MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number MOB37

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Paraplegia (2448)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #dsf1633/ serial #(b)(4)/ udi #(b)(4).Catalog #dsf1833/ serial #(b)(4)/ udi #(b)(4).Catalog #dsf1245/ serial #(b)(4)/ udi #(b)(4).Which are captured in manufacturer report #3007284313-2020-01073 catalog #rlt281218j/ serial #(b)(4)/ udi #(b)(4).Catalog #plc271000j/ serial #(b)(4)/ udi #(b)(4).Catalog #pla280300j/ serial #(b)(4)/ udi #(b)(4).Which are captured in manufacturer report #3007284313-2020-01072.Catalog #ceb231210a/ serial #(b)(4)/ udi #(b)(4).Catalog #hgb161207a/ serial #(b)(4)/ udi #(b)(4).Which are captured in manufacturer report #3013164176-2020-01042.Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.According to the gore® molding & occlusion balloon catheter instructions for use (ifu), adverse events which may require intervention include, but are not limited to, local neurologic damage.

Event Description

On (b)(6) 2020 the patient underwent endovascular treatment of an abdominal aortic aneurysm, a common iliac artery aneurysm, and an internal iliac artery aneurysm using gore® excluder® aaa endoprostheses, gore® excluder® iliac branch endoprostheses, and gore® dryseal flex sheaths as accessories in the procedure.It was reported that the patient's aorta had severe degeneration and was extremely friable (shaggy).It was also noted that the patient's left internal iliac artery had been embolized as a preventative measure about 1 month prior to this procedure.The procedure was completed with no reported issue.It was reported that on the same day the patient developed post-procedure paraplegia.The physician noted that the patient's left internal iliac artery had been embolized to prevent paraplegia, but paraplegia occurred anyway.The physician reported that it was possible that thrombus or something similar may have been scattered due to the patient's shaggy aorta.Spinal drainage was performed.It was reported that the patient is undergoing hyperbaric oxygen therapy and taking naloxone and steroids.Reportedly the patient is also undergoing walking rehabilitation.On (b)(6) 2020 it was reported that the patient's right leg was gradually becoming able to move.

• Brand Name: GORE MOLDING & OCCLUSION BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10564100
• MDR Text Key: 207893918
• Report Number: 3007284313-2020-01074
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172567
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• Date Device Manufactured: 02/17/2020
• 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): Other; Required Intervention
• Patient Age: 73 YR