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

Model Number HPT040010A

Device Problem Complete Blockage (1094)

Patient Problems Bacterial Infection (1735); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 11/13/2020

Event Type  Injury  

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.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient underwent a right thoracotomy as part of a blalock-taussig shunt procedure utilizing a gore® propaten® vascular graft configured for pediatric shunt device.Physician confirmed all shunts are on prophylactic heparin until they¿re able to transition to aspirin and that aspirin responsiveness is checked in everyone prior to stopping heparin.On the same day as the initial procedure, (b)(6) 2020, evidence of decreasing saturations and echo studies could not confirm shunt patency.A few hours after, no shunt flow could be detected.On the following day, (b)(6) 2020, the shunt is difficult to see by doppler and there doesn't appear to be any flow through it.A thrombectomy was performed and the original shunt remained.Progressive narrowing of the shunt was described with echo beginning on (b)(6), 2021.On (b)(6) 2021 shunt ligation and takedown was performed and purulent material was found around the shunt, which was subtotally thrombosed.Pcr detected staphylococcus epidermidis around the shunt.

Manufacturer Narrative

H6: type of investigation, investigation findings, and investigation conclusions updated to reflect completion of investigation.

Manufacturer Narrative

Completed sterilization records review: a review of the manufacturing records indicated the lot met all pre-release sterilization specifications.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12011235
• MDR Text Key: 264502401
• Report Number: 2017233-2021-02084
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606276
• UDI-Public: 00733132606276
• Combination Product (y/n): Y
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: HPT040010A
• Device Catalogue Number: HPT040010A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 14 DA
• Patient Weight: 2