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

Model Number MOB37

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Perforation of Vessels (2135)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

A manufacturing evaluation is in process.Further information will be provided.Also, a gore® excluder® aaa endoprosthesis (plc231000j/ 20685473) was involved.Please note that the medwatch# 3013164176-2020-00012 was emailed to fda on february 4, 2020.510(k) number: k172567.

Event Description

On (b)(6) 2020, the patient underwent an endovascular repair for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.When the touch up ballooning was performed by a gore® molding & occlusion balloon (mob) to a stent graft implanted in the left common iliac artery, the blood pressure became decreased.It was confirmed that the left common iliac artery was ruptured.The blood pressure became stable after occluding the proximal part of the stent graft using the balloon.Then the left internal iliac artery was coil embolized and an additional stent graft was extended into the left external iliac artery.The patient tolerant the procedure.Reportedly, the balloon was not over inflated.No resistance was felt during advancement or retraction of the balloon catheter.The vessel¿s size at the ballooning area was 19mm.There was nothing in patient¿s anatomy caused or contributed to the event.The physician commented: another manufacturer¿s balloon expands proximally and distally during ballooning.However, mob doesn¿t.Therefore, pressure of mob transmitted to vessel directly which resulted the left common iliac artery rupture.

Manufacturer Narrative

H.6.Code 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the gore® molding & occlusion balloon catheter instructions for use (ifu), adverse events which may require intervention include, but are not limited to trauma to the vessel wall, including spasm, dissection, perforation or rupture.

• Brand Name: AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9667170
• MDR Text Key: 188872523
• Report Number: 3007284313-2020-00031
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Device Lot Number: 21298133
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR