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

Catalog Number 0650HYB0905A

Device Problems Folded (2630); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The engineering evaluation stated that the device was returned to w.L.Gore & associates for investigation.Submitted in this event was a 6-9mm x 5cm gore® hybrid vascular graft.The abluminal and luminal surfaces of the graft were largely devoid of tissue.No histopathological examination was performed.The graft was examined with the aid of a stereomicroscope.There was heavy to moderate staining along the abluminal surface of the returned graft.The nitinol reinforced section was fully deployed.The vascular graft section had a rough cut end.Delamination was identified on several struts, indicating stress.The examination found no anomalies attributable to the manufacture of the device.

Event Description

On (b)(6) 2016 a gore® hybrid vascular graft was being used for an arteriovenous access revision.An open technique was used to implant the stent portion of the gore® hybrid vascular graft.It was reported to gore that the device partially deployed.When the deployment line was pulled, it was stated that the stent folded on itself and the tip came back through the initial puncture in the axillary vein.The venotomy was extended in order to take the stent out.The device was removed and has been returned to gore for evaluation.Another gore® hybrid vascular graft was used to complete the procedure.The patient is doing fine.

Manufacturer Narrative

Corrected data: it is unclear when or how the bowstringing with full deployment occurred.The hospital is unwilling to provide any further information.

Event Description

On (b)(6) 2016 a gore® hybrid vascular graft was being used for an arteriovenous access revision.An open technique was used to implant the stent portion of the gore® hybrid vascular graft.When the deployment line was pulled, it was stated that the stent fully deployed and folded on itself and the tip came back through the initial puncture in the axillary vein.The venotomy was extended in order to take the stent out.The device was removed and has been returned to gore for evaluation.Another gore® hybrid vascular graft was used to complete the procedure.The patient is doing fine.

• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6249243
• MDR Text Key: 64761134
• Report Number: 2017233-2017-00022
• 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,Followup
• Report Date: 01/13/2017

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: 09/24/2018
• Device Catalogue Number: 0650HYB0905A
• Device Lot Number: 14310068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 83