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

Catalog Number H060040A

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

Patient Problems Swelling (2091); Stenosis (2263)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

On (b)(6) 2017, a gore® propaten® vascular graft (6mm x 40cm, straight, standard wall, non-stretch, non-tapered) was implanted in the patient's right upper arm as a conduit.On (b)(6) 2017, the patient presented with significant right arm swelling.A physical exam revealed a thrill and 2+ right upper extremity edema.An ultrasound was performed and a 6fr sheath was used during the angiography.Two areas of stenosis were identified.The first was a 60% stenosis of the axillary vein proximal to the venous anastomosis.The second was at the distal brachiocephalic vein, which was 90% stenosed.The patient was diagnosed with central venous stenosis of the graft (intensity: moderate).Both areas of stenosis was crossed with a bentson wire from the inferior vena cava.An angled glide catheter was inserted into the inferior vena cava which was then exchanged for an amplatz wire.Angioplasty was then performed of the brachiocephalic vein stenosis using an 8 mm and a 10 mm balloons.It was reported that this area of stenosis likely was from having his catheter in position, secondary to the 60% stenosis, which was causing backfill of the arm.In order to direct all the flow back centrally to prevent further arm swelling, a 6 mm x 10 mm covered stent (unknown manufacturer) was placed over this area.The blood flow was good and inflow was rapid.The patient was reported to be feeling well after the procedure.Patient was discharged the same day with the central venous graft stenosis resolved.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6516515
• MDR Text Key: 73556974
• Report Number: 2017233-2017-00216
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2020
• Device Catalogue Number: H060040A
• Device Lot Number: 5164879PP044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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: 65 YR
• Patient Weight: 75