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

Catalog Number 0650HYB0710A

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Patient presented for an arteriovenous access procedure in the left upper arm.A gore® hybrid vascular graft was placed at the intended treatment site and deployment was started.The nitinol reinforced section (nrs) of the graft partially expanded when the deployment line got stuck and would not release.The physician cut and removed the section of the nrs that was still constrained.A new gore® hybrid vascular graft was implanted with no issues.The patient did not experience any adverse consequences.

Manufacturer Narrative

This report is being withdrawn (retracted) because it was incorrectly reported as a malfunction.After further information and discussion, the event was concluded as non-reportable.

• 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: 6209633
• MDR Text Key: 63809620
• Report Number: 2017233-2016-00964
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 0650HYB0710A
• Device Lot Number: 15230748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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