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

Model Number MOB37

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 07/27/2020

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2020, this patient underwent endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.The endoprosthesis was deployed, and touch-up ballooning was performed by a gore® molding and occlusion balloon catheter.A proximal type i endoleak was observed during the procedure, and it was resolved after an additional touch-up ballooning was done.Also a type ii endoleak originating from the hypogastric artery was observed, and the procedure was completed.After returning to the hospital ward, the patient complained of lower back pain or back pain.As the patient had complained of lower back pain prior to the procedure, the physician decided to monitor it.On (b)(6) 2020, computed tomography showed a false lumen of an aortic dissection (type iiib) from the distal aortic arch to the proximal portion of the endoprosthesis (around 1.5 cm distal to the proximal end of the endoprosthesis).There was no complications from the dissection.It seemed that the false lumen was almost occluded.The physician monitored the dissection.The patient will discharge from the hospital within some days.The physician reported as follows: it was possible that some excessive force was used during the touch-up ballooning.I thought the dissection developed either during the procedure or after the procedure.Another physician reported as follows: i believed that the dissection developed either during the procedure or after the procedure.It seemed that the endoprosthesis itself did not cause the dissection since the entry tear was small, the false lumen was almost occluded and there was no specific enlarged portion of the false lumen.Manipulation of a guidewire or pre-existing arterial condition (poor condition of artery was observed around the distal arch) might have involved in the dissection.

Manufacturer Narrative

Results code 1: 213: a review of the manufacturing records for the device verified the lot met pre-release specifications conclusion code 1: 22: according to the gore® molding and occlusion balloon catheter instructions for use, excessive inflation volume may result in balloon rupture, embolization, vessel damage, vessel rupture, or patient death.

• 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: 10446262
• MDR Text Key: 204175613
• Report Number: 3007284313-2020-01043
• 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: 09/09/2020

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: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 82 YR