ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2019-01672
- Event Type
- Injury
- Date Received
- July 11, 2019
- Date of Event
- June 24, 2019
- Report Date
- December 31, 2019
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552422
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INVESTIGATION OF THE SECOND DEVICE POTENTIALLY INVOLVED IN THE TYPE 1B ENDOLEAK HAS BEEN COMPLETED. ANY NEW INFORMATION SPECIFIC TO THE COMPLAINT DEVICE MENTIONED IN THIS REPORT IS BELOW. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 7084901 FOUND NO NON-CONFORMANCES AS THIS IS A ONE-DEVICE LOT, THUS ELIMINATING THE POTENTIAL FOR OTHER NON-CONFORMING PRODUCTS. A TRACKWISE SEARCH FOUND THIS TO BE THE ONLY REPORTED EVENT ASSOCIATED WITH LOT 7080941 AS WELL. THEREFORE, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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, UNCHANGED 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, 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.
INVESTIGATION EVALUATION: A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION OF PHOTOS PROVIDED FROM THE CUSTOMER, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, IMAGES FROM THE ANGIOGRAPHY PROCEDURE WERE PROVIDED BY THE CUSTOMER. BASED ON THE FIRST IMAGE, A SMALL AMOUNT OF CONTRAST PASSING ON THE CONTRALATERAL EDGE WAS OBSERVED, THOUGH IT DOES NOT APPEAR TO FLOW BACK INTO THE SAC. BASED SOLELY ON THE IMAGES PROVIDED, IT APPEARS THAT THE ORIGINAL LEG GRAFT SEALED WELL, BUT NOT COMPLETELY. THE ENDOLEAK WAS NOT CONFIRMED THROUGH IMAGE REVIEW; HOWEVER, THE COMPLAINT WAS ABLE TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION AND THAT THERE IS NO EVIDENCE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 6405467 FOUND NO NON-CONFORMANCES AS THIS IS A ONE-DEVICE LOT, THUS ELIMINATING THE POTENTIAL FOR OTHER NON-CONFORMING PRODUCTS. A TRACKWISE SEARCH FOUND THIS TO BE THE ONLY REPORTED EVENT ASSOCIATED WITH LOT 6405467 AS WELL. THEREFORE, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT INSTRUCTIONS FOR USE (IFU) (T_ZAAASZ_REV2) STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: ¿4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP: ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10MM IN LENGTH AND 7.5-20MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR FOR SIZING REQUIREMENTS AND A LIST OF KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL ANEURYSM EXCLUSION USING A MAIN BODY OR RENU FROM THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, REFER TO THE APPROPRIATE INSTRUCTIONS FOR USE.4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10MM IN LENGTH AND 7.5-20MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR FOR SIZING REQUIREMENTS AND A LIST OF KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL ANEURYSM EXCLUSION USING A MAIN BODY OR RENU FROM THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, REFER TO THE APPROPRIATE INSTRUCTIONS FOR USE. 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 17 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS AND/OR INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS. THE ZENITH SPIRAL-Z AAA ILIAC LEG HAS NOT BEEN EXPLICITLY EVALUATED CLINICALLY; HOWEVER, ITS PERFORMANCE IS REPRESENTED BY THE ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG (A PREVIOUS VERSION OF THE DEVICE), WHICH HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: KEY ANATOMICAL ELEMENTS THAT FALL OUTSIDE THE SIZING REQUIREMENTS SPECIFIED IN THE APPROPRIATE MAIN BODY OR RENU INSTRUCTIONS FOR USE SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; PLEASE SEE SECTION. 4.3, PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING: 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. 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: 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. INADEQUATE FIXATION OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT MAY RESULT IN INCREASED RISK OF MIGRATION OF THE STENT GRAFT. INCORRECT DEPLOYMENT OR MIGRATION OF THE ENDORPOSTHESIS MAY REQUIRE SURGICAL INTERVENTION. 11.1.7 MOLDING BALLOON INSERTION: EXPAND THE MOLDING BALLOON WITH DILUTED CONTRAST MEDIA (AS DIRECTED BY THE MANUFACTURER) IN THE AREA OF THE MOST PROXIMAL COVERED STENT AND THE INFRARENAL NECK, STARTING PROXIMALLY AND WORKING IN THE DISTAL DIRECTION. