MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AXILLOBIFEMORAL GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number SRGR-08AXF

Device Problems Accessory Incompatible (1004); Partial Blockage (1065)

Patient Problem Seroma (2069)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: user facility was unable to determine which axillobifemoral gore-tex® stretch vascular graft is implicated in this event.Therefore, second lot number is being supplied - lot number 16540111; (b)(4).A review of the manufacturing records verified that both graft lots involved in this event met all pre-release specifications.The grafts remain implanted.Therefore, direct product analysis was not possible.Instructions for use, section vi possible complications with the use of any vascular prosthesis states, complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.Section viii operative techniques states, when applying clamps, care should be taken to avoid mechanical damage to or disruption of the graft.Use the appropriate atraumatic or guarded (for example, rubber shod) clamps.Avoid repeated, localized clamping or excessive clamping on any section of the graft.

Event Description

The following was reported to gore: in (b)(6) 2018, a right and left axillary artery - left common carotid artery bypass surgery was performed using an axillobifemoral gore-tex® stretch vascular graft for thoracic endovascular aortic repair (tevar).During a follow-up in 2018 (exact date not specified), seroma was suspected around the anastomosis of the right axillary artery.It was reported the graft is still in use and that the seroma might be due to the clamp placement during the implant procedure.On (b)(6) 2018, a tissue sealing sheet was placed, then a filling technique with latissimus dorsi muscle was performed.A negative pressure wound therapy was applied periodically after the procedure.The patient tolerated the procedure.No further information was made available.

• Brand Name: AXILLOBIFEMORAL GORE-TEX® STRETCH 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; 9285263030
• MDR Report Key: 7753999
• MDR Text Key: 116144277
• Report Number: 2017233-2018-00487
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K901641
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/04/2022
• Device Catalogue Number: SRGR-08AXF
• Device Lot Number: 17191319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• 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