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

Catalog Number MOB37

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 02/19/2024

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2024, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses and gore® molding & occlusion balloon catheters as accessories.A distal type i endoleak and type ii endoleak were observed after placing the contralateral leg.While inflating the balloon for molding the distal side, the left common iliac artery was ruptured.Coil embolization was not performed as no blood flow was observed in the left internal iliac artery via contrast imaging.Additional stent grafts were implanted towards the left external iliac artery as a treatment.Blood flow was found to be refluxing from the left internal iliac artery via second contrast imaging.The physician chose to covert to surgical repair.A dissection was found near the ruptured area of the left common iliac artery when the abdomen was opened.The ruptured area was sutured and the left internal iliac artery was ligated.Blood pressure was stabilized and hemostasis was completed.No additional treatment was given for a type ii endoleak.The patient tolerated the procedure.Physician¿s comment: ¿pressure on the balloon was too strong.I over inflated the balloon as i focused on treating the endoleak.The lack of blood flow in the left internal iliac artery during contrast imaging may have been due to the dissection.¿.

Manufacturer Narrative

H.6.Investigation findings code c20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d1101: according to the gore® molding & occlusion balloon catheter instructions for use, excessive inflation volume may result in vessel 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 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.

Manufacturer Narrative

H.6.Investigation findings code c20: the device was discarded at the treating facility and was therefore not available for analysis.H.6.Investigation findings code c19: the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met creagh medical specifications and procedures.The statements for h.6.Investigation findings code c19 and c20 have been corrected.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18918501
• MDR Text Key: 337844208
• Report Number: 3007284313-2024-03109
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2023
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Female