MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number HT066080A

Device Problems Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problems Chest Pain (1776); Swelling/ Edema (4577)

Event Date 03/30/2021

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 via medwatch: on (b)(6) 2021, the patient underwent bilateral femoral endarterectomies and a right axillary to femoral bypass utilizing a gore® propaten® vascular graft.The patient tolerated the procedure and was discharged on (b)(6) 2021.On (b)(6) 2021, the patient noted swelling and chest pain and underwent reintervention.The patient received a right axillary cutdown and reportedly received additional stent(s).The physician stated the suture line remained intact but required 10 units of blood.Further information has been requested but has not been made available at this time.

Event Description

The following was reported to gore via medwatch: on (b)(6), 2021, the patient underwent bilateral femoral endarterectomies and a right axillary to femoral bypass utilizing a gore® propaten® vascular graft.The patient tolerated the procedure and was discharged on (b)(6), 2021.On (b)(6), 2021, the patient noted swelling and chest pain and underwent reintervention.An angiogram revealed a large right chest wall hematoma with active bleeding, occlusion of the patients axillary femoral and fem-fem bypass grafts, chronic occlusion of the inferior aspect of the abdominal aorta, pulmonary emphysema with no acute intrathoracic abnormalities, and no acute intra-abnormality.The patient received a right axillary cutdown, which correlated anatomically to where there was suspected graft disruption.The surgeon documented that there was a large tear in the middle of the graft, but the suture line remained completely intact.The physician was concerned that if the graft was repaired the patient would bleed again, so a stent was placed across the graft to ensure there was no blood flow through it.There were no pre-existing stents in the treatment zone prior to implant of the gore® propaten® vascular graft.It was reported that the patient required 10 units of blood.The patient was discharged on (b)(6), 2021 to a nursing home.The physician did not have any input on how the tear in the graft could have occurred.

Manufacturer Narrative

The following was added or updated to reflect additional information received: a4: patient weight - 120 lbs.B5: event description.B7: medical history - diabetes, hypertension, a-fib, pad.D4: catalog number, serial number, expiration date.H4: device manufacture date.H6: impact code - code 4642 added.H6: medical device problem code - updated to code 4008.H6: component code - code 525 added.H6: investigation findings - updated to code 213 g4: pma/510(k) number corrected to k062161.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11850534
• MDR Text Key: 251523875
• Report Number: 2017233-2021-02018
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HT066080A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Race: White