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

Model Number	HPT040010A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Bacterial Infection (1735); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
H6: type of investigation, investigation findings, and investigation conclusions updated to reflect completion of investigation.
Additional 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
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12011235
• Report Number: 2017233-2021-02084
• Device Sequence Number: 3196893
• Product Code: DSY
• UDI-Device Identifier: 00733132606276
• UDI-Public: 00733132606276
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: HPT040010A
• Device Catalogue Number: HPT040010A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 05/19/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/19/2021; 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 14 DA
• Patient Weight: 2