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

Model Number MOB37

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information will be provided.The balloon was discarded at the facility and is not available for investigation.

Event Description

The following was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis, a gore® excluder® iliac branch endoprosthesis, gore® dryseal flex introducer sheaths and a gore® molding & occlusion balloon catheter.After all devices were implanted, final angiography suspected a dissection at about 3cm below from the proximal end of the trunk ipsilateral leg component.An aortic extender endoprosthesis was implanted.Then, the angiography still suspected the dissection, but no additional treatment was performed.The procedure was concluded.The physician stated that it was unknown when the dissection occurred.Reportedly, it was unknow if there was something in patient¿s anatomy caused or contributed to the event.The fsa reported also that two 16fr sheaths and a balloon which were used during the procedure might have been related to the dissection.Reportedly, there was no other reportable issue during the procedure.The patient tolerated the procedure.No reintervention was performed.The physician is monitoring the patient.

Manufacturer Narrative

H6.Code 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.The balloon was discarded at the facility and is not available for investigation.The physician stated that it was unknown what caused and when the dissection occurred.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: 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
• MDR Report Key: 12310758
• MDR Text Key: 266164307
• Report Number: 3007284313-2021-01544
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR