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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number MOB37
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 07/24/2019
Event Type  Injury  
Manufacturer Narrative
Pma (510k) #: k172567. According to the instructions for use (ifu) for the gore® molding and occlusion balloon catheter (mob); adverse events that may occur include, but are not limited to include: embolization. A review of the manufacturing records for the device(s) is being conducted.
 
Event Description
On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system. Angioplasty was performed using a gore® molding and occlusion balloon catheter (mob). It was reported that preoperatively the patient¿s left renal artery had stenosis present. However, no problem with blood flow was observed. It was also reported that many mural thrombus was noted within the patient¿s aorta. Post deployment of all endoprostheses; a type ii endoleak originating from the inferior mesenteric artery, and diminished blood flow to the left renal artery was reported due to a plaque shifting during the procedure the physician chose to monitor the type ii endoleak and implant a express sd renal monorail premounted stent system in the left renal artery to secure blood flow to the left renal. Post implant, improved blood flow to the left renal artery was reported. The patient tolerated the procedure. The physician does not know if placement of the device; or angioplasty that was performed, caused or contributed to the shift of plaque.
 
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Brand NameAORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
laura crawford
1500 n. 4th street
9285263030
MDR Report Key8869452
MDR Text Key153544195
Report Number3007284313-2019-00243
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/20/2021
Device Catalogue NumberMOB37
Device Lot Number20549525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2019 Patient Sequence Number: 1
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