MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB); CATHETER, PERCUTANEOUS

Model Number MOB37

Device Problem Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: k172567.(b)(4).

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.Post deployment of all devices, during touch up angioplasty the contralateral leg component positioned in the right common iliac artery (rcia) was unintentionally moved proximally, leaving a distal type i endoleak.An additional contralateral leg component was implanted to extend coverage and treat the endoleak and resulted in unintentional coverage of the right internal ilac artery (riia).It was reported that the physician misinterpreted the position of the radiopaque marker.Angiography confirmed the distal type i endoleak on the right side was resolved, however a distal type i endoleak in the left leg was now observed.Touch-up ballooning was performed again, and the distal type i endoleak in the left leg was resolved.To alleviate the possibility of postoperative occlusion of the riia, a bare metal stent was implanted distal to the right leg.Post operative ballooning was performed with a pta balloon.The patient tolerated the procedure.

Manufacturer Narrative

G1, g5, h6: additional/corrected information.

Manufacturer Narrative

H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

• Brand Name: AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9665412
• MDR Text Key: 188868849
• Report Number: 3007284313-2020-00029
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Device Lot Number: 21297915
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 77 YR