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

Catalog Number	MOB37
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Tamponade (2226); Vascular Dissection (3160)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The following literature was reviewed."retrograde type a dissection and rupture of the aortic root during endovascular aortic repair" ishida s, ihara t, mori a, yagami k.J surg case rep.2025 oct 17;2025(10):rjaf823.Doi: 10.1093/jscr/rjaf823.An 80-year-old woman presented with a progressively enlarging intrarenal aaa, measuring up to 50 mm.The patient¿s performance status was relatively low; therefore, evar was selected to treat the aaa instead of open surgery.Evar was performed under local anesthesia, and the procedure was conducted as usual.Ballooning was performed after implanting gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa contralateral leg endoprosthesis.Subsequently, aortography was performed, which showed a proximal type i endoleak.Therefore, ballooning was added at the top of the trunk-ipsilateral leg endoprosthesis (main body stent graft); however, the endoleak persisted.Thus, an additional aortic extender endoprosthesis was implanted at the upper end of the main body stent graft.Aortography was performed after ballooning; however, the flow was stagnating in the stent graft.At the same time, the pulse rate of the patient decreased suddenly, and she lost consciousness.She had pulseless electrical activity.Cardiopulmonary resuscitation was initiated, and an aortography was performed again.The presence of an aortic dissection was unclear; however, massive pericardial effusion was confirmed.Cardiac tamponade by rtad was suspected, and median sternotomy was performed emergently.After pericardiotomy, the pericardial cavity was filled with blood and hematoma, and spontaneous pulse returned after their removal.However, the adventitia of the aortic root was ruptured, and bleeding persisted.Therefore, ascending aortic replacement or aortic root replacement was performed.Cardiopulmonary bypass was established via left femoral artery perfusion and bicaval drainage.After the nasopharyngeal temperature reached 22°c, circulatory arrest was initiated.The ascending aorta was incised, and the lumen was checked.No tear was found at the intima of the ascending aorta and aortic root.Therefore, ascending aortic replacement was performed (triplex advanced 26 mm, vascutek terumo, tokyo, japan) with retrograde cerebral perfusion.The operation was completed without incident.The patient was extubated on the first postoperative day, and the postoperative course was uneventful.The postoperative enhanced computed tomography (ct) revealed that the entry of the dissection existed at the top of the stent at the abdominal aorta, and the dissection was connected to the distal side of the ascending aortic artificial graft.The patient was discharged 30 days postoperatively.At the 1-year follow-up, the aorta treated for dissection remained stable.In this case, the dissection occurred intraoperatively during evar for aaa, reaching the aortic root and rupturing the adventitia.The cause of the severe condition may be due to two points.First, it occurred at the end of the surgery.The aortic dissection occurred from the top of the abdominal aortic stent, and the pressure in the dissected lumen could not escape to the distal side because of the completed abdominal stent graft.Thus, the proximal side of the aorta may have suffered from severe pressure, causing a rupture of the adventitia.Second, the patient was heparinized and not injected with protamine because the evar was still ongoing.This may have contributed to the dissection.Other factors may also have contributed to this occurrence, such as the elderly case and low performance status.
Additional Manufacturer Narrative
Emdr section h6, codes c19 and d15 updated to reflect results of product history review.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• Brand Name: GORE® MOLDING & OCCLUSION BALLOON CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: hiroko sakamiya ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23663332
• Report Number: 3007284313-2025-04403
• Device Sequence Number: 8910170
• Product Code: MJN
• UDI-Device Identifier: 00733132639489
• UDI-Public: (01)00733132639489(17)270418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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 Catalogue Number: MOB37
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female