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

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 06/14/2022

Event Type  Injury  

Event Description

Article reviewed: periprosthetic seroma occurrence after femoropopliteal bypass grafting: surgical management after failure of non-surgical measures in relieving symptoms.Prior to implant of a 6mm ringed gore® propaten® vascular graft (vascular graft), a patient had a non-healing right calf ulcer after suffering a spider bite.At another institution, the patient underwent angiography with stent placement for a >60% stenosis in the right external iliac artery.Endovascular treatment to open a long segment right superficial femoral artery (sfa) occlusion was attempted from an antegrade approach.This was unsuccessful.Subsequent attempts at sfa recanalization from the popliteal approach also proved unsuccessful.Clinical exam showed right sfa occlusion and clti.The femoral pulses were 2þ bilaterally.Popliteal, dorsalis pedis, and posterior tibial pulses were absent bilaterally.Patient had a right lateral calf ulcer measuring 3.5 by 2.5 by 0.8 cm with surrounding erythema.Angiography indicated he was a candidate for below the knee right femoropopliteal bypass (fpb) grafting for right leg limb salvage.The native saphenous veins bilaterally were used for coronary artery bypass surgery and right carotid endarterectomy.The patient underwent a fpb procedure and the vascular graft was placed in the sub-sartorial position using a kelly-wick tunneler.Five months post-implant, the patient presented with leg edema and lower leg tightness.Ultrasound and computed tomography arteriogram showed a periprosthetic seroma with a patent graft.Patient was initially managed conservatively with diuretics, elevation, and compressive stockings.Patient was on bactrim for localized infection (mrsa) of the groin incision.In progressive treatment, the seroma fluid was aspirated, culture and sensitivity showed no growth.No improvement was noted.Treatment went to aggressive therapy utilizing exploration and surgical resection of the seroma drainage.Seroma collection was largest at the knee but did not extend below the knee.A 19-french blake drain was placed from the suprageniculate popliteal fossa to the proximal anastomosis within the seroma capsule without exposing the entire graft.This approach was chosen to reduce graft contamination.Repeat intraoperative ultrasound did not show any undrained seroma.The seroma fluid was sent for culture and sensitivity and was negative.Drains were removed after drainage ceased.At his two-month post-operative follow-up, the patient returned with an obvious recurrence of the seroma and symptoms at the distal aspect of his thigh incision.There was no evidence of graft infection and aspiration culture showed no growth.Because of symptomatic seroma recurrence, the patient underwent a right thigh exploration for seroma capsule resection and right fpb graft exploration.At surgery, the seroma capsule was resected in its entirety from the suprageniculate popliteal fossa to the proximal anastomosis.Substantial amounts of clear, clean appearing amber fluid were evacuated.A 19-french blake and 7 mm jackson¿pratt drains were placed longitudinally along the course of the graft.Surgical cultures were negative.Patient¿s post-operative course was unremarkable.Drains were discontinued when drainage ceased.Patient was subsequently seen at the three-month follow-up with no recurrence of seroma.

Manufacturer Narrative

Article reviewed: periprosthetic seroma occurrence after femoropopliteal bypass grafting: surgical management after failure of non-surgical measures in relieving symptoms.Authors: joseph a adedigba, angela s volk and harry m roach.Vascular 2021, vol.29(2) 244¿247.Patient information, including identifier and weight were requested, but not made available.Based on article information, the vascular graft remains implanted.Therefore, direct product analysis was not possible.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Ifu for gore® propaten® vascular graft possible complications with the use of any vascular prosthesis states: 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.

Manufacturer Narrative

After further review, it was determined the complaint from the publication was previously reported.A medwatch report #2017233-2021-02220 was submitted.Therefore, mdr #2017233-2022-03081 will be retracted due to duplication of report.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14880518
• MDR Text Key: 295116467
• Report Number: 2017233-2022-03081
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male