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

Model Number HPT350010A

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/12/2021

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) 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.

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 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
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12015811
• MDR Text Key: 256706721
• Report Number: 2017233-2021-02088
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606412
• UDI-Public: 00733132606412
• 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
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HPT350010A
• Device Catalogue Number: HPT350010A
• 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; Other
• Patient Age: 4 MO
• Patient Weight: 4