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

Catalog Number HT087080A

Device Problem Material Rupture (1546)

Patient Problem Aneurysm (1708)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: ht087080a lot #4690177pp006, ht084050a, lot #4761029pp022, and ht066070a, lot #4843964pp003 were implanted into the patient on (b)(6) 2016.It is unclear which device was involved with the rupture.Lot #4690177pp006 - udi (b)(4); lot #4761029pp022 - udi (b)(4); lot #4843964pp003 - udi (b)(4).Review of the manufacturing records for all three lots verified that the lots met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.

Event Description

The following was reported to gore: the patient presented for a femoral bypass procedure on (b)(6) 2016.Three gore® propaten® vascular grafts were implanted at that time.The patient returned to the operating room on (b)(6) 2016 for aneurysmal enlargement.It was discovered that one of the grafts had ruptured.The rupture was repaired and the patient is fine.

Manufacturer Narrative

Additional information: (b)(6) was the surgeon.

Manufacturer Narrative

Additional manufacturer narrative: two gore® propaten® vascular graft fragments were returned to w.L.Gore & associates for investigation.There was evidence of partial graft rupture at one pole of one fragment consistent with a longitudinal force.The identified disruption was not associated with handling or the manufacturing process at w.L.Gore & associates.The identified disruption is consistent with a surgical procedure.The cause or timing of the rupture cannot be determined.The hospital reported the patient is doing well.The gore® propaten® vascular graft instructions for use, section vi.Possible complications with the use of any vascular prosthesis, section a.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.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6380900
• MDR Text Key: 69158929
• Report Number: 2017233-2017-00111
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: HT087080A
• Device Lot Number: 4690177PP006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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: 73 YR
• Patient Weight: 73