MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT231412J

Device Problems Off-Label Use (1494); Physical Resistance (2578); Patient-Device Incompatibility (2682)

Patient Problem Aneurysm (1708)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, this patient underwent emergent treatment with gore excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses for a suspected abdominal aortic aneurysm believed to be pending rupture; and bilateral common iliac artery aneurysms.The patient tolerated the procedure with no evidence of endoleak or rupture of the aneurysm.On (b)(6) 2017, follow-up computed tomography(ct) showed a proximal type i endoleak, and a type iii endoleak involving the (plc271400j/15555544) which bridged to the iliac branch component(ibc) (ceb231410a/16492051) on the right side but had become disconnected due to reported distal migration of the ibc.On (b)(6) 2018, the patient underwent re-intervention to treat the proximal type i and type iii endoleaks.Using a 16 fr gore dryseal sheath with hydrophilic coating the device was advanced up the left femoral artery and an additional contralateral leg component was successfully implanted and resolved the type iii endoleak by bridging the gap.It was reported that the physician experienced strong resistance when advancing the sheath through the ostium of the left external iliac artery due to tortuousity.When preparing to advance a gore® aortic extender component to treat the proximal type i endoleak it was noticed that the sheath was level with the left femoral artery, when the sheath was pushed up again the cut down section of the left femoral artery was damaged (torn).The sheath and gore® aortic extender component were removed from the patient.A coda balloon catheter was used to stop the bleeding and the tear was sutured and closed.The patient tolerated the procedure.The proximal type i endoleak was not treated.Patient anatomy is reported to have contributed to the patient¿s proximal type i endoleak as the patient¿s proximal neck angle was reported to exceed 60 degrees.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7213460
• MDR Text Key: 98019828
• Report Number: 2953161-2018-00009
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Catalogue Number: RLT231412J
• Device Lot Number: 15506750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 74 YR