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

Report

Report Number: 1820334-2021-02600
Event Type: Malfunction
Date Received: December 1, 2021
Date of Event: July 28, 2021
Report Date: December 1, 2021
Manufacturer: COOK INC
Product Code: MIH
PMA / PMN Number: P020018
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(6). INITIAL REPORTER OCCUPATION: UNKNOWN. INVESTIGATION ¿ EVALUATION: THE COMPLAINT FACILITY ILLUMEN FZE INFORMED COOK OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-74-ZT) FROM AN UNKNOWN LOT. COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT THE PATIENT WAS LOST TO FOLLOW-UP AFTER THE IMPLANTATION ON (B)(6) 2018 AND PRESENTED WITH AN ABDOMINAL PULSATION AND MILD ABDOMINAL PAIN ON (B)(6) 2021. A TYPE 1B ENDOLEAK WAS DISCOVERED DURING THE REVIEW OF THE IMAGING PROVIDED BY THE USER FACILITY. THE PATIENT LIKELY REQUIRED INTERVENTION, BUT NO DETAILS WERE PROVIDED. NO ADDITIONAL HARM WAS REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL CHECKS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. THEY DID, HOWEVER, PROVIDE TWO POST-OPERATIVE IMAGING SETS FOR REVIEW. SUPRA-RENAL STENT SEPARATION WAS CONFIRMED BY THE IMAGE REVIEWER. THE LIKELY CAUSE OF THE SEPARATION WAS AN ENDOLEAK THAT COMPROMISED THE PROXIMAL SEAL. ADDITIONALLY, THE TORTUOSITY OF THE PATIENT'S VESSEL IS A POSSIBLE CAUSE OF THE SEPARATION. IT IS NOTED THAT THE TYPE 1B ENDOLEAK WAS CAUSED BY CIA DILATION AND THE CIA DILATION WAS INDEPENDENT OF THE AORTIC ANEURYSM. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE MASTER RECORD SHOWED SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. DESIGN VERIFICATION AND VALIDATION TESTING SHOWED THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. HOWEVER, IT SHOULD BE NOTED THAT THIS DEVICE IS DISTRIBUTED VIA ONE DEVICE LOTS. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE FAILURE ANALYSIS, COMPLAINT HISTORY, MANUFACTURING DOCUMENTS, AND VERIFICATION TESTING SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_ZAAASZ_REV4 ¿ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER 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. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. 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 SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE INTERNAL ILIAC ARTERIES. 5 ADVERSE EVENTS: 5.2 POTENTIAL ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK. 11 DIRECTIONS FOR USE. 11.1 ZENITH SPIRAL-Z AAA ILIAC LEG SYSTEM. 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. FINAL ANGIOGRAM: POSITION ANGIOGRAPHIC CATHETER JUST ABOVE THE LEVEL OF THE RENAL ARTERIES. PERFORM ANGIOGRAPHY TO VERIFY THAT THE RENAL ARTERIES ARE PATENT AND THAT THERE ARE NO ENDOLEAKS. VERIFY PATENCY OF INTERNAL ILIAC ARTERIES. CONFIRM THERE ARE NO ENDOLEAKS OR KINKS AND VERIFY POSITION OF PROXIMAL GOLD RADIOPAQUE MARKERS. REMOVE THE SHEATHS, WIRES AND CATHETERS. IF ENDOLEAKS OR OTHER PROBLEMS ARE OBSERVED, REFER TO THE SUGGESTED INSTRUCTIONS FOR USE FOR THE ZENITH AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENTS. 12IMAGING GUIDELINES AND POST OPERATIVE 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. 12.2 ADDITIONAL SURVEILLANCE AND TREATMENT ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ANEURYSMS WITH TYPE I ENDOLEAK. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF IMAGING PROVIDED, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THAT DISEASE PROGRESSION IS THE LIKELY CAUSE OF THE TYPE 1B ENDOLEAK. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

