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

Catalog Number HT084050J

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Vascular Dissection (3160)

Event Date 11/15/2021

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2021, the patient underwent tevar with debranching for impending aortic rupture associated with stanford type b aortic dissection, and the propaten graft was used for axillo-axillary bypass.On (b)(6) 2021, the patient visited the hospital presenting a swelling of the graft implanted site which developed two weeks ago.On (b)(6) 2021, the patient was admitted to the hospital and aspiration of the seroma fluid was performed.The fluid was pale yellow (almost no color).Triglyceride of the fluid was low at 3 mg/dl and lymphatic leakage was unlikely.On (b)(6) 2021, the swelling was resolved.On an unknown date, aspiration of the seroma fluid was performed again.On (b)(6) 2021, since the patient condition was stable, an additional procedure was performed.The propaten graft was replaced with a new propaten graft.On an unknown date, the patient was discharged from the hospital.The device will be returned to gore for further investigation.

Manufacturer Narrative

¿other¿ was selected as device is still awaiting phr and evaluation.(b)(4).

Manufacturer Narrative

Added g3/g4, h1/h2, h6: investigation findings and conclusion.

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13011097
• MDR Text Key: 283180450
• Report Number: 2017233-2021-02613
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HT084050J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 49 KG