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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

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W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 04/08/2024
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing records for the device could not be conducted because the serial / lot number remains unknown.Without a lot number or device serial number, the manufacturing date and / or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
On an unknown date, the patient underwent a procedure in an unknown anatomical location where a gore® acuseal vascular graft was used.It was reported there was dissection inside the graft.
 
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Brand Name
GORE® ACUSEAL VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL WEST B/P
1505 n. fourth street
flagstaff AZ 86004
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key19182400
MDR Text Key341633038
Report Number2017233-2024-04870
Device Sequence Number1
Product Code DSY
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K130215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/25/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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