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

Catalog Number HT087080J

Device Problem Torn Material (3024)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 03/26/2015

Event Type  Injury  

Event Description

The following was reported to gore: the patient underwent vascular graft replacement of the popliteal artery on (b)(6) 2015.The patient fell, twisting his previously treated leg on (b)(6) 2015.A circumferential tear at the distal end of the graft along the suture line was noted.On (b)(6) 2015, the torn portion of the graft was explanted and replaced with a new gore® propaten® vascular graft.The patient is doing well.

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device is in process.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Summary of returned device evaluation: the returned device was subjected to an acid digestion process to remove biologic debris.Following digestion, the device was examined for material disruptions with the aid of a stereomicroscope.The device was then prepared for scanning electron microscopy (sem) using platinum sputter coating and examined.Disruptions identified were not associated with handling or manufacturing process at wl gore and associates.The disruptions are consistent with a surgical procedure.Marks consistent with a surgical instrument are present on the abluminal surface.Pull through of the anastomotic sutures and an area of graft rupture were identified.The suture pull tracks and their associated angles, and section of graft rupture indicate that the anastomotic site was subjected to sudden tension in multiple directions.The instructions for use state: caution the patient against extreme or abrupt movements of the arm, shoulder, or legs during a convalescent period of six-to-eight weeks to allow for adequate healing.Routine activities such as reaching out in front, raising arms above the shoulder level, throwing, pulling, striding, or twisting should be avoided.

• Brand Name: GORE PROPATEN® 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4719774
• MDR Text Key: 5579851
• Report Number: 2017233-2015-00251
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• 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

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: HT087080J
• Device Lot Number: 4262988PP024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• 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: 84 YR
• Patient Weight: 52