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL LIMB OVERLAP REGION AND EXPAND. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL DISTAL FIXATION SITE AND EXPAND. DEFLATE AND REMOVE MOLDING BALLOON. TRANSFER MOLDING BALLOON ONTO THE CONTRALATERAL WIRE GUIDE AND INTO THE CONTRALATERAL ILIAC LEG INTRODUCTION SYSTEM. ADVANCE MOLDING BALLOON TO THE CONTRALATERAL LIMB OVERLAP AND EXPAND. WITHDRAW THE MOLDING BALLOON TO THE CONTRALATERAL ILIAC LEG/VESSEL DISTAL FIXATION SITE AND EXPAND. REMOVE MOLDING BALLOON AND REPLACE IT WITH AN ANGIOGRAPHIC CATHETER TO PERFORM COMPLETION ANGIOGRAMS. 12.3 ABDOMINAL RADIOGRAPHS: THE FOLLOWING VIEWS ARE REQUIRED: FOUR FILMS: SUPINE-FRONTAL (AP), CROSS-TABLE LATERAL, 30 DEGREE LPO AND 30 DEGREE RPO VIEWS CENTERED ON UMBILICUS. RECORD THE TABLE-TO-FILM DISTANCE AND USE THE SAME DISTANCE AT EACH SUBSEQUENT EXAMINATION ENSURE ENTIRE DEVICE IS CAPTURED ON EACH SINGLE IMAGE FORMAT LENGTHWISE. IF THERE IS ANY CONCERN ABOUT THE DEVICE INTEGRITY (E.G. KINKING, STENT BREAKS, BARB SEPARATION, RELATIVE COMPONENT MIGRATION), IT IS RECOMMENDED TO USE MAGNIFIED VIEWS. THE ATTENDING PHYSICIAN SHOULD EVALUATE FILM FOR DEVICE INTEGRITY (ENTIRE DEVICE LENGTH INCLUDING COMPONENTS) USING 2-3X MAGNIFICATION VISUAL AID. 12.6 ADDITIONAL SURVEILLANCE AND TREATMENT: ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ANEURYSMS WITH TYPE I ENDOLEAK, ANEURYSMS WITH TYPE III ENDOLEAK, ANEURYSM ENLARGEMENT, [GREATER THAN OR EQUAL TO] 5MM 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 PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED BUT IS A KNOWN INHERENT RISK OF USING THIS DEVICE. THE MOST LIKELY CONTRIBUTING FACTORS CAN BE ATTRIBUTED TO DISEASE PROGRESSION AND INSUFFICIENT BALLOONING AT THE SEAL ZONES. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
NO ADDITIONAL INFORMATION REGARDING PATIENT/EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT,
IN ADDITIONAL INFORMATION RECEIVED ON 11SEP2019, IT WAS REPORTED THAT NO CALCIUM WAS PRESENT IN THE SEAL ZONE. THERE WAS NO SIGNIFICANT TORTUOSITY OF THE PATIENT'S VESSELS. IT WAS CONFIRMED THAT BALLOONING WAS PERFORMED IN THE DISTAL SEAL STENT DURING IMPLANTATION. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2019 TO EXTEND THE GRAFT. THE PROCEDURE WAS SUCCESSFUL IN SEALING THE LEAK. ADDITIONAL IMAGING WAS PROVIDED TO THE MANUFACTURER.
ADDITIONAL INFORMATION REGARDING A SPECIFIC RPN AND LOT NUMBER OF A DEVICE IMPLANTED DURING THE THIRD PROCEDURE WAS RECEIVED ON 14OCT2019. A ZSLE-13-74-ZT FROM LOT 9578024 WAS IMPLANTED DURING THE THIRD PROCEDURE BY (B)(6) TO EXTEND INTO THE EXTERNAL ILIAC ARTERY FOR A BETTER SEAL.
RPN FOR SECOND DEVICE: ZSLE-24-74-ZT. LOT FOR SECOND DEVICE: 708490.1 IMPLANT DATE: ZSLE-24-74-ZT IMPLANTED ON (B)(6) 2019. CONCOMITANT PRODUCTS: G48418 TFFB-28-96-ZT (LOT 6959129), G55233 ZSLE-13-90-ZT (LOT 6485953), 32-CODA BALLOON, LUNDERQUIST WIRE. (B)(4). THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH 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 MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(4) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS PLACED ON HEPARIN FOR ANTI-COAGULATION THERAPY. A TYPE IB ENDOLEAK IN THE LEFT COMMON ILIAC WAS IDENTIFIED IN THE TIME SINCE THE INITIAL PROCEDURE. A SECOND PROCEDURE TO EXTEND THE LIMB AND SEAL OFF THE ENDOLEAK WAS COMPLETED ON (B)(4) 2019. A CODA BALLOON WAS USED IN THE OVERLAP OF THE MAIN BODY (TFFB) AND THE DISTAL EDGE ABOVE THE HYPOGASTRIC ARTERY. IT WAS FOUND THAT THE ADDITIONAL ZSLE-24-74 DID NOT SEAL ABOVE THE HYPOGASTRIC ARTERY. THE RETROGRADE FLOW HAD BEEN DELAYED, BUT WAS STILL PRESENT. THE PHYSICIAN CONSULTED WITH THE PATIENT TO GET CONSENT TO COIL THAT HYPOGASTRIC ARTERY AND EXTEND IN THE EXTERNAL ILIAC ARTERY FOR A BETTER SEAL. IT WAS LATER REPORTED THAT AN ADDITIONAL PROCEDURE TO COIL THE HYPOGASTRIC ARTERY AND EXTEND INTO THE EXTERNAL ILIAC ARTERY WAS COMPLETED SUCCESSFULLY. A GOOD SEAL WAS ACHIEVED AND THE PATIENT IS CURRENTLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573006 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 6405467 | 10827002552422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |