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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
Model Number MOB37
Device Problem Human-Device Interface Problem (2949)
Patient Problem Aneurysm (1708)
Event Date 10/08/2020
Event Type  Injury  
Manufacturer Narrative

Patient medical history includes but is not limited to: cto in the right common iliac artery to the right external iliac artery. The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: vascular spasm or vascular trauma (e. G. , ilio-femoral vessel dissection, bleeding, rupture, death) a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

 
Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system. The patient's right common iliac artery (rcia) down to the right external iliac artery (reia) was reported to have a chronic total occlusion. Post implant of a contralateral leg component in the reia, touch up angioplasty was performed using a gore® molding & occlusion balloon catheter. Post angioplasty a rupture of the reia was reported and the patient's blood pressure dropped due to bleeding. An iliac extender component was implanted to treat the rupture and post implant a distal type i endoleak was observed. The cause of the rupture was thought to have been due to the edge of the contralateral leg combined with the angioplasty and the condition of the rcia. No additional angioplasty was performed as it was believed the rupture may have progressed to the femoral head. A gore® viabahn® endoprosthesis was implanted to extend coverage to the femoral head. Intraprocedure imaging showed a slight type iii endoleak originating from overlap site the contralateral leg and the iliac extender component. An additional contralateral leg was implanted proximal to the gore® viabahn® endoprosthesis. The endoleak and bleeding resolved and the patient's vital signs stabilized. Angiography revealed the ipsilateral leg had been pushed up by the contralateral gate due to the ballerina placement and the ipsilateral leg was re-ballooned and an additional stent graft was implanted. The procedure was concluded with good patency of the lumen reported. The patient was tolerated the procedure.

 
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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, AZ 86004
9285263030
MDR Report Key10693715
MDR Text Key211871893
Report Number3007284313-2020-01115
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK172567
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 10/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberMOB37
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 Received10/08/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/08/2020
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: 10/16/2020 Patient Sequence Number: 1
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