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

Model Number MOB37

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Vascular Dissection (3160)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #k172567.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring® delivery system.The trunk ipsilateral leg component was advanced into position via a gore® dryseal flex introducer sheath; however when deployed, the introducer sheath had not been completely withdrawn back to the light colored shaft marker on the delivery catheter and the ipsilateral leg deployed within the sheath.The physician then chose to cannulate the contralateral gate with the sheath still in place but met with difficulty due to the narrowness of the date due to patient anatomy.After multiple attempts, successful cannulation of the gate was achieved and the delivery catheter was removed from the patient.The physician then cut the trailing end of the (locking mechanism) of the dilator of the sheath and inserted it from the trailing and pushed the ipsilateral leg out of the sheath and successfully deployed in the left common iliac artery.Post deployment of all the devices touch up angioplasty was performed throughout the entire system with a gore® molding & occlusion balloon.Final angiography was performed and identified a type ii endoleak and a dissection immediately proximal to the trunk.A gore® aortic extender component was implanted proximally to extend coverage and treat the dissection.At the conclusion of the procedure a slight dissection remained.The physician reported that the dissection may have been caused by calcification in the patient's proximal neck, touch up angioplasty and the complications associated with the ipsilateral leg deployment.The patient tolerated the procedure and will be monitored by the physician.

• Brand Name: AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9886843
• MDR Text Key: 185614817
• Report Number: 3007284313-2020-00079
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132639489
• UDI-Public: 00733132639489
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: MOB37
• Device Catalogue Number: MOB37
• Device Lot Number: 21409738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• 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): Hospitalization; Other
• Patient Age: 91 YR