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

Catalog Number HT066070A

Device Problem Degraded (1153)

Patient Problem No Code Available (3191)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Explant evaluation is in currently in progress.

Event Description

The following was reported to gore: on (b)(6) 2016, a gore® propaten® vascular graft was implanted in a patient's leg, from the femoral to popliteal artery.As reported, the gore® propaten® vascular graft was aspirated at least four or five times since implantation.On (b)(6) 2016, the patient presented for treatment of a seroma.A section of the gore® propaten® vascular graft was explanted and a gore-tex® stretch vascular graft (ringed specification) was implanted in a revision procedure.

Manufacturer Narrative

Additional information was obtained from user facility voluntary report form.Per user facility report, a new propaten graft was used; however, the lot number that was provided matches to fep ringed gore-tex® stretch vascular graft with removable rings for the revision performed on (b)(6) 2016.(b)(6).Histology evaluation was completed and the summary report states the returned sections of the device evaluation process yielded no findings that would lead to a causation of seroma users are informed in the gore® propaten® vascular graft instructions for use: 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.Operative techniques section states: use a tunneler, such as the gore® tunneler, to create a tissue tunnel that closely approximates the graft diameter.A tissue tunnel that is too loose may result in delayed or insufficient perigraft tissue attachment, and may be a contributing factor to perigraft seroma formation.

Event Description

The patient was admitted for incision, drainage, debridement of a large right popliteal seroma.At the time of surgery, the patient was found to have involvement of the entire course of the femoral popliteal bypass graft with chronic seroma in the inguinal region as well, which has recently been enlarging.There were no signs of infection, no malodor.The previous aspirations had revealed negative cultures.A decision was made to place a new interposition graft.The graft was then excised and a new graft pulled through the old tunnel since there was no subcutaneous tissue available.The patient was then heparinized and a small nubbin of proximal and distal graft was maintained using fogarty hydragrips and a new fep ringed gore-tex® stretch vascular graft with removable rings was sewn end-to-end to both pieces.Heparin was reversed with protamine and there was immediate hemostasis.The entire tunnel was then irrigated and the serosal area burned using bovie® cautery until the entire area that could be visualized, both proximally and distally had been cauterized.The proximal wound and tunnel were then packed with surgicel.The wound was closed using 3-0 vicryl ________ and then surgicel was used to seal the wound.The distal wound was then treated by resecting as much redundant skin as possible and then closed using 3-0 vicryl and skin staples, again using surgicel.The next day the patient was ambulating, the graft was functioning well, and patient was discharged.

Manufacturer Narrative

Explant date was entered.Small end pieces of the gore® propaten® vascular graft remained implanted.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5822512
• MDR Text Key: 50448034
• Report Number: 2017233-2016-00652
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2019
• Device Catalogue Number: HT066070A
• Device Lot Number: 4917422PP010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 60