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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Thrombosis/Thrombus (4440)

Event Date 02/09/2001

Event Type  Injury  

Manufacturer Narrative

Due to an unknown lot/serial number and no device return, an investigation could not be performed.

Event Description

The following information was received through literature ¿limb preservation by gore-tex vascular graft for groin recurrence after postoperative adjuvant radiation in vulvar cancer¿ published by academic press, gynecologic oncology 82, 559¿562 (2001).The case was to report a (b)(6) woman had recurrent vulvar cancer involving the right femoral vessels 6 months after a radical vulvectomy plus inguinal lymphadenectomy and postoperative pelvic and groin radiation.On (b)(6) 1997, radical excision of the inguinal soft tissue including a segment of distal external iliac and common femoral artery and femoral vein was performed.Revascularization was performed using a ringed polytetrafluoroethylene (gore-tex) graft 6 mm in diameter for the femoral artery and vein bypasses, respectively.Rectus abdominis myocutaneous flap based on the left inferior epigastric vessels was transposed to cover the tissue defect.Twenty-one months following the surgery, wound discharge with gore-tex infection was suspected.A wound culture grew staphylococcus aureus and pseudomonas aeruginosa.Organism-specific intravenous antibiotics were administered.Multiple biopsies at the inguinal site showed no recurrence.Occlusion of the grafted vessels occurred 21 months following bypass surgery.An angiogram demonstrated complete occlusion of the right external iliac common femoral and proximal superficial femoral arteries.But collaterals of the right popliteal artery as well as the right distal superficial femoral artery were seen.Hence, the wound was radically debrided and the gore-tex graft was removed on (b)(6) 1998.The debrided groin tissues were negative for malignancy.The postoperative leg edema was anticoagulated immediately and improved with long-term warfarin treatment.The patient has been clinically free of disease for more than 48 months since graft reconstruction surgery.

Manufacturer Narrative

Literature citation: literature ¿limb preservation by gore-tex vascular graft for groin recurrence after postoperative adjuvant radiation in vulvar cancer¿ published by academic press, gynecologic oncology 82, 559¿562 (2001).Received february 9, 2001.The authors: angel chao, m.D.Chyong-huey lai, m.D.,1 hung-chi chen, m.D.Hung-chang hsieh, m.D.And kee-min yeow, m.D.Division of gynecologic oncology, department of obstetrics and gynecology, and ¿department of plastic surgery, department of cardiovascular, surgery, and §department of diagnostic radiology, chang gung memorial hospital linkou medical center and chang gung university college of medicine, taoyuan 333, taiwan.

• Brand Name: GORE-TEX 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
• MDR Report Key: 11918336
• MDR Text Key: 261597923
• Report Number: 2017233-2021-02045
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR