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

Catalog Number S46045

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: lot number: udi - (b)(4).Review of the manufacturing records verified that the lot met release requirements.Evaluation of the returned device is in process.

Event Description

The following was reported to gore: the gore-tex® stretch vascular graft, that was placed (b)(6) 2016, was removed (b)(6) 2016 because of serous fluid around the graft.Approximately 2cm of either side of the graft remains.

Manufacturer Narrative

Additional manufacturer narrative: all observed host tissue interaction with the device was expected and within normal limits.The cause of the clinically observed serous weeping through the graft wall was not identified in the microscopically examined sections.Multiple areas of directional radial film disruption were identified along with several surgical clamp impressions.Disruptions identified were not associated with handling or manufacturing process at wl gore and associates.The disruptions are consistent with a surgical procedure.The cause of seroma formation was likely due to multiple areas of radial film disruption.It appears that the radial film disruptions were caused by dragging the device over a sharp edged surgical instrument.Radial film disruption and clamping of the device with surgical instruments have been known to cause fluid weeping thorough the device wall.

• Brand Name: 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6246007
• MDR Text Key: 64657545
• Report Number: 2017233-2017-00019
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903931
• 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

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2019
• Device Catalogue Number: S46045
• Device Lot Number: 13386413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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: 69 YR