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

Catalog Number MOB37

Device Problem Malposition of Device (2616)

Patient Problem Aneurysm (1708)

Event Date 06/22/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.Post deployment of the devices, imaging determined a small proximal type i endoleak.A gore® molding & occlusion balloon (mob) was used to perform additional angioplasty of the proximal trunk.During angioplasty it was reported that the mob was placed with a small portion of the balloon outside the proximal trunk and within the aorta, causing a rupture of the aorta at the level of the renal arteries due to overinflation of the mob.The patient underwent multiple transfusions while receiving treatment of the rupture.Four gore® aortic extenders components and two palmz 40x10 stents were implanted to treat the rupture.The renal arteries were intentionally covered and the aorta was grafted up to the level of the superior mesenteric artery (sma).The patient tolerated the procedure and was transferred to the intensive care unit in critical condition.The patient expired due to cardiac failure at 11:00pm this same day.

• 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: laura crawford ; 1505 n. fourth street; flagstaff 86005 ; 9285263030
• MDR Report Key: 12174000
• MDR Text Key: 261728381
• Report Number: 3007284313-2021-01502
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2021

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 Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 91 YR
• Patient Weight: 68