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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 ECH060040A
Device Problem Peeled/Delaminated (1454)
Patient Problem Insufficient Information (4580)
Event Date 03/08/2021
Event Type  malfunction  
Manufacturer Narrative
Article: evaluation of heparin-bonded eptfe grafts for forearm loop vascular access: comparison between gore® propaten vascular graft and acuseal vascular graft.Authors: takeshi baba , takao ohki, koji maeda, eisaku ito, masamichi momose, yoshihiko chono, makiko omori and kota shukuzawa.The journal of vascular access 2021 mar 8; doi: 10.1177/1129729821998526.Average age is 65; majority of patient are male.Date published was used as date of event.Device lot/serial numbers were not provided by author(s); and no devices were returned for direct product analyses.Therefore, further investigation was not possible.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
The following publication was reviewed: evaluation of heparin-bonded eptfe grafts for forearm loop vascular access: comparison between gore® propaten vascular graft and acuseal vascular graft source: the journal of vascular access 2021 mar 8; doi: 10.1177/1129729821998526.This retrospective study evaluates the clinical outcomes of gore® acuseal vascular grafts and gore® propaten® vascular grafts for forearm loop vascular access.Between january 2015 and december 2019, data was collected on 60 patients.Enrolled were 36 patients in the propaten group (group p) and 24 in the acuseal group (group a).All procedures were successful without any 30-day mortality.The median times to first cannulation were 16.5 days for group p and 3 days for group a.Mean follow-up periods were 13.4 ± 14.5 and 17.3 ± 9.3 months, respectively.Primary patency rates were 81% and 64%, respectively, at 6 months, and 60% and 40%, respectively, at 12 months.Assisted primary patency rates were 96% and 83% at 6 months, 91% and 73% at 12 months, and 81% and 35% at 24 months.Secondary patency rates were 96% and 81% at 12 months, and 87% and 62% at 24 months.The article did not report any early complications.Interventions reported were graft delamination(s) that were due to punctures for dialysis, and thrombectomy(ies) with a fogarty balloon catheter.
 
Manufacturer Narrative
Mfr report # 2017233-2021-02003 was also submitted, based on the same article.Instructions for use (ifu) for gore® acuseal vascular graft state, technical information: the gore® acuseal vascular graft can be cannulated early (within 24 hours after implantation).Patients should be carefully monitored when using gore® acuseal vascular grafts for vascular access.Puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may lead to disruption of the graft material or formation of a perigraft hematoma or pseudoaneurysm.Possible complications with the use of any vascular prosthesis a.Complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.H1: correction made from serious injury to reportable malfunction.H6: health effect: impact code was updated to 'insufficient information' as article did not specify an intervention was performed.
 
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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 Key11821194
MDR Text Key250634530
Report Number2017233-2021-01996
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 foreign,literature
Type of Report Initial,Followup
Report Date 05/21/2021
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? Yes
Device Operator Health Professional
Device Catalogue NumberECH060040A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/20/2021
Initial Date FDA Received05/13/2021
Supplement Dates Manufacturer Received04/20/2021
Supplement Dates FDA Received05/21/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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