Description of Event or Problem · 0

FOLLOWING EXAMINATION OF 3-YR FOLLOW UP IMAGING, A TYPE 1B ENDOLEAK WAS DISCOVERED ON THE LATERAL MARGIN OF A LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. IT WAS REPORTED A (B)(6)-OLD, MALE PATIENT PRESENTED WITH AN MRA [MAGNETIC RESONANCE ANGIOGRAPHY] ON (B)(6) 2018 THAT SHOWED A 72MM ABDOMINAL AORTIC ANEURYSM (AAA). THE MRA ALSO SHOWED A 26MM INFRA RENAL LANDING ZONE, 50 DEGREE INFRA RENAL AORTIC ANGULATION, 17MM LEFT COMMON ILIAC ARTERY, MILD TO MODERATELY TORTUOUS COMMON ILIAC ARTERY, AND 5MM PATENT INFERIOR MESENTERIC ARTERY, 8MM ACCESS VESSELS BILATERALLY, AS WELL AS MULTIPLE PATENT LUMBAR ARTERIES. THE PATIENT'S ANATOMY WAS DEEMED SUITABLE FOR STANDARD ENDOVASCULAR REPAIR (EVAR). ON (B)(6) 2018, THE PATIENT UNDERWENT STANDARD EVAR IN WHICH THE ZENITH LP ZALB-26-108 WAS INSERTED FROM LEFT FEMORAL ACCESS AND TWO ZSLE-20-74 SPIRAL-Z LEGS WERE PLACED IN THE COMMON ILIAC ARTERY BILATERALLY. CONTRALATERAL GATE CANNULATION WAS NOTED AS VERY CHALLENGING, BUT ULTIMATELY SUCCESSFUL. THE PROCEDURE WAS COMPLETED IN 2.5 HOURS WITH 50CC OF CONTRAST. IT WAS ALSO NOTED THAT DUE TO THE PATIENT'S COMPROMISED KIDNEY FUNCTION, A MAJORITY OF THE PROCEDURE WAS CONDUCTED WITH CARBON DIOXIDE DIGITAL SUBTRACTION ANGIOGRAPHY. THE PATIENT DID NOT COMPLY WITH REGULAR FOLLOW-UP PROTOCOL. NO INFORMATION REGARDING THE PATIENT'S ANTICOAGULATION REGIMEN CAN BE PROVIDED. ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN ABDOMINAL PULSATION AND MILD ABDOMINAL PAIN. NO SIGNS OR SYMPTOMS WERE NOTED BY THE PATIENT UNTIL "RECENTLY." ON (B)(6) 2021, IT WAS DISCOVERED VIA CTA THAT THE BARE STENT HAD "[TORN] OFF THE BIFURCATED MAIN BODY, AND WHICH HAS RESULTED IN [A] MASSIVE TYPE 1A ENDOLEAK AND A 10CM IMPENDING TO RUPTURE AAA." EXAMINATION OF THE PROVIDED IMAGING TAKEN SHOWED A TYPE 1B ENDOLEAK ON THE LATERAL MARGIN OF THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE DEVICE WAS JUST INSIDE THE LEFT COMMON ILIAC ARTERY OSTIUM AND ALMOST EXTRACTED INTO THE ANEURYSM. THE LEFT COMMON ILIAC ARTERY (CIA) SEAL ZONE WAS DILATED TO 23.4 MM. IT WAS NOTED THAT THE PATIENT REQUIRED URGENT TREATMENT, HOWEVER SPECIFIC DETAILS REGARDING TREATMENT WERE NOT PROVIDED. NO OTHER ADVERSE EFFECTS WERE REPORTED. IT SHOULD BE NOTED THE MAIN BODY ZENITH LP ZALB-26-108 IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS THIS DEVICE IS NOT SOLD IN THE US AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC THAT IS MARKETED IN THE US.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1811578	ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	COOK INC	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR	Male		COOK LEFT ZSLE-20-74 LEG GRAFT\| COOK ZALB-26-108 MAIN BODY