MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT281412

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis featuring c3® delivery system.Following initial deployment of the trunk-ipsilateral leg component, there was blood seen in the handle of the delivery system handle.The amount of blood was not significant and there were no adverse outcomes for the patient.The contralateral leg component was positioned and deployed and the case was completed with a successful outcome.The only issue was that the case was completed a little more hurriedly because of the bleeding.

Manufacturer Narrative

No udi information is available.Method code 1 updated results code 1 updated.A review of the manufacturing records could not be conducted since the lot number is unknown.The originally reported lot number was incorrect.H.6.Results code 2: 213: the engineering evaluation stated the following: the tuohy-borst valve appeared to be aligned with the spine and fully tightened.Engineering removed the spine covers and the spine was examined.No abnormalities were noted.The septum appeared to be intact with no obvious damage.Green dyed water was pressurized though the septum into the manifold area to determine the location of the leakage.Water was observed leaking out of the septum at what appears to be the constraining loop pre-formed hole.Based on the findings from this evaluation, the physician¿s observation that blood was seen in the handle of the delivery system handle was confirmed.The likely cause for the blood leaking from the delivery system handle could not be determined.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8204256
• MDR Text Key: 131744006
• Report Number: 3007284313-2018-00372
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: 00733132622528
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Catalogue Number: RLT281412
• Device Lot Number: 18447342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91