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 Aneurysm (1708)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

As the device was discarded the other code was selected to indicate that no product evaluation could be performed.(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using gore¿ molding & occlusion balloon (mob), gore¿ excluder¿ aaa endoprosthesis and gore¿ excluder¿ iliac branch endoprosthesis for abdominal aortic aneurysm and left iliac aneurysm.During advancement of the iliac branch component (ibc), it was reported that wire wrap occurred.The delivery catheter was rotated to resolve it.Then, angiography revealed occlusion of the left internal iliac artery.It was considered that the occlusion was due to thrombus embolization.It was decided that the internal iliac component was not to be implanted.The left internal iliac artery was covered by ibc.The aortic extender endoprosthesis was deployed to extend the device proximally, and the whole device was touched up using mob.It was reported that the position of the balloon was slightly out of the device and was at the tortuous part of the proximal neck.It was suggested that the strength of inflation was a little stronger.Then, localized dissection was observed near the lower renal artery.A distal type i endoleak was also observed in the right limb.The dissection and endoleak will be monitored.After all stent graft deployments, the pulse of left dorsalis pedis artery was not confirmed.Angiography revealed narrowed areas in the anterior tibial artery and posterior tibial artery due to thrombus embolization.It was reported that physician believed that the thrombus embolization to the tibialis anterior and tibialis posterior arteries was also likely to had occurred during the first wire manipulation or ibc rotation.Balloon dilation and thrombus removal were performed.The patient tolerated the procedure.The physician stated as follows; it was concerned that this case had many thrombus overall and the condition was bad.The thrombus embolization was likely to had occurred during the first wire manipulation or ceb231210a rotation in the body.Localized dissection in the proximal side was caused by calcification plus balloon position and strength.

Manufacturer Narrative

H6: code 213 ¿ the device either functioned as intended or a problem was not found.H6: code 4315 ¿ the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

• 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: 11847056
• MDR Text Key: 255930646
• Report Number: 3007284313-2021-01432
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR