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

Catalog Number ECH060040J

Device Problems Break (1069); Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombus (2101)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.An explant analysis is currently in process.

Event Description

On (b)(6) 2016, the patient was implanted with a gore® acuseal vascular graft in the upper arm to prepare a loop for arteriovenous access.Prolene suture 6-0 was used and the venous vessel diameter was 6mm.The patient tolerated the procedure.Cannulation to the gore® acuseal vascular graft was performed from the day after the initial implant procedure.The patient visited the clinic three times a week to receive dialysis treatment.Puncture sites were changed every time with 0.5cm - 1.0cm of intervals.It was stated that since the patient was diagnosed with schizophrenia, the nurses pressed the patient¿s arm by hand while cannulating the graft.It was reported to gore that on (b)(6) 2016, the patient presented with a graft occlusion.Urokinase was administered and a percutaneous transluminal angioplasty (pta) intervention was performed.It was reported that the graft was severely damaged at the puncture site due to multiple punctures and a large amount of thrombus was observed in the inner lumen.On (b)(6) 2016, another pta procedure was performed.An echocardiography revealed fibrin in the inner lumen and an unknown object that appeared like a delaminated intimal membrane of eptfe.On (b)(6) 2016, the existing gore® acuseal vascular graft was partially removed (portions of the graft at the arterial and venous anastomosis sites were left) and replaced with a non-gore surgical graft.The patient tolerated the procedure.It was stated that thrombosis of the non-gore surgical graft occurred on (b)(6) 2016.The explanted vascular graft has been returned to gore for further evaluation.

Manufacturer Narrative

The device was returned to w.L.Gore & associates for investigation.Submitted unfixed were two gore® acuseal vascular graft fragments (vgf-1 & vgf-2) and two tissue fragments (tf-1 & tf-2).Vgf-1 abluminal surface was generally devoid of overlying tissue with numerous semilunar aberrations.Within the central aspect of the lumen was friable pale tan soft tissue.In the center of the fragment the lumen contained a moderate quantity of friable pale tan soft tissue.Adherent to the luminal surface, along an area with moderate amount of semilunar aberrations, was a moderately firm white soft tissue mass which protruded into the lumen.Vgf-2 lumen was widely patent and the abluminal surface was devoid of soft tissue with a single semilunar aberration.Also present were two free floating tissue fragments (tf-1 & tf-2) of tan to dark brown friable soft tissue.Histopathological examination of four device/tissue specimens from vgf-1 were submitted: cross sections through the graft and luminal tissue from both poles, luminal tissue from the center of device and luminal tissue from a site with moderate aberrations, was performed.There was a scant quantity of abluminal collagenous tissue consistent with normal healing.The central region of the vgf-1 fragment was heavily cannulated.The cannulated area was associated with luminal collagen deposition which was confluent with a marked accumulation of ribbons and strands of loose and compacted thrombus.Grossly, under stereoscopic magnification, all layers were visible and structurally intact.No assessment of structural integrity can be made on the sections examined microscopically.Vgf-1, vgf-2, tf-1, and tf-2 were subjected to an enzymatic digestion process to remove biologic debris.Following digestion vgf-1 & vgf-2 were examined with the aid of a stereomicroscope.Tf-1 & tf-2 were consumed during digestion process.The identified findings were not associated with handling or manufacturing process at w.L.Gore & associates.The material aberrations identified are consistent with a surgical instrument and cannulation of a gore® acuseal vascular graft.All layers of the gore® acuseal vascular graft fragments were found to be intact and no evidence of delamination of the luminal eptfe was present.

• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5664443
• MDR Text Key: 45473848
• Report Number: 2017233-2016-00497
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/02/2016

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: 04/07/2018
• Device Catalogue Number: ECH060040J
• Device Lot Number: 4812842PP006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• 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: 67 YR