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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameGORE MOLDING & OCCLUSION BALLOON CATHETER
Type of DeviceCATHETER, 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 Key12174000
MDR Text Key261728381
Report Number3007284313-2021-01502
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172567
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMOB37
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/15/2021 Patient Sequence Number: 1
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