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

Catalog Number MOB37

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Perforation of Vessels (2135)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

510k #: k172567.Per the gore® molding & occlusion balloon catheter instructions for use, adverse events that may occur and/or require intervention include but are not limited to trauma to the vessel wall, including spasm, dissection, perforation or rupture.

Event Description

On (b)(6) 2019, the patient underwent an endovascular repair of an abdominal aortic aneurysm.After all stent grafts were advanced and deployed, touch-up ballooning was performed using a gore® molding & occlusion balloon (mob37/ lot unknown).After ballooning, procedural angiography reportedly revealed a right common iliac artery rupture.A decrease in the patient¿s blood pressure was also reportedly noted.The physician reportedly attributed the rupture of the right common iliac artery to the touch-up ballooning.It was also reported that there was a dissection in the patient¿s right common iliac artery prior to the procedure.The right internal iliac artery was embolized with coils, and additional contralateral leg component was placed in the right external iliac artery to treat the rupture.According to the report, no blood transfusion was required.Final angiography revealed a type ii endoleak.The physician elected to take a wait-and-watch approach in regard to the endoleak, and the procedure was concluded without any further reported complications.The patient tolerated the procedure.

Manufacturer Narrative

D4: updated device information (lot, expiration date, udi).H4: updated device manufacture date.H6: updated method and result codes.H6: conclusion codes remain unchanged.Per the gore® molding & occlusion balloon catheter instructions for use, adverse events that may occur and/or require intervention include but are not limited to trauma to the vessel wall, including spasm, dissection, perforation or rupture.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 8884084
• MDR Text Key: 154269895
• Report Number: 3007284313-2019-00248
• Device Sequence Number: 1
• Product Code: DQY
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: MOB37
• Device Lot Number: 20553200
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR