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

Catalog Number RRT07070070L

Device Problem Material Rupture (1546)

Patient Problem Hematoma (1884)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).Further investigation is being conducted and the information will be included in the final report.

Event Description

It was reported to gore that the patient was implanted with a gore-tex® stretch vascular graft in the femoral artery to perform a bypass procedure on (b)(6) 2017.On (b)(6) 2017, the patient presented with a hematoma on the implant side.Therefore the patient was converted to open surgery to cure the hematoma.It was reported to gore that when the hematoma was cured a rupture of the implanted gore-tex® stretch vascular graft was observed.It was stated that the graft rupture was visible next to the ringed section of the device.The anastomosis looked fine.The medical device was explanted.

Manufacturer Narrative

The device was returned to w.L.Gore & associates for investigation.Submitted in formalin were two gore-tex® vascular graft device fragments (vgf-1 & vgf-2) which had been transected prior to arrival at w.L.Gore and associates.Both fragments were light tan, largely devoid of tissue, had multiple areas of serration marks present on the abluminal surfaces, and the lumens were widely patent.Vgf-1 had no rings present and was cut in a beveled pattern and also longitudinally, consistent with site of anastomosis.Beveled and longitudinal cut edges were lined with holes and a full thickness tear was present.Multiple fragments of blue suture were present, looped through the material, along the beveled edge.Vgf-1 had also been transected at the opposite end with radial film disruption present; this pole appeared to align with vgf-2.Vgf-2 had been transected at both poles.One end had an area of irregular edge, consistent with the heel of the anastomosis, with multiple full thickness tears.Three rings remained intact and firmly adhered at the opposite end, eight removed ring sights were visible.Backlighting/ luminal lighting of the graft revealed no holes in the body of the graft or adjacent to the rings.Histopathological examination was not performed due to the paucity of adherent tissue.The device fragments were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all fragments were examined for material disruptions with the aid of a stereomicroscope and scanning electron microscopy.Disruptions identified were not associated with handling or manufacturing process at w.L.Gore and associates.The disruptions are largely consistent with surgical procedures.Vgf-2 had multiple tears consistent with suture pull through due to tension on the graft; time point cannot be determined.There were no full thickness material disruptions adjacent to the ringed portion of graft suggestive of wall failure, nor was there evidence of graft rupture of the returned graft fragment.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6420093
• MDR Text Key: 70409698
• Report Number: 2017233-2017-00135
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K933943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Catalogue Number: RRT07070070L
• Device Lot Number: 14733471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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
• Patient Outcome(s): Required Intervention