ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

Report

Report Number: 1820334-2010-00670
Event Type: Injury
Date Received: December 28, 2010
Date of Event: November 29, 2010
Report Date: December 1, 2010
Manufacturer: COOK, INC.
Product Code: MIH
PMA / PMN Number: P020018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST WITH THIS INVESTIGATION. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE END USER. EACH DEVICE IS SENT WITH AN IFU, WHICH DESCRIBES THE INDICATIONS FOR USE, WARNING, PRECAUTIONS, CORRECT PRODUCT SIZING INSTRUCTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE THE INSTRUCTIONS FOR USE FOR THE MAIN BODY GRAFT STATE: "INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS." THE MAIN BODY IFU ALSO PROVIDES DETAILED INSTRUCTION ON PROPER PLACEMENT OF THE SUPRARENAL STENT IN ORDER TO MAINTAIN PATENCY OF RENAL ARTERIES, THE PROPER DEPLOYMENT SEQUENCE FOR RELEASING THE TOP CAP, AND DEPLOYMENT OF CONTRALATERAL AND IPSILATERAL LEGS, AND PROVIDES GUIDELINES FOR PROPER ANATOMICAL REQUIREMENTS. IN ADDITION, THE IFU PROVIDES INSTRUCTIONS ON PERFORMING ANGIOGRAPHY PRIOR TO TOP STENT DEPLOYMENT TO VERIFY THE POSITION OF THE GRAFT WITH RESPECT TO THE RENAL ARTERIES. STATING "IF NECESSARY, CAREFULLY REPOSITION THE COVERED PORTION OF THE ENDOVASCULAR GRAFT WITH RESPECT TO THE RENAL ARTERIES. (REPOSITIONING CAN ONLY TAKE PLACE OVER A SMALL RANGE OF DISTANCE AT THIS STAGE)." THE FAILURE MODE ASSIGNED TO THIS CASE IS DEPLOYMENT. THE FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION, AS WELL AS THE PHYSICIAN'S COMMENTS. "RADIFOCUS GUIDE WIRE WANDERED OFF INTO THE RIGHT RENAL ARTERY AND PROBABLY PENETRATED THE VESSEL. I ATTEMPTED TO PLACE THE MAIN BODY IMMEDIATELY BELOW THE LEFT RENAL ARTERY AS L1 WAS TOO SHORT. I ASSUME THAT CAUSED OCCLUSION." IT APPEARS THAT PROPER SIZING GUIDELINES AND TECHNIQUES MAY NOT HAVE BEEN FOLLOWED IN THIS CASE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. NO FURTHER RISK REDUCTION ACTIVITIES ARE REQUIRED PER QUALITY ENGINEERING RISK ANALYSIS (QERA) AND THE RISKS REMAIN AT AN ACCEPTABLE LEVEL.

Description of Event or Problem · 1

A (B)(6) MALE PATIENT WITH LUNG DISEASE AND HYPERTENSION UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PATIENT'S ANATOMICAL FORM WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR. THE PATIENT HAD COMMON ILIAC AND INTERNAL ILIAC ARTERY ANEURYSMS. THE ANEURYSM DIAMETER WAS 40MM AND L1 (DISTANCE FROM RENAL ARTERIES TO THE AORTIC BIFURCATION) WAS 87MM. THE PROCEDURE WAS PERFORMED AS LABELED. ONE FLEX MAIN BODY AND THREE ILIAC LEG GRAFTS WERE PLACED. UPON COMPLETION OF THE PROCEDURE, THE PATIENT'S CONDITION DETERIORATED. THEN PENETRATION OF THE RIGHT RENAL ARTERY BY A COMPETITOR'S IRE GUIDE AND OCCLUSION OF THE LEFT RENAL ARTERY WAS CONFIRMED. COIL EMBOLIZATION WAS PERFORMED FOR THE RIGHT RENAL ARTERY AND PTRA WAS PERFORMED FOR THE LEFT RENAL ARTERY. BLEEDING OF THE RIGHT RENAL ARTERY STOPPED AND THE LEFT RENAL ARTERY WAS SUCCESSFULLY OPENED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	COOK, INC.	NA	F2563542

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Other