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

Catalog Number RLT281216

Device Problem Material Rupture (1546)

Patient Problems Calcium Deposits/Calcification (1758); Failure of Implant (1924)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: additional device associated with event include: qxmédical q50® plus stent graft balloon catheter (item and lot number unknown) patient medications include but are not limited to: lipitor, aspirin, advil.(b)(4).

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.During angioplasty of the distal end of the trunk ipsilateral leg component in the right common iliac artery (rcia) with a qxmédical q50® plus stent graft balloon catheter (item and lot number unknown) the rcia was ruptured.The ipsilateral leg component was extended with an additional device which covered the right internal iliac artery (riia).It was reported that the rcia was highly calcified and the q-50 balloon had been overinflated.The patient tolerated the procedure.

• 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 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6552459
• MDR Text Key: 74679704
• Report Number: 3007284313-2017-00115
• 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
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2019
• Device Catalogue Number: RLT281216
• Device Lot Number: 15833515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2016
• 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: 65 YR
• Patient Weight: 69