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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Vessels (2135)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Attempts were made to obtain the device lot number, and the lot number was unable to be obtained.No device history record review was able to be completed 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 such as perforation or rupture.Furthermore, the ifu cautions users to not inflate the balloon to a diameter larger than the vessel it is being inflated within.To avoid vessel trauma, do not over-inflate the balloon in relation to the diameter of the vessel or other devices.

Event Description

On (b)(6) 2020 the patient underwent endovascular repair of a right iliac artery aneurysm using gore® excluder® aaa endoprostheses.It was noted that there was dissection of the patient's left iliac artery.It was reported that the gore® excluder® aaa trunk-ipsilateral leg and contralateral leg components were advanced and deployed with no reported issues.Reportedly, a gore® molding & occlusion balloon (mob) catheter was used to balloon the contralateral leg component, located on the patient's left side.Upon inflation of the mob catheter, the patient's left iliac artery was ruptured.The physician and clinical specialist reported that iliac artery rupture was due to over ballooning.Reportedly there was no issue with either the gore® excluder® aaa contralateral leg component, or the mob catheter.The patient adverse event occurred solely due to over ballooning.The physician converted to an open procedure.The contralateral leg component was removed.The trunk-ipsilateral leg component remained in the patient.The patient's left iliac artery was clamped and sutured, and a right femoral to left femoral artery bypass was performed.The mob catheter was discarded at the facility.The contralateral leg component was returned for evaluation.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

Additional devices included in this adverse event include: item #plc231000/lot #20900215/ udi (b)(4) which is captured in manufacturer report #3013164176-2020-00075.

• 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: 10121582
• MDR Text Key: 194109505
• Report Number: 3007284313-2020-00143
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K172567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OMEGA 3, PRILOSEC, CLARITIN, MELATONIN, MYRBETRIQ
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 88