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

Model Number	HPT350010A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/12/2021
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) 2021, the patient underwent a blalock-taussig shunt procedure utilizing a gore® propaten® vascular graft configured for pediatric shunt device.At an unknown date the patient presented with thrombosis in the gore® propaten® vascular graft configured for pediatric shunt device.Further information has been requested but is not available at this time.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.
Additional Manufacturer Narrative
Additional information was received and the following sections were updated accordingly: a4: patient weight added.B2: "other serious (important medical events)" added to adverse event outcomes.B5: description of event updated to include additional information received.H6: health effect - impact codes: 4625;4644.H6: investigation findings code: 213.H6: investigation conclusions code: 4315.
Event or Problem Description
The following was reported to gore: on (b)(6), 2021, the patient underwent a blalock-taussig shunt procedure utilizing a gore® propaten® vascular graft configured for pediatric shunt device.Within 30 minutes of completion of the procedure, the patient experienced oxygen desaturations and hypotension.The patient received fluid resuscitation.The shunt murmur was recorded as notably "altered".An echocardiogram showed no definite flow visualized through the blalock-taussig shunt.The patient received heparin bolus and tpa infusion.The patient initially improved, but desaturations continued and the patient was returned to the operating room for a thrombectomy of the blalock-taussig shunt.As of (b)(6), 2021, the shunt remains implanted.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.

• 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: 12015811
• Report Number: 2017233-2021-02088
• Device Sequence Number: 4636835
• Product Code: DSY
• UDI-Device Identifier: 00733132606412
• UDI-Public: 00733132606412
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: No Information
• Device Expiration Date: 08/07/2024
• Device Model Number: HPT350010A
• Device Catalogue Number: HPT350010A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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; Other
• Patient Age: 4 MO
• Patient Weight: 4