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

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.

• 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, AZ 86004 ; 9285263030
• MDR Report Key: 10693715
• MDR Text Key: 211871893
• Report Number: 3007284313-2020-01115
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

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: No Information
• Device Expiration Date: 04/08/2022
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/16/2020
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other