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

Catalog Number RLT261418

Device Problems Material Invagination (1336); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: patient medications include but are not limited to: albuterol, lipitor.(b)(4).Additionally, the ifu specifies, the physician and patient should review the risks and benefits when discussing the endovascular device and procedure including: risks and differences between endovascular repair and open surgical repair.Potential advantages of traditional open surgical repair.Potential advantages of endovascular repair.The possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.

Event Description

On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprosthesis featuring c3® delivery system.It was reported that post implant of the trunk ipsilateral leg component the physician was able to cannulate the contralateral gate with the guidewire; but was unable to advance the guidewire past the flow splitter due to the device being collapsed (invaginated) at this level.It was reported that the 80 degree angle of the patient's aorta at the level of the flow splitter was the cause of the invagination.The physician chose to explant the trunk ipsilateral leg component and convert the patient to open abdominal aortic aneurysm repair.The patient tolerated the procedure.The explanted device was discarded at the site.

Manufacturer Narrative

A review of the manufacturing records for the device(s) is being conducted.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release specifications.

• 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 PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6487084
• MDR Text Key: 72613625
• Report Number: 3007284313-2017-00085
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 04/12/2017

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: 02/08/2020
• Device Catalogue Number: RLT261418
• Device Lot Number: 15972326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/12/2017; 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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: 84 YR
• Patient Weight: 52