MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TRI-LOBE BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number	BCM1634
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Ischemia (1942); Muscle Weakness/Atrophy (1967)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #: mob37/ serial #: (b)(4)/ udi #: (b)(4) which is captured in manufacturer report #3007284313-2022-01981.Catalog # : mob37/ serial #: (b)(4)/ udi #: (b)(4) which is captured in manufacturer report #3007284313-2022-01982.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 or Problem Description
On (b)(6) 2020 the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe), gore® molding & occlusion balloon catheters, and a gore® tri-lobe balloon catheter in the aaa1701 tambe pivotal study.On (b)(6) 2020 spinal cord ischemia was reported.It was reportedly noted in the op notes that the spinal cord ischemia was suspected to be related to balloon molding versus device manipulation.Bilateral lower extremity weakness was also reported.It was reported that the patient was admitted to an in-patient rehabilitation center about an hour away.The event is ongoing.
Event or Problem Description
As of june 23, 2022, the event remains ongoing.The patient is now wheelchair bound.
Additional Manufacturer Narrative
H.6.Type of investigation code b14 remains unchanged.H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® tri-lobe balloon catheter instructions for use, adverse events which may require intervention include, but are not limited to, local neurologic damage.H.6.Investigation findings code 3233 updated to code c19.H.6.Investigation conclusions code 11 updated to code d15.

• Brand Name: GORE® TRI-LOBE BALLOON CATHETER
• Common Device Name: 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14794787
• Report Number: 3007284313-2022-01983
• Device Sequence Number: 20278435
• Product Code: DQY
• UDI-Device Identifier: 00733132605231
• UDI-Public: 00733132605231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: BCM1634
• Device Catalogue Number: BCM1634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN 81MG
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White