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

Catalog Number ECH060040A

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Seroma (2069); Test Result (2695)

Event Date 05/15/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a gore® acuseal vascular graft was implanted in the patient's right thigh.On (b)(6) 2015, the gore® acuseal vascular graft was explanted due to an infected seroma.It was reported the physician did not observe any oozing in the graft.On an unknown date, the explanted graft tested positive for gram negative bacteria.

Manufacturer Narrative

Review of device manufacturing and sterilization record history confirmed device met pre-release specifications.Evaluation is in progress for the small section of the specimen that was returned.

Manufacturer Narrative

Explant evaluation - submitted in formalin was one approximately 1.5 cm gore® acuseal vascular graft fragment which had been transected at both poles.Histopathological examinations revealed no gross or microscopic evidence of infection and the lumen of the vascular graft segment was widely patent.The specimen was examined with a stereomicroscope.The transected poles and serration marks were consistent with manipulation of the graft fragment with surgical instruments during a surgical procedure.

Manufacturer Narrative

(b)(4).

• Brand Name: GORE® ACUSEAL 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 86004 ; 9285263030
• MDR Report Key: 4841074
• MDR Text Key: 5937590
• Report Number: 2017233-2015-00355
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2015

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
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: ECH060040A
• Device Lot Number: 4534598PP018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2014
• 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: 70 YR