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

Device Problem Contamination (1120)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 08/29/2021

Event Type  Injury  

Manufacturer Narrative

Patient id was requested from the author but no information was provided.Due to an unknown lot/serial number and no device return, an investigation could not be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The literature article: ¿single-institution learning curve for management of mega-fistulae revision¿ published by stephanie rodriguez was reviewed.The article was published online or accepted on august 29, 2021.The use of gore® acuseal vascular graft and gore® propaten® vascular graft were evaluated for arteriovenous (av) access.In a total population of 12 patients, all patients had arteriovenous (av) access with either gore® acuseal vascular graft or gore® propaten® vascular graft.8 propaten patients; 1 long- term catheter was already in place in an acuseal patient.Average time to cannulation was 6 weeks with propaten and 4.5 days with acuseal.At 30- days, 3 propaten patients developed complications including one instance of skin necrosis, 1 seroma, and 1 hematoma.Two acuseal patients developed complications including one with central venous occlusion, and one with graft infection requiring new av access.Of the 6 patients with follow-up after 6 weeks, 5 patients continue to use their access, however, two have required further intervention with 1 thrombectomy and one central venous angioplasty.One patient required av access ligation and placement of a new contralateral av access 17 months postoperative due to a central venous occlusion that could not be recannulated.After further discussion with the product specialist, the information in the reviewed article does not meet the definition of a potential complaint.

Manufacturer Narrative

Please disregard the following statement from the previous medwatch report: after further discussion with the product specialist, the information in the reviewed article does not meet the definition of a potential complaint.

• Brand Name: GORE® ACUSEAL 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13254564
• MDR Text Key: 289001986
• Report Number: 2017233-2022-02667
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K130215
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• 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: 12/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization