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

Catalog Number ISRTW-064040L

Device Problem Fluid/Blood Leak (1250)

Patient Problem Edema (1820)

Event Date 04/03/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a composite graft consisting of a gore-tex® intering stretch vascular graft and a non-gore vascular graft (sealptfe) was implanted in a cross loop-shape for vascular access in the patient¿s forearm.On an unknown date in (b)(6) 2014, a serum leakage was observed at the area where the two grafts were crossed.The edema measured about 2x2cm in size.On an unknown date in (b)(6) 2014, serum leakage was observed on the side of the intering.The edema measured about 2x2cm in size.On (b)(6) 2014, the enlargement in the size of edema was observed.The partial replacement of the intering and the sealptfe were performed using non-gore vascular grafts.On (b)(6) 2014, the patient was doing well.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.An explant evaluation is currently in process.

Manufacturer Narrative

Results: segments of the gore-tex® intering stretch vascular graft were returned to gore for evaluation.An explant evaluation was performed on the returned devices.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices were examined with the aid of a stereomicroscope.The findings identified were not associated with handling or manufacturing process at w.L.Gore & associates.The findings identified during the explant examinations are consistent with instruments used during a surgical procedure and the subsequent cannulation of the graft.

Event Description

On (b)(6) 2014, a composite graft consisting of a gore-tex interring vascular graft (stretch) and a non-gore vascular graft (terumo sealptfe wrap graft) was implanted.On (b)(6) 2014, seroma was observed at the area where the two grafts were crossed; serum leakage was suspected.The seroma measured about 2cm x 2cm in size.On (b)(6) 2014, seroma was observed on the side of the interring graft; serum leakage was suspected.The seroma measured about 2cm x 2cm in size.On (b)(6) 2014, enlargement of the edematous area was observed.As a result, segments of the interring graft and the sealptfe graft were explanted, and the vasculature was repaired using non-gore vascular grafts on (b)(6) 2014.On (b)(6) 2014 the patient was doing well.

• Brand Name: GORE INTERING® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL EAST B/P; 1500 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4153126
• MDR Text Key: 4781933
• Report Number: 2017233-2014-00519
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991602
• 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,Followup
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: ISRTW-064040L
• Device Lot Number: 11624702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2013
• 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: SEALPTFE VASCULAR GRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR