMPONENTS. THESE RECONSTRUCTIONS SHOULD BE PERFORMED IN SAGITTAL, CORONAL, AND 3-D. 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 (TABLE 10.5.1). 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 ALPHA SPIRAL-Z AAA ILIAC LEG AND ASSURE AND ACCURATE APPOSITION TO THE VESSEL WALL. 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. AS THE SHEATH AND/OR WIRE GUIDE IS WITHDRAWN, ANATOMY AND GRAFT POSITION MAY CHANGE. CONSTANTLY MONITOR GRAFT POSITION AND PERFORM ANGIOGRAPHY TO CHECK POSITION AS NECESSARY. 5.2 POTENTIAL ADVERSE EVENTS: 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; PERI GRAFT FLOW; AND CORROSION 7.1 INDIVIDUALIZATION OF TREATMENT: COOK RECOMMENDS THAT THE ZENITH ALPHA SPIRAL-Z ENDOVASCULAR LEG DIAMETERS BE SELECTED AS DESCRIBES IN TABLE 9.5.1. ALL LENGTHS AND DIAMETERS OF THE DEVICES NECESSARY TO COMPLETE THE PROCEDURE SHOULD BE AVAILABLE TO THE PHYSICIAN TO THE PHYSICIAN, ESPECIALLY WHEN PREOPERATIVE CASE PLANNING MEASUREMENTS (TREATMENT DIAMETERS/LENGTHS) ARE NOT CERTAIN. THIS APPROACH ALLOWS FOR GREATER INTRAOPERATIVE FLEXIBILITY TO ACHIEVE OPTIMAL PROCEDURAL OUTCOMES. PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES WITH A DELIVERY PROFILE OF 12 FR TO 14 FR. 9 HOW SUPPLIED: STORE IN A COOL, DRY PLACE. 10.2 INSPECTION PRIOR TO USE: INSPECT THE DEVICE AND PACKAGING TO VERIFY THAT NO DAMAGE HAS OCCURRED AS A RESULT OF SHIPPING. DO NOT USE THIS DEVICE IF DAMAGE HAS OCCURRED OR IF THE STERILIZATION BARRIER HAS BEEN DAMAGED OR BROKEN. IF DAMAGE HAS OCCURRED, DO NOT USE THE PRODUCT, AND RETURN IT TO COOK. PRIOR TO USE, VERIFY CORRECT DEVICES (QUANTITY AND SIZE) HAVE BEEN SUPPLIED FOR THE PATIENT BY MATCHING THE DEVICE TO THE ORDER PRESCRIBED BY THE PHYSICIAN FOR THAT PARTICULAR PATIENT. 11 DIRECTIONS FOR USE: ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIUM AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES. ARTERIAL CONDUIT TECHNIQUES MAY BE REQUIRED. 11.1.4 CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT: 4. CONFIRM POSITION OF THE DISTAL END OF THE CONTRALATERAL ILIAC LEG GRAFT. REPOSITION THE CONTRALATERAL ILIAC LEG GRAFT IF NECESSARY TO ENSURE BOTH INTERNAL ILIAC PATENCY AND MINIMUM OVERLAP OF 2 STENTS (16 MM) WITHIN THE MAIN BODY ENDOVASCULAR GRAFT. 11.1.5 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT: 3. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY. 5. UNDER FLUOROSCOPY AND AFTER VERIFICATION OF ILIAC LEG GRAFT POSITION, LOOSEN PIN VISE, RETRACT INNER CANNULA TO DOCK TAPERED DILATOR TO GRAY POSITIONER. TIGHTEN PIN VISE. MAINTAIN MAIN BODY SHEATH POSITION WHILE WITHDRAWING THE ILIAC LEG SHEATH AND GRAY POSITIONER WITH SECURED INNER CANNULA. 11 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP: 11.1 GENERAL: 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. EVIDENCE PROVIDED BY THE CUSTOMER, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DEVICE FAILURE ANALYSIS, 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 AND THE RESULTS OF THE INVESTIGATION, COOK COULD NOT ESTABLISH A DEFINITIVE CAUSE FOR THE REPORTED LENGTH OF THE DEVICE APPEARING TOO SHORT DURING THE PROCEDURE. AND WHILE THE CAUSE IS NOT KNOWN, IT IS POSSIBLE THAT THE MEDICAL PROCEDURE MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE GRAFT WAS DEPLOYED WITHIN THE SAME DIAMETER GRAFT SO IT MAY HAVE CONSTRAINED THE GRAFT SO IT COULD NOT EXPAND OUT OR LENGTH WISE. THE DEPLOYMENT SPACE WAS EXTREMELY TIGHT. THE IMAGE REVIEWER STATED, ¿THERE IS NO SIGNIFICANT TORTUOSITY AT THIS SEGMENT, AND BOTH LEG GRAFTS ARE WITHIN THE SAME LOCATION. GRAFT FORESHORTENING COULD BE DUE TO DEPLOYMENT TECHNIQUE, BUT THE CONSTRAINED GRAFT PRIOR TO DEPLOYMENT ALSO APPEARS SHORTER THAN EXPECTED. A CAUSE FOR GRAFT FORESHORTENING CANNOT BE DETERMINED FROM THE IMAGING PROVIDED." 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 - (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.
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 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED TO COOK THAT THE LENGTH MEASUREMENT FOR A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS INCORRECT. A 75-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE TO TREAT AN ABDOMINAL AND ILIAC ANEURYSM. FIRST A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-107-ZT WAS IMPLANTED IN THE RIGHT COMMON ILIAC. NEXT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-122-ZT WAS IMPLANTED. RADIOLOGICAL GUIDANCE AND PHYSICIAN MEASUREMENTS WERE COMPLETED TO COMPARE THE GRAFT LENGTHS. IT WAS DETERMINED BY THE PHYSICIAN THAT THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-122-ZT WAS THE SAME LENGTH AS THE PREVIOUSLY PLACED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-107-ZT. DESPITE THE DIFFERENTIAL IN LENGTH, THE DEVICE REMAIN IMPLANTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
ADDITIONAL INFORMATION WAS PROVIDED ON 15MAY2024. THE PROCEDURE THAT TOOK PLACE ON (B)(6) 2024 WAS A REINTERVENTION PROCEDURE TO ADDRESS/CORRECT A TYPE 1B ENDOLEAK IN A PREVIOUSLY PLACED DEVICE. THE IDENTIFICATION OF THE PRODUCTS PLACED IN THE INDEX ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE WERE NOT ABLE TO BE OBTAINED AS THE INFORMATION IS KEPT BY THE INSTITUTION IN THE PATIENT'S MEDICAL RECORD. THERE WAS NO SIGNIFICANT TORTUOSITY OF THE DISTAL AORTA, ILIAC ARTERIES, AND/OR FEMORAL ARTERIES. PLANNING AND SIZING IS NOT AVAILABLE AS IT WAS NOT POSSIBLE TO COMPLETE A COMPUTED TOMOGRAPHY ANGIOGRAPHY DUE TO THE PATIENT'S ALTERED CREATININE LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 531023 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55235 | 15811156 | 10827002552354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | COOK (RPN: TSCMG-35-260-LESDC, LOT E4339841)| COOK CODA (RPN: CODA-2-9.0-35-120-32 LOT 15783223)| COOK ILIAC GRAFT(RPN: ZSLE-13-107-ZT LOT 15633207)| COOK INC. RPN: ZSLE-13-107-ZT LOT 15633207 |