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

Catalog Number HT074050A

Device Problem Entrapment of Device (1212)

Patient Problems Swelling (2091); Fluid Discharge (2686)

Event Date 12/12/2014

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The devices were returned to w.L.Gore & associates for investigation.Submitted were five gore® propaten® vascular graft (thin-walled removable ringed) fragments (vgf-1 through vgf-5).The abluminal surface of all fragments had adherent to firmly adherent minimal multifocal tan brown tissue and were largely devoid of tissue.The luminal surface of vgf-4 was largely occupied by blood that clotted during the explant process.Directly adjacent to this was an area on the abluminal surface that contained focal tan to red brown tissue and multiple rows of evenly spaced serration marks.The luminal surfaces of vgf-1, 2, 3 and 5 contained minimal scattered multifocal red brown tissue.All fragments had been transected at both poles prior to arrival at w.L.Gore & associates.Vgf-1 had multiple rows of evenly spaced serration marks present on the abluminal surface of one pole.Vgf-2 had a compressed ring at one pole.Vgf-3 and vgf-5 are beveled at one pole with multiple suture holes and white suture fragments present.Vgf-4 consists of a 7 cm fragment attached perpendicularly to a 4 cm fragment; rings had been removed from both fragments.Histopathological examination of six specimens was performed; four cross-sections from one section of vgf-4 (graft and tissue), one tissue specimen from the abluminal surface of vgf-1, and one from a free-floating mass of tissue.The lumens of the vgf-4 sections were widely patent with a thin layer of compacted fibrin and variable amounts of clot, both of which formed at the time of explant.Proteinaceous material completely filled the interstices of vgf-4.The abluminal tissue from vgf-1 and the free-floating tissue consisted largely of unorganized fibrin with scattered streaks of collagen.Significant inflammation, calcification and infectious agents were also not observed.Overall, virtually all gross and histologic observations were typical and expected for an implanted vascular graft.Slightly unexpected was the minimal organization of the abluminal fibrin/proteinaceous fluid identified with vgf-4.Peri-graft fluid accumulation would have prevented organization of the abluminal tissue.The device fragments were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all device fragments were examined for material disruptions with the aid of a stereomicroscope.Disruptions identified were not associated with handling or manufacturing process at wl gore and associates.The disruptions are consistent with instruments used during a surgical procedure.Two graft were used during this event.Lot #4469044pp013 - (b)(4).Lot #4367222pp014 - (b)(4).Mfr report#2017233-2015-00608.

Event Description

As reported, two gore® propaten® stretch vascular grafts were implanted in an axillobifemoral bypass procedure on (b)(6) 2014.Within 1 to 2 weeks following implantation, the physician noted that the implanted grafts had taken on a tortuous appearance.Swelling was evident at 3 to 6 months following implant.No compromise of flow through the grafts was observed.The gore® propaten® stretch vascular grafts were explanted on (b)(6) 2015.The physician noted a copious amount of clear colorless fluid surrounding the grafts in its entirety.

• Brand Name: GORE PROPATEN® 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: roger smith ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5084719
• MDR Text Key: 26071854
• Report Number: 2017233-2015-00608
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 08/24/2015

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: 12/31/2017
• Device Catalogue Number: HT074050A
• Device Lot Number: 4367222PP014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2014
• Is the Device Single Use?: No
• 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: 59 YR
• Patient Weight: 79