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

Catalog Number ECH060040A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Still images were received and are still being evaluated.The explanted specimen is expected to be returned for evaluation.

Event Description

On (b)(6) 2016, gore® acuseal vascular graft was implanted for arteriovenous access in a patient with end stage renal disease.The acuseal vascular graft was implanted from the femoral artery to femoral vein.As reported, the physician used an 8mm tunneler (unknown manufacturer) to create a tissue tunnel.The acuseal vascular graft was then pulled through the tissue track.Graft declotting procedures were done on multiple dates: (b)(6) 2017.On (b)(6) 2017, the patient's treatment record indicates a 7fr french argon cleaner thrombectomy device was used for mechanical thrombectomy.A 7mm diameter balloon was also used to angioplasty the stenosed areas of venous anastomosis and segments of the patient's fistula.Result was a successful thrombolysis of the acuseal vascular graft.On (b)(6) 2017, the patient returned for exploratory surgery and revision of the existing graft.During the procedure, the physician noted a thin strip of what may be the graft's inner lining, that had been dissected from the lumen of the graft.Using forceps, the physician pulled the strip out.At this time, the acuseal vascular graft was excised and a new gore® acuseal vascular graft was implanted.The patient was reported to be doing well following the procedure.

Manufacturer Narrative

Imaging evaluation summary states the images provided do not allow for evaluation in elation to the reported event.The explanted specimen was not returned for evaluation.The user facility elected to retain the specimen.

Manufacturer Narrative

Event date was corrected from (b)(6) 2017 to (b)(6) 2017, which is the reportable event date.Date of this report was corrected from 07/18/2017 to 07/25/2017, which is the date the event was reported to gore.

Manufacturer Narrative

Device fragments were returned to w.L.Gore & associates for investigation.Submitted fixed were two gore® vascular graft fragments (vgf-1 & vgf-2) and three fragments of synthetic material (sf-1, sf-2, & sf-3).The lumina of the fragments were widely patent.Plaques of tan-brown tissue was present in the lumina of vgf-1 and vgf-2.The luminal surfaces of sf-1, sf-2, and sf-3 were grossly devoid of tissue.The abluminal surfaces of vgf-1 and vgf-2 were covered in firmly adherent yellow-brown tissue.The abluminal surfaces of sf-1, sf-2, and sf-3 were grossly devoid of tissue.Histopathological examination of samples collected from vgf-2 and sf-1 (sections a & b) was performed.Analysis showed connective tissue within the basetube perforation sites (needle punctures, presumptive) extended as mature vascular tissue into the basetube lumen.This is consistent with a separation of the silicone and cbas luminal surface from the basetube in that region a minimum of several weeks prior to explant.The tissue response to the device material was normal for a long term explant.The fragments were subjected to an enzymatic digestion process to remove biologic debris.Following digestion the fragments were examined for material disruptions with the aid of a stereomicroscope.Sf-3 was then lengthwise opened to visualize the lumen.The lumen of sf-3 was examined by stereoscopic magnification and scanning electron microscopy (sem).No other manipulation of the fragments was performed.Identified findings were not associated with handling or manufacturing process at wl gore and associates.The material findings identified are consistent with use of surgical instruments and cannulation of a gore® acuseal vascular graft.The degree of manipulation by surgical instruments, likely at the time of explant, prevents the ability to identify evidence of in vivo delamination/material separation.

• Brand Name: GORE® ACUSEAL 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: 6769373
• MDR Text Key: 81899229
• Report Number: 2017233-2017-00404
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• 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,Followup
• Report Date: 12/22/2017

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: 05/31/2019
• Device Catalogue Number: ECH060040A
• Device Lot Number: 5237394PP020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/16/2017; 12/04/2017; 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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
• Patient Age: 38 YR