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

Model Number	HPT350010A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, a gore® propaten® vascular graft configured for pediatric shunt was placed for treatment of severe pulmonary stenosis in a patient with tetralogy of fallot (tof).At 1651 on (b)(6) 2021, the patient came out of the operating room to the intensive care unit uneventfully, at 1830 an emergency redo sternotomy emergency cardiac resuscitation on cardiopulmonary bypass in the unit was performed, using a 3fr fogarty arterial embolectomy catheter to declot graft and flushed with a heparinized solution.The patient did not experience any adverse consequences.The physician stated: the thrombosis possibility formed due to the hypercoagulable state of the baby and small size of the branch pulmonary artery stenosis.On (b)(6) 2021 patient extubated and placed on continuous positive airway pressure therapy.
Additional Manufacturer Narrative
D2- product code, dsy prosthesis, vascular graft updated.G4- pma/510(k)number, correct to k062161.H6 - investigation findings, corrected to 213 (no device problems found).
Additional Manufacturer Narrative
H6 - investigation findings, code updated to 3221 (no findings available).H6 - investigation conclusions, code updated to 4315 (cause not established).

• 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11496114
• Report Number: 2017233-2021-01768
• Device Sequence Number: 2844081
• Product Code: DSY
• UDI-Device Identifier: 00733132606412
• UDI-Public: 00733132606412
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2022

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: 02/07/2024
• Device Model Number: HPT350010A
• Device Catalogue Number: HPT350010A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/01/2022; 03/21/2022
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 03/01/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 7 DA
• Patient Sex: Unknown
• Patient Weight: 3 KG