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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Model Number HT087080A
Device Problem Material Separation (1562)
Patient Problem Death (1802)
Event Date 01/14/2020
Event Type  Death  
Manufacturer Narrative
A review of the manufacturing records indicated the device met pre-release specifications.The device was not returned for an engineering evaluation.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.
 
Event Description
The following was reported to gore: on (b)(4) 2019 an 8mm gore® propaten® vascular graft was implanted as a bypass, common iliac to distal sfa.On (b)(6) 2020 the physician performed a re-exploration as a result of an identified occlusion within the graft.The doctor performed a graft thrombectomy as well as revision of the distal anastomosis, extending treatment by sewing a second graft to the distal anastomosis to the popliteal below knee position.On (b)(6) the graft to graft anastomosis disrupted.According to the doctor, the patient bled out very rapidly and expired.
 
Manufacturer Narrative
Additional manufacturer narrative: 2 devices were reported to gore.Reference medwatch 2017233-2020-00132 for other device.
 
Manufacturer Narrative
The following engineering evaluation was performed with no devices returned to w.L.Gore & associates: two device serial numbers associated with this event were provided, but the identity of the associated devices could not be confirmed.Md142775, gore-tex® vascular graft and gore® propaten® vascular graft process failure modes and effects analysis (pfmea), revision 9 was reviewed for process steps with suture line disruption as a potential device failure mode or occlusion as a potential hazardous situation.Process steps identified span the component/kitting processes in medical west, the heparin coatings/cutting/packaging processes in kendrick peak, and the boxing process in fisher point.All device history records associated with both device serial numbers were reviewed across all aforementioned processes.All appropriate signatures and other evidence of process conformation were verified.The event description could not be confirmed with the information provided.The reported codes reflect the event description, but cannot be confirmed.Additional devices included on this report are as follows: item #h080040a/ lot #6299684pp033, which is captured in manufacturer report #2017233-2020-00132.
 
Manufacturer Narrative
B3, date of event - updated to (b)(6) 2020.
 
Manufacturer Narrative
Additional manufacturing narrative: c1.Name (#1) cbas® heparin surface.Manufacturer/compounder: w.L.Gore & associates, inc., lot #5918388pp019.Cbas® heparin surface incorporates, cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface.And is essentially non-eluting.
 
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Brand Name
GORE PROPATEN VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key9689891
MDR Text Key178501510
Report Number2017233-2020-00082
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00733132606849
UDI-Public00733132606849
Combination Product (y/n)N
PMA/PMN Number
K062161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/30/2020
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 Expiration Date04/19/2022
Device Model NumberHT087080A
Device Catalogue NumberHT087080A
Device Lot Number5918388PP019
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/10/2020
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received02/27/2020
05/12/2020
05/19/2020
07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age53 YR
Patient Weight70
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