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

Catalog Number MOB37

Device Problem Device Handling Problem (3265)

Patient Problem Rupture (2208)

Event Date 09/19/2023

Event Type  Death  

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.According to the gore® molding & occlusion balloon instructions for use (ifu) state ¿do not inflate the balloon in areas of significant calcified plaque.Balloon rupture and / or vessel damage may occur.¿ additionally, per ifu, 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 and death.¿ 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 required 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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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.

Event Description

The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular zone 9 infrarenal procedure to treat an aortic aneurysm utilizing a gore® excluder® iliac branch endoprosthesis.Reportedly, the gore device was put in for an occlusive disease and patient had a very calcified diseased aorta.After the initial procedure on the icu floor, the patient experienced a drop in blood pressure.There was a cta done that showed possible extravasation.The patient was brought back to the or for an angiogram that did not show anything and the patient stabilized.The patient again experienced pressure drops and the patient was surgically opened.Upon surgery, it was found that the device was visible through the aorta.The patient ended up expiring on the surgical table.The physician believes there was an aorta rupture when ballooning the device and are still unsure why blood was still leaking into the pericardial space.The physician doesn't believe the device was cause for the death and the device is visible through the 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
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17931362
• MDR Text Key: 325618236
• Report Number: 3007284313-2023-02820
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MOB37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Death
• Patient Age: 84 YR
• Patient Sex: Male