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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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W. L. GORE & ASSOCIATES, INC. GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Catalog Number ECH060040
Device Problem Contamination (1120)
Patient Problem Bacterial Infection (1735)
Event Date 09/04/2020
Event Type  Injury  
Manufacturer Narrative
Device evaluated by manufacturer: other code - the medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.The investigation is still ongoing.The results will be included in the final report.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
 
Event Description
It was reported to gore that patient underwent endovascular treatment for a left arteriovenous humero-axillary bypass with a gore® acuseal vascular graft.It was stated that the prosthesis was implanted on (b)(6) 2020 in order to create an access for hemodialysis.It was reported that on (b)(6) 2020, after about 1 month, the prosthesis was explanted due to an infection to enterococcus faecalis.
 
Manufacturer Narrative
H6 evaluation codes investigation findings 213 refers to the phr-review.Phr-review: a review of the manufacturing records indicated the lot met all pre-release specifications.A review of the sterilization records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations: tissue present: yes.Minimal, scattered plaques of red/brown material were present on the abluminal surface.A foci of red/brown tissue was observable in the lumen when viewed from extremity b.The lumen patency could not be determined with the images provided.Multiple forceps marks were present on the abluminal surface.One perforation (presumptive cannulation) was present.Partially circumferential blue running suture was present near extremity a, closing a clean-edge transection.Both extremities were transected, with extremity b presenting in an ovular shape.Material disruptions observed (i.E., forceps marks, perforation, transections) are consistent with those caused by surgical instrumentation (i.E., forceps, cannulation needle, scalpel/scissors) likely used during a surgical procedure.Request for additional analysis: no.Reason: based on the ei¿s review of the geprovas report and reason for explant (infection), no additional analysis is requested.
 
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Brand Name
GORE ACUSEAL VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10868234
MDR Text Key217131897
Report Number2017233-2020-01465
Device Sequence Number1
Product Code DSY
Combination Product (y/n)Y
PMA/PMN Number
K130215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/16/2021
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 Date09/10/2021
Device Catalogue NumberECH060040
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/19/2020
Supplement Dates Manufacturer Received08/06/2021
Supplement Dates FDA Received08/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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