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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Catalog Number IRTH068080
Device Problem Contamination (1120)
Patient Problem Bacterial Infection (1735)
Event Date 09/14/2020
Event Type  Injury  
Manufacturer Narrative
Device evaluated by manufacturer: 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 critical ischemia with trophic disorders (deep calcaneal ulcer) with a gore® propaten® vascular graft - thin-walled, integrated rings.It was stated that the prosthesis was implanted on (b)(6) 2015 as a femoro-tibio-peroneal trunk bypass.It was reported that the patient presented several septic episodes and liquid was observed around the bypass.On (b)(6) 2020, after about 5 years, prosthesis was therefore explanted due to the suspicion of infection and a new bypass was performed.It was stated that bacterial cultures performed on a short segment of the prosthetic segment identified to pseudomonas aeruginosa species.
 
Manufacturer Narrative
Product history 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 of the gore® propaten® vascular graft.Tissue present: yes.The device fragment was generally devoid of tissue.The fragment was encased by a large tissue mass (mix of native vessel/tissue; dark brown, tan, and yellow in appearance) at extremity a.The fragment could not be observed inside of the mass of tissue at extremity a.The tissue extremity was occluded by tan/white tissue with some blue running suture being visible.Extremity b was transected and ovular in shape with a blue suture ligaturing the extremity.The luminal patency could not be determined with the information provided.Material disruptions (i.E.Transections, blue suture) are consistent with those caused by surgical instrumentation (i.E., scalpel/scissors, suturing), likely used during a surgical procedure.Request for additional analysis: no.Reason: based on the ei¿s review of the third party report and reason for removal (infection), no additional analysis is requested.
 
Manufacturer Narrative
After consultation with the physician it was revealed that the patient has a history of pre-existing infection in the field of treatment, therefore this incident no longer meets the criteria of a reportable serious incident, and is considered non-reportable.The report is retracted.
 
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Brand Name
GORE® PROPATEN® 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
Manufacturer (Section G)
MEDICAL WEST B/P
1505 n. fourth street
flagstaff AZ 86004
Manufacturer Contact
gunter marte
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10868680
MDR Text Key217154535
Report Number2017233-2020-01467
Device Sequence Number1
Product Code DSY
Combination Product (y/n)Y
Reporter Country CodeFI
PMA/PMN Number
K062161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/09/2022
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 Date09/30/2017
Device Catalogue NumberIRTH068080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/19/2020
Supplement Dates Manufacturer Received09/14/2021
03/07/2022
Supplement Dates FDA Received10/08/2021
03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexFemale
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