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

Catalog Number 0650HYB0710A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Death (1802)

Event Date 06/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, a patient presented for an arteriovenous access procedure in the right upper arm.Access was gained through an axillary vein cutdown.A venogram was performed.A peel-away sheath was placed and the gore hybrid vascular graft was advanced over a guidewire.The peel-away sheath was removed and deployment was initiated when the deployment line became stuck after about 2cm was deployed.It was reported some exertion was used during attempts to release the deployment line and continue deployment.The nitinol reinforced section (nrs) of the gore hybrid vascular graft folded on itself due to the deployment line tension and possible loss of wire.As reported, some of the nrs struts had become distorted and bent.The patient's vein was compromised in the process of removing the damaged nrs.The nrs portion of the graft was cut off and a gore viabahn endoprosthesis was placed through the vascular graft as a conduit into the vein.Hemostasis was achieved and the patient was stable at the conclusion of the procedure.On (b)(6) 2016, the patient expired of unknown causes.As reported, the gore devices were patent at the time of patient's death.

• Brand Name: GORE® HYBRID 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: 5765201
• MDR Text Key: 48651309
• Report Number: 2017233-2016-00608
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093934
• 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: 06/05/2016

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: 07/23/2018
• Device Catalogue Number: 0650HYB0710A
• Device Lot Number: 14112777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• 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
• Treatment: PEEL-AWAY SHEATH, GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68