MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GRAFT PROPATEN STANDARD WALL INTEGRATED RINGS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Fluid/Blood Leak (1250)

Patient Problem Seroma (2069)

Event Date 07/19/2021

Event Type  Injury  

Event Description

The following publication was reviewed: 'periprosthetic seroma occurrence after femoropopliteal bypass grafting: surgical management after failure of non-surgical measures in relieving symptoms'.The patient underwent a right common femoral to below the knee popliteal artery bypass grafting using a 6mm ringed propaten graft under general endotracheal anesthesia with the graft placed in the sub-sartorial position using a kelly-wick tunneler.Five months post-operatively, lower extremity examination showed right leg edema.Ultrasonography of the right leg was performed which showed a seroma around the graft.The patient underwent conservative management with diuretics, elevation, and compressive stockings.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.Substantial amounts of clear, clean appearing amber fluid were evacuated.A 19-french blake and 7mm jackson¿pratt drains were placed.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

H6 - component code, 515 (stent) added.Patient and event information were requested, but author declined to provide any details.As a result, further investigation was not possible.Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 - investigations conclusions updated, 4315 (cause not established).

Manufacturer Narrative

Article: 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.Additional manufacturer narrative: average age and gender are based on article information.Patient and event information were requested, but author declined to provide any details.As a result, further investigation was not possible.Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GRAFT PROPATEN STANDARD WALL INTEGRATED RINGS
• 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12289168
• MDR Text Key: 265432395
• Report Number: 2017233-2021-02220
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• 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): Other
• Patient Sex: Male