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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 08/19/2019
Event Type  Injury  
Manufacturer Narrative
510(k) number: k172567.
 
Event Description
On (b)(6) 2019, the patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis with gore® molding & occlusion balloon for abdominal aortic aneurysm. Reportedly the patient had pre-existing localized dissections in both the external iliac arteries. It was report that after deployment of gore® excluder® aaa trunk-ipsilateral leg endoprosthesis and contralateral leg endoprosthesis, an aortic extender endoprosthesis was deployed proximally. Touch up ballooning was then performed. It was reported that the contrast medium had flowed out of the blood vessel from the proximal neck, the aortic artery had ruptured at this area. To treat the rupture, four aortic extender endoprostheses were deployed on the proximal side. The outflow of contrast medium disappeared. After angiography, the blood flow to the left internal iliac artery was not confirmed. The possibility of occlusion of effects due to thrombosis was reported. Since blood flow to the right internal iliac artery was confirmed, the physician chose to monitor the left internal iliac artery occlusion. During closure of wound, the pulse in distal of right leg was weak. When angiography was performed, a dissection appeared to have occurred on the distal side of the stent graft, and blood flow in the right internal iliac artery could not be confirmed. It is unknown if the implanted device or the dryseal flex sheath was responsible for the additional dissection in the right iliac artery. In addition, angiography to below the knee was performed, the occlusion was confirmed. Two bare metal stents were implanted from the distal side of the stent graft to the right external iliac artery. After pta ballooning and passing wire and micro catheter below the knee, a slight blood flow was confirmed. The doctor stated "the no blood flow to the right internal iliac artery might be due to the dissection. " the patient tolerated the procedure.
 
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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
rachael chascsa
1500 n. 4th street
9285263030
MDR Report Key9074040
MDR Text Key161930273
Report Number3007284313-2019-00284
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 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/19/2021
Device Catalogue NumberMOB37
Device Lot Number20549753
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 Manufactured03/20/2019
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: 09/16/2019 Patient Sequence Number: 1
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