MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number HT084050J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Seroma (2069)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: during a tevar procedure on (b)(6) 2017, a gore® propaten® vascular graft was implanted from the patient's left common carotid artery to left subclavian artery.On (b)(6) 2017, ct scan was performed and seroma was suspected around a removed ring area of the graft.On (b)(6) 2017, seroma had expanded to 8.0 cm and was removed.Tissue sealing sheet was attached to the treated area and the vascular graft remains implanted.The patient tolerated the procedure.

Manufacturer Narrative

Was updated with patient identifier.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7238492
• MDR Text Key: 98918819
• Report Number: 2017233-2018-00070
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

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: 11/17/2020
• Device Catalogue Number: HT084050J
• Device Lot Number: 5408914PP016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• 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): Required Intervention
• Patient Age: 82 YR