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

Model Number MOB37

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Aneurysm (1708)

Event Date 01/21/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical devices: as gore was unable to determine which device was involved in the event if any; additional device(s) associated include: mob37/20317994, udi: (b)(4), mob37/20317983, udi: (b)(4).Patient medications include but are not limited to: norvasc, cozaar, ativan, lipitor, prilosec, k-dur, klor-con, vitamin d, tylenol.Pma/510(k) #: k172567.(b)(4).

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an enlarging 5.5cm abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.It was reported that post deployment of the devices when performing completion angiography using a gore® molding & occlusion balloon (mob) the aorta was ruptured at the origin of the left renal artery caused by suspected over inflation of the balloon.The patient was converted to open repair.

Manufacturer Narrative

B5,b6: additional/corrected information.G9: please note that this event was reported in medwatch #3013164176-2020-00007.Details of the event required a separate medwatch submission for the gore® molding & occlusion balloon catheter; as such this medwatch is being submitted.H6: code 213- 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 enlarging 5.5cm abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.It was reported that post deployment of the devices a proximal type i endoleak was seen and a gore® aortic extender component was placed proximally.During angioplasty of the aortic extender component using a gore® molding & occlusion balloon (mob), increased extravasation was seen and angiography determined a rupture at the origin of the left renal artery due to suspected over inflation of the balloon.Reportedly due to the patient's short angulated neck coupled with calcification in the aortic neck; good seal was unable to be achieved.The physician converted to open repair wherein grafts were sewn in to reline the devices.Massive transfusion protocol was initiated for the patient who was transfused with 11 litres.The procedure was concluded with an "open" close for the patient, with a plan was to reintervene the next day and perform an ax femoral bypass.On (b)(6) 2020, the patient expired.The cause of death was not available.

• 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: 9616018
• MDR Text Key: 188987600
• Report Number: 3007284313-2020-00014
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Device Lot Number: 21167099
• 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: SEE H10/11.
• Patient Outcome(s): Death; Hospitalization; Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 69