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

Catalog Number HT087080

Device Problem Fracture (1260)

Patient Problem Blood Loss (2597)

Event Date 12/05/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a patient underwent an axillary to bifemoral artery bypass procedure.On (b)(6) 2019 a reintervention took place using a gore propaten vascular graft.During the reintervention there was bleeding noted midgraft after tunnelling with an atrium tunneller.This required the use of pledgets for patching.Mild traction was placed on the graft during the procedure and this resulted in the graft fracturing and separating from the axillary end.A 6 mm atrium tunneller was passed through the graft but it perforated the graft at the groin end.The entire graft was explanted.The status of the patient is unknown currently.

Manufacturer Narrative

H.6.Results code 2: 213: a review of the manufacturing records verified the lot met all pre-release specifications.H.6.Results code 2: 213: the engineering evaluation stated the following: the device fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a segment of a gore® propaten® vascular graft (stretch removable ring).The abluminal and luminal surfaces of the graft were largely devoid of tissue.No histopathological examination was performed.The graft was examined for material disruptions with the aid of a stereomicroscope.The returned segment exhibited a propaten® blue line pattern, had an inner diameter of approximately 8mm, and had a relaxed length of approximately 35cm.Mild yellow/brown staining was observed throughout the abluminal surface, and the segment was covered in mostly adhered rings.Neither end appeared cleanly cut.The ¿axillary¿ end exhibited a number of evenly spaced serrations, consistent with marks from a surgical instrument; some disrupted radial film was observed within the marks.A large hole was present about 2cm from the ¿groin¿ end of the segment.Two pledgets were sutured to the outer diameter approximately half-way down the returned segment.Removing the pledgets revealed multiple full thickness perforations and fep ring damage consistent with damage from a surgical instrument.The pledgets appeared to be cut-up pieces of a gore® propaten® vascular graft.The identity of the returned device matches the device described in the event.The condition of the returned device is consistent with the event description.The examination found no anomalies attributable to the manufacture of the device.

Manufacturer Narrative

D.6.Updated.

Manufacturer Narrative

Implant/ explant date updated.

Manufacturer Narrative

Updated.Updated.Confirmed.

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient underwent an axillary-femoral or axillary bi-femoral bypass procedure with a using a gore® propaten® vascular graft.On (b)(6) 2019 a reintervention took place, possibly due to bleeding.During the reintervention there was bleeding noted midgraft after tunnelling with an atrium tunneller.This required the use of pledgets for patching.Mild traction was placed on the graft during the procedure and this resulted in the graft fracturing and separating from the axillary end.A 6mm atrium tunneller was passed through the graft but it perforated the graft at the groin end.The entire graft was explanted.The patient outcome is unknown.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9587017
• MDR Text Key: 174902975
• Report Number: 2017233-2020-00031
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/30/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Catalogue Number: HT087080
• Device Lot Number: 6431947PP008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2020; 03/17/2020; 03/31/2020; 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 87