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

Catalog Number RLT311417

Device Problem Collapse (1099)

Patient Problem Not Applicable (3189)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Lot 16372754: udi (b)(4).(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Refer to field for the results of the imaging evaluation.

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of an infrarenal abdominal aortic aneurysm and iliac aneurysm with gore® excluder® aaa endoprostheses and a gore® excluder® iliac branch endoprosthesis.It was reported, pre-operative imaging identified extremely tortuous bilateral iliac arteries and an ¿s curve shaped¿ abdominal aorta.According to the report, the procedure concluded without any reported adverse events and final angiography showed exclusion of the aneurysms with patency of all devices.On (b)(6) 2017, follow-up imaging identified device lumen narrowing/compression of the ipsilateral limb implanted on the patient¿s left side.No evidence of thrombus within the device was identified and the limb was reported to be patent without evidence of occlusion.The cause of the device compression is reportedly unknown, however it was reported the compression is believed to be caused by the patient¿s tortuous anatomy.As the patient is reported to be asymptomatic and all devices are reported to be patent, an intervention to treat the compression has not been scheduled.According to the report, the physician will continue to monitor the patient.

Manufacturer Narrative

(b)(4).Added patient medications - acetaminophen, aspirin, atorvastatin, cartia xt, eliquis, famotidine, finasteride, furosemide, isosorbide mononitrate, loratadine, oxycodone, potassium chloride.Corrected office contact information.Corrected type of reportable event.Conclusion code remains unchanged.

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of an infrarenal abdominal aortic aneurysm and iliac aneurysm with gore® excluder® aaa endoprostheses and a gore® excluder® iliac branch endoprosthesis.It was reported pre-operative imaging identified extremely tortuous bilateral iliac arteries and an ¿s curve shaped¿ abdominal aorta.According to the report, the procedure concluded without any reported adverse events and final angiography showed exclusion of the aneurysms with patency of all devices.On (b)(6) 2017, follow-up imaging identified device lumen narrowing of the trunk ipsilateral limb implanted on the patient¿s left side.No evidence of thrombus within the device was identified, and the limb was reported to be patent without evidence of occlusion.On (b)(6) 2017, an additional procedure was performed as a preventative measure to treat the device narrowing of the (b)(4) ipsilateral limb.The patient has reportedly remained asymptomatic from the narrowing with no evidence of occlusion or outflow issues.It was reported the narrowing of the ipsilateral limb was noted at the aortic bifurcation.It was also reported the device lacked complete wall apposition at the proximal left common iliac artery with no report of endoleak.During the (b)(6) 2017 procedure, two gore® viabahn® vbx balloon expandable endoprostheses were implanted in order to obtain complete device expansion in both areas.Final imaging reportedly showed good expansion of the devices, and the patient tolerated the procedure.According to the additional information received, the narrowing was noted directly after deployment of the trunk on (b)(6) 2017.Additionally, it was reported the ipsilateral limb was implanted in an extremely tortuous areas of the left common iliac artery, and the tortuosity of the iliac artery caused the narrowing of the ipsilateral limb.

• 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: claire west ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6883891
• MDR Text Key: 87353322
• Report Number: 3007284313-2017-00228
• 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
• Report Date: 12/19/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Catalogue Number: RLT311417
• Device Lot Number: 16372754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 200