GORE® EXCLUDER® AAA ENDOPROSTHESIS

Report

Report Number: 3013164176-2025-02385
Event Type: Injury
Date Received: February 14, 2025
Date of Event: June 21, 2024
Report Date: April 3, 2025
Manufacturer: W. L. GORE & ASSOCIATES, INC.
Product Code: MIH
PMA / PMN Number: P020004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. D10: CONCOMITANT MEDICAL PRODUCTS: (RELEVANT ASSOCIATED DEVICES USED WITH THE DEVICE BEING REPORTED ON): GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CEB231410). AS PART OF OUR ROUTINE QUALITY PROCEDURES, EACH BATCH OF DEVICES UNDERGOES COMPREHENSIVE QUALITY CONTROL TESTING AND INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. GORE REVIEWED THE MANUFACTURING RECORDS ASSOCIATED WITH THE REPORTED LOT NUMBER AND VERIFIED THAT ALL RELEASE CRITERIA HAD BEEN MET. ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED. PATIENT IMAGING IS BEING REVIEWED. LITERATURE CITATION: BOUDREAU, C., CARADU, C., BÉRARD, X. AND DUCASSE, E. (2025). ANNALS OF VASCULAR SURGERY - BRIEF REPORTS AND INNOVATIONS 5, 100363. HTTPS://DOI.ORG/10.1016/J.AVSURG.2025.100363. THIS EVENT INVOLVES ANOTHER DEVICE, REPORTED WITH GORE REFERENCE NUMBER (B)(4) (MANUFACTURER REPORT NUMBER). W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

Additional Manufacturer Narrative · 0

THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: 2-RADIOGRAPHIC JPEG IMAGES AVAILABLE FOR EVALUATION. NO NAME, DATE, OR DEMOGRAPHICS ON THE IMAGES. CONTRAST IS VISUALIZED OUTSIDE THE IMPLANTED DEVICES IN THE LEFT COMMON ILIAC ARTERY. THERE IS A COMPLETE DEVICE SEPARATION OF THE CONTRALATERAL LEG, BRIDGING DEVICE, AND THE PROXIMAL STENT GRAFT ILIAC BRANCH COMPONENT (IBE). TYPE III ENDOLEAK ¿ COMPONENT DISCONNECTION IS CONFIRMED. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED. BASED ON THE INCIDENT DESCRIPTION, THE ADDITIONAL LITERATURE DESCRIBING THE CASE, AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK. UPDATED H6: UPDATED INVESTIGATION FINDINGS CODE TO C24, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D15 AND D12, CODE D16 IS NO LONGER APPLICABLE.

Description of Event or Problem · 0

IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM ASSOCIATED WITH A LEFT COMMON ILIAC ANEURYSM UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). AT THE END OF THE PROCEDURE, THE FINAL ANGIOGRAPH DID NOT SHOW ANY SIGNS OF ENDOLEAK AND CONFIRMED SUCCESSFUL ANEURYSM EXCLUSION AND PATENCY OF BOTH INTERNAL ILIAC ARTERIES. A CTA PERFORMED THE SAME DAY AS THE SURGERY REVEALED AN IBE DISPLACEMENT WITH COMPLETE SEPARATION FROM THE MAIN AORTO-ILIAC BIFURCATED GRAFT. THE PHYSICIAN SUMMARIZED LATER IN HIS PUBLICATION REGARDING THIS CASE THAT THE FINAL ANGIOGRAM WAS PERFORMED WITH AN EXTRA STIFF LUNDERQUIST WIRE IN PLACE, AS PER THEIR STANDARD PRACTICE. HE SUSPECT THAT THE TYPE III ENDOLEAK LIKELY OCCURRED WHEN THE EXTRA STIFF WIRE WAS REMOVED, AS VESSEL COMPLIANCE SHIFTED AND CAUSED THE COMPONENTS TO DISCONNECT. THE PATIENT UNDERWENT REINTERVENTION TWO DAYS LATER; A TYPE III ENDOLEAK WAS CONFIRMED AND THE GRAFTS WERE RELINED USING TWO ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC271000 AND PLC 271400). THE FINAL ANGIOGRAPHY WAS PERFORMED WITH 0.035'¿ ANGLED TERUMO ADVANTAGE GLIDEWIRES IN PLACE TO ACCOUNT FOR MAXIMUM ILIAC TORTUOSITY AND CONFIRMED SUCCESSFUL EXCLUSION OF THE LEFT COMMON ILIAC ARTERY ANEURYSM WITH PATENT INTERNAL ILIAC ARTERIES. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED. THE PATIENT WAS DISCHARGED ON DAY ONE. A ONE-MONTH FOLLOW-UP CTA CONFIRMED COMPLETE ANEURYSM EXCLUSION WITH NO ENDOLEAK. THE PHYSICIAN CONCLUDED IN HIS PUBLICATION THAT THE EXTREME ILIAC TORTUOSITY, SHORT LEFT COMMON ILIAC ARTERY LANDING ZONE, AND ANGULATION OF THE IIA ORIGIN WERE ANATOMIC FEATURES THAT LIKELY CONTRIBUTED TO DEVICE FAILURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1489943	GORE® EXCLUDER® AAA ENDOPROSTHESIS	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W. L. GORE & ASSOCIATES, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR	Male	Other